chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dyspnoea, Gait disturbance, Hypoaesthesia, Oropharyngeal pain
Clinical narrative: This spontaneous case, initially received from other professional (nurse) on 13-Nov-2017, concerning a 48-year-old adult female patient. The patient had been allergic to animals, mushrooms and onions. On 09-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: XF33408, and expiry date: 30-Jun-2018). On the same day of vaccination, the patient experienced itching on chest, shoulders, back and sides, difficulty in breathing, slow, thick speech and vocal changes. The patient also experienced tremors, numbness, weakness, sore throat and unbalanced gait on right side. The treatment medications included BENADRYL, prednisone and epinephrine. On an unspecified date, the patient had recovered from the events. The reporter assessed the events as non-serious. Follow up received on 11-Jan-2018: The indication (influenza prophylaxis) of the suspect product and outcome of the events (from recovering to recovered) were updated. The narrative was amended accordingly.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Speech disorder, Tremor
Clinical narrative: This spontaneous case, initially received from other professional (nurse) on 13-Nov-2017, concerning a 48-year-old adult female patient. The patient had been allergic to animals, mushrooms and onions. On 09-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: XF33408, and expiry date: 30-Jun-2018). On the same day of vaccination, the patient experienced itching on chest, shoulders, back and sides, difficulty in breathing, slow, thick speech and vocal changes. The patient also experienced tremors, numbness, weakness, sore throat and unbalanced gait on right side. The treatment medications included BENADRYL, prednisone and epinephrine. On an unspecified date, the patient had recovered from the events. The reporter assessed the events as non-serious. Follow up received on 11-Jan-2018: The indication (influenza prophylaxis) of the suspect product and outcome of the events (from recovering to recovered) were updated. The narrative was amended accordingly.
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site pain, Syringe issue
Clinical narrative: This initial non-serious spontaneous case, was received from other non-health professional on 16-Nov-2017, concerns a female patient of unspecified age. On 09-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (anatomical location: deltoid, dose, route of administration, batch number and expiry date: not reported). It was reported that the patient received flu shot at a clinic, but no fluid was released in the first attempt from Stratis NFIS (Needle-free Injection System). The same result with the second attempt, the Stratis NFIS did not release the vaccine at time of administration. It was reported that the patient felt very strong punch each time she was injected. She was vaccination with a conventional needle/syringe injection, which occurred without incident. On 09-Nov-2017, the patient's arm was bruised and sore at the injection site. The outcome of the events was not reported. Follow up received on 07-Dec-2017: The vaccination date (09-Nov-2017) was updated. It was confirmed that, vaccination was not delivered from Stratis NFIS (Needle-free Injection System). 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 adult male patient. This refers 28th 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 31 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 case refers to 30th 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 (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: 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 36 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 38th 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 (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: 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 39 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (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: 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 40th 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 (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 an adult male patient of unspecified age. This refers 41 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (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 not 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 non-serious initial spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult, female patient of unspecified age. This refers to 43 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (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 (not 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 an adult female patient of unspecified age. This refers 44 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (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: 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 xx of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (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: 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 46 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (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: 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 47 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: 68.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Blood immunoglobulin E normal, Blood sodium decreased, Full blood count normal, Injection site pain
