chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 20-MAR-2013, patient received improperly stored VARIVAX dose 2, from lot # 0610AE (dose and expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site reed and itchy, some edema warm to touch - tried ice and BENADRYL sx getting better.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Rash generalised, Urticaria
Clinical narrative: Pt has rash all over body and raised bumps/hives. Took BENADRYL. New to area, no PCP- recommended going to urgent care, will follow up w/patient.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Cellulitis, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid area swollen, itchy and warm to touch. Cellulitis of left arm patient placed on KEFLEX x 7 days and hydrocortisone 2.5 % cream.
Age: 43.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Arthralgia, Diarrhoea, Nausea, Pyrexia, Rash
Clinical narrative: Fever, rash starting 8/27/16, joint pain, nausea/vomiting/diarrhea (8/29/16-> ? due to ADVIL) Supportive care: ADVIL/TYLENOL/fluids/rest.
Age: 43.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Vomiting
Clinical narrative: Fever, rash starting 8/27/16, joint pain, nausea/vomiting/diarrhea (8/29/16-> ? due to ADVIL) Supportive care: ADVIL/TYLENOL/fluids/rest.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. Information on the medical history, concurrent conditions and drug allergies of the patient was not reported. On 27-JUL-2016, the patient was vaccinated with improperly stored dose of (Oka/Merck)VARIVAX lot # L025208, expiry date 07-JUN-2017, 0.5 ml, subcutaneously (incorrect product storage). Concomitant medication were not reported. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. Temperature and time frame at which the administered vaccine was stored was -0.15 degree Centigrade for 5 hours. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV, VARCEL
Symptoms: Erythema, Injection site pain, Pain in extremity, Swelling
Clinical narrative: Came to ER next day (8-24-16), per that documentation: 'Chief Complaint: Left arm pain, swelling, redness. History of Present Illness: A 71-year-old male who got the pneumonia shot yesterday at the primary care office, started last night with left arm pain, swelling and redness. Pain level 9/10. No fever. Patient states there has been improvement in the swelling from yesterday.' Given KENALOG IM 40mg once, and discharged with diphenhydramine, methylprednisolone dosepak, clindamycin. Symptoms: and erythema, injection site pain, swelling. Treatment: diphenhydramine 25 mg PRN, methylprednisolone as instructed on card, clindamycin 300 mg QID.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. On unknown dates in 2016 (between 30-JUN-2016 and 20-JUL-2016), the patients received doses of PNEUMOVAX 23 (Lot# reported as M006141, expiry date: 20-MAY-2017) that were improperly stored. Temperature/Time: Multiple excursions between 30-JUN-2016 and 20-JUL-2016. Freezer: maximum 30.6F, cumulative time 96 hours, 51 minutes. Refrigerator: 31.3F minimum/maximum 49.4 for cumulative out of range: 35 hours 9 minutes. Data logger was involved. No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to patients of unknown demographics. On unknown dates in 2016 (between 30-JUN-2016 and 20-JUL-2016), the patients were vaccinated with unspecified doses of PROQUAD immunization series (lot # M006102, expiry date: 01-AUG-2017) that were improperly stored (incorrect product storage). Temperature/Time: Multiple excursions between 30-JUN-2016 and 20-JUL-2016. Freezer: maximum 30.6F, cumulative time 96 hours, 51 minutes. Refrigerator: 31.3F minimum/maximum 49.4F for cumulative out of range: 35 hours 9 minutes. Data logger was involved. No adverse effect reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received form the same reporter. Additional information is not expected as the reported did not wish further contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated  VARIVAX dose 1, (dose, lot # and expiry date unknown). On 24-APR-2013, the patient received improperly stored VARIVAX dose 2, from lot # 0610AE (dose, vaccination site, route, expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Mumps antibody test positive, Orchitis, Polymerase chain reaction, Viral test negative
Clinical narrative: This literature market report has been received from the authors of a published literature article, concerning a 23 year old male patient, who was a medical student. The patient had lifted weights with a sports team. The patient had received 2 doses of childhood MMR (manufacturer unknown) (lot#, dose and route unspecified) vaccinations. On an unknown date, the patient presented with orchitis. Fever was the second most common symptom, followed by upper respiratory symptoms. At the time of the initial student health visit, the patient was found to have high mumps immunoglobulin G (IgG) levels of greater than 4 index (positive was >= 1.10) and negative immunoglobulin M (IgM) levels (< 1:20). The patient had a negative buccal swab mumps virus ribonucleic acid (RNA) reverse transcription polymerase chain reaction (RT-PCR). The outcome of the event was unknown. The reporter considered orchitis to be related to MMR (manufacturer unknown). This is one of several reports received from the same source (linked with MARRS # 1608USA002099, 1608USA015163, 1608USA015164). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 20-MAR-2013, the patient was vaccinated VARIVAX dose 1, lot # 0610AE (dose, vaccination site, route, expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 16-MAY-2013, patient received improperly stored VARIVAX dose # not reported, from lot # 0610AE (expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: No adverse effect until 8/23/16. Red, swollen, warm to touch. Took ADVIL still no change. 8/31. Per patient, took BENADRYL and ADVIL and symptoms subsided before even seeing her physician so never saw Dr.