chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This case refers to 65th out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored o 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This refers to 68th out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F. And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event and reporter's comment: Amended narrative accordingly.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 04-Dec-2017, concerning a 64-year-old adult female patient. The patient had no medical history and she did not receive any concomitant medications. On 01-Dec-2017, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, route of administration; intramuscular, anatomical location: deltoid, batch number: XT30006 and expiry date: 07-Jun-2018) which underwent temperature excursion of maximum 55-degree Fahrenheit for 3.5 hours (explicitly coded as incorrect product storage and drug administration error). It was reported that, no adverse event was noted. The reporter assessed the events as non-serious. Non-significant follow up received on 03-Jan-2018: The reporter confirmed the age (64-year-old) of the patient and batch number (XT30006) of the vaccine.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This refers to 63rd out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event and reporter's comment. Amended narrative accordingly.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers to 64 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This case refers to 70th out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that  the temperature was not monitored on 24-Oct-2017 and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event and reporter's comment: Amended narrative accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an elderly male patient of unspecified age. This refers to 69 of 84 patients. On an unspecified date in 2017, the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8 degree C) and was administered to the patient (explicitly considered as drug administration error). It was reported that the temperature was no monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received from the reporter on 09-Nov-2017: Added event as no adverse effect. The narrative was amended accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 71 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F. And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event and reporter's comment. Amended narrative accordingly.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 72 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This refers to 73rd out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F. And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-217 and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event and reporter's comment. Amended narrative accordingly.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers to 74 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2107 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This refers to 75th out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This refers to the 78th out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporters comment. Amended narrative accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an elderly male patient of unspecified age. This refers 76 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This refers 77 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult female patient of unspecified age. This refers to 80th out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers to 79 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult female patient of unspecified age. This refers 81 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 82 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This refers to 83rd out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Swelling face, Urticaria
Clinical narrative: This spontaneous case, initially received on 14-Nov-2017, from a physician, concerning a 48-year-old, adult female patient. The patient's medical history and concomitant medication was not reported. On 26-Oct-2013, the patient was administered with AFLURIA (dose: 0.5ml, batch number: R54607 (as reported), expiry date: 30-Jun-2014, dose, route of administration, anatomical location: not reported). On the same day of vaccination, patient experienced hives and facial swelling. The patient also experienced chest tightness. The patient received BENADRYL as treatment measure for the events. At the time of this report, the patient had completely recovered from the events. The reporter assessed the case as non-serious. Non-significant follow-up received on 23-Feb-2018: Added reference number in the additional information tab med info number (SEQ17-6144). Non-significant case-correction received 14-Nov-2017: Narrative sentence was corrected.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial spontaneous case, was received from other health professional (nurse) on 08-Nov-2017, concerning a patient of unspecified age and gender. On 20-Oct-2017, the patient was administered with AFLURIA (TIV) (dose: (reported as one dose), expiry date: Jun-2018 (as reported) route of administration, anatomical location, and batch number: not reported). On the same day, the patient was administered with the vaccine that had been left out at room temperature from 9AM to 5PM. It was reported that, the patient did not experience any adverse event. The reporter assessed the case as non-serious.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure via skin contact, Underdose