Clinical narrative: Pt administered PNEUMOVAX 23 L deltoid 6/14/18. Within few hrs, pain/tenderness at steroid site of injection progressed to shoulder/exam/neck/ (L) mid back used MOTRIN sparingly (pt with H/O intolerance to prednisone) slowly improving Sx's. Had no RXN to PREVNAR 13, Tdap. Saw allergist 6/18/18 Dx'd with Adverse RXN to vaccine, but not hypersensitivity RXN.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Metabolic function test, Musculoskeletal pain, Neck pain, Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: Pt administered PNEUMOVAX 23 L deltoid 6/14/18. Within few hrs, pain/tenderness at steroid site of injection progressed to shoulder/exam/neck/ (L) mid back used MOTRIN sparingly (pt with H/O intolerance to prednisone) slowly improving Sx's. Had no RXN to PREVNAR 13, Tdap. Saw allergist 6/18/18 Dx'd with Adverse RXN to vaccine, but not hypersensitivity RXN.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Thyroid function test normal, Vaccination complication
Clinical narrative: Pt administered PNEUMOVAX 23 L deltoid 6/14/18. Within few hrs, pain/tenderness at steroid site of injection progressed to shoulder/exam/neck/ (L) mid back used MOTRIN sparingly (pt with H/O intolerance to prednisone) slowly improving Sx's. Had no RXN to PREVNAR 13, Tdap. Saw allergist 6/18/18 Dx'd with Adverse RXN to vaccine, but not hypersensitivity RXN.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) deltoid swollen and red. No fever. Resolved after 2-3 days.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Pain
Clinical narrative: Pain in arm where given, Body aches, Rash below injection site.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperhidrosis, Injection site swelling, Pain, Pruritus
Clinical narrative: Pt received Tdap 6/1/18 Left deltoid at 243PM. During evening of 6/1/18 she experience pain 8/10, itching, sweating and swelling to left deltoid. Denies Fever and body rash. Prescribed AUGMENTIN 0 500mg-125mg 1 tablet 3x day. Pt saw PCP and was given 21 days of methylprednisolone and did not take AUGMENTIN. Follow care at PCP.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Incomplete course of vaccination, Swelling
Clinical narrative: Within 24 hrs, redness, swelling and gen'l discomfort. I treated area with liquid cortisone II swab. It took 7-8 days for the swelling to subside. Because of my reaction to the shingles shot, I will not get the 2nd shot. The cost is too expensive, greater than $150. For someone who is on primary and secondary insurance I cannot recommend this immunization to any of my peers. Most disappointed that CDC is backing this!!! I felt the professional responsibility to share with you my total experience and my personal, professional response even though it was rather hard to obtain this form for a senior citizen not computer proficient.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient's arm was sore and began swelling on 6/15/18 after BEXSERO and MENACTRA was given. Patient was seen at 2:00 pm for a F/U and given 25 mg of BENADRYL.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Gait disturbance, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: He received shots PROQUAD and KINRIX (L) thigh on 6-15-18, the next day there was swelling and redness at the injection site, gradually increased and limping in the afternoon. Mom applied ice pack and gave MORTIN the next day (48H) he woke up w/whole (L) thigh swollen more rash and painful, itching. Seen at urgent care, given BENADRYL.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: He received shots PROQUAD and KINRIX (L) thigh on 6-15-18, the next day there was swelling and redness at the injection site, gradually increased and limping in the afternoon. Mom applied ice pack and gave MORTIN the next day (48H) he woke up w/whole (L) thigh swollen more rash and painful, itching. Seen at urgent care, given BENADRYL.
Age: 1.42
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Cough, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: (L) thigh/leg red and swollen with palpable lump. Was coughing. Taken BENADRYL orally.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Prenatal screening test, Ultrasound antenatal screen normal
Clinical narrative: This spontaneous case, was received from other non-health professional on 20-Dec-2017, concerning a 32-year-old, adult, female pregnant patient with weight 116 lbs, height 61.4 cm. The patient history included, one previous pregnancy which is full term live birth. 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. The historical drugs included ZITHROMAX for chlamydia. The concomitant medication included VITAFOL-ONE for healthy pregnancy. The patient LMP (last menstrual period) was reported as 16-May-2017. On 04-Aug-2017, the cystic fibrosis mutation analysis had performed and the results were found to be normal (no major congenital malformations noted). On 07-Aug-2017, 1st trimester screen and panorama had performed and the results were found to be normal (no major congenital malformations noted). On 06-Sep-2017, 2nd trimester screen had performed and the results were found to be normal (no major congenital malformations noted). On 04-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose, route of administration, anatomical location, batch number: 00644623A (as reported), expiry date: not reported) at 20th week of pregnancy. The estimated date of delivery (EDD) was reported as 20-Feb-2018. The reporter assessed this case as non-serious.