chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 21-APR-2016, the patient was vaccinated with improperly stored ZOSTAVAX, lot no. L040442, expiration date 15-JAN-2017, (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Temperature was 33F, time frame 6  hours and data logger was not used. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with improperly stored VAQTA (lot # J014584 with expiration date 16-JAN-2016; lot# K012457 with expiration date 04-JUN-2017, dose, dose# and route unknown). No symptoms reported. The vaccines were stored under 9 C for 1 hour and 15 minutes without previous temperature excursion. No doses were administered past labeled expiry. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # K020215 with expiration date 15-MAY-2016, dose, dose# and route unknown). No symptoms reported. The vaccines were stored under 9 C for 1 hour and 15 minutes without previous temperature excursion. No doses were administered past labeled expiry. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with improperly stored GARDASIL (lot #K004205 with expiration date 12-JAN-2017; lot# K008931 with expiration date 04-MAR-2017 and lot# L006459 with expiration date 06-APR-2017, dose, dose# and route unknown). No symptoms reported. The vaccines were stored under 9 C for 1 hour and 15 minutes without previous temperature excursion. No doses were administered past labeled expiry. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
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 11-year-old patient of unknown gender. No information about the patient's medical history and concurrent conditions were reported. On 05-FEB-2016, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K008931, expiry date 04-MAR-2017, (dose and route of administration were not reported). Concomitant therapy was not reported. Administered doses were exposed to the following conditions: temperature of 33 Fahrenheit degrees for 15 hours and 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required correspondence was received.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a health professional refers to a 14 year old patient of unknown gender. On 18-JAN-2016, the patient was vaccinated with a third dose of GARDASIL lot # K008931 (expiration date 04-MAR-2016) in the right arm (dose and route were not reported), which was stored for 15 hours and 15 minutes in a 33 Fahrenheit (F) degrees. There was no previous temperature excursion and the call was not because of a data logger. Concomitant therapies included influenza virus vaccine (unspecified). Additional information is not expected, as all required correspondence was received.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a health professional refers to a 13 year old patient of unknown gender. On 27-JAN-2016, the patient was vaccinated with a dose of GARDASIL lot # K008931 (expiration date 04-MAR-2016) in the left arm (dose and route were not reported), which was stored for 15 hours and 15 minutes in a 33 Fahrenheit (F) degrees. There was no previous temperature excursion and the call was not because of a data logger. Additional information is not expected, as all correspondence was received.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a multiple patients of unknown age and gender. No pertinent medical history or concomitant medications were reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored PNEUMOVAX23, lot # L031459 with expiration date 30-APR-2017 and lot # M005286 with expiration date 08-OCT-2017 (dose and route of administration not provided). The vaccine products were exposed to the following conditions: temperature 0.3 degrees Celsius for 8 hours. There was no previous temperature excursion. The temperature excursion was captured via a Digital Data Logger. 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 was received from a certified medical assistant and refers to an unspecif8ied number of patients of unknown age and gender. The patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unspecified dates, the patients might had been vaccinated with improperly stored ROTATEQ (lot # K023537, expiration date: 02-JUN-2016; dose was not provided) orally. The vaccine was exposed to temperature of 30 degrees Fahrenheit for 3 months. No previous temperature excursion was reported. No adverse symptoms were reported. Administration of vaccine was possible. There was no product quality complaint. This is one of two reports received 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 medical assistant refers to a 14-year-old patient of unknown gender. No information about the patient's medical history and concurrent conditions were reported. On 08-FEB-2016, the patient was vaccinated with an improperly stored, the third dose of GARDASIL lot # K008931, expiry date 04-MAR-2017, (dose and route of administration were not reported). Concomitant therapy was not reported. Administered doses were exposed to the following conditions: temperature of 33 Fahrenheit degrees for 15 hours and 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required correspondence was received.
