chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Nerve compression, Pain
Clinical narrative: This spontaneous case, initially received from other non-health professional on 21-Feb-2018, concerning an adult female patient. The patient's current condition included: hypothyroid, high blood pressure, osteopenia and arthritis. The patient was allergic to sulfa drugs. Concomitant medications included: multivitamin, SYNTHROID and unspecified blood pressure medications. On an unspecified date in Oct-2014, the patient received INN Flu Vaccine Seasonal (anatomical location: right arm, dose, route of administration, batch number, expiry date, trade name and manufacturer: not reported). On an unspecified date, the patient experienced a pinched nerve with pain radiating from the injection site (right arm) to the base of my skull. The pain lasted for over several months and hence, the patient was sent for physical therapy on an unspecified date in May-2015 until the pain ended. The patient had recovered from all the events. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: This initial non-serious spontaneous case, received on 02-Mar-2018, reported by other non-health professional, concerns an adult female patient of unspecified age. On an unspecified date (5 years ago), the patient was administered influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported). On an unspecified date, after the administration of vaccine, the patient experienced nausea, vomiting and diarrhoea. At the time of this report, the outcome of the events was not reported.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Liquid product physical issue
Clinical narrative: This spontaneous case, initially received on 28-Feb-2018 combinedly processed with the source document received on 05-Mar-2018, reported by other health professional and concerns a 41-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 09-Feb-2018, the patient was administered with AFLURIA in which particles were floating (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: XT33908, expiry date: 30-Jun-2018) (explicitly coded as particle present in liquid product and drug administration error). The PTC (product technical complaint) number was PR493672. The product was stored properly without any temperature excursion or leakage. The reporter assessed this case as non-serious. Follow-up received on 23-Mar-2018 for other health professional: The reporter confirmed that, the product was stored properly, and no temperature excursion had occurred. Product leakage was also not reported prior to administration. Narrative was amended accordingly. Case correction received 28-Feb-2018: The LLT of the event "Particles floating in all of the AFLURIA TRIVALENT prefilled syringes' was changed from 'Product contamination particulate matter' to 'Particle present in liquid product' in the event tab. The narrative was amended accordingly.
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: This is an initial non-serious spontaneous case, received on 02-Mar-2018, reported by other non-health professional, concerning a male patient of unspecified age. On an unspecified date (5 years ago), the patient was administered with influenza vaccine, (dose, route of administration, anatomical location, batch number, expiry date, manufacture and trade name: not reported). On an unspecified date, after the administration of vaccine, the patient experienced nausea, vomiting and diarrhoea. At the time of this report, the outcome of the events was not reported.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Liquid product physical issue, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received from pharmacist on 14-Mar-2018 and concerns a 36-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 05-Feb-2018, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: XT33908, and expiry date: 30-Jun-2018) with foreign particles floating in syringe. No adverse event was noted after vaccination. Non-significant case correction received with IRD 14-Mar-2018: It was reported that, no adverse event was noted after vaccination. Follow up report received from the pharmacist on 16-Apr-2018: The vaccination date (05-Feb-2018) was added. The patient's age was updated from 35 to 36 years. The narrative was amended accordingly. Significant case correction received with IRD 14-Mar-2018: LLT for the event 'particles in the AFLURIA/[Four patients were administered vaccine with] foreign particles floating in syringe' was changed from 'product contamination particulate matter' to 'particle present in liquid product'. Amended narrative accordingly.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 15-Mar-2018, concerning a 62-year-old, adult, male patient. The patient's historical vaccine included pneumonia vaccine (unspecified date). The patient received other unspecified vaccinations within last 4 weeks (as reported). The patient's current conditions included asthma, wheezing, heart disease and lung disease (unspecified date). The patient was a smoker. On an unspecified date first temperature excursion of the vaccine occurred. On 18-Jan-2018, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, anatomical location: left arm, batch number: XT59906, expiry date: 06-Jun-2018 and route of administration: not reported) after first temperature excursion. On an unspecified the vaccine was stored out of range for 65 hours and 35 minutes, reaching a highest temperature of 60 degree F which was the fifth (5th) excursion with those vaccines.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Liquid product physical issue