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous case, initially received on 20-Dec-2017 from other non-health professional, concerning a 28-year-old, adult, female pregnant patient of weight 110 lbs and height 62 cm. The patient had no history of pregnancies and concomitant diseases. The concomitant medication included VITAFOL ONE. The patient had no habit of tobacco, alcohol or illicit drug use. The patient last menstrual period was reported as 10-Apr-2017. On 19-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (batch number: 00644623A, dose, anatomical location, route of administration and expiry date: not reported) at 23th week of pregnancy (explicitly considered as vaccine exposure during pregnancy). The patient had no pregnancy complications. It was reported that there is no evidence of defect/adverse finding from a prenatal test and patient had no adverse pregnancy outcome, birth defect/congenital anomalies and spontaneous abortion. It was reported that there was no adverse event reported in the pregnant woman and foetus. The estimated date of delivery (EDD) on 15-Jan-2018. The reporter assessed this case as non-serious.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Prenatal screening test, Prenatal screening test abnormal, 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 34-year-old female adult pregnant patient of weight: 165 pounds and height: 64 inches. The patient had history of spontaneous abortion. The patient's LMP (last menstrual period) was reported as 15-May-2017. The patient's current condition included Down's syndrome (screened positive for increased risk of Down syndrome). The patient's concomitant medication included VITAFOL-ONE. The patient had no family history of congenital malformations. It was reported that the patient did not use tobacco, alcohol or illicit drug. On 04-Aug-2017, the cystic fibrosis mutation analysis was normal with no major congenital malformations. On 08-Aug-2017, first trimester screen and panorama showed normal result with no major congenital malformations. On 28-Aug-2017, second trimester screen was positive for increased risk of Down syndrome. On 25-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (batch number: 00644623A (as reported), dose, route of administration, anatomical location, expiry date: not reported) at 19 weeks of gestation period (singleton pregnancy) (explicitly considered as vaccine exposure during pregnancy). At the time of the report the outcome was not reported. The CEDD (expected date of delivery) was reported as 19-Feb-2018.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event, Prenatal screening test
Clinical narrative: This spontaneous case, initially received on 20-Dec-2017 from other health professional, concerning a 28-year-old, adult, female pregnant patient of weight 103 lbs and height 61 cm. The patient had no history of pregnancy and concomitant diseases. The concomitant medication included PRENATE MINI. The patient was not tobacco, alcohol or illicit drug user. The patient's last menstrual period was reported as 27-May-2017. On 23-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (batch number: 00644623A, dose, anatomical location, route of administration and expiry date: not reported) at 17th week of pregnancy (explicitly considered as vaccine exposure during pregnancy). The patient had no pregnancy complications. It was reported that there was no evidence of defect/adverse finding from a prenatal test. It was reported that there was no adverse event reported in the pregnant woman and foetus. The estimated date of delivery (EDD) was on 03-Mar-2018. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event, Prenatal screening test
Clinical narrative: This non-serious spontaneous case, initially received on 12-Dec-2017, by other non-health care professional, concerning a 33-year-old, adult female pregnant patient with weight 110 lb and height 63 inches. The patient had one previous pregnancy with stillbirth or miscarriage occurred in the previous pregnancy. The patient had no history of tobacco, alcohol or illicit drug use and no concomitant diseases was reported. Concomitant medications included VITAFOL-ONE for healthy pregnancy. The patient's last menstrual period was reported as on 26-Jun-2017. It was reported that there was no evidence of a defect/adverse finding from a prenatal test. On 11-Sep-2017, the patient received AFLURIA QUADRIVALENT (batch number: 00644623A, dose, route of administration, anatomical location, expiry date: not reported) at 11th 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: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Amniocentesis normal, Exposure during pregnancy, Prenatal screening test