Age: 15.0
Sex: U
Vaccine: FLU3, HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a health professional refers to a 15 year old patient of unknown gender. On 11-JAN-2016, the patient was vaccinated with a second dose of GARDASIL lot # K008931 (expiration date 04-MAR-2016) in the left arm (dose and route were not reported), which was stored for 15 hours and 15 minutes in a 33 Fahrenheit (F) degrees. There was no previous temperature excursion and the call was not because of data logger. Concomitant therapies included influenza virus vaccine (unspecified). Additional information is not expected, as all required correspondence was received.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Dysgeusia, Headache, Muscle spasms, Pyrexia
Clinical narrative: Shot given around 8:00 pm. Juvenile woke up about 3:00 am shakey. He states "uncontrolled muscle spasm". Severe headache, dizzy, metallic taste in mouth. Temp 101.8. TYLENOL for fever and headache.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Tremor
Clinical narrative: Shot given around 8:00 pm. Juvenile woke up about 3:00 am shakey. He states "uncontrolled muscle spasm". Severe headache, dizzy, metallic taste in mouth. Temp 101.8. TYLENOL for fever and headache.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to unspecified multiple patients of unknown demographics. The concurrent conditions, medical history and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored (Merck) VARIVAX (lot # L034369, Expiry: 29-SEP-2017 and lot# L034369, Expiry: 08-SEP-2017). The vaccine was stored at a temperature of 13 F for 1 hour. There were no previous excursions. There were no adverse effects. It was also reported that MMR II also appeared on the product list as temperature stability, however no doses of improperly stored MMR II were administered to the patients. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Rash
Clinical narrative: Skin rash and injection site reaction.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a health professional refers to a 16 year old patient of unknown gender. On 22-JAN-2016, the patient was vaccinated with a third dose of GARDASIL lot # K0089831 (expiration date 04-MAR-2016) in the left arm (dose and route were not reported), which was stored for 15 hours and 15 minutes in a 33 Fahrenheit (F) degrees. There was no previous temperature excursion and the call was not because of a data logger. Additional information is not expected, as all required correspondence was received. Event and narrative were updated.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 21-APR-2016, the patient was vaccinated with expired PNEUMOVAX 23 lot # K018528, expiration date-14-APR-2016 (expired product administered). No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Nurse stated PNEUMOVAX 23 did not have any temperature excursions prior to administration. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a health professional refers to a 17 year old patient of unknown gender. On 20-JAN-2016, the patient was vaccinated with a third dose of GARDASIL lot # K008931 (expiration date 04-MAR-2016) in the right arm (dose and route were not reported), which was stored for 15 hours and 15 minutes in a 33 Fahrenheit (F) degrees. There was no previous temperature excursion and the call was not because of a data logger. Additional information is not expected, as all required correspondence was 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 a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 26-APR-2016 the patient was vaccinated with an improperly stored (Merck) VARIVAX (lot# was reported as L048466, expiration date was reported as 02-DEC-2017, route and dose were not reported). The vaccine was exposed to 15 F for 30 minutes because of a data logger. There was no previous temperature excursion. Concomitant drug was not reported. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a healthcare professional concerning a patient of unknown age and gender. Information regarding patient's concurrent condition, medical history and concomitant therapy was not reported. On 20-APR-2016, the patient was vaccinated with a dose of PROQUAD (Merck) and a dose of VARIVAX (Merck) (for both vaccine, dose, route and lot# was not reported). No adverse effects were reported. At the time of report, the patient's status was unknown. 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 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 (Merck) VARIVAX 0.5 ml, subcutaneously, lot # L025205, expiration date: 07-JUL-2017: lot # L030160, expiration date: 11-AUG-2017; Lot # L043619, expiration date 02-NOV-2017. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 23.3 degrees Fahrenheit for 2 hours 10 minutes; 10.4 degrees Fahrenheit for 1 hour 30 minutes: 10.9 degrees Fahrenheit for 1 hour 20 minutes. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No pertinent medical history or concomitant therapy was reported. It was reported that on 25-APR-2016, the patient was vaccinated with expired MMR II lot # K004949, expiration date 04-APR-2016, subcutaneously (dose was not provided). There was no known adverse effects. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple, unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored doses of VAQTA via unreported route (batch# L041676, exp. 15-MAR-2017; L045713, exp. 14-JAN-2017). Concomitant medication was not mentioned. The vaccines underwent a temperature excursion by being stored at 0.9 degree centigrade for a time frame of 11 hours 35 minutes (Incorrect product storage) on 18-MAR-2016. The call was a result of "data logger". There was no previous temperature excursion mentioned. No adverse effects were reported. Product quality complaint was not filed. Additional information has been requested. This is one of the four reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patients' concurrent condition and medical history were not provided. On 29-MAR-2016 the patient was vaccinated with improperly stored (Merck) VARIVAX (lot # L019125, exp.: 27-MAY-2017) (dose, route and site of administration not reported). Concomitant medication was not mentioned. The vaccine was stored at 12F for a time frame