chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial spontaneous case, was received from a pharmacist on 20-Oct-2017, concerns a 11-year-old, child male patient. On 10-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch no: 195216 and expiry date: 30-Apr-2018). On 10-Oct-2017, the patient was administered with influenza vaccine that reached 72F for up to 90 hours and had no adverse effects. It was reported that the FLUCELVAX was left out of the refrigerator for a couple of days. The reporter assessed the case as non-serious. Significant follow-up received up on 26-Oct-2017: It was reported that the patient had no adverse event after the vaccination. Narrative amended accordingly. Significant case correction received 26-Oct-2017: The event 'no adverse event' was removed, expiry date of the product was updated and narrative was amended.
Age: 50.0
Sex: F
Vaccine: FLUC4, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Case number PHEH2016US033075, is an initial spontaneous report received from a medical assistant on 15 Dec 2016. This report refers to a 50 years old female patient. Prior vaccination history included vaccination with influenza vaccine (unknown whether seasonal or pandemic, other manufacturer) with no side effects (well tolerated). Current condition included drug allergies with ADIPRA, ibuprofen, NOVOLOG and VALIUM. Concomitant medications were not reported. The patient was vaccinated with a single dose of FLUCELVAX (batch number: 185325A, expiry date: Apr 2017) at a dose of 0.5 ml intramuscularly into left deltoid on 14 Dec 2016 11.16 AM. The patient was also vaccinated with ENGERIX B (manufacturer unknown, batch number: 3SG7C) at a dose of 40 mcg into right deltoid on 14 Dec 2016 11.16 AM. The medical assistant stated that, the first excursion occurred with 57 degrees F for 14.5 hours for prefilled syringe (PFS) FLUCELVAX. One FLUCELVAX was administered to a patient. The medical assistant upon follow up reported that the patient was doing well and no adverse reactions were reported following this administration error. Follow up received from a medical assistant on 06 Jan 2017: Updated reporter details (fax number), added prior vaccination history, current condition (drug allergies), updated the dosage regimen anatomical location for FLUCELVAX and time of administration, added co-suspect vaccine (ENERGIX B), and updated the reporter's comment.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Pruritus
Clinical narrative: This non-serious initial spontaneous case, was received from other Non-health professional on 13-Nov-2017, concerning a 54-year-old, adult, female patient. On an unspecified date in Oct-2017, the patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical location, batch number and expiry date: not reported). On 15-Oct-2017, the patient experienced pain in whole arms down to her wrists. It was reported that the pain lasted for 20 minutes. On the following day, her arms were little bit itchy. The outcome of the events was not reported.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This initial spontaneous case, was received from other health professional on 13-Nov-2017, concerns a 63-year-old female patient. The patient's medical history and concomitant medications were not reported. On 13-Nov-2017, the patient was administered with FLUCELVAX (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch no: 195230 and expiry date: May-2018). The reporter stated that the patient received two flu shots, the second one was FLUCELVAX and the details of the first flu shot was unknown. It was reported that the first shot was received a month ago but the exact date was unknown. The reporter stated that there was no adverse events after second vaccination and the patient was fine. The reporter assessed the case as non-serious.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: Case number PHEH2017US005204, is an initial spontaneous report received from a pharmacist on 16 Feb 2017. This report refers to a 62 years old female patient. Medical history was not reported. Concomitant medication was not reported. The pharmacist reported that, the temperature excursion was occurred in Jan for 10 hours, max temperature of 51.8 Fahrenheit and the patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186867, expiry date: May 2017) at a dose of 0.5 ml, intramuscularly on 13 Feb 2017, following the temperature excursion. No adverse event was reported following this medication error.
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: Case number PHEH2017US002474 is initial report received from nurse on 18 Jan 2017. This report refers to female patient of unknown age. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number not reported) on 18 Jan 2017. Nurse reported that the FLUCELVAX QUADRIVALENT reached 15F (Fahrenheit) for approximately 11.5-12 hours. It was first temperature excursion. One patient received the vaccine. The nurse was reported that a mother and daughter were seen in their clinic and one patient received vaccine from the refrigerator without any issues and one patient received vaccine from the refrigerator that had malfunctioned but she did know which patient received the vaccine with the excursion. No adverse event was reported following this medication error.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Pruritus
Clinical narrative: This non-serious initial spontaneous case was received from other non-health professional on 13-Nov-2017, concerning a 42-year-old, adult, female patient. On an unspecified date in Oct-2017, the patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical location, batch number and expiry date: not reported). On 15-Oct-2017, the patient experienced pain in whole arms down to her wrists. It was reported that, the pain lasted for 20 minutes. On the following day, her arms were little bit itchy. The outcome of the event pain was recovered and 'little bit itchy' was not reported.