Clinical narrative: This non-serious spontaneous case, initially received from other health professional on 20-Dec-2017, concerning a 36-year-old, adult female pregnant patient with weight 153 lb and height 65.2 inches. The patient had history of 2 previous pregnancies with 1 full term live birth and 1 was elective abortion. No family history of major congenital malformations. The patient had no history of tobacco, alcohol or illicit drug use. Concomitant medication included VITAFOL-ONE. The patient's LMP (last menstrual period) was on 17-May-2017. On 12-Aug-2017, the cystic fibrosis mutation analysis was done and the result was normal (no major congenital malformations noted). On 15-Aug-2017, the first trimester screening was done that showed increased risk of Down syndrome. On 08-Sep-2017, the amniocentesis test was done and the result was normal (no major congenital malformations noted). On 11-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (batch number: 00644623A, dose, route of administration, anatomical location, expiry date: not reported) at 16th week of pregnancy (explicitly coded as vaccine exposure during pregnancy). The outcome of the event was not reported. The EDD (estimated date of delivery) was reported on 21-Feb-2018.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Alpha 1 foetoprotein normal, Amniocentesis normal, Exposure during pregnancy, Prenatal screening test, Ultrasound antenatal screen normal
Clinical narrative: This spontaneous case, initially received on 20-Dec-2017 from other non-health professional, concerning a 34-year-old, adult, female pregnant patient of weight 136 lb and height 61.5 cm. The patient's history included, two previous pregnancies and one spontaneous abortion previously. The patient's family history had no congenital malformations. The patient had no habit of tobacco, alcohol or illicit drug use. The patient's current condition included anemia and cramps. The concomitant medication included Ferrousul for anemia, VITAFOL-ONE for healthy pregnancy and CALTRATE with vitamin D3 for cramps. The patient last menstrual period (LMP) was reported as 15-Mar-2017. On 05-Jun-2017, cystic fibrosis mutation analysis had performed and the result was normal (no major congenital malformations noted). On 10-Jun-2017, firs trimester screen and panorama had performed and the result was normal (no major congenital malformations noted). On 03-Jul-2017, alpha fetoprotein sequential screen (AFP-SEQ) had performed and the result was normal (no major congenital malformations noted). On 07-Jul-2017, amniocentesis had performed and the result was normal (no major congenital malformations noted). On 11-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (batch number: 00644623A, dose, route of administration, anatomical location and expiry date: not reported), at 25th week of pregnancy. The nature of the pregnancy was reported as singleton. The estimated date of delivery (EDD) was reported as 20-Dec-2017. The reporter assessed this case as non-serious.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Amniocentesis normal, Exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: This is a spontaneous case, initially received from other non-health professional on 20-Dec-2017, concerning a 41-year-old, adult, female pregnant patient with weight of 145 lbs and height of 63 cm. The patient's history included, four previous pregnancies in which one was full term live birth and two elective abortions. The patient's family history had no congenital malformations. The patient had no habit of tobacco, alcohol or illicit drug use. The patient's current condition included anemia and streptococcus agalactiae. The concomitant medication included Ferrousul for anemia, Amoxicillin for streptococcus agalactiae and VITAFOL-ONE for healthy pregnancy. The patient last menstrual period (LMP) was reported as 28-May-2017. On 16-Sep-2017, amniocentesis had performed, and the result was normal (no major congenital malformations noted). On 16-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (batch number: 00644623A, dose, route of administration, anatomical location and expiry date; not reported), at 16th week of pregnancy. On 18-Oct-2017, ultrasound was performed, and the result were normal (no major congenital malformations noted). The nature of the pregnancy was reported as singleton. The estimated date of delivery (EDD) on 04-Mar-2018. The reporter assessed this case as non-serious.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Rash vesicular
Clinical narrative: This spontaneous case, initially received on 13-Mar-2018, reported by a physician, and concerns a 26-year-old adult female patient. The patient's current conditions included urticaria, attention deficit/hyperactivity disorder (ADHD), headache and allergies (since age 4-5 years). The patient was allergic to many foods (unspecified) and environmental things. The patient's concomitant medications were reported as none. On 16-Jan-2018, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, expiry date: not reported). On the same day, after the administration of vaccine, the patient developed 1.5-1.75 cm wide rash, which was raised with bubbles. The patient also experienced pain, induration for 2 weeks and depigmentation at the injection site. 4 weeks after vaccination, the skin at the injection site was white and was no longer red. The patient was treated with Ibuprofen. The symptoms completely resolved by 4 weeks after vaccination. It was reported that, eventually the patient's skin peeled off (as reported) and at the time of the 4th week, the patient's skin had come off (as reported). The patient had recovered from the events.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Skin depigmentation, Skin exfoliation
