chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding unspecified number of patients whose demographics were unknown. The pertinent medical histories and concurrent conditions of patients were unknown. On an unknown date in SEP-2015 unspecified number of patients were vaccinated with unspecified number of improperly stored doses of VAQTA (lot # K005958, expiry date 09-FEB-2017; lot # L009445, expiry date 01-JUN-2017) through unknown route. Concomitant medications were not reported. No adverse events were reported. No adverse events were reported. Product quality complaint was not filed. This is one of the four reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding unspecified number of patients whose demographics were unknown. The pertinent medical history and concurrent conditions of patients were unknown. On an unknown date in SEP-2015 unspecified number of patients were vaccinated with unspecified number of improperly stored doses of ROTATEQ (lot # K011948, expiry date 07-JUN-2016; lot # K020181, expiry date 24-JUN-2016, lot # K024700, expiry date 30-JUL-2016) through unknown route. Concomitant medications were not reported. No adverse events were reported. Product quality complaint was not filed. This is one of the four reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Red round warm lump (R) leg.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site infection, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 5-6 days after shot, patient developed redness, swelling, itching, warmth at injection site. Patient went to doctor on 9/16/15. MD said left upper arm has infection.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Localized redness on (L) arm, itching, hot to touch, redness is 4in x 2in.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: This spontaneous report was received from a female patient of unknown age and refers to herself. There was no information about patient's concomitant medications, pertinent medical history, drug reactions or allergies provided. In June or July 2014, the patient was vaccinated with a dose of ZOSTAVAX injection (lot#, expiration date, dose, site and route of administration were not reported) one time vaccine. The patient reported that it did not help her because on unknown date, she got mild case of shingles, which lasted about a month. It was also stated that at the time of this report, she still got pangs. The outcome of the pangs and vaccination failure was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected, as no contact details were provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. An unspecified number of patients received unspecified dose of ROTATEQ lot # K011663, expiration date: 24-MAY-2016 (strength and dose unspecified) series between 25-AUG-2015 and 28-SEP-2015 that were improperly stored. No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Madarosis
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 9 year old female patient. The patient's concurrent conditions and drug allergies were unspecified. Approximately in September 2015 (reported as about three weeks ago), the patient was vaccinated with first dose of 0.5 ml GARDASIL 9. On an unknown date in September 2015, the patient lost her eyebrows. The patient's eyebrows are starting to come back in some places but have not fully returned. It was unclear if the patient will continue therapy with the remaining GARDASIL 9 series. The patient sought medical attention. The outcome of the event was reported as recovering/resolving. The relatedness of the event with GARDASIL 9 was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Bacterial test, Chlamydia test, HIV test, Hepatitis viral test
Clinical narrative: This spontaneous report as received from a medical assistant refers to approximately 14 year old female patient. Medical history was not reported. Drug reactions/allergies were none. Concurrent condition included cognitive disorder. On 14-NOV-2011, the patient was vaccinated with a first dose of GARDASIL. Concomitant therapy included IMPLANON. On 11-MAR-2013, the patient was vaccinated with a second dose and on 05-NOV-2013, with the third dose of GARDASIL (inappropriate schedule of drug administration). Approximately on 19-SEP-2015 (a couple days ago), the patient experienced vaginal itching and was then diagnosed with genital warts (anogenital warts). No treatment was provided. On 21-SEP-2015, the following test were performed RPR (Rapid Plasma Reagin) to test for syphilis, hepatitis panel, HIV test, urine test to check for gonorrhea and chlamydia. Results were not provided. Patient sought medical attention (had come to the office on 21-SEP-2015 because of the event). The outcome of anogenital warts was not recovered/not resolved. The causality of anogenital warts was not provided. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Treponema test, Urine analysis, Vulvovaginal pruritus