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On an unspecified dates, the patients received an improperly stored doses of ROTATEQ orally (dose was not provided) (lot number: K007244, expiration date: 16-MAR-2016; J015689, expiration date: 11-NOV-2015; K016261, expiration date: unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse referring to an unknown number of unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates starting on or after 21-JUL-2016, the patients were administered doses of improperly stored VARIVAX injection (lot# L013826, expiration date 21-APR-2017) (dose and route unknown). The vaccines were exposed to 24.3 Fahrenheit degree (F) for 2 hours 50 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was inadvertently vaccinated with a dose of improperly stored M-M-R II injection, lot # L026553, expiration date 16-JUL-2017 (albumin status, dose, route and site of administration were not reported). No adverse effect was reported. Administered dose of vaccine experienced the temperature excursion at 47.1 degrees Fahrenheit for 11 minutes. Data logger was involved. There were no previous temperature excursions. Product quality complaint was not involved. No additional information was available. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Headache, Pain
Clinical narrative: Achy, headache, shooting pain radiating from lower back.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Patient fainted as she was exiting exam room after receiving immunizations.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Rash around injection about size of tennis ball; slightly swollen, itch, burn; used ice and rubbing alcohol.
Age: 65.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Erythema, Pruritus generalised
Clinical narrative: Generalized itching which worsened until 3 am, 8/31/16. Patient got up and applied hydrocortisone cream. No rash. Patient stated skin reddish (she feels from scratching).
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 20-SEP-2012, patient received improperly stored VARIVAX dose 2, from lot # 0610AE (dose and expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 25-AUG-2016, the patient was vaccinated with an expired dose of properly stored VAQTA injection, lot # reported as J016016 (verified to be an invalid lot #), expiry date 18-AUG-2016 (dose, route of administration and anatomical location were not specified). No adverse reactions were reported. Product quality complaint (PQC) was not involved. 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 medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in 2016 (reported as after 29-JUL-2016), the patients received improperly stored (at 0.3 degrees Celsius for a total of five hours and five minutes) doses of VAQTA 2.5/0.5 (units not provided), lot number M009377, expiration date: 17-JUN-2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 10-OCT-2011, patient received improperly stored VARIVAX dose 1, from lot # 669601/0138AA expiry 26-JAN-2013. On 12-NOV-2012, the patient received second dose of VARIVAX from lot # 0610AE (dose and expiry date unknown) which was improperly stored. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the 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: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # M007764, expiration date 30-JAN-2018 (dose, anatomical location and route of administration were not specified). No adverse effect were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant 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 therapies was provided. On 24-AUG-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # M015698, expiration date: 26-SEP-2017, dose was not provided), subcutaneously. No adverse effect was reported. Product quality complaint was not involved. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Rash, Urticaria
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age, who usually experienced a rash after swimming at one particular pool. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (lot #, dose, route and site of administration were not reported). Concomitant medications were not reported. On the same day by 18:00 and after swimming at the particular pool, the patient experienced hives and rash. The outcome of hives was unknown. The relatedness between the hives and GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid, lot # L033545, expiration date 30-MAY-2017 (dose was not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. 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 registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot # L015460, expiration date 20-JUL-2017 (dose, anatomical location and route of administration were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, Human papilloma virus test positive
Clinical narrative: This spontaneous report was received from a nurse and refers to a 52 year old patient. The patient was human papilloma virus (HPV) positive prior to receiving vaccination. No other information concerning the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in 2015, the patient received the first dose of GARDASIL 9 0.5 ml, subcutaneously (lot # and expiration date not reported). In February 2016, the patient was vaccinated with the second dose GARDASIL 9 0.5 ml, subcutaneously (lot # and expiration date not reported). At the time of the report, the nurse declined to give the third dose to the patient. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II injection, lot # L009214, expiration date 17-MAR-2017 (dose, albumin status, anatomical location and route of administration were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies reported. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX injection, lot # L042266, expiration date 27-OCT-2017 (dose, anatomical location and route of administration were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # L040458, expiration date 04-FEB-2018 (dose, anatomical location and route of administration were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. 