chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 19 year old patient of an unknown gender. On 06-MAR-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K005083 and expiry date: 04-NOV-2016). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 year old patient of an unknown gender. On 13-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot# K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 18 year old patient of an unknown gender. On 26-JAN-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 year old patient of an unknown gender. On 29-JAN-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of several reports from the same reporter. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 18 year old patient of an unknown gender. On 20-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Herpes zoster, Mammogram, Pain, Ultrasound breast
Clinical narrative: This spontaneous report was received from a 68 year old female patient. The patients concurrent condition included diabetes and allergy to ZOCOR, captured in case #1505USA04238. On an unknown date in October 2011 the patient was vaccinated with ZOSTAVAX, 1 injection (strength, route, lot number and expiration dates were not reported). Concomitant therapies included HUMALOG, NEXIUM, PLAVIX, BENICAR, NEURONTIN, low dose baby aspirin and metapleural. On an unknown date in 2013 (reported as 2 years after ZOSTAVAX) the patient experienced shingles pain. Around 01-APR-2015 the patient experienced another episode of shingles pain in both of her breasts and sides. The patient had sought medical attention and she was treated with LIDODERM patch and oral pain medication. A mammogram and ultrasound of breasts were performed on 11-MAY-2015 and nothing was found. The patient reported that the shingles pain never broke into rash but was excruciatingly painful but was less painful than the last shingles pain. She stated that the shingles pain happened every 3 to 4 years. there was no product quality complaint involved. The outcome of the events was unknown. The causality of the events was not reported. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 18 year old patient of an unknown gender. On 13-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot # J013277 and expiry date: 06-AUG-2015). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 year old patient of an unknown gender. On 03-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 year old patient of an unknown gender. On 03-MAR-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 year old patient of an unknown gender. On 03-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 year old patient of an unknown gender. On 14-JAN-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 year old patient of an unknown gender. On 02-MAR-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 year old patient of an unknown gender. On 26-JAN-2015, the patient was vaccinated with improperly stored GARDASIL (lot # H012643 and expiry date: 30-MAR-2015). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 year old patient of an unknown gender. On 10-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 year old patient of an unknown gender. On 17-FEB-2015, the patient was vaccinated with improperly schedule GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 year old patient of an unknown gender. On 26-JAN-2015, the patient was vaccinated with improperly stored GARDASIL (lot # H012643 and expiry date: 30-MAR-2015). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Chills, Headache, Influenza virus test negative, Muscular weakness, Nausea
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 year old patient of unknown gender. Pertinent medical history and concurrent conditions were not reported. At the time of this report, the patient had none drug reactions or allergies. On 13-APR-2015 the patient was vaccinated with GARDASIL, 0.5 ml, once, intramuscular, (dose number, anatomical location, lot number and expiration date were unspecified). Concomitant therapies included adapalene for topical dermatologic treatment and albuterol sulfate (manufacturer unknown). On 14-APR-2015 the patient experienced muscular weakness, nausea, chills and pyrexia. The reporter stated that the patient went to the emergency room, at the hospital, and was treated with intravenous fluids (unspecified) and MOTRIN; then, the patient was released. On 16-APR-2015, the patient experienced throat irritation, headache and a return of the symptoms previously mentioned (muscular weakness, nausea, chills and pyrexia). The patient returned to the emergency room and was again treated with intravenous fluids (unspecified) and MOTRIN, and then released. Laboratory diagnostic studies performed, on an unspecified date in 2015, included "strep and flu tests" (unspecified); which resulted negative. The outcome of throat irritation, headache, nausea, chills, pyrexia and muscular weakness was reported as recovered/resolved (also reported as "doing fine now"). The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Pyrexia, Streptococcus test negative, Throat irritation