of 20 minutes daily for 140 days (incorrect product storage). The call was a result of a data logger. There was no previous temperature excursion reported. No adverse effects reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested. This is one of the four reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients received doses of improperly stored GARDASIL 9 lot# L014415 with expiration date: 25-JUL-2017, lot# L038917 with expiration date: 20-FEB-2018, lot# L045700 with expiration date: 22-FEB-2018 and lot# L036245 with expiration date: 09-FEB-2018 (dose, route of administration and injection site were not reported). Administered doses of GARDASIL 9 underwent temperature excursions at 52.5 Fahrenheit degrees, for 9 hours and 10 minutes. Digital data logger was involved. Unspecified number of doses of GARDASIL 9 were also previously exposed to a high temperature of 48.9 Fahrenheit degrees for 13 hours and 40 minutes. Cumulative time out of range was 22 hours and 50 minutes. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patients' concurrent condition and medical history were not provided. On 25-MAR-2016 the patient was vaccinated with improperly stored (Merck) VARIVAX (lot # L019125, exp.: 27-MAY-2017) (dose, route and site of administration not reported). Concomitant medication was not mentioned. The vaccine was stored at 12F for a time frame of 20 minutes daily for 140 days (incorrect product storage). The call was a result of a data logger. There was no previous temperature excursion reported. No adverse effects reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested. This is one of the four reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patients' concurrent condition and medical history were not provided. On 28-MAR-2016 the patient was vaccinated with improperly stored (Merck) VARIVAX (lot # L019125, exp.: 27-MAY-2017) (dose, route and site of administration not reported). Concomitant medication was not mentioned. The vaccine was stored at 12F for a time frame of 20 minutes daily for 140 days (incorrect product storage). The call was a result of a data logger. There was no previous temperature excursion reported. No adverse effects reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested. This is one of the four reports received from the same reporter.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a health professional refers to a 17 year old patient of unknown gender. On 22-JAN-2016, the patient was vaccinated with a second dose of GARDASIL lot # K008931 (expiration date 04-MAR-2016) in the left arm (dose and route were not reported), which was stored for 15 hours and 15 minutes in a 33 Fahrenheit (F) degrees. There was no previous temperature excursion and the call was not because of a data logger. Additional information is not expected, as all required correspondence was received.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a health professional refers to a 14 year old patient of unknown gender. On 25-JAN-2016, the patient was vaccinated with a second dose of GARDASIL lot # K008931 (expiration date 04-MAR-2016) in the right arm (dose and route were not reported), which was stored for 15 hours and 15 minutes in a 33 Fahrenheit (F) degrees. There was no previous temperature excursion and the call was not because of a data logger. Additional information is not expected, as all required correspondence was received.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Lymph node pain, Lymphadenopathy, Nausea, Pruritus
Clinical narrative: Itchy rash on bilateral proximal upper extremities. Nausea and vomiting X2 with severe generalized abdominal pain. Left single mobile posterior cervical lymphadenopathy with tenderness upon palpating. All symptoms improved by day 4 with some lingering abdominal pain and lymphadenopathy.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Rash, Vomiting
Clinical narrative: Itchy rash on bilateral proximal upper extremities. Nausea and vomiting X2 with severe generalized abdominal pain. Left single mobile posterior cervical lymphadenopathy with tenderness upon palpating. All symptoms improved by day 4 with some lingering abdominal pain and lymphadenopathy.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) referring to multiple patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L008578, expiration date 14-DEC-2016; dose was not reported) orally. No adverse effects were reported. It was reported that the vaccines had been exhausted and there was no previous temperature excursion. The reporter called because of the data logger. Temperature/time frame was reported as: 10-DEC-2015: 25.7 (unit not provided), 9 hours, 37 minutes; 15-DEC-2015: 30.0 (unit not provided), 2 hours, 52 minutes. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 75 year old female patient via a company representative concerning herself. The patient concurrent condition included bone strength disorder and cholesterol abnormal. The patient did not have drug reactions/allergies. On an unknown date in 2012 the patient was vaccinated with a dose of ZOSTAVAX (one time vaccination, dose and route not reported). Concomitant therapies included BONIVA and LIPITOR. On an unknown date (reported as a few months ago) the patient experienced shingles rash on her waste. The rash went away within three weeks but the pain was still there. The patient went to doctor to seek medical attention. The physician prescribed pain medication as treatment for patient. There was no diagnostics studies performed. The outcome of event was not resolved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition and medical history were not provided. On 24-MAR-2016 the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # L019125, exp.: 27-MAY-2017) (dose, route and site of administration not reported). Concomitant medication was not mentioned. The vaccine stored at 12F for a time frame of 20 minutes daily for 140 days (incorrect product storage). The call was a result of a data logger. There was no previous temperature excursion reported. No adverse effects reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested. This is one of the four reports received from the same reporter.