Clinical narrative: This non-serious spontaneous case, initially received from pharmacist on 14-Mar-2018 and concerns an 18-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 05-Feb-2018, the patient was administered with AFLURIA (TIV) dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: XT33908 and expiry date: 30-Jun-2018) with foreign particles floating in syringe (explicitly coded as product contamination particulate matter and drug administration error). This case was associated with PTC (product technical complaint) with PTC reference number: PR485504. It was reported that, no adverse effects were noted after the vaccination. Follow-up report received from Pharmacist on 16-Apr-2018: The reporter confirmed the age of the patient (18-year-old) and date of vaccination (05-Feb-2018). Narrative amended accordingly. Case correction received with IRD 14-Mar-2018: The LLT of the event 'Particles in the AFLURIA pre-filled syringe' was changed from 'product contamination particulate matter' to 'particle present in liquid product' in the event tab. The narrative was amended accordingly.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Liquid product physical issue
Clinical narrative: This non-serious spontaneous case, initially received from a pharmacist on 14-Mar-2018, concerning a 56-year-old adult, female patient. The patient's medical history and concomitant medications were not reported. On 06-Feb-2018, the patient was administered with AFLURIA (TIV) with foreign particles floating in syringe (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: XT33908 and expiry date: 30-Jun-2018). This case was associated with PTC (product technical complaint) reference number: PR485504. It was reported that, the patient did not experience any adverse event. Follow-up received with IRD 16-Apr-2018: Updated age at vaccination (in patient tab). Added start date of vaccination (in product tab). Added start date for 'drug administration error' in the event tab. Upon external review, it was realised that the event coding for the event was incorrect in the event tab. Hence, the LLT for the event (Particles in the AFLURIA pre-filled syringe/[Four patients were administered vaccine with] foreign particles floating in syringe) was corrected from 'product contamination particulate matter' to 'particle present in liquid product' in the event tab. The narrative was amended accordingly.
Sex: F
Vaccine: FLUX
Symptoms: Gout
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 11-Mar-2018 and concerns an adult, female patient of unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date in Oct-2015, the patient was administered with influenza virus vaccine, dose, route of administration, anatomical location, batch number and expiry date: not reported). On an unspecified date, the patient experienced gout on right big toe. At the time of the report, the outcome of the event (gout) was not reported.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 15-Mar-2018, was reported by other health professional and concerns a male patient of unspecified age. On an unspecified date first temperature excursion of the vaccine occurred. On 23-Jan-2018, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: XT59906, expiry date: 06-Jun-2018) stored out of range. On an unspecified the vaccine was stored out of range for 65 hours and 35 minutes, reaching a highest temperature of 60 F which was the fifth (5th) excursion with those vaccines.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 15-Mar-2018, was reported by other health professional, concerning a 34-year-old, adult male patient. On 18-Jan-2018, the patient was administered with AFLURIA after the first excursion (dose: 0.5 ml, anatomical location: right arm, batch number: XT59906, expiry date: 06-Jun-2018, route of administration: not reported)(explicitly coded incorrect product storage and drug administration error). On an unspecified date, the vaccine was stored out of range for 65 hours and 35 minutes, that reached highest temperature of 60 F which was the fifth (5th) excursion with those vaccines.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 15-Mar-2018, concerning a 28-year-old, adult, male patient. On an unspecified date first temperature excursion of the vaccine occurred. On 30-Jan-2018, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XT59906, expiry date: 06-Jun-2018) after first temperature excursion. On an unspecified the vaccine was stored out of range for 65 hours and 35 minutes, reaching a highest temperature of 60 F which was the fifth (5th) excursion with those vaccines. Follow-up report received on 04-Apr-2018: Route of administration (intramuscular) was added.
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: The non-serious initial spontaneous case was received on 11-Oct-2017, concerning a female patient of an unspecified age. On an unspecified date, the patient was vaccinated with AFLURIA (TIV) (dose: 0.5 ml, route of administration, anatomical location, batch number expiry date: not reported). On an unspecified date, after vaccination, the patient experienced rash at injection site. The outcome of the event was not reported. The reporter assessed this case as non-serious.