Clinical narrative: This spontaneous case, initially received on 13-Mar-2018, reported by a physician, and concerns a 26-year-old adult female patient. The patient's current conditions included urticaria, attention deficit/hyperactivity disorder (ADHD), headache and allergies (since age 4-5 years). The patient was allergic to many foods (unspecified) and environmental things. The patient's concomitant medications were reported as none. On 16-Jan-2018, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, expiry date: not reported). On the same day, after the administration of vaccine, the patient developed 1.5-1.75 cm wide rash, which was raised with bubbles. The patient also experienced pain, induration for 2 weeks and depigmentation at the injection site. 4 weeks after vaccination, the skin at the injection site was white and was no longer red. The patient was treated with Ibuprofen. The symptoms completely resolved by 4 weeks after vaccination. It was reported that, eventually the patient's skin peeled off (as reported) and at the time of the 4th week, the patient's skin had come off (as reported). The patient had recovered from the events.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Ear pruritus, Erythema, Incorrect route of drug administration, Palpitations
Clinical narrative: This spontaneous case, initially received on 12-Jan-2017, was reported by a health authority and concerns a 39-year-old female patient. Weight: not provided; Height: not provided. The patient had no illness at the time of vaccination. Medical history: none. Concomitant medication: none. Administration had no illness at the time of vaccination. Medical history: none. Concomitant medication: none. Administration of company suspect drug(s). The patient received AFLURIA for indication not reported from 18-OCT-2016 to 18-OCT-2016. Dose regimen: Not reported, Route of administration: Intradermal. Batch number: WT52305. Site: Left arm (LA). No additional suspect drugs. Adverse reactions/events and outcomes: On 18-Oct-2016 20 minutes after the flu shot, the patient experienced dizziness, itchy ears, itchy throat that progressed to throat tightness and palpitations and (outcome: recovered/resolved). Special circumstances: Incorrect route of drug administration. On 18-Oct-2016, the patient experienced redness to face (outcome: recovered/resolved). Special circumstances: incorrect route of drug administration. Lab data: none. Reporter comments: The health authority considered all events as non-serious. Case correction 21-Mar-2017: The lower level (LLT) for the event "itchy ears' changed from 'itchy' to 'ear pruritus'. The event 'pruritus' (outcome: recovered/resolved, start date: 18-Oct-2016, special circumstance: incorrect route of drug administration) added. The health authority report the preferred term: pruritus.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation, Throat tightness
Clinical narrative: This spontaneous case, initially received on 12-Jan-2017, was reported by a health authority and concerns a 39-year-old female patient. Weight: not provided; Height: not provided. The patient had no illness at the time of vaccination. Medical history: none. Concomitant medication: none. Administration had no illness at the time of vaccination. Medical history: none. Concomitant medication: none. Administration of company suspect drug(s). The patient received AFLURIA for indication not reported from 18-OCT-2016 to 18-OCT-2016. Dose regimen: Not reported, Route of administration: Intradermal. Batch number: WT52305. Site: Left arm (LA). No additional suspect drugs. Adverse reactions/events and outcomes: On 18-Oct-2016 20 minutes after the flu shot, the patient experienced dizziness, itchy ears, itchy throat that progressed to throat tightness and palpitations and (outcome: recovered/resolved). Special circumstances: Incorrect route of drug administration. On 18-Oct-2016, the patient experienced redness to face (outcome: recovered/resolved). Special circumstances: incorrect route of drug administration. Lab data: none. Reporter comments: The health authority considered all events as non-serious. Case correction 21-Mar-2017: The lower level (LLT) for the event "itchy ears' changed from 'itchy' to 'ear pruritus'. The event 'pruritus' (outcome: recovered/resolved, start date: 18-Oct-2016, special circumstance: incorrect route of drug administration) added. The health authority report the preferred term: pruritus.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Feeding disorder, Frequent bowel movements, Pain, Pyrexia
Clinical narrative: This spontaneous case, initially received on 12-Jan-2017, was reported by a health authority and concerns a 26-year-old male patient. Weight: not provided; Height: not provided. The patient had no illness at the time of vaccination. The patient is a very active and healthy individual other than when he received the influenza vaccination annually as required by his workplace. Medical history: none. Concomitant medication: none. Administration of company suspect drug(s): The patient received AFLURIA for indication not reported from 17-OCT-2016 to 17-OCT-2016. Dose regimen: Not reported, Dose number: 1. Route of administration: Intramuscular. Batch number: WT52706. Site: Left arm (LA). No additional suspect drugs. Adverse reactions/events and outcomes: On 20-Oct-2016, the patient experienced body aches (outcome: unknown), low grade fever of 99.2 (outcome: unknown) and was unable to eat anything (outcome: unknown). On 20-Oct-2016 at 13:00, the patient experienced