Clinical narrative: This initial spontaneous case, was received from other non-health care professional on 21-Nov-2017, concerning a 62-year-old, adult, female patient. On 17-Nov-2017, the patient was administered with AFLURIA (TIV) (dose: less than 0.5ml (as reported), route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: was not reported). On the same day, while administration of the vaccine, it dripped down her arm (explicitly coded as under dose and underdose). It was reported that, the patient had cleansed her arm after contact. The reporter considered the event as non-serious.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious initial spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult, male patient of unspecified age. This refers to 84 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: This initial spontaneous case, was received on 13-Oct-2017, by a pharmacist, concerning a patient of unspecified age and gender. The patient's medical history and concomitant medications were not reported. It was reported that, on an unspecified date, one of the resident was given last year's AFLURIA (TIV) (explicitly coded as expired vaccine used) (dose, route of administration, anatomical location, batch number, expiry date was not reported). The outcome of the event was not reported. The reporter considered this case as non-serious.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous case, was initially received from other health professional on 05-Oct-2017, concerning a 3.5-year-old child patient. On 05-Oct-2017, the patient was administered with AFLURIA (dose: 0.5 ml, batch number: XT33908, expiry date: 30-Jun-2018, anatomical location: right deltoid, route of administration: intramuscular). The 3.5-year-old patient received AFLURIA TRIVALENT (not approved for use in children less than 5 years of age) (explicitly coded as Inappropriate age at vaccine administration). It was reported that, the patient was well and did not have any fever after the administration of the vaccine. The reporter assessed the event as non-serious. Follow up report received on 17-Oct-2017: The route of administration (intramuscular) of the vaccine was updated. It was reported that, the patient was well and did not have any fever after the administration of the vaccine. The narrative was amended accordingly. Non-significant case correction received 05-Oct-2017: Batch number (XT33908) was captured in the case form and narrative was amended accordingly.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Lymphadenopathy
Clinical narrative: This is a spontaneous case, initially received from other healthcare professional (nurse) on 27-Nov-2017, concerning a female patient of an unspecified age. The patient's medical history and concomitant medication were not reported. On 10-Nov-2017, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: XF30306 and expiry date: 28-Jun-2018). On the same day (10-Nov-2017), evening after vaccination, the patient developed swollen lymph nodes on the left side, where the shot was given. It was reported that, after a week, the patient felt little sore on the area, but the swelling went down. At the time of this report, the patient was recovering from the event lymphadenopathy and had not recovered from the event injection site pain. The reporter assessed the events as non-serious. Follow-up received on 27-Feb-2018: It was reported that, 3 attempts were made to contact the reporter to obtain information but there was no response. Hence, this case was considered as lost to follow-up. Significant case correction received with the IRD 27-Nov-2017: The LLT of the event "Lymphadenopathy" was changed from lymphadenopathy to swollen lymph nodes.
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: This spontaneous case, initially received from a nurse on 27-Nov-2017, concerning a female patient of an unspecified age. The patient's medical history and concomitant medications were not reported. On 18-Oct-2017, the patient was administered with AFLURIA (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: XF30306 and expiry date: 28-Jun-2018). On an unspecified date, after the vaccination, the patient complained of sound like motorcycle motor in her ear and described vibration as a noise similar to the back windows of the car up and the front ones down (tinnitus). It was reported that, the patient felt better ("but event come and go"). No treatment was taken for the event. The patient had recovered from the event (reported as couple of weeks ago). The reporter assessed the event as non-serious and considered the causality of the event as related to the suspect vaccine. Follow up received on 28-Dec-2017: The outcome of the event was updated from not recovered to recovered. The narrative was amended accordingly. Significant case correction received 27-Nov-2017 on 28-Nov-2017: LLT was changed from tinnitus to ear noises for the event "Patient complains of feeling like she hears a motorcycle motor in her ear/Described vibration as a noise similar to that occurring when one has the back windows of the car up but the front ones down". Amended narrative accordingly. Non-significant case correction received 27-Nov-2017: Was changed from 27-Nov-2018 to 27-Nov-2017. Non-significant case correction received 27-Nov-2017: Case comment was corrected.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Granuloma annulare, Injection site erythema
Clinical narrative: This spontaneous case, initially received from other health professional (Pharmacist) on 29-Nov-2017, concerning a 58-year-old, adult, female patient. On 15-Oct-2017, the patient was administered with AFLURIA trivalent (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch no: XT30006 and expiry date: 07-Jun-2018). On 20-Oct-2017, the patient noticed a dot at the vaccination site. It was reported that the dot is red and was radiating (reported as growing). The patient consulted a physician and was diagnosed with granuloma annulare. The patient was prescribed with unspecified steroid cream but had no improvement. At the time of this report, the patient had recovered from the event granuloma annulare and the event injection site redness was not resolved. The reporter assessed this case as non-serious. Significant case correction received with IRD 29-Nov-2017: The "description to be coded" term was changed from 'injection site dentation' to 'injection site redness'. Follow-up received on 17-Jan-2018: It was reported that, the patient was not previously vaccinated, and the vaccine was administered on 15-Oct-2017. The patient was diagnosed with granuloma annulare and it had resolved on an unspecified date. Narrative was amended accordingly.