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 year old patient of unknown gender. Pertinent medical history and concurrent conditions were not reported. At the time of this report, the patient had none drug reactions or allergies. On 13-APR-2015 the patient was vaccinated with GARDASIL, 0.5 ml, once, intramuscular, (dose number, anatomical location, lot number and expiration date were unspecified). Concomitant therapies included adapalene for topical dermatologic treatment and albuterol sulfate (manufacturer unknown). On 14-APR-2015 the patient experienced muscular weakness, nausea, chills and pyrexia. The reporter stated that the patient went to the emergency room, at the hospital, and was treated with intravenous fluids (unspecified) and MOTRIN; then, the patient was released. On 16-APR-2015, the patient experienced throat irritation, headache and a return of the symptoms previously mentioned (muscular weakness, nausea, chills and pyrexia). The patient returned to the emergency room and was again treated with intravenous fluids (unspecified) and MOTRIN, and then released. Laboratory diagnostic studies performed, on an unspecified date in 2015, included "strep and flu tests" (unspecified); which resulted negative. The outcome of throat irritation, headache, nausea, chills, pyrexia and muscular weakness was reported as recovered/resolved (also reported as "doing fine now"). The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 4 year old patient of unknown gender. Concurrent condition, medical history and concomitant medications were not provided. On 27-APR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (lot # K010797, expiry 04-FEB-2016). No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 (reported as 18) year old patient of an unknown gender. On 05-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 year old patient of an unknown gender. On 03-MAR-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a 36 year old female pharmacist refers her. The patient did not have any pertinent medical history and did not have any drug allergy. The patient was pregnant with last menstrual period (LMP) of 08-AUG-2014 and estimated date of delivery (EDD) of 15-MAY-2015. Initial exposure to ZOSTAVAX was at 21 weeks. On 02-JAN-2015, the patient was administering vaccine with ZOSTAVAX vial (strength, dose, route, location, lot and expiry date not reported). No concomitant medication was reported. On 02-JAN-2015, while preparing the vaccine for administration she inadvertently splashed reconstituted ZOSTAVAX on her face and lip. She stated that the needle slipped out of the vaccine vial as she was withdrawing the dose of ZOSTAVAX. No adverse effects were reported. The patient did not receive any treatment and did not seek medical attention. The outcome of the event was unknown. No further information provided. A product quality complaint (PQC) was not reported. Additional information has been requested.
Age: 0.35
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 month old patient of an unknown gender. On 11-FEB-2015, the patient was vaccinated with improperly stored ROTATEQ (lot # K007247 and expiry date: 17-MAR-2016 or lot # K006805 and expiry date:24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.34
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 month old patient of an unknown gender. On 16-FEB-2015, the patient was vaccinated with improperly stored ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 10 week old patient of an unknown gender. On 19-JAN-2015, the patient was vaccinated with improperly stored ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.35
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 month old patient of an unknown gender. On 16-JAN-2015, the patient was vaccinated with improperly stored ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.53
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 month old patient of an unknown gender. On 13-FEB-2015, the patient was vaccinated with improperly stored ROTATEQ (lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.51
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 month old patient of an unknown gender. On 26-JAN-2015, the patient was vaccinated with improperly stored ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.62
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 7 month old patient of an unknown gender. On 16-FEB-2015, the patient was vaccinated with improperly stored ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.52
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 month old patient of an unknown gender. On 10-FEB-2015, the patient was vaccinated with improperly stored ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.54
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 month old patient of an unknown gender. On 29-JAN-2015, the patient was vaccinated with improperly stored ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.34
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 month old patient of an unknown gender. On 09-FEB-2015, the patient was vaccinated with improperly stored ROTATEQ (lot # K007247 and expiry date: 17-MAR-2016 or lot # K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.16
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 8 week old patient of an unknown gender. On 16-JAN-2015, the patient was vaccinated with improperly stored ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 3 month old patient of an unknown gender. On 05-FEB-2015, the patient was vaccinated with improperly stored oral, ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for oral, ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 19 year old patient of an unknown gender. On 09-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: TYP, YF
Symptoms: Abdominal pain, Nausea
Clinical narrative: Pt presents to ED with mother c/o nausea and abd pain that started this afternoon. Pt was vaccinated and given a pill for typhoid for travel. Nauseas started after he took pill.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 9 week old patient of an unknown gender. On 19-JAN-2015, the patient was vaccinated with improperly stored ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.18
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 9 week old patient of an unknown gender. On 19-JAN-2015, the patient was vaccinated with improperly stored ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On 28-APR-2015, the patients were vaccinated with doses of VARIVAX (Merck) (lot # K010336 exp date 22-JUL-2016) (dose and route not reported) that were improperly exposed to 7 degrees C from 07-JAN-2015 to 28-APR-2015. This is one of several reports received from the same source. Additional information is not expected. All follow ups requested to complete the case were received.
