chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Rash pruritic
Clinical narrative: This non-serious spontaneous case, was initially received on 05-Oct-2017, from other health professional, concerning a 53-year-old, adult female patient. The medical history of the patient had, three years of allergy to oral food which included cucumber, banana, malar, squash and developed poison ivy type of reaction, and lifelong allergy to latex and nickel that resulted in contact dermatitis. The concomitant medications were not reported. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: XF31507, expiry date: 30-Jun-2018). On 28-Sep-2017, after 8 days of vaccination, the patient developed rash near injection site on arm and rash on trunk, forehead and scalp. The trunk lesions were described as 0.5 to 0.2 cm macules - red with central clearing and had significant itching. One of the macule was on left deltoid region at the injection site. The patient had a total of 6 lesions on trunk. The patient had diffused maculopapular rash, flesh coloured, covering entire forehead, scalp, back of neck and very itchy. At the time of the report, the events were neither recovered nor worsened. The reporter assessed the report as non-serious. Non-significant case correction received with IRD 05-Oct-2017: Batch number (XF31507) was added on the screen. The narrative was amended accordingly.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Aphthous ulcer, Swollen tongue
Clinical narrative: This initial spontaneous case, was received from other health professional via health authority (VAERS ID: 718187) on 05-Dec-2017, concerning a 64-year-old female patient. The patient had allergy to blueberry and CLOROX (as reported) since an unspecified date. The patient was not taking any medications. On 15-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (reported as UNK), route of administration: intramuscular, anatomical location: right arm, batch no: XF31507, expiry date: not reported). On the same day, few hours after the vaccination, the patient experienced swelling of tongue and canker sore on the bottom of tongue. Reportedly, there were no other facial swelling and airway did not close off as per the patient. On an unspecified date, the patient was treated with BENADRYL for the events. On an unspecified date, the patient recovered from the events. The reporter considered the report as non-serious.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017, reported by regulatory authority (VAERS ID: 718200) via other non-health professional, concerning a 46-year-old adult female patient. On 22-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported). On 23-Sep-2017, after 2 days of vaccination, the patient had severe left arm pain which was affecting the patient while dressing her upper body and sleep. It was reported that, on (10/9 as reported) pain was less but it was still present during left arm movement. At the time of this report, the patient recovered from all the events except pain (not recovered). The reporter assessed the events as non-serious. Significant case correction received with IRD 05-Dec-2017: The outcome of the event (painful L arm) was corrected to not recovered. The narrative was amended accordingly.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 05-Dec-2017 by Seqirus from VAERS (VAERS ID: 718210), concerning a 25-year-old adult female patient. The patient pain in arm due to previous vaccination (unspecified). It was reported that, the patient was allergic to latex. On 09-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, anatomical location: left arm, route of administration: intradermal (reported as ID), batch number, expiry date: not reported). On the same day, after administration of vaccine, the patient experienced extreme pain from collar bone to finger tips on left side, which was very difficult to move. At the time of this report, the patient had not yet recovered from the events. The reporter assessed this case as non-serious. Non-significant case correction received with IRD 05-Dec-2017: Added history of previous vaccination in narrative. Narrative was amended accordingly. Significant case correction received with IRD 05-Dec-2017: The LLT and PT for the event (very difficult to move) was corrected from mobility decreased to injected limb mobility decreased. Non-significant case correction received with IRD 05-Dec-2017: The event verbatim for the event bone pain was corrected from 'extreme pain from collar bone to finger tips on left side' 'extreme pain from collar bone [to finger tips on left side]' in the event tab.
