chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and 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 ROTATEQ (lot # L008054, expiration date: 30-NOV-2016) (dose and route of administration were not reported). No symptoms were reported. Administered doses of vaccine experienced the temperature excursion of 0 degrees Celsius for 6 days. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: This spontaneous report was received from a nurse (patient's mother), via company representative, regarding her daughter of 12 or 13 years old (currently she is 19 years old). The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patient was vaccinated with doses of GARDASIL intramuscular, (dosing details not provided). It was reported that the patient received all 3 doses of GARDASIL at the age of 12 or 13 years (exact age uncertain). The patient had unspecified adverse event on an unknown date while on therapy with GARDASIL. Then on unknown date, the patient was vaccinated with GARDASIL 9 as a fourth dose, (dose and route not provided) (Extra dose administered). Subsequently, on an unknown date, the patient experienced sore at injection site arm. The patient did not seek medical attention and no treatment was given to her. The outcome of the events was reported as recovered. Causality assessment was not provided. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. The nurse reported that a patient received her first dose of the GARDASIL on 23-OCT-2014 and then received a second dose of the HPV series which was GARDASIL 9 on 13-JUN-2016. No adverse effects were reported. No product quality complaint (PQC) was reported for the suspect products. 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 pharmacist refers to multiple unspecified patients of unknown age. On multiple unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (lot # K010323 and expiry date: 10-MAY-2017). No adverse effects were reported. The vaccine was stored as 63F for 156 hours. There was no previous excursion reported and no data logger. No product quality complaint was reported for ROTATEQ. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 6 month 10 days old infant patient. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with first dose of ROTATEQ in immunization series (lot # L035637, with expiry date: 09-JUN-2017 which is outside recommended schedule. No adverse effects were reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient with breast cancer. There was no information about the patent's concomitant medications and drug reactions or allergies reported. On 08-JUN-2016, the patient was vaccinated with PNEUMOVAX 23 injection (lot# L019835, 23-MAR-2017; dose and anatomical location were not reported) intramuscularly for prevention of pneumococcal disease. On the same day, the patient experienced a sore arm, swelling and redness which began in the evening, that she received the vaccine. The reporter also stated that the patient applied warm compresses to the arm. The outcome of the events was not recovered. The patient sought medical attention and called the reporting pharmacist. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: This spontaneous report was received from a nurse, via company representative, refers to an 18 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-APR-2016, the patient was vaccinated with a dose of GARDASIL lot # K010215, intramuscularly, (dose and expiry date not provided). Subsequently, on the same day, the patient experienced throat closed and she could not breathe. The patient did not go to emergency room that day. Then the next day, on 13-APR-2016, the patient family sought medical attention and took her to urgent care (facility unknown), where she was treated with unspecified steroid pack. The patient's parent strongly thought that physician may have given the patient something other than GARDASIL. The outcome of the throat tightness and dyspnoea was reported as recovered in approximately 2016. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age. On multiple unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot # J014281 and expiry date: 16-SEP-2016. No adverse effects were reported. The vaccine was stored as 63F for 156 hours. There was no previous excursion reported and no data logger. No product quality complaint was reported for PEDVAXHIB. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a radiology technician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-MAR-2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection (lot# L016123, expiration date 06-MAY-2017; dose, anatomical location and route of administration were not reported). No adverse events were reported. Temperature was 10.6 degrees Fahrenheit for 9 days. The data logger was involved and there was no previous temperature excursion reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to 3 patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On 10-JUN-2016, the patients were vaccinated with improperly stored (72 degrees Fahrenheit for 12 hours) dose of M-M-R II lot # L009214, expiration date 17-MAR-2017 (dose and route of administration were not reported. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a radiology technician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies of medical history provided.  On 22-APR-2016, the patient was vaccinated with and improperly stored dose of VARIVAX injection (lot # L016123, expiration date 06-MAY-2017; dose, anatomical location and route of administration were not reported). No adverse events were reported. Temperature was 10.6 degrees Fahrenheit for 9 days. The data logger was involved and there was no previous temperature excursion reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practitioner nurse regarding 2 patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored VARIVAX lot # L021215/expiration date- 10-JUN-2017. No adverse event was reported. No concomitant medication was reported. Excursion temperature was 10.5 F and timeframe was 4 hours and 45 minutes. There was no prior temperature excursion. Call was because of the data logger. No concomitant medication was reported. The outcome of the event was unknown. No PQC(product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to approximately 7 patients of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. It was reported that, temperature excursion was occurred for ZOSTAVAX in April at a temperature of 21F for 11 hours and 30 minutes. On unspecified dates, approximately 7 patients were vaccinated with improperly stored ZOSTAVAX of dose 0.65 ml, lot # L044529, expiry date 09-FEB-2017, subcutaneously (dose number, strength, vaccination site not provided) since temperature excursion. No adverse events were reported by patients. On 20-JUN-2016 (reported as "last night"), temperature excursion was occurred again at temperature of 6.8F for 11 hours and 30 minutes. The vaccine was not administered to the patients since 20-JUN-2016 (reported as "last night excursion"). Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 year old patient. It was reported that on 10-AUG-2011, the patient may had been vaccinate with ZOSTAVAX instead of VARIVAX. The reporter stated that she cannot read the complete lot#/expiry date on the patient's vaccination record, however she provided the product lot#/exp ad possibly "13862/expiry date: 19-JAN-2012". No product quality complaint (PQC) was reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, patients were vaccinated with improperly stored doses of PEDVAXHIB (lot number reported as M010439 and expiration date 08-DEC-2018, dose and route of administration were not reported). The temperature of excursion was minus 2 Celsius degrees and the time frame was 20 hours. The conditions were back in range at the time of the report. There was no previous temperature excursion. It was stated that it was because of a data logger. No adverse effects were reported. No product quality complaint (PQC) 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 radiology technician refers to a patient of unknown age and gender. There was no  information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection (lot# L016123, expiration date 06-MAY-2017; dose, anatomical location and route of administration were not reported). No adverse events were reported. Temperature was 10.6 degrees Fahrenheit for 9 days. The data logger was involved and there was no previous temperature excursion reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, patients were vaccinated with improperly stored doses of VAQTA (lot # M021124 and expiration date 02-FEB-2018, dose and route of administration were not reported). The temperature of excursion was minus 2 Celsius degrees and the time frame was 20 hours. The conditions were back in range at the time of the report. There was no previous temperature excursion. It was stated that it was because of a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 19 year old patient. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On 25-AUG-2015, the patient was vaccinated with first dose of GARDASIL 9 and second dose of GARDASIL 9 was vaccinated on 05-JAN-2016 (dosing details were not reported). On 10-JUN-2016 the patient received third dose of GARDASIL (interchange of vaccine products and inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L044475 and expiration date 12-MAY-2017, dose and route of administration were not reported). The temperature of excursion was minus 2 Celsius degrees and the time frame was 20 hours. The conditions were back in range at the time of the report. There was no previous temperature excursion. It was stated that it was because of a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of 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 licensed practitioner nurse regarding 1 patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX lot # L037791/expiration date - 30-DEC-2016. No adverse event was reported. No concomitant medication was reported. Excursion temperature was 10.5 F and timeframe was 4 hours and 45 minutes. There was no prior temperature excursion. Call was because of the data logger. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to multiple unspecified patients of unknown demographics. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patients' were vaccinated with improperly stored doses of M-M-R II lot # L024267 with expiration date 01-JUL-2017 (dose, strength, and route unknown (incorrect product storage). The vaccine was exposed to temperature of 71.2 Fahrenheit )F) for 7  hours and 31.8 F for 106 hours. Data logger was involved. It was unknown if there was any previous temperature excursion. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with first dose of (Oka/Merck) VARIVAX (dosing details were not reported). On an unknown date the patient experienced chicken pox. The nurse inquired about the administration of second dose of (Oka/Merck) VARIVAX when the patient developed chickenpox at an unspecified time after first dose. The outcome of the event was not reported. The reporter did not provide the causality assessment between the event and the suspect therapy. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 29-APR-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot number and expiration date were not reported). The patient was inadvertently administered a second dose of GARDASIL 9 (dose, route of administration, lot number and expiration date were not reported) on 16-MAY-2016. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 19 year old patient on an unknown gender. On an unspecified date in September 2002, the patient was vaccinated with the first dose of M-M-R II (lot # L040961, expiration date 19-OCT-2017) (dose and route not reported). The second dose of M-M-R II was administered on 20-MAY-2016 (lot # L040961 exp. 19-OCT-2017) and a third dose was administered on 14-JUN-2016 (L040961, exp. 19-OCT-2017). No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's pertinent medical history and drug allergies were not reported. On 20-JUN-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # L040442 and expiry date: 15-JAN-2017). Concomitant medications were unknown. The pharmacist reported that a patient may have been administered a dose of ZOSTAVAX via the intramuscular route instead of the subcutaneous route. The patient experienced itching and redness at the injection site shortly after administration. The outcome of the events was not reported. The causality of the events was not provided. No product quality complaint (PQC) was reported for ZOSTAVAX. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Injection site rash, Pain
Clinical narrative: Rash developed at injection site roughly 1 day after vaccination. Around 2 in x 1 in red and inflamed.  Painful to touch.