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 registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD injection, lot # M003436, expiration date 19-JUL-2017 (dose, albumin status, anatomical location and route of administration were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 30-MAY-2013, the patient was vaccinated with improperly stored VARIVAX dose 1, lot # 0610AE (dose, route, vaccination site, expiry date unknown). On 01-JUL-2013, the patient received improperly stored VARIVAX dose 2, from lot # H018451, expiry date 09-OCT-2014 (dose, route, vaccination site unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Information has been received from a registered nurse referring to a 19 year old female patient. The patient pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 05-JUL-2016, the patient had her second dose of GARDASIL 9 (lot # M003659, expiration date 20-SEP-2017, intramuscular; dose was unknown). On 01-AUG-2016, the patient came to the office and had positive pregnancy urine test in the office. An ultrasound had not yet been performed on the patient. The last menstrual period was 15-JUN-2016 and estimated date of delivery (EDD) was 22-MAR-2017. The pregnancy outcome was pending. The outcome of the event was unknown. 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 certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since 22-AUG-2016, the patients were vaccinated with the doses of the improperly stored ROTATEQ (orally, lot # reported as M017514, expiration date 07-NOV-2017; dose was not reported). The vaccines were stored in 35.8 F for one hour and 15 minutes. All the vaccines were supported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since 22-AUG-2016, the patients were vaccinated with the doses of the improperly stored RECOMBIVAX HB (lot # L027733, expiration date 13-SEP-2017; dose and route were not reported. The vaccines were stored in 35.8 F for one hour and 15 minutes. All the vaccines were supported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since 22-AUG-2016, the patients were vaccinated with the doses of the improperly stored VAQTA (lot # L015460, expiration date 20-JUL-2017; dose and route were not reported. The vaccines were stored in 35.8 F for one hour and 15 minutes. All the vaccines were supported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates, the patients were inadvertently vaccinated with improperly stored doses of M-M-R II injection, subcutaneously, lot # L011528 with expiry date 03-APR-2017 and lot # L032044 with expiry date 24-AUG-2017 (dose and anatomical location were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information is not expected as there was no consent for further contact.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored PNEUMOVAX 23, lot no. M012156/expiration date-15-OCT-2017, (incorrect product storage). No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. 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: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The pertinents' medical history and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored (Oka-Merck) PROQUAD (lot # M006104, expiration date: 01-AUG-2017 (dose and route unspecified). No adverse effects reported. This is one of several reports received from the same source. 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 patients of unknown age and gender. The pertinents' medical history and concomitant therapy were not reported. On unknown date, the patients were vaccinated with doses of improperly stored VARIVAX (lot # L026406, expiration date: 15-JUL-2017) (dose and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Muscle disorder
Clinical narrative: This solicited report has been received from a consumer, concerning her daughter, a female patient of unknown age who enrolled in a marketed research. No relevant medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with GARDASIL (dose number, dose, route, lot# and expiration date were not reported). Since unknown dates (reported as "now"), the patient had issues with pain and her muscles. the reporter stated that the patient was an amazing dancer who "now: no longer could dance. the outcome of the events was not reported. Causality assessment was not reported. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. On 31-MAY-2013, the patient was vaccinated with improperly stored VARIVAX dose 1, lot#:0610AE. No adverse effect reported. This is one of several reports received 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 nurse practitioner refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose, route and frequency unknown. On 20-MAY-2013, the patient was vaccinated with improperly stored VARIVAX dose 2, lot#: 0610AE. No adverse effect reported. This is one of several reports received 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 as received from a phlebotomist refers to 3 or 4 unspecified patients of unknown age. Information on pertinent medical history of patients was not reported. On an unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX (dose not reported, lot # L034736, expiry 09-DEC-2016). No adverse effects reported. No further information was provided. This case is one of the several reports received 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 nurse practitioner refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose, route and frequency unknown. On 13-MAY-2013, the patient was vaccinated with improperly stored VARIVAX dose 2, lot#: 0610AE. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a phlebotomist refers to 2 different unspecified patients of unknown age. Information on pertinent medical history of patients was not reported. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX (Merck) (dose not reported, lot # L026406, expiry 15-JUL-2017). No adverse effects reported. No further information was provided. This case is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: General physical health deterioration