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Musculoskeletal pain, Pain
Clinical narrative: This initial spontaneous case, was received from other health professional via regulatory authority (FDA number: 718216), concerns a 28-year-old adult female patient. On 29-Sep-2017, the patient was administered AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, batch number: XF31307, anatomical location: left arm, expiry date: not reported). On the same day, after vaccine administration, the patient experienced immediate-pain in shoulder, pain continued without resolving especially when abducting and backward rotation. At the time of this report, the patient was not recovered from the events. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Injection site pain, Muscular weakness, Musculoskeletal disorder, Swelling
Clinical narrative: This non-serious initial spontaneous case, was received from other health professional via health authority (VAERS ID: 718252) on 05-Dec-2017, concerns a 42-year-old, adult female patient. The patient's medical history and concomitant medications were not reported. On 05-Oct-2017 at 11 am, the patient received AFLURIA QUADRIVALENT (dose: 0.5 ml (reported as 1 dose), route of administration: intramuscular, anatomical location: left deltoid (left arm), batch no: XF30506, expiry date: not reported). On the same day evening at 9 pm, the patient began having severe pain and slight swelling in the left armpit. It was reported that the injection site was tender but there was no redness or swelling at the site. The patient had taken ibuprofen for relief at home without success. After reporting to work, she was unable to help lift any patient or objects of any substantial weight and she had constant armpit pain at a level of 6-7/10 coupled with weakness of the entire left upper extremity. She was sent to emergency department for further evaluation. It was reported that the outcome of the events was not recovered. The reporter assessed this case as non-serious.
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017, from other health professional via health authority (VAERS ID: 719419), concerning a 15-year-old adolescent male patient. The patient's medical history and current illness were not reported. On 10-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF30306, expiry date: not reported). On the same day, after 30 minutes of vaccination, patient fainted. It was reported that the patient had to visit the emergency room, but felt fine at the time of leaving the vaccination room. At the time of the report, the patient had recovered from the event. The reporter considered the case as non-serious.
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Impaired work ability, Nausea
Clinical narrative: This initial spontaneous case, was received on 05-Dec-2017, from other health professional via health authority (VAERS ID: 719444), concerning a 64-year-old adult male patient. The patient's concomitant medications included finasteride and rosuvastatin for unknown indications. On 09-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: 0054461A, expiry date: not reported). On the same day, within 2 hrs of vaccination, patient experienced the symptoms of nauseous and dizzy. The next day, same symptoms of nauseous and dizzy continued and the patient had to take sick day from work. The reporter assessed the case as non-serious.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Pain in extremity
Clinical narrative: This initial spontaneous case, was received from other health professional via health authority (VAERS ID: 719517) on 05-Dec-2017, concerning a 65-year-old elderly female patient. The patient's current condition included: hypertension and allergic to shellfish and concomitant medications include LASIX, Potassium, SYNTHROID, Ibuprofen, SINGULAIR, HCTZ, Losartan, Albuterol, cefdinir, ADVAIR for unknown indications. On 06-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (route of administration: intramuscular, anatomical location: right arm, batch number: XF30707, dose and expiry date: not reported). On the same day co-suspect vaccine administered: PREVNAR vaccine (batch number: S3524 (as reported) route of administration: intramuscular, anatomical location: left arm, dose and expiry date: not reported). On 07-Oct-2017, after 1 day of vaccination, the patient experienced pain in her arm, injection site was red, warm, with a lump. On an unspecified date, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram, Laboratory test, Nausea, Vertigo, Vomiting
