chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a consumer (friend of the patient), refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX vial, (lot #, expiry date, dose, frequency and route of administration not reported). On an unknown date, the patient experienced rash. The outcome of rash was unknown. Causality assessment was not provided. No product quality complaint (PQC) was involved. No further information obtained for adverse event. 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-JUL-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-JUL-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 07-JUL-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 07-JUL-2015 (also reported as 06-JUL-2015), the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-JUL-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 10-SEP-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Headache, Migraine, Muscle twitching, Nausea
Clinical narrative: This spontaneous report was received from a 26 year old female patient regarding herself. Patient had no pertinent medical history and no drug reactions/allergies. On 19-JAN-201, the patient was vaccinated with the 'last dose' of GARDASIL 120 Y, intramuscularly  (lot# and expiration date was not provided). Concomitant therapy included an unspecified oral contraceptive medication. Two days later, on approximately 21-JAN-2016, after receiving vaccination, the patient started to experience a severe headache/migraine. She also experienced nausea when standing up and would vomit if she stood up too fast. Patient sought medical attention-she visited the urgent care facility on the same day was given anti-inflammatory shots, ibuprofen and an unspecified anti-emetic. Her symptoms continued to 24-JAN-2016, when she had also experienced blurred vision, more vomiting and twitching. Again, on 25-JAN-2016, the patient visited the urgent care facility and received treatment. Urine analysis and blood testing was performed (date of test and results was not provided). Outcome of the adverse events was reported as not recovered. Causality assessment was not provided. No product quality complaint was involved. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Urine analysis, Vision blurred, Vomiting
Clinical narrative: This spontaneous report was received from a 26 year old female patient regarding herself. Patient had no pertinent medical history and no drug reactions/allergies. On 19-JAN-201, the patient was vaccinated with the 'last dose' of GARDASIL 120 Y, intramuscularly  (lot# and expiration date was not provided). Concomitant therapy included an unspecified oral contraceptive medication. Two days later, on approximately 21-JAN-2016, after receiving vaccination, the patient started to experience a severe headache/migraine. She also experienced nausea when standing up and would vomit if she stood up too fast. Patient sought medical attention-she visited the urgent care facility on the same day was given anti-inflammatory shots, ibuprofen and an unspecified anti-emetic. Her symptoms continued to 24-JAN-2016, when she had also experienced blurred vision, more vomiting and twitching. Again, on 25-JAN-2016, the patient visited the urgent care facility and received treatment. Urine analysis and blood testing was performed (date of test and results was not provided). Outcome of the adverse events was reported as not recovered. Causality assessment was not provided. No product quality complaint was involved. 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 10-JUL-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-SEP-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-SEP-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 17-SEP-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-SEP-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-SEP-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 15-SEP-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. On 04-FEB-2016, the patient was vaccinated with expired dose of VARIVAX (Merck) (lot # J007013, expiry: 05-JUN-2015). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 15-SEP-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 16-SEP-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative, and refers to a male patient of unknown age. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route, lot # and expiration date were not reported). No concomitant medications were reported. On 03-FEB-2016, the patient experienced a varicella like rash after being vaccinated with ZOSTAVAX. The patient sought medical attention through an unspecified contact. No intervention to prevent serious criteria was requested. No product quality complaint was involved. At the time of the report, the outcome of varicella like rash was unknown. The relatedness between varicella like rash and the ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant (healthcare worker) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-JAN-2016, the patient was vaccinated with an improperly stored VAQTA lot # L023232, 25-FEB-2017. This is one of the several reports received 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 healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates since 09-NOV-2015, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # L017138 with exp. 13-AUG-2016, (dose and route were not provided). No adverse effects were reported. The temperature excursion was 13.89F, during 65 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant (healthcare worker) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JAN-2016, the patient was vaccinated with an improperly stored VAQTA lot # L023232, 25-FEB-2017. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 22-SEP-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 29-SEP-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from the patient's mother and refers to a 1 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was taken for her 1 year booster shot and received doses of both PROQUAD (Merck) (lot #, dose and route were not provided) and M-M-R II (lot #, dose and route were not provided) vaccines. The reporter stated the provider informed her that there should not be any real cause for concerns. No adverse effect was reported. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-FEB-2016, the patient was vaccinated with the expired dose of VARIVAX (Merck) (lot # reported as J006162 (verified to be non-valid lot # for VARIVAX (Merck), expiration date 20-MAY-2015; dose and route of administration were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative, Extra dose administered