Sex: M
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This initial non-serious spontaneous case was received on 23-Oct-2017, from a pharmacist, concerning a male patient of unspecified age. This refers to fifth out of 06 reports. The patient had no relevant medical history and concomitant medications. On 23-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195210A, expiry date: Mar-2018, route of administration: intramuscular, anatomical location: left deltoid). It was reported that, the vaccine was at a maximum temperature of 55F overnight and it was administered. The pharmacist stated that the refrigerator was at 40.6 f last night but that morning the temperature was 55F and that was the first-time excursion. Follow-up received on 27-Nov-2017: Added gender of the patient, route of administration and anatomical location. The narrative was amended accordingly.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This non-serious initial spontaneous case, was received on 01-Nov-2017, from a pharmacist, concerning a 36-year-old, adult, female patient. The patient had no medical history or any concomitant medications. On 01-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: less than 0.5 ml (as reported), route of administration: intramuscular, anatomical location: right deltoid, batch number: 195227, expiry date: 31-May-2018). The PTC (product technical complaint) number provided was 1025704). It was reported that, at the time of administration, the plunger got stuck and stopped (explicitly coded as syringe issue). When it was pulled out the vaccine spilled out, but was not exposed to the vaccine. The patient received only half of the dose (explicitly coded as Incomplete dose administered) and had no adverse events. The QAIR (quality assurance investigation report) for the PTC (product technical complaint: 1025704) concluded that FLUCELVAX Batch 195227 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the syringes or stopper components, and no trends were identified for the batch or for the 2017/2018 FLUCELVAX Commercial Season for plunger rod issues. The reporter assessed the events as non-serious. Follow-up received on 27-Nov-2017: Added date of vaccination. No adverse event was deleted from the screen. The narrative was amended accordingly. Follow-up received from QA (quality assurance department) on 15-Dec-2017: Added PTC number (1025704) and the QAIR (quality assurance investigation report). Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195227 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the syringes or stopper components, and no trends were identified for the batch or for the 2017/2018 FLUCELVAX Commercial Season for plunger rod issues. Narrative amended accordingly.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHEH2016US031851, is an initial spontaneous report received from a healthcare professional (medical assistant) on 01 Dec 2016. This report refers to a 21 years old pregnant female patient. Past medical history and concomitant medication were not reported. It was reported that she was 27 weeks pregnant. This pregnant female patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) intramuscularly on 10 Nov 2016. Further she was vaccinated with a second dose of FLUCELVAX QUADRIVALENT (batch number: 185886) intramuscularly at a dose of 0.5 ml on 01 Dec 2016 (inappropriate schedule of vaccine administered). The case was assessed as non serious. No adverse event was reported following this maladministration (inappropriate schedule of vaccine administered) and (vaccine exposure during pregnancy).
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: Case number PHEH2017US003563, is an initial spontaneous report received from a nurse on 31 Jan 2017. This report refers to a 39 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml intramuscularly on 27 Jan 2017. It was reported that temperature excursion was reported with FLUCELVAX QUADRIVLENT. The temperature excursion happened last week. Flu vaccine was given to one of the patients and the vaccines were discarded afterwards. It was reported that the customer wanted to know the next steps in treating the patient. The temperature of the vaccine did not exceed 77 degrees F and the excursion lasted overnight (24 hours). This was the first excursion. No adverse event was reported following this administration error.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: Case number PHEH2016US031774, is an initial spontaneous report received from a healthcare professional (physician assistant) on 02 Dec 2016. This report refers to a 60 years old female patient. Prior vaccination history included vaccination with influenza vaccine (unknown whether seasonal or pandemic, other manufacturer, batch number: not reported) with no side effects (well tolerated). Past medical history and concomitant medication were not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: 185286 and expiry date: Apr 2017) at a dose of 0.5 ml, Intramuscularly on 02 Dec 2016 at 01:15 pm. It was reported that, first time temperature excursion occurred and vaccine reached 47 Fahrenheit for less than 24 hours, vaccine administered to patient on 02 Dec 2016 at 01:15 pm. It was reported that the temperature variation was discovered after the administration of vaccine. No adverse event was reported following this medication error (incorrect product storage). The case was assessed as non serious by the physician assistant. Follow up report received from a health care professional (physician assistant) on 09 Jan 2017: Updated reporter details (phone number), added prior vaccination history, updated suspect product information (time of administration) and updated reporter comment.