frequent diarrhea (outcome: unknown). On 20-Oct-2016 at 15:30, the patient started to vomit fluid and food (outcome: unknown). Body aches and low grade fever of 99.2. At 13:00, the patient was experiencing frequent diarrhea. At 15:30, the patient started to vomit fluid and food. The patient continued to vomit every two or three hours until 05:00 the following morning. The diarrhea frequency increased to every 30 minutes until 13:00 on 21-Oct-2016 after which it decreased to an hour and a half. This continue until the morning of 22-Oct-2016. The patient had eaten breakfast on 20-Oct-2016 but was unable to eat anything again until 19:00 on 21-Oct-2016 and that was chicken soup with crackers and Sprite. As of 23-Oct-2016, the bowel movements have not returned to normal baseline. I am on no medications and a very active healthy individual other than when I received the influenza vaccination annually as required by my workplace. Reporter comments: The health authority considered the events as non-serious. Case correction 20-Mar-2017: the lower level term (LLT) for the event 'unable to eat anything' changed from 'decreased appetite' to 'unable to eat'. The event 'decreased appetite' (outcome: unknown, start date: 20-Oct-2016) added. The health authority reported the preferred term: decreased appetite and considered the event as non-serious.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: This spontaneous case, initially received on 12-Jan-2017, was reported by a health authority and concerns a 26-year-old male patient. Weight: not provided; Height: not provided. The patient had no illness at the time of vaccination. The patient is a very active and healthy individual other than when he received the influenza vaccination annually as required by his workplace. Medical history: none. Concomitant medication: none. Administration of company suspect drug(s): The patient received AFLURIA for indication not reported from 17-OCT-2016 to 17-OCT-2016. Dose regimen: Not reported, Dose number: 1. Route of administration: Intramuscular. Batch number: WT52706. Site: Left arm (LA). No additional suspect drugs. Adverse reactions/events and outcomes: On 20-Oct-2016, the patient experienced body aches (outcome: unknown), low grade fever of 99.2 (outcome: unknown) and was unable to eat anything (outcome: unknown). On 20-Oct-2016 at 13:00, the patient experienced frequent diarrhea (outcome: unknown). On 20-Oct-2016 at 15:30, the patient started to vomit fluid and food (outcome: unknown). Body aches and low grade fever of 99.2. At 13:00, the patient was experiencing frequent diarrhea. At 15:30, the patient started to vomit fluid and food. The patient continued to vomit every two or three hours until 05:00 the following morning. The diarrhea frequency increased to every 30 minutes until 13:00 on 21-Oct-2016 after which it decreased to an hour and a half. This continue until the morning of 22-Oct-2016. The patient had eaten breakfast on 20-Oct-2016 but was unable to eat anything again until 19:00 on 21-Oct-2016 and that was chicken soup with crackers and Sprite. As of 23-Oct-2016, the bowel movements have not returned to normal baseline. I am on no medications and a very active healthy individual other than when I received the influenza vaccination annually as required by my workplace. Reporter comments: The health authority considered the events as non-serious. Case correction 20-Mar-2017: the lower level term (LLT) for the event 'unable to eat anything' changed from 'decreased appetite' to 'unable to eat'. The event 'decreased appetite' (outcome: unknown, start date: 20-Oct-2016) added. The health authority reported the preferred term: decreased appetite and considered the event as non-serious.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Differential white blood cell count, Full blood count, Platelet count, Pyrexia, Vaccination site inflammation
Clinical narrative: This spontaneous case, initially received on 12-Jan-2017, was reported by a health authority and concerns a(n) 41-year-old female patient. Weight: not provided; Height: not provided. Past medical history included Hypertension, Anxiety. Drug history included Penicillin Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA for Indication reported from 27-SEP-2016 to 27-SEP-2016 Dose regimen: 0.5 ml, Site: left arm, Route of administration: Intramuscular, Batch number: 12849211A. Additional suspect drug: The patient received PNEUMOVAX for Indication not reported from 27-SEP-2016 to 27-SEP-2016 Dose regimen: Not reported, Site: right arm, Route of administration: Intramuscular. Batch number: M022552. Adverse reactions/events and outcomes: On 28-Sep-2016, the patient developed inflammation ad pain at the site of vaccination, mild subjective fever with bone pain (9/10). The patient received ibuprofen at 800 mg (1 oral every 6 hours as needed). "QTP 90". She underwent laboratory tests for complete blood count, differential white blood cell count and platelet count. The outcome was recovered. Reporter's comments: The health authority assessed the events as non-serious. Case correction 21-Mar-2017: The lower level (LLT) for the event 'pain at site of vaccination' changed from 'injection site pain' to 'vaccination site pain'. The event 'injection site pain' (outcome: recovered/resolved, start date: 28-Sep-2016) was added. The health authority report the preferred term: injection site pain.