Age: 0.56
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 month old patient of an unknown gender. On 05-FEB-2015, the patient was vaccinated with improperly stored ROTATEQ (lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient  of unknown age. On 08-APR-2015, the patient was vaccinated with an improperly stored GARDASIL lot # K004205, expiry date 12-JAN-2017. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant therapy was not reported. On an unknown date, the patient received one dose of improperly stored ZOSTAVAX (0.65 ml, subcutaneously, lot # K020186, expiration date 27-JAN-2016). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patients were vaccinated with improperly stored ZOSTAVAX (dose and batch no. unknown). No adverse effects were reported. The outcome of events was unknown. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On 19-AUG-2014, the patients were vaccinated with doses of VARIVAX (Merck) (lot # J012377 exp date 03-OCT-2015 also reported as 08-NOV-2014) (dose not reported) subcutaneously that were improperly exposed to 7 degrees C from 13-MAY-2014 to 19-AUG-2014. No known adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected. All follow ups requested to complete the case were received.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, CD4 lymphocytes decreased, CD8 lymphocytes increased
Clinical narrative: Information has been reported in a published literature article, concerning a 59 year old male who had undergone thymectomy and received a total radiation of 62 Gy (Gray) over six weeks following surgery. The patient later developed and sought treatment for generalized urticaria. Initial evaluation revealed a low absolute lymphocyte count (615 cells/microliter), prompting further analysis. The patient's immune globulin levels, CD4 and CD8 counts and antigen response to a polysaccharide pneumococcal vaccine were monitored for several months. To prevent opportunistic infections, the patient was placed on BACTRIM prophylaxis. Although the patient's IgG, IgA, and IgM levels were unremarkable, the patient failed to respond to 11 of 12 serotypes of the PNEUMOVAX 23 (strength, dose, dose #, lot #, route and application site were not reported). The patient's low CD4 lymphocyte count and failed response to pneumococcal vaccination were consistent with immunodeficiency. After radiation alone, a recovery of T lymphocytes were usually observed after about three weeks. Even a year later, the patient still had not made a full recovery of T-lymphocytes suggesting a possible role of the adult thymus in immune recovery. To prevent serious complications, the authors reported that it was necessary for patient's who underwent radiation to be closely monitored for immunodeficiency, especially if they had undergone thymectomy as well. Follow up information has been received on 19-MAY-2015 from Sanofi Pasteur MSD. Follow-up information was received in published literature. It describe the longitudinal progress of the male with a thymectomy for a microinvasive thymoma involving the capsule. The patient tested negative for human immunodeficiency virus. His lymphocyte counts 87 months after thymectomy and 85 months after radiation therapy were as follows: absolute lymphocyte count 956 cells/mel, absolute CD3+/CD4+ 164/mm3 (16%) and absolute CD3+/CD8+ 257/mm3 (25%). The patient was able to discontinue BACTRIM prophylaxis after 9 years of treatment. Over the course of 8 years, the patient had still not made a full recovery according to laboratory markers, which seemed to have stabilized at chronically low levels. Additional information is not expected. Reporter's information, lab data, product information, AE and narrative were updated.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: HIV test negative, Immunodeficiency, Lymphocyte count, Lymphocyte count decreased, No therapeutic response
Clinical narrative: Information has been reported in a published literature article, concerning a 59 year old male who had undergone thymectomy and received a total radiation of 62 Gy (Gray) over six weeks following surgery. The patient later developed and sought treatment for generalized urticaria. Initial evaluation revealed a low absolute lymphocyte count (615 cells/microliter), prompting further analysis. The patient's immune globulin levels, CD4 and CD8 counts and antigen response to a polysaccharide pneumococcal vaccine were monitored for several months. To prevent opportunistic infections, the patient was placed on BACTRIM prophylaxis. Although the patient's IgG, IgA, and IgM levels were unremarkable, the patient failed to respond to 11 of 12 serotypes of the PNEUMOVAX 23 (strength, dose, dose #, lot #, route and application site were not reported). The patient's low CD4 lymphocyte count and failed response to pneumococcal vaccination were consistent with immunodeficiency. After radiation alone, a recovery of T lymphocytes were usually observed after about three weeks. Even a year later, the patient still had not made a full recovery of T-lymphocytes suggesting a possible role of the adult thymus in immune recovery. To prevent serious complications, the authors reported that it was necessary for patient's who underwent radiation to be closely monitored for immunodeficiency, especially if they had undergone thymectomy as well. Follow up information has been received on 19-MAY-2015 from Sanofi Pasteur MSD. Follow-up information was received in published literature. It describe the longitudinal progress of the male with a thymectomy for a microinvasive thymoma involving the capsule. The patient tested negative for human immunodeficiency virus. His lymphocyte counts 87 months after thymectomy and 85 months after radiation therapy were as follows: absolute lymphocyte count 956 cells/mel, absolute CD3+/CD4+ 164/mm3 (16%) and absolute CD3+/CD8+ 257/mm3 (25%). The patient was able to discontinue BACTRIM prophylaxis after 9 years of treatment. Over the course of 8 years, the patient had still not made a full recovery according to laboratory markers, which seemed to have stabilized at chronically low levels. Additional information is not expected. Reporter's information, lab data, product information, AE and narrative were updated.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: T-lymphocyte count