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 04-Dec-2017, concerning a 42-year-old adult male patient. The patient had no medical history and he did not receive any concomitant medications. On 01-Dec-2017, the patient was administered with AFLURIA (dose: 0.5 ml, route of administration; intramuscular, anatomical location: deltoid, batch number: XT30006 and expiry date: 07-Jun-2018), which underwent temperature excursion of maximum 55 degree Fahrenheit for 3.5 hours (explicitly coded as incorrect product storage and drug administration error). It was reported that, no adverse event was noted. The reporter assessed the events as non-serious. Non-significant follow up received on 03-Jan-2018: The reporter confirmed the age (42-year-old) of the patient and batch number (XT30006) of the vaccine.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Neck pain
Clinical narrative: This non-serious spontaneous case, was initially received on 08-Oct-2017, reported by other non-health professional and concerns a patient of unspecified age and gender. The patient's medical history and concomitant medications were not reported. The patient's historical drug included Influenza vaccine. On an unspecified date, the patient received AFLURIA (dose, route of administration, anatomical location: left arm, batch number: 14649211A and expiry date: 30-Jun-2018). On an unspecified date, after receiving the vaccine, the patient experienced severe pain on left side of neck and shoulder. It was reported that, the patient felt bad that it has been limiting his range of motion, particularly of his neck. It was reported that, the patient has been getting flu vaccine every year of the past 15 years and have never experienced this. The patient was worried that this is a usual side effect of this particular vaccine or lot. The outcome of the events was not reported. Non-significant case correction received 08-Oct-2017: Batch number (14649211A) was added on the screen. The narrative was amended accordingly. Non-significant case correction received with 08-Oct-2017: The narrative was corrected in a comprehensive manner.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal, Flushing, Headache, Hypoaesthesia
Clinical narrative: This spontaneous case, was received from other-non health professional on 13-Oct-2017, concerns a 68-year-old, elderly female patient. Since an unspecified date, the patient had allergy to latex, glutamate, and formaldehyde. On 13-Oct-2017, at 13:30 hours, the patient was administered with AFLURIA (dose: 0.5 ml, route of administration, anatomical location, batch number and expiry date: not reported). On 13-Oct-2017, 02 hours after the vaccination, the patient was flushed all over, felt dizzy, her heart was racing and had headache. The patient also experienced numbness in legs twice a day, which recovered in few days and she still experienced strong headaches. No treatment was given for the events. The patient inquired if there was anything in vaccine which could make her feel that way. The patient did not search for any medical assistance. At the time of this report, the patient had not recovered from the events (reported as symptoms persists) and recovered from the event numbness in legs. The reporter assessed the events as non-serious. Follow up report received on 18-Oct-2017: The new event numbness in leg was added. It was reported that, her leg started feeling weird (numbness), twice that day, which recovered after few days, she still experienced strong headaches and she did not search for any medical assistance. The narrative was amended accordingly. Significant case correction received 13-Oct-2017: HLT (high level term) of the event flushing was corrected to general signs and symptoms NEC from peripheral vascular disorders NEC.  Onset from the last dose of the event headache and dizziness was corrected to 2 hrs.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations
Clinical narrative: This spontaneous case, was received from other-non health professional on 13-Oct-2017, concerns a 68-year-old, elderly female patient. Since an unspecified date, the patient had allergy to latex, glutamate, and formaldehyde. On 13-Oct-2017, at 13:30 hours, the patient was administered with AFLURIA (dose: 0.5 ml, route of administration, anatomical location, batch number and expiry date: not reported). On 13-Oct-2017, 02 hours after the vaccination, the patient was flushed all over, felt dizzy, her heart was racing and had headache. The patient also experienced numbness in legs twice a day, which recovered in few days and she still experienced strong headaches. No treatment was given for the events. The patient inquired if there was anything in vaccine which could make her feel that way. The patient did not search for any medical assistance. At the time of this report, the patient had not recovered from the events (reported as symptoms persists) and recovered from the event numbness in legs. The reporter assessed the events as non-serious. Follow up report received on 18-Oct-2017: The new event numbness in leg was added. It was reported that, her leg started feeling weird (numbness), twice that day, which recovered after few days, she still experienced strong headaches and she did not search for any medical assistance. The narrative was amended accordingly. Significant case correction received 13-Oct-2017: HLT (high level term) of the event flushing was corrected to general signs and symptoms NEC from peripheral vascular disorders NEC.  Onset from the last dose of the event headache and dizziness was corrected to 2 hrs.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: UrticariaPruritus.