Sex: F
Vaccine: HPV9
Symptoms: Eye pruritus, Fungal infection, Lymphadenopathy, Pruritus
Clinical narrative: This spontaneous report was received from a nurse practitioner (midwife) regarding a female patient of unknown age. Current condition and Medical history were not provided. On an unknown date, the patient started therapy with GARDASIL 9 (dose, route of administration and lot# were not provided). Concomitant medications were not reported. On an unknown date, the patient developed lymphadenopathy and itching of the eyes and face a week after receiving her 2nd dose of GARDASIL 9. Patient went to an urgent care clinic where she was prescribed an unspecified antibiotics (manufacturer unknown). The nurse reported that the unspecified antibiotic caused a yeast infection on an unknown date. Nurse prescribed VISTARIL as treatment for itching. Outcome of the events were not reported. Causality was not reported. 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 healthcare worker and refers to multiple patients of unknown demographics. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patients' were vaccinated with improperly stored doses of ROTATEQ lot # L039228 with expiration date of 27-JUN-2017 (dose, strength, and route unknown). The vaccine was exposed to temperature of 71.2 Fahrenheit (F) for 7 hours and 31.8 F for 106 hours. Data logger was involved. It was unknown if there was any previous temperature excursion. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a radiology technician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-MAR-2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection (lot# L016123, expiration date 06-MAY-2017; dose, anatomical location and route of administration were not reported). No adverse events were reported. Temperature was 10.6 degrees Fahrenheit for 9 days. The data logger was involved and there was no previous temperature excursion reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 09-JUN-2016 the patient was vaccinated with improperly stored (72 degrees Fahrenheit for 12 hours) dose of MMR II lot # L009214, expiration date 17-MAR-2017 (dose and route of administration were not provided). No adverse effect was reported. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 16 year old patient of unknown gender. Medical history, concurrent conditions and concomitant medications were not reported. On 10-JUN-2016 (also reported as 10-JUN-2017) when the patient was 16 years, was vaccinated with (Oka-Merck) PROQUAD lot # M004895 expiry date 26-JUL-2017. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to multiple patients of unknown demographics. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patients' were vaccinated with improperly stored doses of VAQTA lot # M009377 with expiration date of 17-JUN-2017 (dose, strength, and route unknown) (improper product storage). The vaccine was exposed to temperature of 71.2 Fahrenheit (F) for 7 hours and 31.8 for 106 hours. Data logger was involved. It was unknown if there was any previous temperature excursion. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. In June 2016 (reported as "within the past 3 days"), multiple patients were vaccinated with ROTATEQ (lot # L046318, expiration date 28-SEP-2017; oral, dose was not reported) which had been through a temperature excursion. The nurse reported that ROTATEQ with lot # reported as L035637, expiration date 09-JUN-2017, was also administered to multiple patients on multiple unknown dates following temperature excursion (temperature: 34 F 10 minutes; previous temperature excursion: 35 for 10 minutes; the call was not because of a data logger). No adverse effects were reported. Additional information is not expected as no consent was given to contact the physician.