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with the first and the second dose of M-M-R II (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. On an unknown date, patients have received the third dose of M-M-R II (dose, route of administration, lot number and expiration date were not reported) due to have negative titers (date not reported). The outcome of the event was not reported. The relatedness between the event and M-M-R II was not reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Information regarding to the patients' medical history, concurrent condition and concomitant medication was not reported. On unknown dates in 2016 (reported as since 01-JAN-2016), the patients were vaccinated with improperly stored doses of ROTATEQ (orally, dose was not reported, lot# 004466 with expiration date of 02-AUG-2016 and lot# reported as L029615 with expiration date of 15-MAY-2017). No adverse effects had been reported. The oral, ROTATEQ vaccines underwent a temperature excursion of -3 Celsius degrees for 19 hours. No product quality complaint was 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
Clinical narrative: This spontaneous report was received from a certified medical assistant (healthcare worker) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JAN-2016, the patient was vaccinated with an improperly stored VAQTA lot # L023232, 25-FEB-2017. This is one of the 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 was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 15-DEC-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L006384, expiry date: 25-FEB-2017; dose and route were not provided). No adverse events were reported. 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 was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 05-FEB-2016, the patient was inadvertently vaccinated with an expired dose of VAQTA (lot # K001296, expiration date 15-JAN-2016, exact dose and route of administration were not reported). No adverse effect was reported. No PQC (product quality complaint) was involved. 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-JUN-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid  (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. Patient's pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with the first and the second doses of MMR II (doses, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. On an unknown date, patients have received the third dose of MMR II (dose, route of administration, lot number and expiration date were reported) because of a mumps outbreak at their school. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 15-JUN-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 18-JUN-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Information regarding the patients' medical history, concurrent condition and concomitant medication was not reported. On unknown dates in 2016 (reported as since 01-JAN-2016), the patients were vaccinated with improperly stored doses of VAQTA (dose and route of administration were not reported, lot# L031196 with expiration date of 05-FEB-2017 and lot# L030442 with expiration date of 19-DEC-2016). No adverse effects had been reported. The VAQTA vaccines underwent a temperature excursion of -3 Celsius degrees for 19 hours. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. On 16-APR-2007 and on 30-MAY-2007, the patient was vaccinated with doses of VARIVAX (Merck) (dose, lot #, route of administration were not reported). On an unknown date, the patient was found to have negative varicella titers. Product quality complaint (PQC) was not involved. The outcome of the event and the relatedness between the event and VARIVAX (Merck) were not reported. 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 healthcare worker refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 18-JAN-2016, the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which were improperly stored (incorrect product storage) (Temperature: 9.5 F, Time frame: 2 hours). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 24-JUN-2015, the patient was vaccinated with a dose of VAQTA, intramuscular (lot# and expiration date were not provided). On 14-DEC-2015, the patient received a vaccine boost (inappropriate schedule of drug administration). No concomitant therapies were reported, neither was any adverse effects. 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 medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 19-JAN-2016, the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which were improperly stored (Incorrect product storage) (Temperature: 9.5 F, Time frame: 2 hours). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a 52 year old female patient. The patient's pertinent medical history and concurrent conditions were not provided. On 23-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX(Lot# not provided), 1 single shot, subcutaneous. On 24-JUL-2015, the patient experienced swelling in the upper left arm. The upper left arm was red and hot to the touch. The physician reported that the adverse reactions resolved themselves in approximately August 2015 (reported as in approximately 10 days from 24-JUL-2015). There was no treatment given for the patient's adverse events. The patient did not seek medical attention. Additional information is not expected as the reporter did not wish further contact.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) arm - red swollen area around injection site. Rx: Ibuprofen, topical triamcinolone oint 0.1%.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # K010215, expiration date 05-MAY-2017 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 21 degrees Fahrenheit for 6 days. There was no adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Drug effect incomplete
Clinical narrative: This spontaneous report was received from an unspecified reporter as part of a Market Research program, referring to multiple unspecified elderly patients. The patients' age, concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (dose, administration route, anatomical site, lot number and expiry date were not reported). Concomitant therapies were not provided. The reporter stated that they have heard or seen in the last three months, that PNEUMOVAX 23 was "not as effective in elderly" (drug effect incomplete). At the time of this report, the outcome of drug effect incomplete was unknown. The original reporting source did not provide a causality assessment. Additional information is not expected, as the reporter did not wish to be contacted.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Started day after with lightheadedness foggy comes and goes increasing in frequency as days go by excluding while laying in bed. No nausea lasting each episode minutes to seconds. No sinus all other problems has lasted weeks. Blood sugar good BP 140/70.
Age: 1.17
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Administration site pain, Injection site swelling
Clinical narrative: Patient has swelling to right thigh where MRM and Varicella were administered on 2/5/16. Patient was seen 2/9/16, swelling was reported as 3cm at the longest diameter. No fevers, no illness. Pain noted to site on administration date.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Pruritus, Swelling
Clinical narrative: Burning, itching, swelling.
Age: 14.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Local reaction
Clinical narrative: Rcv'd 2 vaccines in (L) arm (one IM/one subq) started having redness- local rxn on 2-3-16 mom had started cold compresses and BENADRYL before visit so site has reduced in size. Continue home tx as directed by PAC on 2-4-16.