Clinical narrative: Information has been reported in a published literature article, concerning a 59 year old male who had undergone thymectomy and received a total radiation of 62 Gy (Gray) over six weeks following surgery. The patient later developed and sought treatment for generalized urticaria. Initial evaluation revealed a low absolute lymphocyte count (615 cells/microliter), prompting further analysis. The patient's immune globulin levels, CD4 and CD8 counts and antigen response to a polysaccharide pneumococcal vaccine were monitored for several months. To prevent opportunistic infections, the patient was placed on BACTRIM prophylaxis. Although the patient's IgG, IgA, and IgM levels were unremarkable, the patient failed to respond to 11 of 12 serotypes of the PNEUMOVAX 23 (strength, dose, dose #, lot #, route and application site were not reported). The patient's low CD4 lymphocyte count and failed response to pneumococcal vaccination were consistent with immunodeficiency. After radiation alone, a recovery of T lymphocytes were usually observed after about three weeks. Even a year later, the patient still had not made a full recovery of T-lymphocytes suggesting a possible role of the adult thymus in immune recovery. To prevent serious complications, the authors reported that it was necessary for patient's who underwent radiation to be closely monitored for immunodeficiency, especially if they had undergone thymectomy as well. Follow up information has been received on 19-MAY-2015 from Sanofi Pasteur MSD. Follow-up information was received in published literature. It describe the longitudinal progress of the male with a thymectomy for a microinvasive thymoma involving the capsule. The patient tested negative for human immunodeficiency virus. His lymphocyte counts 87 months after thymectomy and 85 months after radiation therapy were as follows: absolute lymphocyte count 956 cells/mel, absolute CD3+/CD4+ 164/mm3 (16%) and absolute CD3+/CD8+ 257/mm3 (25%). The patient was able to discontinue BACTRIM prophylaxis after 9 years of treatment. Over the course of 8 years, the patient had still not made a full recovery according to laboratory markers, which seemed to have stabilized at chronically low levels. Additional information is not expected. Reporter's information, lab data, product information, AE and narrative were updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On 07-AUG-2014, the patients were vaccinated with doses of VARIVAX (Merck) (lot # J012377 exp date 03-OCT-2015 also reported as 08-NOV-2014) (dose not reported) subcutaneously that were improperly exposed to 7 degree C from 13-MAY-2014 to 07-AUG-2014. No known adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected. All follow ups requested to complete the case were received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On 24-JUL-2014, the patients were vaccinated with doses of VARIVAX (Merck) (lot # J012377 exp date 03-OCT-2015 also reported as 08-NOV-2014) (dose not reported) subcutaneously that were improperly exposed to 7 degrees C from 13-MAY-2014 to 24-JUL-2014. No known adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected. All follow ups requested to complete the case were received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patients were vaccinated with improperly stored VARIVAX (Merck). No adverse effects were reported. The outcome of events was unknown. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On 22-JUL-2014, the patients were vaccinated with doses of VARIVAX (Merck) (lot # J012377 exp date 03-OCT-2015 also reported as 08-NOV-2014) (dose not reported) subcutaneously that were improperly exposed to 7 degrees C from 13-MAY-2014 to 22-JUL-2014. No known adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected. All follow ups requested to complete the case were received.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Product quality issue, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a healthcare worker via company representative refers to a patient of unknown age. On an unknown date during administration of GARDASIL to an unspecified patient, the syringe hub popped off and the dose ran out of the syringe instead of going into the patient's arm. Healthcare worker did not know if the patient received any of the dose but definitely did not received a full dose. No adverse effects were reported. Product quality complaint was filled for the syringe hub popping off the syringe. The outcome of events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as receivd from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On 11-JUL-2014, the patients were vaccinated with doses of VARIVAX (Merck) (lot # H020250 exp date 06-NOV-2014 also reported as 08-NOV-2014) (dose not reported) subcutaneously that were improperly exposed to 7 degrees C from 15-MAY-2013 to 11-JUL-2014. No known adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected. All follow ups requested to complete the case were received. Additional information has been requested.