Sex: M
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Syringe issue
Clinical narrative: This non-serious spontaneous case, initially received on 31-Jan-2018, was reported by other health professional and concerns a patient of unspecified age and gender. On an unspecified date, during the administration of AFLURIA (TIV) (dose, route of administration, anatomical location, batch number, expiry date: not reported), vaccine was not released when the eject button was pushed twice in the first attempt and in the second attempt the syringe was pushed with great pressure against arm and flew for about 10 feet. Following the vaccination, the patient had bleeding from the injection site. The next day, the patient was fine (recovered). During investigation of the injector, it was found that, the injector core was damaged which ultimately did not allow the syringe to be loaded approximately. The syringe was not verified to be fully seated by the user, but it was believed to cause the occurrence of the event. The injector core damage was believed to be caused by user abuse through repeated "dry firing" prior to the occurrence. Significant case correction received with the IRD 31-Jan-2018: The causality of the event injection site bleeding spot was changed from unassessable to not related. Follow-up received from other health professional on 26-Feb-2016: During investigation of the injector, it was found that the injector core was damaged which ultimately did not allow the syringe to be loaded approximately. The syringe was not verified to be fully seated by the user, but it was believed to cause the occurrence of the event. The injector core damage was believed to be caused by user abuse through repeated "dry firing" prior to the occurrence. The narrative was amended accordingly.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 15-Mar-2018, reported by other health professional (nurse), concerning a 47-year-old, adult, female patient. On 19-Jan-2018, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, anatomical location: left thigh, batch number: XT59906, expiry date: 06-Jun-2018 and route of administration: not reported) after first temperature excursion. On an unspecified date, the vaccine was stored out of range for 65 hours and 35 minutes, that reached highest temperature of 60 F which was the fifth (5th) excursion with those vaccines.
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This initial spontaneous case, initially received on 21-Feb-2018, reported by other non-health professional, concerning a female patient of unspecified age. On an unspecified date, the patient was administered with influenza vaccine, (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacture: not reported). On an unspecified date, after the administration of vaccine, the patient experienced increased pain and swelling of the left shoulder at the injection site. At the time of this report, the outcome of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 15-Mar-2018 was reported by other health professional, concerning a non pregnant female patient of unspecified age. It was reported that, the patient had a weakened immune system. On an unspecified date first temperature excursion of the vaccine occurred. On 24-Jan-2018, after the first temperature excursion, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: XT59906, expiry date: 06-Jun-2018). On an unspecified the vaccine was stored out of range for 65 hours and 35 minutes, reaching a highest temperature of 60 F which was the fifth (5th) excursion with those vaccines. Follow up report received on 04-Apr-2018: The vaccination date (24-Jan-2018) was added. The narrative was amended accordingly.
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 15-Mar-2018, was reported by other health professional, concerning a female patient of unspecified age. The patient's historical drug included: Pneumococcal vaccine. On 03-Feb-2018, the patient was administered with AFLURIA (TIV) after first excursion (dose: 0.5 ml, anatomical location: right arm, batch number: XT59906, expiry date: 06-Jun-2018, route of administration: not reported). On an unspecified date, the vaccine was stored out of range for 65 hours and 35 minutes, that reached highest temperature of 60 F which was the fifth (5th) excursion with those vaccines.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 15-Mar-2018, concerning a 35-year-old, adult, male patient. On an unspecified date first temperature excursion of the vaccine occurred. On 29-Jan-2018, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XT59906, expiry date: 06-Jun-2018) after first temperature excursion. On an unspecified the vaccine was stored out of range for 65 hours and 35 minutes, reaching a highest temperature of 60 F which was the fifth (5th) excursion with those vaccines. It was reported that, the patient did not experience any adverse event after vaccination. Follow up report received from other health professional (nurse) on 16-Apr-2018: The route of administration (intramuscular) of the suspect vaccine was added. It was reported that, the patient did not experience any adverse event after vaccination. The narrative was amended accordingly.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Myalgia
Clinical narrative: This spontaneous case, initially received from other non-health professional on 21-Feb-2018, concerns a 23-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2015, the patient was administered with influenza vaccine, (dose, route of administration, anatomical location, batch number and expiry date: not reported). On an unspecified date in 2015, the patient had malaise and myalgia. At the time of the report, the outcome of the events (malaise and myalgia) was not reported. The reporter assessed the case as non-serious. Non-significant case correction received with the IRD 21-Feb-2018: The case comment corrected accordingly.