Clinical narrative: This is spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 719583), concerns a 60-years-old, elderly male patient. The patient's current conditions included hypertension (HTN as reported), hyperlipidaemia (HLD as reported), diabetes mellitus (DM2 as reported) and seasonal allergies. It was reported that, the patient had no known food allergy (NKFA) and no known drug allergy. The patient's concomitant medications included MVI (multivitamin intravenous infusion), metformin, pravastatin, lisinopril, amlodipine, ASA, BENADRYL, SUDAFED. On 05-Oct-2017, at 09:30 hours, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: XF33108, anatomical location: arm, route of administration: intramuscular). On the same day, at 10:30 hours, one hour after administration of the vaccine, the patient experienced nausea, vomiting and vertigo. It was reported that, the patient went home from work at 12:00 hours. The symptoms worsened after a few days for which the patient was admitted in ER (emergency room) on 08-Oct-2017. The patient was given IV fluids in ER. On an unspecified date, the patient had laboratory test and computed tomography scan for which results not reported. As of 11-Oct-2017, the patient was on medication for nausea and vertigo. At the time of this report, the outcome of the events was not yet recovered. The reporter assessed the case as non-serious.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Neuralgia, Pain in jaw, Paraesthesia
Clinical narrative: This initial spontaneous case, was received on 05-Dec-2017, from other health professional via health authority (VAERS ID: 719683), concerning a 38-years-old adult female patient. The patient's current condition included: asthma, GI reflux (gastrointestinal), inappropriate sinus tachycardia and allergy to penicillin and latex. The concomitant medications included: LOPRESSOR, SINGULAIR, CLARITIN, DEXILANT, ZANTAC for unknown indications. On 20-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch: XT59906, expiry date: not reported). On 28-Sep-2017, after 8 days of vaccination, the patient experienced the pain in bilateral lower jaws with shooting nerve pain from mouth to left side of the ear. On 05-Oct-2017, the patient experienced nerve pain all over the body in chest, back arms and legs with tingling in hands and feet. On 04-Oct-2017, the subject recovered from the event jaw pain, while the events nerve pain and tingling sensation persisted (not recovered). The reporter assessed the case as non-serious.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Asthma, Condition aggravated
Clinical narrative: This spontaneous case, initially received from other health professional via health authority (VAERS ID: 719778) on 05-Dec-2017, concerns a 42-year-old adult female patient. The patient's current illness included asthma. She had seasonal allergies. It was reported that she was allergic to amoxicillin-family drugs prescribed in another country. On 11-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, anatomical location: left arm, batch no: XT59505, route of administration: syr (as reported), and expiry date: not reported). On the same day, the patient had asthma attack and she was treated with albuterol inhaler and BENADRYL. The patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This non-serious initial spontaneous case, was received from Other Health Professional via health authority (VAERS ID: 719810) on 05-Dec-2017, concerning a 26-year-old, adult female patient. The patient was allergic to eggs and sulfa drugs. On 10-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF33008, expiry date: not reported). On 11-Oct-2017, after 1 day of vaccination, the patient experienced redness, swelling, warm to touch, itchy at the injection site. She was treated with prednisone. The patient recovered from all the events. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Dysstasia, Hyperhidrosis, Palpitations
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017, reported by health authority (VAERS ID: 719818) via other health professional, concerning a 54-year-old adult female patient. The patient had no current illness. The patient had penicillin allergy. The patient's concomitant medications included Metoprolol and Sertraline for an unknown indication. On 11-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: injection, anatomical location, batch number and expiry date: not reported). On the same day, after the vaccination, the patient experienced heart racing, dizziness, weakness, sweats and she was not able to stand. At the time of this report, the outcome of the events was not reported. The reporter assessed the events as non-serious. Non-significant case correction received with IRD 05-Dec-2017: The route of administration in the narrative was corrected from SYR to injection. The narrative was amended accordingly.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This initial spontaneous case, initially received on 05-Dec-2017, was reported by other health professional via health authority (719840) and concerns a 59-year-old adult female patient. On 05-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, anatomical location: left Arm, route of administration: intramuscular, batch number: 01144621A, expiry date: not reported). On the same day, after the administration of vaccine, the patient experienced redness and swelling at the injection site, which was hot to touch. On 09-Oct-2017, the redness was recovering, where as hot and swelling reported as recovered. The reporter assessed the event as non-serious.