Clinical narrative: This spontaneous report as received from a medical assistant refers to approximately 14 year old female patient. Medical history was not reported. Drug reactions/allergies were none. Concurrent condition included cognitive disorder. On 14-NOV-2011, the patient was vaccinated with a first dose of GARDASIL. Concomitant therapy included IMPLANON. On 11-MAR-2013, the patient was vaccinated with a second dose and on 05-NOV-2013, with the third dose of GARDASIL (inappropriate schedule of drug administration). Approximately on 19-SEP-2015 (a couple days ago), the patient experienced vaginal itching and was then diagnosed with genital warts (anogenital warts). No treatment was provided. On 21-SEP-2015, the following test were performed RPR (Rapid Plasma Reagin) to test for syphilis, hepatitis panel, HIV test, urine test to check for gonorrhea and chlamydia. Results were not provided. Patient sought medical attention (had come to the office on 21-SEP-2015 because of the event). The outcome of anogenital warts was not recovered/not resolved. The causality of anogenital warts was not provided. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: HEP, HIBV, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 3 year old patient. No information on patient's medical history or concurrent conditions was provided. On an unknown date in 2012, the patient was vaccinated with the dose of PEDVAXHIB, MMR II, VARIVAX and RECOMBIVAX HB (doses, lot number and expiration date were not reported). No information on patient's concomitant medication was provided. On approximately 25-SEP-2015 (reported as "was just administered") (also reported as date unspecified), the patient was administered the "catch up" dose of PEDVAXHIB, MMR II, VARIVAX and RECOMBIVAX HB (doses, lot number and expiration dates were not reported). No adverse effects reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Myalgia, Pain, Pruritus
Clinical narrative: Localized redness, muscle aching on side. Hotness, hard, itching, pain. Taking ZYRTEC and TYLENOL for rxn.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Localized redness, muscle aching on side. Hotness, hard, itching, pain. Taking ZYRTEC and TYLENOL for rxn.
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Abnormal behaviour, Body temperature increased, Decreased appetite, Eye swelling, Jaundice
Clinical narrative: > 102 degrees temp "all weekend:. Decreased appetite. "Pale and clingy". "Jaundiced". "Both eyes were swollen". Mother did not take child to PCP for evaluation.
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Pallor
Clinical narrative: > 102 degrees temp "all weekend:. Decreased appetite. "Pale and clingy". "Jaundiced". "Both eyes were swollen". Mother did not take child to PCP for evaluation.
Age: 0.26
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Agitation, Drooling, Screaming, Skin discolouration, Strabismus
Clinical narrative: According to foster parent pt became agitated on way home from getting vaccines at home pt was screaming, drooling, (L) eye turned in toward nose, and turned purple from screaming. Pt taken to hosp ER by 1700 - not seen by PCP until around 10pm at that time pt wore out and asleep. PCP did not see any issues with pt at that time. Pt could also have possible fetal alcohol syndrome per foster parent. Foster parent denies issues this AM.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 65-year-old female patient. The patient's medical history was not reported and concurrent condition included unspecified pain. The patient had received PREVENAR 13 and unspecified influenza virus vaccine (Manufacturer unknown) on 09-SEP-2015. On 16-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX (injection, subcutaneous, lot # K020186, expiry: 27-JAN-2016) dose and frequency unspecified in the arm. Concomitant medications included unspecified pain medication. On 17-SEP-2015, the patient experienced pain at the injection site of ZOSTAVAX. The patient had visited the pharmacist on 19-SEP-2015. The injection site was red, painful and warm to the touch. The pharmacist stated that the "redness encompassed the patient's whole tricep and down onto the elbow of the patient." Pharmacist declined the VZV packet as he stated there was no visible rash outside of the redness on the arm of the patient that was administered with ZOSTAVAX. The outcome of the events was reported as not recovered/not resolved. The reporter did not provide the causality assessment between the events and ZOSTAVAX, PREVENAR 13 and unspecified influenza virus vaccine (Manufacturer unknown). 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 pharmacist and refers to an unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored (Merck) PROQUAD (lot # L001420, expiration date: 23-JUL-2016; dose, indication and route of administration were not reported). Concomitant therapy was not provided. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected, as there was no consent to contact the reporter.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a 61 year old female patient with allergy to amoxicillin and BETADINE. The patient's medical history included colitis. On 28-SEP-2015, the patient was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml (lot#, expiry date, site and route of administration were not reported). On 28-SEP-2015, 4 hours after receiving a PNEUMOVAX 23, the patient experienced extreme pain at the injection site. On the same day, the patient also had a low grade fever, swelling, and patchy red spots at the injection site. The patient was treated with unspecified over the counter pain relievers, ice and heat. No laboratory test was performed. The outcome of the events was unknown. The patient sought medical attention by contacting the pharmacy. The relatedness between the PNEUMOVAX 23 and the events was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age. On 16-SEP-2015, the patient was vaccinated with an expired dose of M-M-R II (batch/lot number #J006141, expiration date 24-MAY-2015, dose and route not provided). No adverse effects were reported. Lot number #J006141 is valid for M-M-R II. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a 48 year old female patient. Information regarding concurrent conditions and medical history was not provided. On 26-SEP-2015 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml ("regular dose/once"), lot # L016283, expiration date: 07-AUG-2016, subcutaneously (application site was not reported). Concomitant therapy was not reported. On 27-SEP-2015, the patient experienced that the injection site was swollen and hard, approximately "softball size". Patient sought medical attention by visiting pharmacist. The gramicidin, NEOSPORIN, BENADRYL and ibuprofen were given as treatment. The outcome of event was reported as not recovered/not resolved. The causality was not reported. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to an 80 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. In approximately April 2014 (reported as one and half years ago), the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). In July 2015, the patient developed shingles. The outcome of shingles was reported as recovered on an unknown date in 2015. The relatedness between the adverse event of shingles and the therapy with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to an unspecified number of patients of unknown age and gender. Medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot# L007560 with expiration date 15-JUN-2017 and lot# L011846 with expiration date 16-JUN-2017, dose and route of administration were not provided). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to an unspecified number of patients of unknown age and gender. Medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot# L009445 with expiration date 01-JUN-2017 and lot# L018499 with expiration date 25-FEB-2017, dose and route of administration were not provided). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse and refers to 5 unspecified patients of unknown age and gender. The patients' pertinent medical history and concomitant medications were not reported. On unknown dates, 5 doses of improperly stored (Merck) PROQUAD (lot # reported as L026728 with expiration date on 15-JAN-2017; dose and route of administration not provided) were administered to 5 unspecified patients. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 62 year old female patient. The patient's pertinent medical history included high blood pressure and heart stent insertion (in 2009). Concomitant therapies included multiple unspecified medications. It was reported that the patient had penicillin allergy (captured in MARRS # 1510USA000803). On 26-SEP-2015, the patient was vaccinated with ZOSTAVAX (lot # L021602, expiration date 10-SEP-2016) dose of 0.65 ml, once, subcutaneously. On 27-SEP-2015, the patient broke out in hives all over her body and the hives were itchy. It was reported that the patient was going to take BENADRYL but she did not seek any medical attention. No lab diagnostic studies were performed. No PQC (product quality complaint) was involved. The outcome of the event was reported as not recovered. The relatedness between the event and ZOSTAVAX was not provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: FLU3, PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 30-SEP-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K007822, expiration date 15-AUG-2015) (dose and route of administration were not reported). Concomitant therapy was not provided. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On unspecified dates, the patient was vaccinated with a total of 4 doses of GARDASIL (dose, indication, route of administration, lot# and expiration date were not reported). Concomitant therapy was not provided. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency, route, lot # and expiration date were not reported). No concomitant medications were reported. On an unknown date, the patient developed shingles after being administered the ZOSTAVAX. At the time of the report, the outcome of shingles was unknown. The reporter's causality assessment between the shingles and the ZOSTAVAX was not provided. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to unspecified number of patients of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown date in 2015 (reported as "since 18-APR-2015"), the patients were vaccinated with doses of (Merck) VARIVAX (doses and routes were not reported) lot # K011802, expiration date 21-AUG-2016 and lot # reported as L001328, expiration date 13-JAN-2017 that were exposed to temperatures outside of the recommended range. No adverse experience has been reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to three patients of unknown age and gender. The patients' pertinent medical history concurrent condition were unspecified by the reporter. On an unknown date, the patients were vaccinated with ZOSTAVAX (strength, dose, frequency and lot # were unspecified by the reporter). No concomitant medications were reported. Within the last 6 months, in 2015, approximately, the patients returned back to the pharmacy with an "outbreak of shingles". They did not receive treatment for the event. They sought medical attention by going back to pharmacy. The outcome of the event shingles was unknown. There was no product quality complaint involved. Causality assessment was not provided. Additional information has been requested.