Sex: M
Vaccine: FLU3, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 15-Mar-2018, reported by other health professional (nurse), concerning a male patient of unspecified age. It was reported that, the patient's current condition included asthma or wheezing (since an unspecified date). It was also reported that, the patient was a weed smoker (since an unspecified date). The concomitant medication included pneumococcal vaccine (administered on 02-Jan-2018). On 02-Jan-2018, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, anatomical location: left arm, batch number: XT59906, expiry date: 06-Jun-2018 and route of administration: intramuscular, anatomical location: left arm) after first temperature excursion). On an unspecified date, the vaccine was stored out of range for 65 hours and 35 minutes, that reached highest temperature of 60 F which was the fifth (5th) excursion with those vaccines. It was reported that, the patient did not experience any adverse effects. This case was cross-linked to the original case 201800429 (due to the same reporter). Follow-up report received on 09-Apr-2018: Route of administration (intramuscular), anatomical location (left arm) was updated. No adverse effects were noted. Amended narrative accordingly.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: This spontaneous case, initially received on 15-Mar-2018 was reported by other health professional and concerns a 54-year-old male patient. The patient's medical history was not reported. The patient's historical vaccine included pneumococcal vaccine. On an unspecified date first temperature excursion of the vaccine occurred. On 01-Feb-2018, after the first temperature excursion, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, anatomical location: right arm, route of administration and batch number: XT59906, expiry date: 06-Jun-2018). On an unspecified the vaccine was stored out of range of 65 hours and 35 minutes, reaching a highest temperature of 60 F which was the fifth (5th) excursion with those vaccines.
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: This spontaneous case, was initially received from a physician on 10-Oct-2017, concerning a female patient of an unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2016, (last year) (as reported), the patient was administered with AFLURIA (TIV) (dose: 05. ml, batch number: 12649211A, expiry date, route of administration and anatomical location: not reported). On an unspecified date in 2016, after the vaccination, the patient developed a rash. Outcome of the event was not reported. The reporter assessed the events as non-serious. Non-significant case correction received with IRD 10-Oct-2017: Batch no. (12649211A) was captured in the case form and narrative was amended accordingly.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: This initial spontaneous case, was received on 19-Oct-2017, from other non-health professional, concerning a 36-year-old, adult, male patient. The patient's medical history included confusion. The patient's concomitant medication included ADDERALL. The patient did not receive any relevant concomitant vaccines. On 17-Oct-2017, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: XT59806, expiry date: 05-Jun-2018). On the same day, the patient had headache. The patient was taken to emergency room, but was not admitted. Treatment measures for the event were reported. The patient received from the event on the same day (17-Oct-2017). The reporter assessed the event was non-serious.
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: This non-serious spontaneous case, initially received from Merck (Ref ID: 00750520) via other health professional (nurse) on 14-Mar-2018, concerning a patient of an unspecified age and gender. On an unspecified date, the patient was administered with AFLURIA (TIV) (dose, route of administration, anatomical location, batch number and expiry date: not reported). On an unspecified date, after the vaccination, the patient experienced allergic reaction. At the time of this report, the outcome of the event was not reported.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Hypersensitivity, Pruritus
Clinical narrative: This initial spontaneous case, was received on 03-Nov-2017, from a nurse, concerning a 20-year-old, adult male patient. The patient's concomitant medication included amlodipine for an unknown indication and the medical history was not reported. On 29-Oct-2017, the patient was administered with AFLURIA (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: XT0338 (as reported), expiry date: 30-Jun-2018). On 30-Oct-2017, after 2 days of vaccination, the patient woke up with a red face and itching in the groin area and received BENADRYL, unspecified steroid shot, MEDROL DOSEPAK. It was stated, the symptoms were subsided for some time but reoccurred later and his face was still red. On an unspecified date, the patient went to the allergist, who diagnosed him with allergy. The reporter stated that, the patient went to visit a cardiologist. At the time of this report, the patient had not yet recovered from the event. The reporter assessed the event as non-serious and considered the causality of the event as related. Follow up received on 22-Nov-2017: New event (allergy) was added and symptoms (red face and itching) were merged to the Allergy. It was reported that, the patient's face was still red, and he went to the allergist, who diagnosed him with allergy and also went to visit a cardiologist. The narrative was amended accordingly.