Age: 78.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Chills, Discomfort, Erythema, Malaise, Myalgia
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Mar-2018 by Seqirus from VAERS (VAERS ID: 719945), concerns a 78-year-old elderly female patient. The patient's medical history was not reported. The patient's concomitant medication included amlodipine and ZOLOFT. On 26-Sep-2017, the patient was administered with FLUAD (dose: 0.5 ml (1 as reported), route of administration: unknown and anatomical location: right arm, batch number: 178302A) and non-company suspect PNEUMOVAX (dose: 1 as reported, route of administration: unknown and anatomical location: left arm, batch number: M033086). On the same day, at 6:00 PM, the patient experienced redness, swelling, discomfort. It was reported that, at the symptoms worsened by the next day (reported as 27-Sep-2017). On 27-Sep-2017, at 17 AM (as reported), the patient had fever, chills, malaise, myalgia (very ill). The symptoms worsened by night and continued until 29-Sep-2017. It was stated that, the patient called to report that, she was feeling much better. The patient had recovered from the event. The reporter assessed the case as non-serious.
Age: 78.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Mar-2018 by Seqirus from VAERS (VAERS ID: 719945), concerns a 78-year-old elderly female patient. The patient's medical history was not reported. The patient's concomitant medication included amlodipine and ZOLOFT. On 26-Sep-2017, the patient was administered with FLUAD (dose: 0.5 ml (1 as reported), route of administration: unknown and anatomical location: right arm, batch number: 178302A) and non-company suspect PNEUMOVAX (dose: 1 as reported, route of administration: unknown and anatomical location: left arm, batch number: M033086). On the same day, at 6:00 PM, the patient experienced redness, swelling, discomfort. It was reported that, at the symptoms worsened by the next day (reported as 27-Sep-2017). On 27-Sep-2017, at 17 AM (as reported), the patient had fever, chills, malaise, myalgia (very ill). The symptoms worsened by night and continued until 29-Sep-2017. It was stated that, the patient called to report that, she was feeling much better. The patient had recovered from the event. The reporter assessed the case as non-serious.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Cheilitis
Clinical narrative: This initial spontaneous case, received on 05-Dec-2017, was reported by other health professional via regulatory authority (VAERS ID: 720025) and concerns 47-year-old adult female patient. The patient's medical history included ADHD (attention deficit/hyperactivity disorder), migraine, C6/C7 DDD (degenerative disc disease). The patient's concomitant medication included: VISTARIL, fish oil, turmeric, ADDERALL. On 11-Oct-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: not reported). On the same day, 2 hours after flu shot, the patient had sore lip ("C/O" "sore on lip" as reported). The outcome of the event was not reported. The reporter assessed the causality as related to the suspect vaccine. The reporter assessed the case as non-serious.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Headache, Pain, Pyrexia
Clinical narrative: This non-serious spontaneous case, initially received from health authority (reported to health authority by other health professional) (VAERS ID: 720109) on 05-Dec-2017, concerning a 52-year-old, adult female patient. The patient's historical conditions included: high blood pressure and high cholesterol. Current conditions included: allergic to penicillin and ZITHROMAX (Z pack). Concomitant medications included: Metoprolol, Simvastatin, Amlodipine besylate and CONTRAVE for unknown indication. On 11-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (reported as 1 dose), route of administration: injection (reported as syringe), anatomical location: left arm, batch number, expiry date: not reported). On 12-Oct-2017, after 1 day of vaccination, the patient experienced upset stomach, body aches, fever of 101 (unit not reported) and headache. At the time of this report, the outcome of the events upset stomach, body aches, fever of 101 and headache was not reported. The reporter assessed the events as non-serious.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Erythema, Flushing, Hyperhidrosis, Pruritus
Clinical narrative: This spontaneous case, initially received from FDA health authority (VAERS ID: 720116) (reported to HA by other non-health professional) on 05-Dec-2017, concerning a 39-year-old adult, female patient. The patient's historical procedures included gastric sleeve (on 13-July-2016), bunionectomy and arthroplasty (on 05-Sep-2017). The patient had seasonal allergy, penicillin allergy, and sulfa antibiotics allergy. The patient's concomitant medications included naproxen, PRILOSEC, SINGULAIR, APRI, FLINTSTONES with iron for an unknown indication. On 10-Oct-2017, at 09:30 hrs, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical site: left arm, batch number: XF30807, expiry date: not reported). On the same day of vaccination, after 30 minutes, at 10:00 hrs, the patient's left arm was pruritic, red and warm to touch. The patient also had redness of chest, flushed face, had sweating and felt clammy. The nurse applied a cold compress on her arm and gave BENADRYL capsule (25 mg). Around 12:30 hrs, the patient had flushed and was sweating again, and she received cold compression. The patient received another dose of BENADRYL 25 mg, immediately as per the PCP (primary care physician) instructions. The patient was advised to take another BENADRYL capsule 25 mg before bedtime. It was reported that, there were no more reactions after a flare up at 12:30 hrs. On 10-Oct-2017, the patient recovered from all the events. The reporter assessed this case as non-serious and considered the causality of the events as related to the suspect vaccine.