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: Fatigue, Headache
Clinical narrative: This initial non-serious spontaneous case, was received on 19-Sep-2017, reported by other non-health professional, concerning a 59-year-old, adult, male patient. The patient's current condition included epilepsy since an unspecified date. The patient's concomitant medications included KEPPRA, TOPAMAX, LAMICTAL, and XANAX. On 18-Sep-2017, the patient received FLUCELVAX QIV (dose: 0.5 ml, route of administration, batch number, expiry date, trade name manufacturer name: not reported). On the same day, after vaccination, the patient experienced headache and had ADVIL (reported as 2 when headache) as treatment medication. After one hour of medication, the patient had not resolved from the headache. It was reported that, headache was not related to epileptic seizure because when the patient had a seizure he would be unaware of what was going on, but he was aware at that moment. In the evening, the patient had felt better and an hour later, the headache started again and the pain persisted but not as bad. The patient took medications (ADVIL) and slept. Next day, at the time of this report, the patient's mother stated that, the patient was better (headache was mild), but tired and was taking rest. The patient had not recovered from the event. The reporter assessed the event as non-serious.
Age: 18.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: Case number PHEH2017US005198, is an initial spontaneous report received from a pharmacist on 16 Feb 2017. This report refers to an 18 years old male patient. Medical history was not reported. Concomitant medication was not reported. The pharmacist reported that, the temperature excursion was occurred in Jan for 10 hours, max temperature of 51.8 Fahrenheit and the patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186867, expiry date: May 2017) at a dose of 0.5 ml, intramuscularly on 05 Feb 2017, following the temperature excursion. No adverse event was reported following this medication error.
Age: 53.0
Sex: M
Vaccine: FLUC3
Symptoms: Expired product administered, Immunisation, No adverse event
Clinical narrative: Case number PHEH2016US033671, is a spontaneous report initially received from medical assistant on 21 Dec 2016. This report refers to a 53 years old male patient. Medical history was not reported. Vaccination history included administration of FLUCELVAX (batch number: not reported) which was tolerated. Concomitant medication was not reported. The patient was vaccinated with a single dose of expired FLUCELVAX (batch number: 173906, expiry date: May 2016) intramuscularly into left deltoid at a dose of 0.5 ml on 20 Dec 2016. It was reported that, there was not an adverse drug reaction, the patient received another flu vaccine and was tolerated well. The case was assessed as non serious. No adverse event was reported following this medication error. Follow up report received from a health care professional on 12 Jan 2017: Added vaccination history, updated vaccination site (left deltoid) and reporter's comment.
Age: 3.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This non-serious initial spontaneous case, was received from Other Non-Health Professional on 07-Nov-2017, concerning a 3-year-10-month-old, child female patient. On 03-NOV-2017, the patient was administered with FLUCELVAX QIV (dose; 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195236, expiry date: 31-May-2018). It was reported that the patient below age of 4 years received vaccine that was indicated for persons 4 years of age and older. The patient had no event following administration of the vaccine. The reporter assessed the event as non-serious.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This initial spontaneous case, was received from other non-health professional on 25-Oct-2017, concerning a 47-year-old adult female patient. The patient's medical history included an unspecified allergies and never reacted to the any vaccines in the past. The patient's concomitant medication included metformin for an unknown indication. On 24-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195129, expiry date: May-2018 and anatomical location: deltoid). On 25-Oct 2017, after 2 days of vaccination, the patient experienced redness about the size of a quarter, hardness, pain at the injection site and no treatment was taken. On an unspecified date (reported as a couple of days), the patient recovered from the events. The reporter assessed the events as non-serious and considered the causality of the events as related. Follow-up received on 13-Nov-2017: The event outcome was changed from not recovered to recovered. Narrative amended accordingly.