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous case, was initially received from other health professional (nurse) on 29-Sep-2017, concerning a 21-year old female pregnant patient. On 28-Sep-2017, the patient (pregnant woman) was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: 00644623A, expiry date: 30-Jun-2018, route of administration and anatomical location: not reported). The reporter assessed the report as non-serious. Non-significant case correction received with IRD 29-Sep-2017: Batch no. (00644623A) was captured in the case form and narrative was amended accordingly. Non-significant follow-up received on 23-Feb-2018: Added reference number in the additional information tab (Med Info Number: SEQ17-3436). No changes were made in the narrative.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: This non-serious spontaneous case, initially received on 07-Feb-2018, was reported by healthcare professional (pharmacist), concerning a 27-year-old, pregnant patient. On 05-Feb-2018, the patient was administered with AFLURIA (TIV) (batch number: 15149211A, expiry date: 30-Jun-2018, route of administration: intramuscular, anatomical site: deltoid). Follow-up received from other health professional on 27-Feb-2018: The reporter confirmed that, no information was available regarding LMP (last menstrual period). Added vaccination details (dose: 05. ml, route of administration: intramuscular, anatomical location: deltoid). Narrative was amended accordingly.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: This non-serious spontaneous case, was initially received from other health professional (nurse) on 27-Sep-2017, concerning a 52-year-old, adult female patient. The patient's medical history included: allergic to tegaderm and had received flu shot in the past. On 20-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: 00444611A, expiry date: 30-Jun-2018, route of administration, anatomical location: not reported). On 22-Sep-2017, after 3 days of vaccination, the patient complained of redness, itching and pain on touch. Injection site described as being red, raised, tender to touch and the size of a half dollar. No pain was experienced while raising the arm. The patient was treated with BENADRYL and hydrocortisone cream. The outcome of the events was not reported. The reporter assessed the report as non-serious. Non-significant case correction received 27-Sep-2017: Batch number (00444611A) was added on the screen and updated expiry date. The narrative was amended accordingly.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: This non-serious spontaneous case, was initially received from other health professional (nurse) on 27-Sep-2017, concerning a 52-year-old, adult female patient. The patient's medical history included: allergic to tegaderm and had received flu shot in the past. On 20-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: 00444611A, expiry date: 30-Jun-2018, route of administration, anatomical location: not reported). On 22-Sep-2017, after 3 days of vaccination, the patient complained of redness, itching and pain on touch. Injection site described as being red, raised, tender to touch and the size of a half dollar. No pain was experienced while raising the arm. The patient was treated with BENADRYL and hydrocortisone cream. The outcome of the events was not reported. The reporter assessed the report as non-serious. Non-significant case correction received 27-Sep-2017: Batch number (00444611A) was added on the screen and updated expiry date. The narrative was amended accordingly.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This initial spontaneous case, was received on 09-Oct-2017 from other non-health professional concerning a female pregnant adult patient of unspecified age. On an unspecified date, the patient was administered with AFLURIA QUADRIVALENT (dose, route of administration, anatomical location, batch number, expiry date: not reported). It was reported that, the pregnant patient was administered with vaccine in the past. The outcome of the event was not reported. The reporter considered the case as non-serious.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous case, was initially received on 13-Oct-2017, from a consumer, concerning a 40-year-old adult female patient of 22 weeks pregnancy. The patient's historical medications included unspecified IVF (intravenous fluids). The patient had no relevant maternal or paternal medical history, congenital anomaly in previous pregnancy, defect in prenatal test, adverse pregnancy outcome, spontaneous abortion/still birth. The patient previously had 2 pregnancies and one miscarriage. It was reported that the patient was not using contraceptives at that time. The concomitant medication included prenatal vitamins. The last menstrual period (LMP) was reported as 13-May-2017. On 11-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: XF30907, expiry date: 30-Jun-2018). The patient was administered with the vaccine at 22 weeks of pregnancy (explicitly coded as vaccine exposure during pregnancy). No adverse event was reported in foetus and the patient. The EDD (estimated date of delivery) was reported as 17-Feb-2018. The reporter assessed the report as non-serious. Non-significant case correction received 13-Oct-2017: Batch number (XF30907) was captured in the case form and narrative was amended accordingly.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site mass, Injection site rash, Injection site urticaria
Clinical narrative: This initial spontaneous case, was received on 17-Oct-2017, from other health professional (nurse), concerning a 48-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 01-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch no: XF31507, expiry date: Jun-2018). On the same day, between 30 minutes to 1 hour after administration of vaccine, the patient developed hives, lumps and rashes around the injection site. Outcome of the events was not reported. The reporter assessed this report as non-serious. Follow up received on 27-Oct-2017: The dose (0.5 ml), route of administration (intramuscular) and anatomical location (deltoid) were updated. The reporter stated that, it was unknown if the patient still had lumps. The narrative was amended accordingly.