Clinical narrative: This solicited report as received from a consumer (also reported as mother), as a part of marketing research program, refers to a patient of an unknown age and gender. On an unknown date, the patient was vaccinated with GARDASIL (dose, lot#, expiration date and route of administration were not reported). the reporter stated that her family knew the patient and his/her health was severely negatively impacted by GARDASIL. the outcome of the event was not reported. the reporter considered the event as related to GARDASIL. Additional information is not expected as there was no consent for further contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in 2016 (reported as after 29-JUL-2016), the patients received improperly stored (at 0.3 degrees Celsius for a total of five hours and five minutes) doses of M-M-R II lot number L036851, expiration date: 23-SEP-2017, therapy type rHA (recombinant human albumin) (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Constipation, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and swelling at injection site, he stopped rolling over (had been successfully rolling over for months prior and I couldn't get him to stop rolling that morning), stopped bearing weight on his legs, was sick for 2 months afterward, had immediate changes in stool (extremely constipated) for 6 months afterward.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site warmth, Mobility decreased, Weight bearing difficulty
Clinical narrative: Redness and swelling at injection site, he stopped rolling over (had been successfully rolling over for months prior and I couldn't get him to stop rolling that morning), stopped bearing weight on his legs, was sick for 2 months afterward, had immediate changes in stool (extremely constipated) for 6 months afterward.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Constipation, Injection site erythema, Injection site swelling, Malaise, Mobility decreased
Clinical narrative: Redness and swelling at injection site, he stopped rolling over (had been successfully rolling over for months prior and I couldn't get him to stop rolling that morning), stopped bearing weight on his legs, was sick for 2 months afterward, had immediate changes in stool (extremely constipated) for 6 months afterward.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Neurological examination, Weight bearing difficulty
Clinical narrative: Redness and swelling at injection site, he stopped rolling over (had been successfully rolling over for months prior and I couldn't get him to stop rolling that morning), stopped bearing weight on his legs, was sick for 2 months afterward, had immediate changes in stool (extremely constipated) for 6 months afterward.
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Asthenia, Computerised tomogram, Cranial nerve disorder, Dizziness, Dysarthria
Clinical narrative: This case was reported by a non-health professional via sales rep and described the occurrence of stroke in a 16-year-old female patient who received BEXSERO. Previously administered products included MENACTRA (1st dose received on an unknown date). Concomitant products included MENACTRA. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced stroke (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the stroke was not recovered/not resolved. The reporter considered the stroke to be probably related to BEXSERO. Additional details were provided as follows: This case was reported by a non-healthcare professional, who was an Infectious Disease Specialist. A clinic's nurse practitioner reported the event to the reporter. The age at vaccination was not reported. The patient concomitantly received 2nd dose of MENACTRA on the same day as BEXSERO. The patient experienced stroke-like symptoms. The healthcare professional attributed the event to BEXSERO. The duration of hospitalization was unknown.
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Mydriasis, Nausea
Clinical narrative: This case was reported by a non-health professional via sales rep and described the occurrence of stroke in a 16-year-old female patient who received BEXSERO. Previously administered products included MENACTRA (1st dose received on an unknown date). Concomitant products included MENACTRA. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced stroke (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the stroke was not recovered/not resolved. The reporter considered the stroke to be probably related to BEXSERO. Additional details were provided as follows: This case was reported by a non-healthcare professional, who was an Infectious Disease Specialist. A clinic's nurse practitioner reported the event to the reporter. The age at vaccination was not reported. The patient concomitantly received 2nd dose of MENACTRA on the same day as BEXSERO. The patient experienced stroke-like symptoms. The healthcare professional attributed the event to BEXSERO. The duration of hospitalization was unknown.
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Cerebrovascular accident
Clinical narrative: This case was reported by a non-health professional via sales rep and described the occurrence of stroke in a 16-year-old female patient who received BEXSERO. Previously administered products included MENACTRA (1st dose received on an unknown date). Concomitant products included MENACTRA. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced stroke (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the stroke was not recovered/not resolved. The reporter considered the stroke to be probably related to BEXSERO. Additional details were provided as follows: This case was reported by a non-healthcare professional, who was an Infectious Disease Specialist. A clinic's nurse practitioner reported the event to the reporter. The age at vaccination was not reported. The patient concomitantly received 2nd dose of MENACTRA on the same day as BEXSERO. The patient experienced stroke-like symptoms. The healthcare professional attributed the event to BEXSERO. The duration of hospitalization was unknown.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Induration, Pain, Skin warm, Swelling
Clinical narrative: Hardness, swelling, redness, hot, painful. Area of redness got larger each day and by 8/28 was covering 2/3 of upper arm. Went to urgent care and was given prescription for Benadryl and antibiotics for possible allergic reaction and infection.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Diarrhoea, Weight decreased
Clinical narrative: Diarhea for three months,loss of appetite and weight (15 pounds in one year), went to several physicians and later to Clinic.