Age: 10.0
Sex: M
Vaccine: HEP, IPV
Symptoms: Extra dose administered
Clinical narrative: Per records, pt needed IPV and HBV and was given. When entered to record these vaccines, patient had received them, Upon further research into records, our former employee, later fired, had entered DTaP only instead of the PEDIARIX that had actually been given. I attempted to call the home and mobile numbers 4 times yesterday, including one at 7:40 pm. And again, no response this am so I left a msg on the home phone. Mom's voice box was full on her cell. I explained what happened, told her we would remove any charges, apologized for our error I forgot to mention that we would be reporting this to VAERS.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Immediate post-injection reaction, Pallor, Vomiting
Clinical narrative: The patient became dizzy immediately after the vaccine was given. His face was pale and he vomited.
Age: 68.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Dyspnoea
Clinical narrative: On the day of vaccine, patient went to emergency room with the symptom of shortness of breath.
Age: 23.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Immediate post-injection reaction, Posture abnormal, Syncope, Unresponsive to stimuli
Clinical narrative: Immediately following administration of VARIVAX, pt. experienced brief episode of syncope.. Pt. was drooped over in chair, unresponsive within minutes, pt. became slow in responsive and was able to talk. Pt. given water and became stable within next 15-20 minutes.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: SkinRash and UrticariaPruritus.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: My arm got progressively more sore and more red until it covered most of my upper arm from the shoulder to the elbow. It was about 6 inches long and 5 inches wide. It felt very hot and was very sore. My arm was also noticeably swollen appearing larger than the other arm. It was not itchy. On day 6, the red spot faded in the center to more pink but a 1 inch brighter red ring surrounded the perimeter. I felt mildly ill on one day. I did not have a fever. It took about 3-4 more days for the redness to go away. I have photos of my arm if you are interested. The only other info is that I'd not ever had Chicken pox. At about age 40 when my kids got the Chicken Pox vaccine, I got it and got Chicken pox mild case.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: My arm got progressively more sore and more red until it covered most of my upper arm from the shoulder to the elbow. It was about 6 inches long and 5 inches wide. It felt very hot and was very sore. My arm was also noticeably swollen appearing larger than the other arm. It was not itchy. On day 6, the red spot faded in the center to more pink but a 1 inch brighter red ring surrounded the perimeter. I felt mildly ill on one day. I did not have a fever. It took about 3-4 more days for the redness to go away. I have photos of my arm if you are interested. The only other info is that I'd not ever had Chicken pox. At about age 40 when my kids got the Chicken Pox vaccine, I got it and got Chicken pox mild case.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Eye inflammation, Gait disturbance, Injection site erythema, Photophobia, Vision blurred
Clinical narrative: May 22 received PREVNAR 13 vaccine then next day pt. stated she notice reduced vision OU and an increase in floaters.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Visual impairment, Vitreous floaters
Clinical narrative: May 22 received PREVNAR 13 vaccine then next day pt. stated she notice reduced vision OU and an increase in floaters.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Intraocular lens implant, Ophthalmological examination abnormal, Visual impairment, Vitreous floaters
Clinical narrative: May 22 received PREVNAR 13 vaccine then next day pt. stated she notice reduced vision OU and an increase in floaters.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Pain, Pain in extremity, Swelling
Clinical narrative: LEFT ARM VERY SORE AFTER SHOT WAS GIVEN. THE SORENESS REMAINS TO THIS DAY 6/19/18. NO FULL RANGE OF MOTION WITHOUT PAIN AND DISCOMFORT. SOMETIME THE AREA THROBS AT NIGHT AND HURTS WHEN WALKING WHEN I SWING MY ARM.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Discomfort, Pain, Pain in extremity, X-ray limb