Age: 1.66
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash located on chest, abdomen, R upper extremity and R lower extremity. Inj administered 4/25/16; pt seen in office 4/26/16. Pt was not uncomfortable and breathing well.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Pt. had a slight fever - day after inj. put that is gone - no other symptoms.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram, Hypoaesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old male patient. Concurrent conditions included diabetes mellitus and hypertension. There was no allergy/drug reaction. The medical history was not reported. On 07-APR-2016, the patient was vaccinated with ZOSTAVAX (lot#L039096, expiry: January 2017) 0.65 ml subcutaneously. The patient took several unspecified concomitant medications. Approximately on 08-APR-2016 (reported as a day after" receiving ZOSTAVAX, the patient experienced numbness in the opposite arm. The patient went to the hospital on an unspecified date for the numbness and the patient was "kept under observation for a day but was not admitted and then sent home and referred to neurology". The pharmacist stated that while the patient was under observation at the hospital, the patient had an unspecified CT scan. No treatment was given for the event. The outcome of 'numbness in the opposite arm' was reported as not recovered. The reporter did not provide the causality between the event and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via field representative refers to a patient of unknown gender and age. Patients concurrent condition included shingles on an unspecified location of their body. Information regarding their medical history and concomitant medications were unspecified. On an unknown date, the patient was vaccinated with ZOSTAVAX 9dosing details were unspecified). Physician reported that an unspecified time after receiving the ZOSTAVAX, the patient's shingles got worse and spread all the way down their unspecified arm and across their back. On an unknown date, the patient required medical attention and was seen by their physician. Outcome of the event was unknown. Reporting physician did not assessed the causality of the event with respect to therapy with ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to an unspecified number of patient of unknown demographics. The concomitant medications, medical history and concomitant medications were unknown. On an unknown date in 2016 (reported as on or after 24-MAR-2016) the patients were vaccinated with unspecified number of improperly stored doses of PNEUMOVAX 23. The vaccine was stored at 47 F for 72. hours. There were no previous excursions. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEP, HEPA, MMRV
Symptoms: Cough, Epistaxis, Nasopharyngitis, Pyrexia, Rash
Clinical narrative: Mother c/o mild rash appearing on face same day after receiving the MMRV vaccine. Also states patient developed a cold w/slight blood in mucus when sneezed out of (R) nostril and cough with fever although mother states patient is also teething and unable to differentiate if fever is from teething or vaccine. (On 4-22-16 mother stated rash was going away).
Age: 1.0
Sex: M
Vaccine: HEP, HEPA, MMRV
Symptoms: Sneezing
Clinical narrative: Mother c/o mild rash appearing on face same day after receiving the MMRV vaccine. Also states patient developed a cold w/slight blood in mucus when sneezed out of (R) nostril and cough with fever although mother states patient is also teething and unable to differentiate if fever is from teething or vaccine. (On 4-22-16 mother stated rash was going away).