Age: 61.0
Sex: F
Vaccine: HEPA
Symptoms: Back pain, Discomfort, Neck pain, Pain in extremity, Stomatitis
Clinical narrative: Patient started experiencing right neck and upper back pain radiating to the right arm starting the morning of 8/24/2016.  She also noticed some sores in the upper palate of her mouth which persisted for about 3-4 days. She used warm compress and took some tylenol to relieve the discomfort.
Age: 20.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Limb discomfort, Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Severe shoulder pain. Pain was "shooting" down arm. Was not able to move shoulder that night or entire next day. Pain started a few hours after administration. Today 9/1/16 patient is able to move arm again with mild pain still very sore and uncomfortable. Patient did take naproxen for pain as directed by pharmacist.
Sex: U
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. In August 2015 (reported as a year ago), the patient was vaccinated with a dose of ZOSTAVAX (dose, lot # and route unknown). In approximately October 2015, 2 months after receiving ZOSTAVAX, the patient developed Bell's Palsy. The outcome of the event was unknown. The causality was not provided. Upon internal review, Bell's Palsy was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: Initial unsolicited report received from pharmacist via other company (Merck) on 23 August 2016. This case involves a patient (age and gender not reported) who was vaccinated with dose of FLUZONE (batch number, expiry date, dose, dose in series, route and site of administration not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced anaphylactic reaction a decade ago. The patient's lab tests and corrective treatment were not reported. The outcome of the event was unknown. Upon medical review, the case was considered as serious due to important medical event: anaphylactic reaction. List of documents held by sender: none. Sender's Comments: Anaphylactic reaction is unlisted with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Sex: M
Vaccine: DTP
Symptoms: Diarrhoea, Pyrexia, Screaming, Vomiting
Clinical narrative: Initial unsolicited report received from consumer (patient's mother) via social media on 22 August 2016. This case is linked with case 2016SA157332, 2016SA158486, 2016SA158504 and 2016SA157319 (same social media report). This case involves a male patient (age not reported) who was vaccinated with a dose of DPT (batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination the patient developed high fever, vomiting, diarrhea and high pitch screaming. Lab data and corrective treatment was not reported. The outcome of the events was not reported. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Pertussis
Clinical narrative: Initial unsolicited report received from consumer (patients sister) via social media on 22 August 2016. This case is linked with case 2016SA157332, 2016SA157340, 2016SA158504 and 2016SA157319 (same social media report). This case involves female patient (age was not reported) who was vaccinated with a dose of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (DTwP) (dose, batch number, expiration date, dose in series, site and route of administration was not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient experienced whooping cough. Laboratory data and corrective treatment were not reported. Patient's outcome of event was not reported. Upon internal review the case was considered as serious because of important medical event: whooping cough. List of documents held by sender: none. Sender's Comments: This poorly documented case concerns of unknown age female developed Whooping Cough after vaccination with DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) of unknown manufacturer. Hence Details regarding date of vaccination, onset of event, relevant medical history, prior history of vaccination and its tolerance are needed to further assess the case. Based on the available information, no conclusion on the role of the vaccine can be drawn.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Pertussis
Clinical narrative: Initial unsolicited report received from social media on 22 August 2016. This case video captures discussions. This case is linked with case 2016SA157332, 2016SA157340, 2016SA158486 and 2016SA157319 (same social media report). This case involves 4 year old patient (gender not reported) who was vaccinated with a dose of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED)) (dose, batch number, expiration date, frequency, site and route of administration was not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient experienced whooping cough. Laboratory data and corrective treatment were not reported. Patient's outcome of event was not reported. Upon internal review the case was considered as serious because of important medical event: whooping cough. List of documents held by sender: none. Sender's Comments: A 4-year-old child developed Whooping Cough after vaccination with DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) of unknown manufacturer. This case is poorly documented, Hence Details regarding date of vaccination, onset of event, relevant medical history, prior history of vaccination and its tolerance are needed to further assess the case. Based on the available information, no conclusion on the role of the vaccine can be drawn.