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: This spontaneous case, initially received from FDA health authority (VAERS ID: 720116) (reported to HA by other non-health professional) on 05-Dec-2017, concerning a 39-year-old adult, female patient. The patient's historical procedures included gastric sleeve (on 13-July-2016), bunionectomy and arthroplasty (on 05-Sep-2017). The patient had seasonal allergy, penicillin allergy, and sulfa antibiotics allergy. The patient's concomitant medications included naproxen, PRILOSEC, SINGULAIR, APRI, FLINTSTONES with iron for an unknown indication. On 10-Oct-2017, at 09:30 hrs, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical site: left arm, batch number: XF30807, expiry date: not reported). On the same day of vaccination, after 30 minutes, at 10:00 hrs, the patient's left arm was pruritic, red and warm to touch. The patient also had redness of chest, flushed face, had sweating and felt clammy. The nurse applied a cold compress on her arm and gave BENADRYL capsule (25 mg). Around 12:30 hrs, the patient had flushed and was sweating again, and she received cold compression. The patient received another dose of BENADRYL 25 mg, immediately as per the PCP (primary care physician) instructions. The patient was advised to take another BENADRYL capsule 25 mg before bedtime. It was reported that, there were no more reactions after a flare up at 12:30 hrs. On 10-Oct-2017, the patient recovered from all the events. The reporter assessed this case as non-serious and considered the causality of the events as related to the suspect vaccine.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Pain in extremity
Clinical narrative: This initial spontaneous case, was received from other non-health professional via regulatory authority (FDA number: 720255), concerns a 46-year-old adult female patient. The patient's historical drug included MMR vaccine for which the patient experienced faint. It was reported that, the patient was allergy to vaccine. The patient's concomitant medication included ZYRTEC. On 11-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, batch number: 01344611A, anatomical location: left arm). On 12-Oct-2017, after 2 days of vaccination, the patient experienced left arm pain, redness and tenderness below the injection site. It was reported that she had erythematous macule 7 cm below injection site 5cmx5cm warm, erythematous and it was tender to touch. At the time of this report, the patient was not recovered from the events. The reporter assessed the events as non-serious.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Rash macular
Clinical narrative: This initial spontaneous case, was received from other non-health professional via regulatory authority (FDA number: 720255), concerns a 46-year-old adult female patient. The patient's historical drug included MMR vaccine for which the patient experienced faint. It was reported that, the patient was allergy to vaccine. The patient's concomitant medication included ZYRTEC. On 11-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, batch number: 01344611A, anatomical location: left arm). On 12-Oct-2017, after 2 days of vaccination, the patient experienced left arm pain, redness and tenderness below the injection site. It was reported that she had erythematous macule 7 cm below injection site 5cmx5cm warm, erythematous and it was tender to touch. At the time of this report, the patient was not recovered from the events. The reporter assessed the events as non-serious.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017 from health authority (VAERS: 720257) (reported to HA by other health professional) concerns a 62-year-old elderly male patient. The patient had a previous history of quadruple bypass surgery (on unspecified date) and he had a spider bite on his back before 10 days of vaccination. It was reported that the patient had no history of allergies. The patient's current condition included hypertension (since an unspecified date) and his concomitant medications included tamsulosin, atorvastatin, amlodipine, metoprolol succinate. On 06-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose:0.5ml (reported as 1 dose), route of administration: intramuscular, anatomical site: left arm, batch number: XF34309 and expiry date: not reported).On 08-Oct-2017, the patient experienced blister on the left arm at the injection site, which was similar to the symptoms of the spider bite on his back. At the time of this report, the patient was recovered from the event. The reporter considered the events as non-serious.