Age: 0.51
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 month old patient of unknown gender. On 26-JAN-2015, the patient was vaccinated with improperly stored oral ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.45
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 5 month old patient of an unknown gender. On 21-JAN-2015, the patient was vaccinated with improperly stored, oral ROTATEQ (lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for oral, ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.52
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 month old patient of an unknown gender. On 26-JAN-2015, the patient was vaccinated with improperly stored ROTATEQ (lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On 09-MAY-2014, the patients were vaccinated with doses of VARIVAX (Merck) (lot # H020250 exp date 06-NOV-2014 also reported as 08-NOV-2014) (dose not reported) subcutaneously that were improperly exposed to 7 degree C from 15-MAY-2013 to 09-MAY-2014. No known adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected. All follow ups requested to complete the case were received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On 16-JUL-2014, the patients were vaccinated with doses of VARIVAX (Merck) (lot # J012377 exp date 03-OCT-2015 also reported as 08-NOV-2014) (dose not reported) subcutaneously that were improperly exposed to 7 degrees C from 13-MAY-2014 to 16-JUL-2014. No known adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected. All follow ups requested to completed the case were received.
Age: 0.56
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 month old patient of unknown gender. On 22-JAN-2015, the patient was vaccinated with improperly stored, oral, ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.35
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 month old patient of an unknown gender. On 28-JAN-2015, the patient was vaccinated with improperly stored, oral ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On 09-JAN-2014, 21-MAR-2014, 09-MAY-2014, 11-JUL-2014 and 03-SEP-2014 the patients were vaccinated with doses of (Oka/Merck) VARIVAX (lot # H020250 exp date 06-NOV-2014 also reported as 08-NOV-2014) (dose and route not reported) that were improperly exposed to 7 degree C from 15-MAY-2013 to dates of vaccination to each patient. No known adverse effects were reported. This is one several reports received from the same source. Additional information is not expected. All follow ups requested to complete the case were received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On 03-SEP-2014, the patients were vaccinated with doses of (Oka/Merck) VARIVAX (lot # H020250 exp date 06-NOV-2014 also reported as 08-NOV-2014) (dose not reported) subcutaneously that were improperly exposed to 7 degrees C from 15-MAY-2013 to 03-SEP-2014. No known adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected. All follow ups requested to complete the case were received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On 21-MAR-2014, the patients were vaccinated with doses of (Oka/Merck) VARIVAX (lot # H020250 exp date 06-NOV-2014 also reported as 08-NOV-2014) (dose not reported) subcutaneously that were improperly exposed to 7 degree C from 15-MAY-2013 to 21-MAR-2014. No known adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected. A follow ups requested to complete the case were received.
Age: 0.35
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 month old patient of an unknown gender. On 03-FEB-2015, the patient was vaccinated with improperly stored oral, ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016. No adverse events were reported. No product quality complaint (PQC) was reported for oral, ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 month old patient of an unknown gender. On 05-FEB-2015, the patient was vaccinated with improperly stored, oral, ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.51
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 month old patient of an unknown gender. On 07-FEB-2015, the patient was vaccinated with improperly stored, oral, ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to an unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (administration routes, lot numbers and expiration dates were not provided). No concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 month old patient of an unknown gender. On 19-JAN-2015, the patient was vaccinated with improperly stored, oral, ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.51
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 month old patient of an unknown gender. On 16-FEB-2015, the patient was vaccinated with improperly stored ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.