Sex: M
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-JUN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB injection, lot # L038018, expiration date: 13-SEP-2017 (exact dose, dose number, route of administration and anatomical location were not reported). There were no adverse effect reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness, itching at left arm (subcutaneous) injection site, per pt of PNEUMOVAX 23 vaccine.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, VARZOS, VARZOS
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse referring to a 16 year old female patient. On 22-JUN-2016 the patient was vaccinated with a dose of ZOSTAVAX (lot # L039095, expiration date: 08-JAN-2017, subcutaneous, once, dose was unknown), instead of VARIVAX. No adverse effects were reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, VARZOS, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse referring to a 16 year old female patient. On 22-JUN-2016 the patient was vaccinated with a dose of ZOSTAVAX (lot # L039095, expiration date: 08-JAN-2017, subcutaneous, once, dose was unknown), instead of VARIVAX. No adverse effects were reported. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Arm very hot and swollen.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Fatigue, Injection site swelling, Myalgia, Nausea
Clinical narrative: Swelling on and around site of reaction (left arm and left upper chest); fever, nausea; fatigue.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: Swelling on and around site of reaction (left arm and left upper chest); fever, nausea; fatigue.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm began to become hot and swollen and was painful the evenening of the vaccine. There were also some small spots within the redness. The redness and swelling were not in the direct area in which the vaccine was delivered. The symptoms became more severe the next day, but started to improve slightly by the 2nd day after vaccine. When the patient came to the pharmacy, The pharmacist on duty looked at the area and suggested that she go to Urgent MD. Patient was headed to church and said she would go in the morning. I reccomended that she apply cold compresses and watch for any sudden changes or worsening of reaction.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site rash, Vaccination site swelling
Clinical narrative: Swelling of vaccination site, development of hard bump approx. 1/25" and red ring rash approx. 3 1/2" around vaccination site.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Hot flush, Middle insomnia, Pain, Pain in extremity, Skin warm
Clinical narrative: My left arm became hot and throbbed, a condition that lasted about a week, and disrupted my sleep each night. Even after the pain lessened, I woke about every two hours every night for more than 6 weeks. Within a couple of weeks after receiving the vaccine, I suddenly began experiencing severe and frequent hot flashes, which went on for 2-3 weeks, then stopped completely. In late April, I also began experiencing shooting pains down my left arm, which may or may not be related to the vaccine.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Sleep disorder
Clinical narrative: My left arm became hot and throbbed, a condition that lasted about a week, and disrupted my sleep each night. Even after the pain lessened, I woke about every two hours every night for more than 6 weeks. Within a couple of weeks after receiving the vaccine, I suddenly began experiencing severe and frequent hot flashes, which went on for 2-3 weeks, then stopped completely. In late April, I also began experiencing shooting pains down my left arm, which may or may not be related to the vaccine.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Febrile convulsion, Pyrexia, Rhinorrhoea
Clinical narrative: Fever. Runny rose. Febrile Seizure.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 15-JUN-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (dose and route not reported, lot # J004332 and expiration date 26-SEP-2014). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
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. On unspecified dates the patients were vaccinated with improperly stored VAQTA (lot # M009377, expiration date 17-JUN-2017, lot # L015460, expiration date 20-JUL-2017, strength, dose and route were not reported). No adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected since it was not allowed to contact the reporter.
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. On  unspecified dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L048849, expiration date 04-FEB-2018, strength, dose and route were not reported). No adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected since it was not allowed to contact the reporter.
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. On unspecified dates the patients were vaccinated with improperly stored ROTATEQ (lot # L037574, expiration date 01-JUL-2017, lot #L038536, expiration date 19-AUG-2017, strength, dose and route were not reported). No adverse event reported. This is one of several reports received from the same reporter. Additional information is not expected since it was not allowed to contact the reporter.
Sex: U
Vaccine: HIBV
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. On unspecified dates the patients were vaccinated with improperly stored PEDVAXHIB (lot # J014279, expiration date 16-SEP-2016, strength, dose and route were not reported). No adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected since it was not allowed to contact the reporter.