Sex: M
Vaccine: FLU4
Symptoms: Exposure via breast milk, No adverse event
Clinical narrative: This initial spontaneous case, was received from pharmacist (consumer) on 18-Oct-2017, concerning a patient of an unspecified age and gender. The patient's mother's current condition included breastfeeding. On 06-Oct-2017, the patient's mother was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, anatomical location: left arm, batch number, expiry date, route of administration: not reported). The patient's mother received the vaccine, which had been stored under temperature up to 53 F for an undetermined amount of time and patient (baby) received the vaccine via breastfeeding. No adverse event was reported. The reporter assessed the events as non-serious.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This initial spontaneous case, was received on 02-Nov-2017, from a consumer, concerning a 31-year-old adult female pregnant patient. The patient had no relevant medical history and the concomitant mediations included prenatal vitamins. It was reported that the patient had not used any contraceptives and her husband was not on any medication prior to the conception. The last menstrual period was reported as 06-Sep-2017. On 02-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, expiry date: not reported). It was reported that the patient was vaccinated at 8 weeks and 1 day of pregnancy (first pregnancy) and developed mild soreness at the site. There was no adverse event reported for the foetus. The estimated date of delivery was reported as 13-Jun-2018. The reporter assessed the events as non-serious.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: This spontaneous case, initially received on 07-Nov-2017, was reported by a other health professional (nurse) and concerns a 44 years old female. The patient's medical history not reported. The patient was not allergic to any components of the vaccine. On 05-Oct-2017, the patient was administered AFLURIA QUADRIVALENT (dose 0.5ml, route of administration: intramuscular, anatomical location: right deltoid, batch number:01344611A, expiry date: 30-Jun-2018). On the same day, within 1 hour after receiving vaccine, the patient experienced hives under the arm. At night, the patient also had itching, and the hives moved to the stomach and thigh. The patient was treated with BENADRYL for the events. The reporter stated that there was no itching and just a few spots were left. Hives were pretty much disappeared. The outcome of the events was reported as recovering. The reporter considered the case as non-serious.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This initial spontaneous case, was received on 15-Nov-2017, from a consumer, concerning a 30-year-old adult female pregnant patient. The patient had a history of previous pregnancy (single). The patient's current condition included thalassemia minor. The concomitant medications included, prenatal vitamins and iron. The last menstrual period was reported as an unspecified date in Mar-2017. On 20-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left side (as reported), batch number, expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy). The estimated due date (EDD) was reported as 27-Dec-2017. The reporter assessed the event as non-serious.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: This initial spontaneous case, received on 10-Nov-2017 reported by a pharmacist and concerns a 37-year-old adult female patient. The patient's concomitant medication included: Omeprazole and Hydrochlorothiazide for an unknown indication. On 02-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: XF32908, expiry date: not reported). On 03-Oct-2017 after the administration of vaccine, the patient experienced soreness on the injection site. At the time of this report, the event was not recovered. The reporter assessed this case as non-serious.