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to an unspecified number of patient of unknown demographics. The concomitant medications, medical history and concomitant medications were unknown. On an unknown date in 2016 (reported as on or after 24-MAR-2016) the patients were vaccinated with unspecified number of improperly stored doses of RECOMBIVAX HB. The vaccine was stored at 47 F for 72. hours. There were no previous excursions. No adverse effects were reported. 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 health professional refers to an unspecified number of patient of unknown demographics. The concomitant medications, medical history and concomitant medications were unknown. On an unknown date in 2016 (reported as on or after 24-MAR-2016) the patients were vaccinated with unspecified number of improperly stored doses of ROTATED. The vaccine was stored at 47 F for 72 hours. There were no previous excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Presyncope
Clinical narrative: This spontaneous report as received from a physician, as part of a marketing research program, refers to a 15 year old female patient. The patient had no concurrent condition. On an unknown date the patient was vaccinated with her first dose of GARDASIL (dose and route were not reported) on an empty stomach. There was no concomitant therapy. On an unknown date in 2009 the patient experienced dizziness and she almost fainted. Blood pressure was normal in 10-15 minutes and she went home. No diagnostic test was performed. The outcome of the events was reported as recovering. The events did not prevent administration of second and third dose of GARDASIL. The reporter considered the events to be related to GARDASIL. Additional information is not expected since the physician does not wish to be contacted.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # K008334 with expiration date 09-JUN-2016; lot# K017721 with expiration date 27-AUG-2016, dose# and route unknown). No symptoms reported. The vaccines were stored under 9 C for 1 hour and 15 minutes without previous temperature excursion. No doses were administered past labeled expiry. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple, unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored doses of RECOMBIVAX HB via unreported route (batch# L040458, exp. 03-FEB-2018; L048236, exp. 31-MAR-2018). Concomitant medication was not mentioned. The vaccines underwent a temperature excursion by being stored at 0.9 degree Centigrade for a time frame of 11 hours 35 minutes (Incorrect product storage) on 18-MAR-2016. The call was a result of "data logger". There was no previous temperature excursion mentioned. No adverse effects were reported. Product quality complaint was not filed. Additional information has been requested. This is one of the four reports received from the same reporter.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: Sore on day given, followed by redness but not itchy, swelling.
Age: 65.0
Sex: F
Vaccine: HEPA, TYP, VARZOS, YF
Symptoms: Asthenia, Cerebrovascular accident, Chills, Headache, Lethargy
Clinical narrative: Could not speak words as I thought them, ran 2° fever, aches, chills, but headache so splitting & so "light sensitive", I thought I had a mild stroke. Could not function to get medical help for 2 days & still have lingering splitting headaches with extreme lethargy, stiffness in neck, and no strength. Could this have made heart condition worse? I have a LBBB, 30% E.F. and congestive heart failure. I just turned 65 in Jan. 2016.
Age: 65.0
Sex: F
Vaccine: HEPA, TYP, VARZOS, YF
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain, Photophobia, Pyrexia
Clinical narrative: Could not speak words as I thought them, ran 2° fever, aches, chills, but headache so splitting & so "light sensitive", I thought I had a mild stroke. Could not function to get medical help for 2 days & still have lingering splitting headaches with extreme lethargy, stiffness in neck, and no strength. Could this have made heart condition worse? I have a LBBB, 30% E.F. and congestive heart failure. I just turned 65 in Jan. 2016.
Age: 65.0
Sex: F
Vaccine: HEPA, TYP, VARZOS, YF
Symptoms: Speech disorder
Clinical narrative: Could not speak words as I thought them, ran 2° fever, aches, chills, but headache so splitting & so "light sensitive", I thought I had a mild stroke. Could not function to get medical help for 2 days & still have lingering splitting headaches with extreme lethargy, stiffness in neck, and no strength. Could this have made heart condition worse? I have a LBBB, 30% E.F. and congestive heart failure. I just turned 65 in Jan. 2016.
Age: 97.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local swelling, Pruritus, Skin warm, Tenderness
Clinical narrative: 4/24/16 - Redness/warmth/localized swelling/tenderness/itching noted, 4 inches in diameter. MD notified. Loratadine 10mg PO daily PRN and cool compress ordered. 4/26/16 - MD evaluated resident for other possible causes, MD felt it was an adverse reaction to PCV-13. PRN Loratadine given again. Mild improvement noted. 4/27/16 - Redness/warmth/swelling/itching as spread in a downward direction. MD notified. MD prescribed Cephalexin 500mg PO TID x7 days for possible cellulitis. Warm moist compress ordered 3x/day x7 days.