Age: 66.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site reaction, Pain, Pain in extremity
Clinical narrative: Case number PHEH2016US033296, is an initial spontaneous report received from a nurse on 16 Dec 2016. This report refers to a 66 year old female patient. Past medical history and concomitant medications were not reported. The patient tolerated vaccine in past. The patient was vaccinated with one single dose of FLUCELVAX QUADRIVALENT (batch number: 186685) at a dose of 0.5 ml intramuscularly into left upper arm on 03 Nov 2016. On 06 Nov 2016 the patient experienced shooting pain up her arm for 4 weeks. It was reported that the symptoms of burning pain in left upper arm while lifting, pushing and pulling began 3 days after FLUCELVAX QUADRIVALENT injection. It was reported that the symptoms were getting better. It was reported that on an unknown date after administration, the patient wrote out report on 15 Nov 2016. The outcome of the event was complete recovery on 01 Dec 2016. Seriousness and causality of the event were not reported. Follow up information was received from a nurse on 07 Mar 2017. Outcome of the events was updated to complete recovery. Past vaccination history added. Patient weight and height. Vaccination site. Updated narrative accordingly.
Age: 10.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial spontaneous case, received on 02-Nov-2017, was reported by other health professional and concerns a 10-year-old male patient. The patient was allergic to cashews, peanuts and pistachios. The concomitant medications were not reported. On 02-Nov-2017, the patient received FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195240A, expiry date: Jun-2018). It was reported by the nurse that, they started using new thermometers from the previous day (when the nurse left it was in range and when she got there in the morning, heard the alarm sound). The minimum temperature was 34.3 and the high temperature was 37.9, it was below 36 for 11 hours 24 minutes (explicitly coded as incorrect product storage). On 02-Nov-2017, the patient received FLUCELVAX QIV after temperature excursion (explicitly coded as drug administration error). The nurse was not aware of the adverse events developed after vaccination; however reported as no adverse event and the patient was fine. The reporter assessed the case non-serious.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Lip swelling, Rash
Clinical narrative: Case number PHEH2017US000832, is an initial spontaneous report from a pharmacist received on 04 Jan 2017. This report refers to a 25 years old female patient. Past medical history was not reported. Current condition included as egg allergy. Concomitant medications was not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: 185284 and expiry date: Apr 2017) at a dose of 0.5 ml, intramuscularly on 04 Jan 2017. On the same day after vaccination, the patient experienced rash (unspecified location), arm rash and swollen lips. Pharmacist instructed the patient to take BENADRYL, which the patient said helped ease her symptoms. The outcome of the events was reported as condition improving. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: Case number PHEH2017US005279, is an initial spontaneous report received from a pharmacist on 16 Feb 2017. This report refers to a 44 years old female patient. Medical history was not reported. Concomitant medication was not reported. The pharmacist reported that, the temperature excursion was occurred in Jan for 10 hours, maximum temperature of 51.8 Fahrenheit and the patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186867, expiry date: May 2017) at a dose of 0.5 ml, intramuscularly on 05 Feb 2017, following the temperature excursion. No adverse event was reported following this medication error.
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy
Clinical narrative: This non-serious spontaneous case, was initially received on 16-Sep-2017, reported by consumer, a female pregnant patient with an unspecified age. On an unspecified date, the pregnant patient received FLUCELVAX QIV (batch number: 195128, dose, route of administration, and expiry date: not reported) (characterized as vaccine exposure during pregnancy). The outcome of the event was not reported. Non-significant case correction received 16-Sep-2017: Batch number (195128) was added in the screen. The narrative was amended accordingly.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug interaction, Heart rate increased, Muscle twitching
Clinical narrative: Case number PHEH2017US001824, is an initial spontaneous report received from healthcare professional through email via other pharmaceutical company (Mylan) on 12 Jan 2017. This report refers to a 34 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) on an unknown date. The patient received butorphanol for the treatment of an unknown indication at an unknown dose on an unknown date. It was reported that on an unknown date, the patient experienced twitching, increased heart rate and had a drug interaction with butorphanol. The outcome of the events twitching and increased heart rate was reported as unknown and for the event drug interaction with butorphanol was not reported. The events twitching and increased heart rate were assessed as non serious by the healthcare professional and for the event drug interaction with butorphanol was not reported. The causality of the events was not reported.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Case number PHEH2017US003559, is an initial spontaneous report received from a nurse on 31 Jan 2017. This report refers to 42 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 187276, Expiry date: Jun 2017) at a dose of 0.5 ml, intramuscularly on 26 Jan 2017. On 28 Jan 2017, the patient experienced headache and was tired and body aches. The patient was afebrile. The outcome of the events was reported as complete recovery on 29 Jan 2017. The seriousness and causality of the events were not reported.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Lip pruritus, Throat irritation, Wheezing
Clinical narrative: This spontaneous case, was received on 09-Oct-2017, from a consumer, concerning a 49-year-old adult female patient. The patient's current condition included allergy to skin of fruits (apples, plums). On 06-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195125 (as reported), expiry date: not reported). On the same day (06-Oct-2017), within 5 minutes of vaccine administration, the patient had itchy lips, throat and mild wheezing. The patient was taken to the urgent care and was prescribed with VENTRANQUIL inhaler. The patient did not use the inhaler and the reaction lasted for 12 hours. The patient recovered from the events. The reporter assessed the events as non-serious.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy
Clinical narrative: This initial spontaneous case, received from other non-health professional on 18-Oct-2017, concerning a 33-year-old female pregnant patient. The patient's concomitant medications included Prenatal vitamins. The patient's last menstrual period date (reported as 18-Aug-2017) and estimated date of delivery (reported as 25-May-2018). On 18-Oct-2017, the pregnant patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195213 and expiry date: 31-Mar-2018). The outcome of the event was not reported. The reporter assessed this case as non-serious.