Sex: U
Vaccine: VARCEL
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 and gender. The patient's medical history and concurrent condition were not reported. On 14-JAN-2016, the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which were improperly stored (incorrect product storage) (Temperature: 9.5 F, Time frame: 2 hours). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Nausea, Pain, Syncope
Clinical narrative: 2 inj. were given. 1st inj HPV (R) deltoid IM, pt was ok concerned about soreness. I then moved over to his left side to administer 2nd vaccine MCV4 on left deltoid. As I gave 2nd inj pt c/o feeling nauseous. After administering 2nd vaccine I stood in front of the patient who was sitting on edge of exam table and then he fainted. I caught him, supported his head and laid him back on the table. I called the other MA's to exam room and when we came in he was sitting up. We told him to lay back down and kept him in the exam room for 10 minutes. Pt stated he was ok and felt fine spoke to Dr. and she advised  to keep him a little longer and make sure is ok then ok to release patient. Pt was able to leave on his own with mom.
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a female patient of unknown age. The patient's concurrent conditions and medical history were not provided. Approximately in July 2014 (also reported as 18 months later), the patient was vaccinated with an unspecified HPV vaccine; it was unknown if it was GARDASIL or GARDASIL 9 as her first dose in HPV vaccine series (dose, route, frequency, lot # and expiry date were not reported). On 27-JAN-2016, the patient was vaccinated with GARDASIL 9 (dose, route, frequency, lot # and expiry date were not reported) as the second dose in the series. Concomitant therapies were not provided. No product quality complaint (PQC) and no adverse events were reported. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Injection site erythema, Injection site swelling, Skin plaque
Clinical narrative: Vaccine administered 2/3/16 - later in evening pt developed swelling/redness at injection site. Over two day area expanded despite ice, BENADRYL. Seen 2/5/15 w/11 x 19 cm warm, indurated erythematous plaque wrapping around arm. Rx: Prednisone, BENADRYL.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Vaccine administered 2/3/16 - later in evening pt developed swelling/redness at injection site. Over two day area expanded despite ice, BENADRYL. Seen 2/5/15 w/11 x 19 cm warm, indurated erythematous plaque wrapping around arm. Rx: Prednisone, BENADRYL.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 02-FEB-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # K012784, Expiry date: 28-NOV-2015), (strength, dose and route of administration were not reported). No concomitant medications were provided. No adverse effects were reported. 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 other health professional refers to an unspecified number of patients of unknown age and gender. On unknown dates since 09-NOV-2015, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L024253 with exp. 01-JUL-2017, (dose and route were not provided). No adverse effects were reported. The temperature excursion was 13.89F, during 65 hours. This is one of several reports received 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 Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Information regarding the patients' medical history, concurrent condition and concomitant medication was not reported. On unknown dates in 2016 (reported as since 01-JAN-2016), the patients were vaccinated with improperly stored doses of GARDASIL (dose and route were not reported, lot# L007560, expiration date 15-JUN-2017). No adverse effects had been reported. The GARDASIL vaccines underwent the temperature excursion of -3 Celsius degrees for 19 hours. No product quality complaint was 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 medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 20-JAN-2016, the patient was vaccinated with (Oka/Merck) VARIVAX (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which improperly stored (Temperature: 9.5 F, Time frame: 2 hours). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: This spontaneous report as received from a physician's assistant via a company representative refers to a 27 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, reported as several years ago, the patient was vaccinated with the series of GARDASIL (dose, lot #, route of administration were not reported). On an unknown date, reported as several weeks ago, the patient received a positive HPV test result from pap smear. Product quality complaint (PQC) was not involved. No treatment was given for the adverse events. The outcome of the event was not reported. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Information regarding the patients' medical history, concurrent condition and concomitant medication was not reported. On unknown dates in 2016 (reported as since 01-JAN-2016), the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose and route of administration were not reported, lot# L044917 with expiration date of 05-OCT-2018 and lot# L010595 with expiration date of 12-NOV-2016). No adverse effects had been reported. The RECOMBIVAX HB vaccines underwent a temperature excursion of -3 Celsius degrees for 19 hours. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 30-SEP-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaint (PQC) involved. No additional information was provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 17-SEP-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaint (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant (healthcare worker) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JAN-2016, the patient was vaccinated with an improperly stored VAQTA lot # L023232, 25-FEB-2017. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant (healthcare worker) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-JAN-2016, the patient was vaccinated with an improperly stored VAQTA lot # L023232, 25-FEB-2017. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Injection site erythema, Pain in extremity
Clinical narrative: Pain in (L) arm extending down into wrist. No fever, head/neck pain. No swelling, redness at injection site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema
Clinical narrative: Injection site reaction 12 cm x 10.5 cm, redness 15.1 cm x 18 cm.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 09-NOV-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # J015378, expiration date: 09-APR-2016) (dose, route and strength were not provided). Concomitant medication was not provided. No adverse effects were reported. It was also reported that temperature was -0.1 degrees C, time frame was 15 minutes and it was not previous temperature excursion. This is one of several cases from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: This spontaneous report was received from a pharmacist concerning a male patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (Lot # and dose unknown). Concomitant medications were not provided. On an unknown date the patient developed a "lump" at the injection site. The outcome of injection site mass was unknown at the time of the report. Additional information is not expected as the reporter details were not provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 30-SEP-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-OCT-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 01-OCT-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.