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: This non-serious initial spontaneous case, was received from nurse on 27-Nov-2017, concerning a 22-year-old, adult, male patient. The patient had no known allergies. The patient's medical history and concomitant medications were not reported. On 01-Nov-2017, patient was administrated with AFLURIA QUADRIVALENT (dose: 05. ml, route of administration: intramuscular, batch number: 00144621A, anatomical location: right deltoid and expiry date: not reported). On the same day, after about 1.5 hours of vaccination, the patient experienced hives all over the body and went to ER (emergency room), where he received the BENADRYL and discharged to home. The same day (01-Nov-2017), the patient recovered from the event. The reporter considered the causality of the event as related to the suspect vaccine.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event, Prenatal screening test
Clinical narrative: This non-serious spontaneous case, initially received on 19-Dec-2017, by other health care professional, concerning a 26-year-old, adult female patient with weight 109 lb and height 61 inches. The patient had one previous pregnancy with no pregnancy complications (reported as no birth defect/congenital anomaly) and no concomitant diseases was reported. The patient had no history of tobacco, alcohol or illicit drug use. Concomitant medications included VITAFOL ONE for healthy pregnancy. The patient's last menstrual period was reported as on 24-Jul-2017. It was reported that there was no evidence of a defect/adverse finding from a prenatal test. On 12-Sep-2017, the patient received AFLURIA QUADRIVALENT (batch number: 00644623A, dose, route of administration, anatomical location, expiry date: not reported) at 7th week of pregnancy. It was reported that neither the patient nor the foetus experienced any adverse event. The outcome of the event was not reported. The patient's EDD (estimated date of delivery) was reported as 02-Apr-2018.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Amniocentesis normal, Exposure during pregnancy, No adverse event, Prenatal screening test, Ultrasound antenatal screen normal
Clinical narrative: This non-serious spontaneous case, initially received on 20-Dec-2017, was reported by other health professional and concerns a 43-year-old adult female pregnant patient of weight 129 pounds and 59 inches. The patient's history included, 3 previous pregnancies in which two are full term live births and one spontaneous abortion. The patient had no family history of major congenital malformations. The patient had no habit of tobacco, alcohol or illicit drug use. The historical conditions included chlamydial infection and UTI (urinary tract infection). The historical drugs included ZITHROMAX for chlamydia and MACROBID for UTI. The patient LMP (last menstrual period) was reported as 28-May-2017. The concomitant medication included VITAFOL-ONE. On 17-Aug-2017, cystic fibrosis mutation analysis was normal (no major congenital malformations noted). On 25-Aug-2017, first trimester screen and Panorama performed was normal (no major congenital malformations noted). On 22-Sep-2017, amniocentesis performed was normal (no major congenital malformations noted). On 28-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose, route of administration, anatomical location, batch number: 00644623A (as reported), expiry date: not reported), at 17th week of pregnancy (explicitly considered as vaccine exposure during pregnancy). The patient had no adverse events. The EDD (estimated date of delivery) was reported as 04-Mar-2018.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Delivery, Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: This non-serious initial spontaneous case, was received on 08-Sep-2017 from nurse, concerning a 36-year-old, adult pregnant female patient. The patient had no medical history. The patient had no maternal and paternal history relevant to pregnancy. The patient had past 4 pregnancies and had 3 children. The patient had no still birth or miscarriage, birth defect or congenital anomaly and spontaneous abortion occurred in any previous pregnancy. The patient's concomitant medication included EFFEXOR for an unknown indication. The patient did not use any contraceptive methods. The patient's LMP (last menstrual period) date was 26-Apr-2017, gestation period and weeks at exposure were 19 weeks. On 08-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: XF30506 (as reported), expiry date: 26-Jun-2018), route of administration: intramuscular and anatomical location: not reported). On an unspecified date, the vaccine was exposed to temperatures up to 70-degree F, which was considered as incorrect product storage. The pregnant patient was administered with vaccine that exposed to temperatures up to 70F instead of storing at 36-46-degree F was considered as drug administration error and vaccine exposure during pregnancy. It was reported that, no adverse event occurred after the vaccination in the patient and foetus. The patient's estimated date of delivery was 18-Jan-2018. The outcome was a live infant with no complications. The reporter assessed the report as non-serious. Follow-up report received on 16-Apr-2018: The patient's estimated date of delivery was confirmed as 18-Jan-2018. The outcome was a live infant with no complications. Upon internal review, no adverse event which no longer exists and added special case scenario with no AE in general tab. Amended narrative accordingly.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, was initially received on 18-Sep-2017 from other non-health professional (HCP staff), concerning a 76-years-old, elderly, female patient. This is the first case of the 2 cases reported. The patient current condition included: blood clotting, non-specified. Concomitant medication included ASA for an unknown indication. On 08-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (batch no: 00144621A and expiry date: 31-May-2018, dose, route of administration and anatomical location: not reported). On an unspecified date, 8 unopened MDV (multi-dosage vial) and 14 syringes drawn from MDV that reached unknown temperature for unknown amount of time, 1st excursion and patient was administered with that vaccine. It was reported that, the patient did not experience any adverse event after the first excursion of the vaccine administered. At the time of this report, the outcome of the events were not reported. Follow up report received on 21-Sep-2017: New event (no adverse event) was added. It was reported that, the patient did not experience any adverse event after the first excursion of the vaccine administered. The narrative was amended accordingly. Non-significant follow up received on 11-Oct-2017: The age of the patient was changed from 89 to 76 in the narrative. The narrative was amended accordingly. Non-significant case correction received with IRD 18-Sep-2017: Batch number was added in the screen and updated expiry date. The narrative was amended accordingly. Significant case correction received with IRD 21-Sep-2017: The event 'no adverse event' was deleted.