Age: 10.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash erythematous
Clinical narrative: This non-serious spontaneous case, was initially received from other non-health care professional on 02-Oct-2017, concerning a 10-year-old, male child patient. The patient's historical conditions included: severe allergic reaction to polymyxin-b and neomycin. The patient has not received any concomitant medications. On 28-Sep-2017, the patient was vaccinated with FLUCELVAX QUADRIVALENT(dose: 0.5ml, Lot no: 195125, route of administration and anatomical location: not reported). On 29-Sep-2017, after one-day of vaccination, the patient developed a very tiny (size of pencil tip) raise red bumps on his upper back and chest. The symptoms of bumps get reduce with 25 mg dose of BENADRYL. At the time of this report, the patient was completely recovered from event. The reporter assessed the report as non-serious. Follow-up received from the reporter on 11-Oct-2017: Non-significant information received. The patient's mother stated that the patient takes no concomitant medications. Narrative amended accordingly. Non-significant case correction received with 02-Oct-2017: Batch number (195125) was added on the screen. The narrative was amended accordingly.
Age: 8.0
Sex: F
Vaccine: FLUC4
Symptoms: Eye swelling, Hypersensitivity, Injection site rash, Injection site vesicles
Clinical narrative: This non-serious spontaneous case, was initially received from other non-health professional on 02-Oct-2017, concerning a 08-year-old, child, female patient. The patient's historical vaccine included unspecified influenza vaccine. The patient's medical history included allergies to animal, pollen, pine straw, shellfish and she did not receive any concomitant medications. On 30-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195210, expiry date: 31-Mar-2018, route of administration: assumed as intramuscular (as reported) anatomical location: left deltoid). On the same day, the patient developed a mild allergy, which included bit swollen of right eye on the same side, where she had the injection and mild rash around the injection site on her shoulder, which were watery blisters. No treatment was taken for the event. It was reported that, patient's symptoms disappeared after 24 hours (on Sunday morning) (as reported). On 01-Oct-2017, the patient had recovered from the event. The reporter assessed the case as non-serious. Follow-up received on 09-Oct-2017: The route of administration of the vaccine was reported as intramuscular (assumed by reporter) and the anatomical location was reported as was left deltoid. Narrative was amended accordingly. Non-significant case correction received 02-Oct-2017: Batch number (195210) was added on the screen and updated expiry date. The narrative was amended accordingly.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This non-serious spontaneous case, was initially received on 05-Oct-2017 from other non-health professional, concerning a 29-year-old, adult, pregnant patient. The patient was not enrolled in the pregnancy registry. It was reported that the last menstrual date was 11-Aug-2017 and estimated delivery date (EDD) was 18-May-2018. On 05-Oct-2017, at gestational age of 8-weeks (first trimester of pregnancy) the patient was administered with FLUCELVAX QIV (dose, route of administration, batch number, expiry date and anatomical location: not reported), which was considered as vaccine exposure during pregnancy. It was reported that, after the administration of vaccine, the patient did not experience any adverse event. The reporter assessed this case as non-serious. Follow up report received on 01-Dec-2017: The patient's date of birth, last menstrual date (LMP), estimated delivery date (EDD) and date of vaccination was added. It was reported that, after the administration of vaccine, the patient did not experience any adverse event. The narrative was amended accordingly.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This initial spontaneous case, was received from other non-health professional on 25-Oct-2017, concerning a 61-year-old, adult, female patient. The patient's historical conditions included hypothyroid and bone spurs. The patient's historical drug included: Flu vaccine, without any reactions. The patient's concomitant medications included: atorvastatin; ADVIL, TYLENOL for shoulder pain and SYNTHROID. On 24-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195129, expiry date: May-2018). On 25-Oct-2017, after 2 days of vaccination, the patient experienced redness about the size of a quarter, hardness, pain at the injection site and no treatment was taken. At the time of this report, the patient recovered from the events (reported as symptoms resolved within a couple of days). The reporter assessed the events as non-serious and considered the causality of the events as related. Follow-up received from the reporter on 21-Nov-2017: The outcome of the events (Injection site redness, Injection site induration and Injection site pain) was changed from not recovered to recovered (reported as symptoms resolved within a couple of days). The narrative was amended accordingly.