Sex: U
Vaccine: HPV9
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. On unspecified dates the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L044475, expiration date 12-MAY-2017, Lot M004116, expiration date 12-OCT-2017, strength, dose and route were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected since it was not allowed to contact the reporter.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local swelling
Clinical narrative: Local swelling, redness
Age: 41.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 41 year old patient of unknown gender. There was no pertinent medical history, concurrent condition or concomitant therapy reported. On 14-JUN-2016 the patient was vaccinated with PROQUAD (Drug Administered to Patient of Inappropriate Age), Lot # L016394 with expiration date of 08-NOV-2016 (strength, dose and route were not reported). No adverse reaction was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates, the patients were vaccinated with improperly stored doses of MMR II (lot# L015282 with expired date 30-APR-2017, lot# L026550 with expired date 16-JUL-2017, therapy type: rHA, dose and route were unknown). No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse via company representative, referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 24-FEB-2016 the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot# and expiration date were not reported). Then on 01-MAR-2016, the patient received a dose of PREVNAR 13 (dose and route were not reported) (inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a physician via a field employee referring to a 20 years old female patient. There was no pertinent medical history, drug reaction or concomitant medication reported. On unspecified dates in 2008, the patient was vaccinated with all 3 doses of GARDASIL (dose, route of administration, Lot# and expiration date were not reported). On an unspecified date, the patient developed human papillomavirus (HPV) infection. The physician reported that the HPV was probably a different strain than what was in the vaccine. The outcome of the event was not reported. The causality 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 registered nurse regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown dates staring on or after 28-MAY-2016, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # L039660/expiration date-04-FEB-2018 (incorrect product storage). No adverse event was reported. No concomitant medication was reported. Excursion temperature was 33 F and timeframe was 1 hour. There was prior temperature excursion of 64F for 4 hours. Call was because of the data logger. No concomitant medication was reported. The outcome of the event was unknown. No PQC(product quality complaint) was involved. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Abdominal pain, Aggression, Chest discomfort, Condition aggravated, Cyanosis
Clinical narrative: Initial unsolicited report received from a consumer (patient's daughter) on 09 June 2016. This case involves a 73-year-old female patient who was vaccinated with a first dose of Fluzone QIV (Batch number: UI422AB, expiration date: 30 June 2016, dose, route and site of administration were not reported) on 18 December 2015. Patient's illness at time of vaccination was not reported. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as Alzheimer's Dementia. Concomitant medications were not reported. Other vaccinations within 4 weeks of vaccinations were reported as none. On 18 December 2015 at night, same day post vaccination, the patient felt ill, experienced head cold that progressed to a chest cold, swollen nose, sore throat, chest pressure pain palpitations a feeling like she would die of a heart attack. On an unspecified date, post vaccination, patient was lethargic, developed rash across her back and her hand turned blue, patients Alzheimer's has become progressively worse, patient was prone to outburst and destroying things and cannot hold a conversation, numbness in her hands and feet and pain in her mid-abdomen to her ovaries area. It was reported that the patient had a residual from Guillain Barre syndrome. It was also reported that the patient received her flu shot before traveling and the symptoms have returned. The patient required ER/doctor visit. Laboratory investigations and corrective treatment were not reported. The patient was not recovered from the events. Upon internal review, the company decided to consider the event serious because of important medical events Guillain Barre syndrome, lethargic, chest pain, heart palpitation, numbness in feet, numbness in hands, feeling abnormal, worsening of Alzheimer's dementia, outburst of anger and chest cold. List of documents held by sender: none. Sender's Comments: The reported events Guillain Barre syndrome is listed and worsening of Alzheimer's dementia is unlisted with INFLUENZA QUADRIVAL A-B VACCINE. Time to onset is not compatible with the role of the vaccine. Further information for e.g investigative details. This case is not sufficiently documented. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 73.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Dementia, Dementia Alzheimer's type, Feeling abnormal, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Initial unsolicited report received from a consumer (patient's daughter) on 09 June 2016. This case involves a 73-year-old female patient who was vaccinated with a first dose of Fluzone QIV (Batch number: UI422AB, expiration date: 30 June 2016, dose, route and site of administration were not reported) on 18 December 2015. Patient's illness at time of vaccination was not reported. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as Alzheimer's Dementia. Concomitant medications were not reported. Other vaccinations within 4 weeks of vaccinations were reported as none. On 18 December 2015 at night, same day post vaccination, the patient felt ill, experienced head cold that progressed to a chest cold, swollen nose, sore throat, chest pressure pain palpitations a feeling like she would die of a heart attack. On an unspecified date, post vaccination, patient was lethargic, developed rash across her back and her hand turned blue, patients Alzheimer's has become progressively worse, patient was prone to outburst and destroying things and cannot hold a conversation, numbness in her hands and feet and pain in her mid-abdomen to her ovaries area. It was reported that the patient had a residual from Guillain Barre syndrome. It was also reported that the patient received her flu shot before traveling and the symptoms have returned. The patient required ER/doctor visit. Laboratory investigations and corrective treatment were not reported. The patient was not recovered from the events. Upon internal review, the company decided to consider the event serious because of important medical events Guillain Barre syndrome, lethargic, chest pain, heart palpitation, numbness in feet, numbness in hands, feeling abnormal, worsening of Alzheimer's dementia, outburst of anger and chest cold. List of documents held by sender: none. Sender's Comments: The reported events Guillain Barre syndrome is listed and worsening of Alzheimer's dementia is unlisted with INFLUENZA QUADRIVAL A-B VACCINE. Time to onset is not compatible with the role of the vaccine. Further information for e.g investigative details. This case is not sufficiently documented. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 73.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Lethargy, Lower respiratory tract infection, Malaise, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Initial unsolicited report received from a consumer (patient's daughter) on 09 June 2016. This case involves a 73-year-old female patient who was vaccinated with a first dose of Fluzone QIV (Batch number: UI422AB, expiration date: 30 June 2016, dose, route and site of administration were not reported) on 18 December 2015. Patient's illness at time of vaccination was not reported. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as Alzheimer's Dementia. Concomitant medications were not reported. Other vaccinations within 4 weeks of vaccinations were reported as none. On 18 December 2015 at night, same day post vaccination, the patient felt ill, experienced head cold that progressed to a chest cold, swollen nose, sore throat, chest pressure pain palpitations a feeling like she would die of a heart attack. On an unspecified date, post vaccination, patient was lethargic, developed rash across her back and her hand turned blue, patients Alzheimer's has become progressively worse, patient was prone to outburst and destroying things and cannot hold a conversation, numbness in her hands and feet and pain in her mid-abdomen to her ovaries area. It was reported that the patient had a residual from Guillain Barre syndrome. It was also reported that the patient received her flu shot before traveling and the symptoms have returned. The patient required ER/doctor visit. Laboratory investigations and corrective treatment were not reported. The patient was not recovered from the events. Upon internal review, the company decided to consider the event serious because of important medical events Guillain Barre syndrome, lethargic, chest pain, heart palpitation, numbness in feet, numbness in hands, feeling abnormal, worsening of Alzheimer's dementia, outburst of anger and chest cold. List of documents held by sender: none. Sender's Comments: The reported events Guillain Barre syndrome is listed and worsening of Alzheimer's dementia is unlisted with INFLUENZA QUADRIVAL A-B VACCINE. Time to onset is not compatible with the role of the vaccine. Further information for e.g investigative details. This case is not sufficiently documented. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 73.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Pain, Palpitations, Rash, Swelling
Clinical narrative: Initial unsolicited report received from a consumer (patient's daughter) on 09 June 2016. This case involves a 73-year-old female patient who was vaccinated with a first dose of Fluzone QIV (Batch number: UI422AB, expiration date: 30 June 2016, dose, route and site of administration were not reported) on 18 December 2015. Patient's illness at time of vaccination was not reported. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as Alzheimer's Dementia. Concomitant medications were not reported. Other vaccinations within 4 weeks of vaccinations were reported as none. On 18 December 2015 at night, same day post vaccination, the patient felt ill, experienced head cold that progressed to a chest cold, swollen nose, sore throat, chest pressure pain palpitations a feeling like she would die of a heart attack. On an unspecified date, post vaccination, patient was lethargic, developed rash across her back and her hand turned blue, patients Alzheimer's has become progressively worse, patient was prone to outburst and destroying things and cannot hold a conversation, numbness in her hands and feet and pain in her mid-abdomen to her ovaries area. It was reported that the patient had a residual from Guillain Barre syndrome. It was also reported that the patient received her flu shot before traveling and the symptoms have returned. The patient required ER/doctor visit. Laboratory investigations and corrective treatment were not reported. The patient was not recovered from the events. Upon internal review, the company decided to consider the event serious because of important medical events Guillain Barre syndrome, lethargic, chest pain, heart palpitation, numbness in feet, numbness in hands, feeling abnormal, worsening of Alzheimer's dementia, outburst of anger and chest cold. List of documents held by sender: none. Sender's Comments: The reported events Guillain Barre syndrome is listed and worsening of Alzheimer's dementia is unlisted with INFLUENZA QUADRIVAL A-B VACCINE. Time to onset is not compatible with the role of the vaccine. Further information for e.g investigative details. This case is not sufficiently documented. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.