Age: 97.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination complication
Clinical narrative: 4/24/16 - Redness/warmth/localized swelling/tenderness/itching noted, 4 inches in diameter. MD notified. Loratadine 10mg PO daily PRN and cool compress ordered. 4/26/16 - MD evaluated resident for other possible causes, MD felt it was an adverse reaction to PCV-13. PRN Loratadine given again. Mild improvement noted. 4/27/16 - Redness/warmth/swelling/itching as spread in a downward direction. MD notified. MD prescribed Cephalexin 500mg PO TID x7 days for possible cellulitis. Warm moist compress ordered 3x/day x7 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Received MMR-V, DTaP-IPV, and Hepatitis A all on R deltoid during office visit 2 days ago, presented with 1.5 days of expanding erythema/edema/warmth and tenderness on R deltoid/upper arm. Afebrile, no fever by history, no n/v. Possible large local reaction to vaccines, however as with typical presentation of cellulitis, treated with cephalexin QID x 7 days.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. Since 23-MAR-2016, the patients were vaccinated with improperly stored PROQUAD (Merck) lot # L033697, expiration date-28-FEB-2017. No adverse event was reported. The outcome of event was unknown. No PQC (product quality complaint) was involved. Temperature was 30.09F for 6 hours. Previous temperature excursion was 47.2F for 2 hours 44 minutes. Temperature was not logged by data logger. 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 was received from a certified medical assistant regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. Since 23-MAR-2016, the patients were vaccinated with improperly stored (Merck) VARIVAX lot # L037559, expiration date-29-SEP-2017 (incorrect product storage). No adverse event was reported. The outcome of event was unknown. No PQC (product quality complaint) was involved. Temperature was 30.09F for 6 hours. Previous temperature excursion was 47.2F for 2 hours 44 minutes. Temperature was not logged by data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Administration site swelling, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Approx 4-6 hrs after administration, patient developed redness, swelling, tenderness at site of administration. Also developed low grade fever. Symptoms worsened over 2 days and pt sought medical care.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent conditions medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (lot # K002991 with expiration date 12-DEC-2014, oral, dose unknown). No symptoms reported. The vaccines were stored under 9 C for 1 hour and 15 minutes without previous temperature excursion. No doses were administered past labeled expiry. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Injection site reaction, Rash papular
Clinical narrative: Papular rash on bilateral thighs, not erythematous or swollen, no active drainage.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: Red, swollen, bumps with hives on forehead above both eye brows.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Arm blisters at site of injection.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: Pink macularopapular raised rash.
Age: 15.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Arthralgia, Blood test, Borrelia test, Headache, Inflammatory marker test
Clinical narrative: Shortly after receiving vaccine she started to get frequent headaches and joint pain.
Age: 15.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Red blood cell sedimentation rate
Clinical narrative: Shortly after receiving vaccine she started to get frequent headaches and joint pain.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Swelling
Clinical narrative: Pain and swelling. Couldn't lift my arm.
Age: 18.0
Sex: F
Vaccine: TYP, YF
Symptoms: Rash
Clinical narrative: Rash seen on her neck but only felt on her face. Went away in without treatment.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Presyncope
Clinical narrative: This spontaneous report as received from a physician, as part of a marketing research program, refers to a 15 year old female patient. In 2009 the patient was vaccinated with the first dose of GARASIL (lot # not provided). In 2009 the patient experienced "dizziness" and she was "almost" fainted, blood pressure was normal in 10-15 minutes and she went home. The physician noted that the patient was vaccinated on an empty stomach. The outcome of the events was reported as recovering, the events did not prevent administration of 2, 3 doses of GARDASIL. The reporter consider the AE to be related to GARDASIL. Additional information is not expected as the reporter was not willing to be contacted.