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This initial spontaneous case, was received from other non-health professional (consumer) on 25-Oct-2017, concerning a 41-year-old, adult, female pregnant patient. The patient's historical drug included doxycycline, ENDOMETRIN, ESTRACE, LUPRON, MEDROL, METROGEL vaginal gel, PROMETRIUM, Progesterone in oil injection prior to pregnancy. The patient's medical history included an unspecified fertility treatment. The patient had two ablation (unspecified) as contraceptive method. The patient had 3 previous pregnancies and had no stillbirth or miscarriage, birth defect or congenital anomaly occurred in any previous pregnancy. The patient had no relevant maternal and paternal medical history relevant to pregnancy. Medications taken by father prior to conception was lisinopril. The patient's concomitant medication included Prenatal vitamins and baby aspirin for an unknown indication. The patient's last menstrual period date was 19-Jun-2017. There was no evidence of a defect/adverse finding from a prenatal test. The patient was permitted to enroll in the pregnancy registry. On 20-Sep-2017, at gestation age of 13 weeks (2nd trimester), the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular route, batch number: 195225A, expiry date: Apr-2018). The patient received the vaccine during pregnancy and no adverse event was reported in the pregnant patient and fetus so far. The estimated date of delivery was reported as 06-Mar-2018. The reporter assessed the event as non-serious.
Age: 37.0
Sex: M
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: This initial spontaneous case, was received from other non-healthcare professional on 09-Nov-2017, concerning a 38-year-old, adult, male patient. On 19-Oct-2016, patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: arm (unspecified), batch number: 185888, expiry date: May-2017). On 22-Oct-2016, after 4 days of vaccination, the patient started to experience hives on arms, hands and feet. The patient took anti-histamines and topical cortisone cream. The patient was completely recovered from the event after 4 days. The reporter assessed the event as non-serious and considered the causality of the event as related to the suspect vaccine. Follow up report received on 27-Nov-2017: The dose, route of administration, anatomical location, indication of the vaccine and onset date of the event were updated. The narrative was amended accordingly.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Urticaria
Clinical narrative: This non-serious initial spontaneous case, was received from other health professional (pharmacist) on 05-Oct-2017, concerning a 54-year-old adult female patient. The patient historical condition included stroke (unspecified date). The patient's current conditions included hypertension, hyperlipidemia, migraine, sleep apnea, depression, asthma, lupus and egg allergy (since an unspecified date). The patient concomitant medications included atorvastatin, clopidogrel, hydroxychloroquine, mycophenolate, pantoprazole and eye drops: brimonidine, dorzolamide, latanoprost for an unknown indication. It was reported that, the patient was already hospitalized for his different unspecified conditions. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration, batch number, expiry date and anatomical location: not reported). On the same day, at 19:30 hrs, after 1 hour of vaccination, the patient experienced hives on face, back and lot of itching. The patient was treated with diphenhydramine. On 05-Oct-2017, at 17:00 hrs, the patient was recovered from the events. The reporter assessed the events as non-serious.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: This initial spontaneous case, was received on 23-Oct-2017, from a pharmacist, concerning a 61-year-old, adult female patient. The vaccine history included, unspecified quadrivalent vaccine in the previous year with no issues. On 13-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, batch number: 195239, expiry date: May-2018, anatomical location: not reported). On 15-Oct-2017, the patient developed red itchy patch on leg. It was reported that, in the following days, the patient developed red itchy patches on the heel on the opposite leg, which then progressed to arms, hands, face, the corners of her eyes, neck, and inside of her ears. The patient consulted a physician and was given unspecified corticosteroids. At the time of this report, the patient was recovering from the event. The reporter assessed the event as non-serious.