Age: 0.65
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 7 months old patient. No medical history, concurrent conditions or concomitant therapies were reported. On 24-SEP-2015, the patient was inadvertently administered with a first dose in the vaccine series of ROTATEQ orally (lot #, dose and anatomical location were not provided), when the patient was 34 weeks of age. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to an unspecified number of patients of unknown age and gender. Medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ vial (route of administration default to oral, lot# L000571, expiration date 26-JUL-2016, dose was not provided). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 68 year old male patient. There was no information about patient's concomitant medications and pertinent medical history reported. In approximately March 2014, (reported as "a year and a half ago"), the patient was vaccinated with a dose of ZOSTAVAX dose, route and site of administration, lot # and expiry date were not reported. On an unknown date, the patient was seen in the physicians' office with shingles "around the eye and the ear". On an unknown date, the unspecified treatment was given for the event. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as the physician did not wish to be further contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 30-SEP-2015, the patient was inadvertently vaccinated with a dose of improperly stored GARDASIL 9 injection (lot # L013429, expiration date 21-JUL-2017, dose and route of administration were not provided). No adverse effects were reported. Additional information is not expected as the reporter did not wish to be contacted.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia
Clinical narrative: Muscle pain.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Nausea, Skin warm
Clinical narrative: This spontaneous report was received from a 57 year old female patient who reported for self. The patient has allergy to red dye and the patient's pertinent medical history was none. On 22-SEP-2015, the patient was vaccinated with ZOSTAVAX 19400 PFU (unknown dose, strength and lot#). Concomitant therapies included tramadol and FLEXERIL. On 23-SEP-2015, developed redness and warmth which was traveling down her arm after receiving ZOSTAVAX. The patient also reported that she also felt nauseous on 23-SEP-2015. No lab diagnostic studies were performed. The patient did not seek medical attention and no treatment was received in response to the events. The patient was not hospitalized. The outcome of the events was reported as not resolved. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Feeling hot, Headache, Injection site erythema
Clinical narrative: This spontaneous report was received from a 57 year old female patient who reported for self. The patient has allergy to red dye and the patient's pertinent medical history was none. On 22-SEP-2015, the patient was vaccinated with ZOSTAVAX 19400 PFU (unknown dose, strength and lot#). Concomitant therapies included tramadol and FLEXERIL. On 23-SEP-2015, developed redness and warmth which was traveling down her arm after receiving ZOSTAVAX. The patient also reported that she also felt nauseous on 23-SEP-2015. No lab diagnostic studies were performed. The patient did not seek medical attention and no treatment was received in response to the events. The patient was not hospitalized. The outcome of the events was reported as not resolved. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site vesicles, Nausea, Pain, Skin warm
Clinical narrative: This spontaneous report was received from a 57 year old female patient who reported for self. The patient has allergy to red dye and the patient's pertinent medical history was none. On 22-SEP-2015, the patient was vaccinated with ZOSTAVAX 19400 PFU (unknown dose, strength and lot#). Concomitant therapies included tramadol and FLEXERIL. On 23-SEP-2015, developed redness and warmth which was traveling down her arm after receiving ZOSTAVAX. The patient also reported that she also felt nauseous on 23-SEP-2015. No lab diagnostic studies were performed. The patient did not seek medical attention and no treatment was received in response to the events. The patient was not hospitalized. The outcome of the events was reported as not resolved. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Diarrhoea, Myalgia, Nausea, Rash, Vomiting
Clinical narrative: Myalgia, rash, diarrhea and nausea vomiting.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. An unspecified number of patients received unspecified dose of LIQUID PEDVAXHIB lot # K004540, expiration date: 03-DEC-2016 (strength and dose unspecified) series between 25-AUG-2015 and 28-SEP-2015 that were improperly stored. No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (certified medical assistant) and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concomitant medications and drug reactions/allergies was reported. On 11-SEP-2015, the patient was vaccinated with improperly stored dose of VAQTA (lot # L004745, expiration date 28-APR-2017, exact dose and route of administration were not provided). It was reported, that on 10-SEP-2015, the dose of VAQTA was drawn up into a plastic syringe, stored overnight in the refrigerator and used the next day. No adverse experience was reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 28-SEP-2015, the patient was vaccinated with ZOSTAVAX at 0.65 ml, subcutaneous (lot # L016284 with expiry date of 07-AUG02016) in the left deltoid and then it was discovered that on 03-OCT-2014, the patient had been already administered a dose of ZOSTAVAX (lot # K007989 and expiry date of 03-SEP-2015). No adverse effects were reported. There was no product quality complaint involved. 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 professional refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with one dose of improperly stored (Merck) VARIVAX injection (lot # L002217, expiration date: 21-JAN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. Additional information is not expected, no contact details were provided.