Age: 89.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, was initially received on 18-Sep-2017 from other health professional (HCP staff), concerning an 89-year-old, elderly, female patient. This is second case of the two cases reported. The patient had an unspecified medical history. Concomitant medication included ASA. On 08-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (batch no: 00144621A and expiry date: 31-May-2018, dose, route of administration and anatomical location: not reported). On an unspecified date, 8 unopened MDV (multi-dosage vial) and 14 syringes drawn from MDV that reached unknown temperature for unknown amount of time i.e., underwent first time excursion (explicitly coded to incorrect product storage) and the patient was administered with that vaccine (explicitly coded to drug administration error). It was reported that, the patient experienced no adverse event. The outcome of the events was not reported.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Feeling of body temperature change, Headache, Hyperhidrosis, Malaise
Clinical narrative: This initial non-serious spontaneous case, was received on 19-Sep-2017, from a pharmacist concerning a 52-year-old female patient adult patient. The patient's medical history and concomitant medications were not reported. On 13-Sep-2107, the patient was administered with AFLURIA QUADRIVALENT (dose:0.5 ml, batch number: XF30506 (as reported), expiry date: 29-Jun-2018, route of administration, anatomical location: not reported). On 14-Sep-2017, 2 days after vaccination, the patient got extremely sick with symptoms such as hot and cold flashes and night sweats. On 15-Sep-2017, the subject had headache, nausea, chills, fever and sweats. The patient was treated with TYLENOL and asked to take rest. At the time of the report, the patient had not recovered (ongoing) from the events night sweats, flushing, sickness and was recovered from the events headache, nausea, chills, fever and sweats. The reporter assessed the events as non-serious. Follow up report received on 27-Sep-2017: The new events nausea, fever and sweats were coded. The indication of the vaccine from influenza vaccination to influenza prophylaxis onset date of the events headache, chills from 14-Sep-2017 to 15-Sep-2017 and outcome of the events headache, chills from not recovered to recovered were updated. The narrative was amended accordingly.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Night sweats, Pyrexia
Clinical narrative: This initial non-serious spontaneous case, was received on 19-Sep-2017, from a pharmacist concerning a 52-year-old female patient adult patient. The patient's medical history and concomitant medications were not reported. On 13-Sep-2107, the patient was administered with AFLURIA QUADRIVALENT (dose:0.5 ml, batch number: XF30506 (as reported), expiry date: 29-Jun-2018, route of administration, anatomical location: not reported). On 14-Sep-2017, 2 days after vaccination, the patient got extremely sick with symptoms such as hot and cold flashes and night sweats. On 15-Sep-2017, the subject had headache, nausea, chills, fever and sweats. The patient was treated with TYLENOL and asked to take rest. At the time of the report, the patient had not recovered (ongoing) from the events night sweats, flushing, sickness and was recovered from the events headache, nausea, chills, fever and sweats. The reporter assessed the events as non-serious. Follow up report received on 27-Sep-2017: The new events nausea, fever and sweats were coded. The indication of the vaccine from influenza vaccination to influenza prophylaxis onset date of the events headache, chills from 14-Sep-2017 to 15-Sep-2017 and outcome of the events headache, chills from not recovered to recovered were updated. The narrative was amended accordingly.