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This initial spontaneous case, was received from other non-health professional (consumer) on 23-Oct-2017, concerning a 29-year-old adult female pregnant patient. The patient had no relevant medical history. The patient had no relevant maternal and paternal medical history relevant to pregnancy. The patient had no previous pregnancies. The patient received unspecified birth control medications prior to pregnancy. The infant's father received unspecified vitamins prior to conception. The patient's concomitant medications during the pregnancy included PNV (prenatal vitamins). The patient did not receive any contraceptive methods. The patient's  last menstrual period was an unspecified date in May/Jun-2017, it was patient's first pregnancy. The gestational age of the fetus was 20-weeks and gender of the fetus was male. There was no evidence of any defect/adverse finding from a prenatal test. The patient gave the permission to enroll in the pregnancy registry. On 23-Oct-2017, at gestational age of 20-weeks (second trimester), the patient was administered with FLUCELVAX QIV (route of administration: Intramuscular, dose, batch number, expiry date, anatomical location: not reported). The patient received the vaccine during pregnancy (explicitly coded as vaccine exposure during pregnancy) and no adverse event was reported in pregnant woman and fetus. The estimated delivery date was 13-Mar-2018. The reporter assessed the event as non-serious.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This initial spontaneous case, was received from other non-health professional (consumer) on 01-Nov-2017, concerning a 31-year-old, adult, female pregnant patient. The patient's historical drug included MIRENA (until 15-Jun-2017) as contraceptive prior to pregnancy. The patient had no relevant medical history. The patient had 1 previous pregnancy and had no stillbirth or miscarriage, birth defect or congenital anomaly in previous pregnancy. There was no maternal and paternal medical history relevant to pregnancy. Medications taken by father prior to conception was omeprazole. The patient did not receive any concomitant medications during the pregnancy. The patient's last menstrual period date was 20-Aug-2017. There was no evidence of a defect/adverse finding from a prenatal test and birth defect or congenital anomaly during the pregnancy. The patient was permitted to enroll in the pregnancy registry. On 01-Nov-2017, at gestation age of 10 weeks (1 trimester), the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular route, batch number: 195223, expiry date: Apr-2018) and no adverse event was occurred in the pregnant patient and fetus. The estimated date of delivery was reported as 28-May-2018. The reporter assessed the event as non-serious.
Age: 32.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous case, was initially received from other health professional on 10-Oct-2017, concerning a 32-year-old, adult, patient of an unspecified gender. The patient's medical history and concomitant medications were not reported. On 05-Oct-2017, the patient was administered with FLUCELVAX QUADRIVALENT (dose: 0.5 ml, batch number: 195128, expiry date: 30-Apr-2018, route of administration: intramuscular and anatomical location: deltoid). On the same day, 1 hour after vaccination, the patient experienced redness, itching and swelling at the injection site. It was reported that, the patient had applied ice at the injection site. On 07-Oct-2017, the patient had recovered from the events (reported as after 48 hours). The reporter assessed the events as non-serious. Non-significant case correction received 10-Oct-2017: Batch number (195128) was captured in the case form and narrative was amended accordingly.
Age: 23.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: This initial spontaneous case, was received from pharmacist on 10-Nov-2017, concerning a 23-year-old adult patient of unspecified gender. On 06-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195230, expiry date: May-2018). On the same day of vaccination, the patient experienced pain and soreness in the arm at the site of injection while sleeping in night. Pharmacist recommended analgesic. At the time of this report, the outcome of event was not recovered. The reporter assessed this case as non-serious. Non-significant follow-up received on 01-Dec-2017: The reporter confirmed that, the pain was in arm at injection site and not in leg.