Age: 0.73
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 38 week old infant of unknown gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 30-SEP-2015 the 38 week old infant was administered dose three of ROTATEQ (oral, dose and lot# were not provided) (outside of indicated age). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-AUG-2013, the patient was vaccinated with the first dose of VAQTA (route of administration, lot # and expiration date were not reported). On 14-FEB-2014, a few days earlier than minimum interval of 6 months from the first dose, the patient was vaccinated with the second dose of VAQTA (route of administration, lot # and expiration date were not reported). There was no adverse effect reported. Additional information is not expected as there was no consent for follow up.
Age: 1.3
Sex: M
Vaccine: DTAP, MMR
Symptoms: Dermatitis bullous
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a 15 month old male patient. Medical history or concurrent conditions were not reported. On 15-SEP-2015, the patient was vaccinated with a dose of MMR II, subcutaneously (lot number and expiration date was not provided. Concomitant therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) (+) TE) received on an unspecified date. On 23-SEP-2015, 8 days after receiving MMR II, the patient developed a "bulls eye" type rash on the trunk of their torso (Bullous rash). He was given prednisone as treatment for the event, therefore, at the time of the report, it was unknown if the patient had recovered from Bullous rash. Additional information has been requested.
Age: 53.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 53 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-SEP-2015, the patient was vaccinated with a dose of (Merck) PROQUAD (route of administration, lot # and expiration date were not reported) (drug administered to patient of inappropriate age). No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to a male patient of unknown age (also reported as baby). No concurrent conditions and medical history were reported. On an unknown date approximately in 2015 (also reported as unspecified time between 25-AUG-2015 and 25-SEP-2015) the patient was vaccinated with first dose of incorrectly stored (incorrect product storage) (Merck) VARIVAX (lot # K008823, expiry date 19-JUN-2016) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was reported. The action taken with the therapy with (Merck) VARIVAX was unknown. The outcome of the events was unknown. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse (RN) referring to a patient of unknown gender and unknown age. The information of concurrent conditions, medical history and concomitant medications was not provided. On 22-SEP-2015, the patient received an expired dose of PNEUMOVAX 23 single dose vial (lot # J009723, expiration date 30-JAN-2015) 0.5 ml, intramuscularly (Expired product administered). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker via company representative refers to an unspecified number of unspecified patients. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, an unspecified number of unspecified patients who were each administered either one of two doses of GARDASIL (dose, route of administration, lot# and expiration date not reported), then each were administered either one of two doses of GARDASIL 9 (dose, route of administration, lot# and expiration date not reported) to complete their HPV vaccination series. No adverse effect reported. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored (Merck) VARIVAX (lot # K008821, expiration date: 19-JUN-2016; dose, indication and route of administration were not reported). Concomitant therapy was not provided. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected, as there was no consent to contact the reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pain, Pruritus, Rash, Varicella
Clinical narrative: 1 hour - silver dollar-sized bruise. 2 days - first rash, itching, pain. 7 days - diagnosed chicken pox per pt prescribed ZOVIRAX and ALLEGRA.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L015416, expiration date 01-AUG-2016 (dose, route of administration and indication were not reported). Concomitant therapy was not provided. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients were vaccinated with doses of improperly stored GARDASIL (lot # K006124, expiration date: 02-FEB-2017; lot# K007264, expiration date: 02-MAR-2017, route and dose were unknown) between 15-JUN-2015 and 24-SEP-2015. No adverse effected were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (lot # K020215, expiration date: 15-MAY-2016, route and dose were unknown) between 15-JUN-2015 and 24-SEP-2015 (incorrect product storage). No adverse effected were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an approximately 9 days old neonate of unknown gender. No pertinent medical history or concurrent conditions were reported. On 10-AUG-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K024552, 0.5 ml, intramuscularly. No adverse effects were reported. This report was linked to case 1509USA012524 as it was received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to an unspecified number of patients of unknown age (the patients were under the age of 50 year old) and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. 