Clinical narrative: LEFT ARM VERY SORE AFTER SHOT WAS GIVEN. THE SORENESS REMAINS TO THIS DAY 6/19/18. NO FULL RANGE OF MOTION WITHOUT PAIN AND DISCOMFORT. SOMETIME THE AREA THROBS AT NIGHT AND HURTS WHEN WALKING WHEN I SWING MY ARM.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: LEFT ARM VERY SORE AFTER SHOT WAS GIVEN. THE SORENESS REMAINS TO THIS DAY 6/19/18. NO FULL RANGE OF MOTION WITHOUT PAIN AND DISCOMFORT. SOMETIME THE AREA THROBS AT NIGHT AND HURTS WHEN WALKING WHEN I SWING MY ARM.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: X-ray
Clinical narrative: LEFT ARM VERY SORE AFTER SHOT WAS GIVEN. THE SORENESS REMAINS TO THIS DAY 6/19/18. NO FULL RANGE OF MOTION WITHOUT PAIN AND DISCOMFORT. SOMETIME THE AREA THROBS AT NIGHT AND HURTS WHEN WALKING WHEN I SWING MY ARM.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Vaccination site swelling
Clinical narrative: Extreme back pain on the 4th day after receiving shot. Patient tried TYLENOL, but pain did not go away.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain
Clinical narrative: Extreme back pain on the 4th day after receiving shot. Patient tried TYLENOL, but pain did not go away.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Musculoskeletal pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 72-year-old female patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020) for prophylaxis. On 6th June 2018, the patient received the 1st dose of SHINGRIX. On 9th June 2018, 3 days after receiving SHINGRIX, the patient experienced injection site warmth (serious criteria other: as per reporter) and erythema (serious criteria other: as per reporter). On 12th June 2018, the patient experienced shoulder pain (serious criteria other: as per reporter). The patient was treated with ibuprofen and BENADRYL. On an unknown date, the outcome of the injection site warmth, erythema and shoulder pain were not recovered/not resolved. The reporter considered the injection site warmth, erythema and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: At the beginning, on 9th June 2018, the patient began to notice redness, and fever at the injection site, described as 4-5 inches outside of the area. On an unknown date, the symptoms began to improve. Six days, after receiving SHINGRIX, on 12th June 2018, the symptoms worsened and began spreading down her arm. Beginning of the 12th June 2018, the patient reported to her pharmacist that she felt like she was hurting up in her shoulder. As treatment, the patient was given Ibuprofen and BENADRYL and recommended to apply ice. The reporting healthcare professional contacted the patient's primary doctor, but no emergency room or doctor visit was required at the time of the report. The batch number of SHINGRIX was updated from EX279 to EK279, as per sales data sheet.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, CSF glucose increased, CSF lymphocyte count increased, CSF protein increased, CSF test abnormal
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of varicella zoster virus infection in a 77-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included Aspirin, finasteride, FLOMAX, Lidocaine, HUMALOG and atenolol. In May 2018, the patient received the 1st dose of SHINGRIX. On 6th June 2018, 21 days after receiving SHINGRIX, the patient experienced varicella zoster virus infection (serious criteria hospitalization), redness (serious criteria hospitalization), skin scaly (serious criteria hospitalization) and rash (serious criteria hospitalization). In June 2018, the patient experienced confusion. The patient was treated with acyclovir. On an unknown date, the outcome of the varicella zoster virus infection, redness, skin scaly, rash and confusion were unknown. It was unknown if the reporter considered the varicella zoster virus infection, redness, skin scaly, rash and confusion to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX 3 weeks prior to being hospitalized. The patient experienced rash mostly in C6T1 dermatome and lesions scattered in chest and back. The patient also presented with redness and scaling over thoracic dermatome. The patient presented to the hospital on 6th June 2018. Prior to admission, the patient also presented as being confused. On 6th June 2018, Varicella antibody Ig G and Ig M test results came out positive. On 9th June 2018 lumbar puncture was performed and PCR results showed presence of varicella zoster. The patient was currently still hospitalized, had been put on intravenous Acyclovir in the hospital. No further details were provided by the reporter.