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy
Clinical narrative: This initial non-serious spontaneous case, was received on 12-Oct-2017, from other health professional, concerning a female pregnant patient of unspecified age. On an unspecified date, the patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical site, batch number, expiration date: not reported). It was reported that a pregnant woman was administered with FLUCELVAX vaccine and further information were not available.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy
Clinical narrative: This initial spontaneous case, received on 06-Nov-2017 was reported by other non-health professional (consumer), concerns a 37-year-old female pregnant patient. The patient's medical history was not reported. The patient's current condition included inflamed cyst. The patient's concomitant medications included unspecified antibiotics for inflamed cyst. It was reported that, the patient had no stillbirth, miscarriage, birth defect or congenital anomaly, no spontaneous abortion during her previous pregnancy, no evidence of adverse finding from prenatal test. It was reported that her last menstrual period was on an unspecified date in Jun-2017 and estimated delivery date was 07-Mar-2018. On 03-Nov-2017, the patient was administered with FLUCELVAX QUADRIVALENT (dose: 0.5 ml, anatomical location: left arm, route of administration: Intramuscular, batch number and expiry date: not reported). The pregnant woman received vaccination (explicitly coded as vaccine exposure during pregnancy). The reporter assessed the case as non-serious. Following information was received on 28-Nov-2017: The patient's current condition was added (inflamed cyst). Narrative was amended accordingly.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Case number PHEH2016US030620, is an initial spontaneous report received from other health professional (other health care professional) on 18 Nov 2016. This report refers to a 54 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185286) on an unspecified date. On 17 Oct 2016 (after vaccination), the patient experienced pain in arm (injection site). It was reported that when the patient moved left arm, she had pain in upper area. The outcome of the event was condition unchanged. The event was reported as non serious. The causality of the event was not reported.
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy
Clinical narrative: This initial spontaneous case, was received from a Pharmacist on 20-Oct-2017, concerns a pregnant female patient of an unknown age. On 25-Oct-2017, the patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical location: not reported, batch no: 195242 and expiry date: Jun-2018). FLUCELVAX QIV was administered to pregnant patient (explicitly coded as: vaccine exposure during pregnancy). The reporter assessed this report as non-serious.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: This non-serious initial spontaneous case, was received from Other Health Professional on 20-Oct-2017, concerning 25-year-old adult female patient. On 20-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195128, expiry date: Apr-2018). On the same day, shortly after receiving the vaccine, the patient developed a firm, raised are at the injection site. The raised area was about the size of a marble. It was reported that the vaccine was administered from the same lot previously and no one experienced an adverse reaction. At the time of this report, the patient had not yet recovered from the event (reported as ongoing). The reporter assessed the event as non-serious.
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: This initial spontaneous case, was received from other non-health care professional on 09-Nov-2017, concerning a 39-year-old adult male patient. The patient's historical drug included FLUCELVAX, which was administered on 19-Oct-2016, (batch number: 185888, expiry date: May-2017), anti-histamine and topical cortisone cream. The patient's historical conditions included broken arm x (2) and hives on arms, hands and feet, which was started about 3 days after injection. The patient had allergic to mold, and maple pollen. cine was updated. The narrative was amended accordingly. On 29-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195219, expiry date: Apr-2018. On 03-Oct-2017, after 5 days of vaccination, the patient experienced hives, but it was not localized, and it covered 80 percent of his body. The patient was treated with BENADRYL and steroid (hydrocortisone) cream. On 07-Oct-2017, the patient completely recovered from the event. The reporter assessed the case as non-serious. Follow up received on 27-Nov-2017: Dose, route of administration, anatomical location and indication of suspect vaccine was updated. The narrative was amended accordingly.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Case number PHEH2017US001062, is an initial spontaneous report received from a nurse on 05 Jan 2017. This report refers to a 58 years old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186866, expiry date: May 2017) intramuscularly at a dose of 0.5 ml on 22 Dec 2016. On 23 Dec 2016 (next day) after vaccination, the patient experienced soreness in arm which has extended down to elbow. It was reported that, the event was not resolved for 02 weeks. No redness, swelling or fever was reported. The final outcome of the event was reported as condition unchanged. The seriousness of the event was reported as non serious and causality was not reported.
Age: 16.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: This initial spontaneous case, was received on 25-Oct-2017, reported by other non-health professional, concerning a 16-year-old, adolescent, female patient. The patient's medical history and concomitant medications were not reported. On 25-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195227, expiry date: May-2018). On the same day, 2 hours after vaccination, the reporter stated that, the patient developed hives all over her body. It was also reported that, the patient had no difficulty in breathing. No treatment measures were given to the patient. At the time of this report, the patient had not recovered from the event. The reporter assessed this case as non-serious.