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 a licensed practical nurse refers to a 12 year old patient of unknown gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 23-SEP-2015, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot number L000610 and expiration date 31-JAN-2017) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to an unspecified number of patients of unknown age and gender. Medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot# L004754 with expiration date 10-NOV-2016 and lot# L010595 with expiration date 12-NOV-2016, dose and route of administration were not provided). No adverse effect was reported. This is one of several reports received from the same reporter. 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 healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 22-SEP-2015, the patient was vaccinated with expired dose of ZOSTAVAX (unknown strength, dose and route) lot # K008885 with expiry date of 20-SEP-2015. Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, 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, concomitant medication and drug reactions or allergies were reported. On 30-SEP-2015, the patient was vaccinated with extra doses of MMR II (strength, dose, lot # and expiration date were not provided) and (Merck) VARIVAX (strength, dose, lot # and expiration date were not provided). The past doses of MMR II were administered on 01-FEB-2011, 04-MAY-2011 and 01-NOV-2011. The past doses of (Merck) VARIVAX were administered on 07-NOV-2013 and 25-FEB-2014. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients were vaccinated with doses of improperly stored M-M-R II (lot # K024035, expiration date: 26-NOV-2016; lot# K024036, expiration date: 26-NOV-2016, route and dose were unknown) between 15-JUN-2015 and 24-SEP-2015. No adverse effected were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Background: A routine 2-dose varicella vaccination program was adopted in 2007 to help further decrease varicella disease and prevent varicella outbreaks. We describe trends and characteristics of varicella outbreaks reported to the Centers for Disease Control and Prevention (CDC) during 2005-2012 from 9 states. Methods: Data on varicella outbreaks collected by 9 state health departments were submitted to CDC using the CDC outbreak reporting worksheet. Information was collected on dates of the outbreak, outbreak setting and number of cases by outbreak; aggregate data were provided on the numbers of outbreak cases related by age group, vaccination status and laboratory confirmation. Results: Nine hundred and twenty-nine outbreaks were reported from the 6 states, which provided data for each year during 2005-2012. Based on data from these 6 states, the number of outbreaks declined by 78%, decreasing from 147 in 2005 to 33 outbreaks in 2012 (P = 0.0001). There were a total of 1015 varicella outbreaks involving 13,595 cases reported by the 9 states from 2005 to 2012. The size and duration of outbreaks declined significantly over time (P <0.001). The median size of outbreaks was 12, 9 and 7 cases and median duration of outbreaks was 38, 35 and 26 days during 2005-2006, 2007-2009 and 2010-2012, respectively. Majority of outbreaks (95%) were reported from schools, declining from 97% in 2005-2006 to 89% on 2010-2012. Sixty-five percent of outbreak-related cases occurred among 5-year to 9-year olds, with the proportion declining from 76% in 2005-2006 to 45% during 2010-2012. This literature marketed report as received from an author of the article regarding unspecified patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with VARIVAX. No concomitant medication was reported. On an unknown date the patient experienced varicella outbreaks. The outcome of varicella outbreaks was unknown. The reporter considered varicella outbreaks to be related to VARIVAX. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient reported two weeks of pain and limited range of motion in arm and shoulder. Was seen by her PCP and treated with 6 days of prednisone - she reports improvement after first dose.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical histories, drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with improperly stored dose of (Merck) VARIVAX (lot# L010146, expiration date 24-MAR-2017, dose, route and site of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical histories, drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with improperly stored doses of (Merck) PROQUAD (lot# L011080, expiration date 01-OCT-2016, dose, route and site of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 56 year old male patient. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 25-SEP-2015, the patient was vaccinated with a shot of PNEUMOVAX 23 (lot #, expiration date and exact dose were not reported), subcutaneously. The next day, on 26-SEP-2015, the patient developed a rash and experienced redness and swelling in the arm in which the shot was given. It was reported that the patient went to his family doctor. No PQC (product quality complaint) was involved. The outcome of the events was reported as recovering. The relatedness between the events and PNEUMOVAX 23 was not provided. Additional information has been requested.