Age: 16.0
Sex: U
Vaccine: HPV4, MEN
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 16-year-old patient of unknown gender. No information about the patient's medical history and concurrent conditions were reported. On 19-FEB-2016, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K008931, expiry date 04-MAR-2017, injected in the left arm (dose and route of administration were not reported). Concomitant therapy included meningococcal vaccine (unspecified). Administered doses were exposed to the following conditions, temperature of 33 Fahrenheit degrees for 15 hours and 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required correspondence was received.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple, unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL 9 via unreported route (batch # L026602, exp. 19-OCT-2017; L045711, exp. 08-MAY-2017; K006124, exp. 02-FEB-2017). Concomitant medication was not mentioned. The vaccines underwent a temperature excursion by being stored at 0.9 degree centigrade for a time frame of 11 hours 35 minutes on 18-MAR-2016. The call was a result of "data logger". There was no previous temperature excursion mentioned. No adverse effects were reported. Product quality complaint was not filed. Additional information has been requested. This is one of the four reports received from the same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Diarrhoea, Injection site erythema, Nausea
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 61 year old female patient. The medical history and concurrent conditions were not reported. Concomitant medications were none. On 12-APR-2016, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. Approximately on 12-APR-2016, couple of hours later the patient developed redness at the injection site, nauseous, diarrhoea and loss of appetite. No treatment was rendered. No lab tests were performed. The outcome of the events were reported as not recovered/not resolved. The patient sought medical attention. 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 vocational nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an improperly stored dose of GARDASIL (incorrect product storage). The patient received either lot # K011562 (expiry date: 08-APR-2017) or K016966 (expiry date: 10-MAY-2017). There were no previous temperature excursions. Temperature was reported to be 34 F and the timeframe was 5 hours. There was no data logger. No symptoms were reported. Outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 26-APR-2016, the patient was inadvertently administered a dose of PNEUMOVAX 23 lot # K018528, intramuscularly (dose not reported) that expired on 14-APR-2016. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple, unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored dose of ROTATEQ via unreported route (batch# L037574, exp. 01-JUL-2017;  L038536, exp. 19-AUG-2017; L013034, exp. 28-JAN-2017; L039297; exp-19-JUN-2017). Concomitant medication was not mentioned. The vaccines underwent a temperature excursion by being stored at 0.9 degree centigrade for a time frame of 11 hours 35 minutes (incorrect product storage) on 18-MAR-2016. The call was a result of "data logger". There was no previous temperature excursion mentioned. No adverse effects were reported. Product quality complaint was not filed. Additional information has been requested. This is one of the four reports received from the same reporter.
Age: 53.0
Sex: M
Vaccine: HEPAB
Symptoms: Erythema, Rash
Clinical narrative: Two dime-sized rashes appear on left arm later in the evening shot was given. Several days later radiating red streaks appeared. Spouse called to report reaction on 4-28-2016. Since then the red streaks have disappeared but a rash remains on arms, stomach and ears. They have done no treatments. Referred to medical provider.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) referring to multiple patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. Since 10-DEC-2015, the patients were vaccinated with improperly stored doses of GARDASIL  (lot # K010215, expiration date 05-MAY-2017; route not reported). No adverse effects were reported. It was reported that the vaccines had been exhausted and there was no previous temperature excursion. The reporter called because of the data logger. The doses and vaccination dates were listed below: 10-DEC-2015, 2 doses; 11-DEC-2015, 3 doses; 12-DEC-2015, 2 doses; 14-DEC-2015, 2 doses; 16-DEC-2015, 1 doses; 17-DEC-2015, 1 dose; 21-DEC-2015, 2 doses; 22-DEC-2015, 9 doses; 23-DEC-2014, 3 doses; 28-DEC-2015, 2 doses; 04-JAN-2017. 2 doses; 06-JAN-2016, 4 doses; 07-JAN-2016, 1 doses, 14-JAN-2016, 1 doses; 15-JAN-2016, 2 doses'; 18-JAN-2016, 3 doses; 23-JAN-2016 (reported as 23-JAN-2015), 1 dose. Temperature/time frame was reported as : 10-DEC-2015: 25.7 (unit not provided), 9 hours, 37 minutes; 15-DEC_2015: 30.0 (unit not provided), 2 hours , 52 minutes. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Disorientation, Dizziness, Feeling abnormal, Limb discomfort, Mental status changes
Clinical narrative: Approximately 5-10 minutes after vaccine was administered patient reported feeling like she could fly, her arms later felt heavy. She was dizzy and disoriented. She was taken to her private physician. Admitted for altered mental status.
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: 3" x 3" hive on right subcat. area when immunization was given. Seen by clinic 48 hours later.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Pain
Clinical narrative: Mother went by office on April 26 stating that the patient also had debilitating symptoms and body pain just like her sister. And continues with symptoms. Not been medically evaluated. Mother is counsel  to do so.