Age: 38.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: This non-serious spontaneous case, initially received from health authority (reported to health authority by other health professional, VAERS ID: 720266) on 05-Dec-2017, concerning a 38-year-old, adult male patient. On 12-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (reported as 1 dose), route of administration: intramuscular, anatomical location: arm, batch number: XF32908, expiry date: not reported) and non-company suspect drug PNEUMOVAX (1 dose (as reported), route of administration: intramuscular, anatomical location: arm, batch number, expiry date: not reported). On the same day, after vaccination, the patient developed erythema, high fever (102 degrees Fahrenheit), severe pain in arm and had swelling at the injection site. The patient had not yet recovered from the events erythema, fever, pain in arm and injection site swelling. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram head, Dysgeusia, Hypoaesthesia, Immediate post-injection reaction, Laboratory test
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017, reported by other health professional via health authority (VAERS ID: 720291) and concerns a 31-year-old female adult patient. The patient had no history of allergies to medications, but was allergic to many fruits such as apples, pears, strawberries, prunes and peaches. The historical condition included sinusitis 2 weeks prior. On 12-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF30506, expiry date: not reported). On the same day, the patient had tasting of the vaccine, immediately after administration. At 8 am, the patient described numbness and tingling in left jaw down left side to knee lasting for 24 hours. CT (computed tomography) scan of head, vitals, Rainbow panel lab work was performed. The patient was given IV (intravenous) NS (normal saline) 1000 ml bolus. At the time of the report, the patient had not recovered from the events.
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017, reported by other health professional via health authority (VAERS ID: 720291) and concerns a 31-year-old female adult patient. The patient had no history of allergies to medications, but was allergic to many fruits such as apples, pears, strawberries, prunes and peaches. The historical condition included sinusitis 2 weeks prior. On 12-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF30506, expiry date: not reported). On the same day, the patient had tasting of the vaccine, immediately after administration. At 8 am, the patient described numbness and tingling in left jaw down left side to knee lasting for 24 hours. CT (computed tomography) scan of head, vitals, Rainbow panel lab work was performed. The patient was given IV (intravenous) NS (normal saline) 1000 ml bolus. At the time of the report, the patient had not recovered from the events.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 720323), concerns a 65-year-old, elderly male patient. The patient historical conditions included coronary artery disease and an episode of MI (myocardial infarction on an unspecified date in Sep-2007). The concomitant medications included carvedilol, lisinopril, omeprazole DR, LIPITOR, B complex, gabapentin, COQ, Multi Vitamin, Omega 3, aspirin, ferrous sulfate, trazodone. The patient had no allergies. On an unspecified date in Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration, anatomical location, batch number, expiry date: not reported), too high in shoulder (explicitly considered as drug administered at inappropriate site). On the same day, the patient experienced chronic shoulder pain and limited range of motion. The patient had visited primary care physician. The patient was treated with anti-inflammatory medicines like ibuprofen and diclofenac sodium topical gel. At the time of this report, the patient had not recovered from the events, chronic shoulder pain and limited range of motion. The reporter assessed the case as non-serious. Non-significant case correction received on IRD 21-Feb-2018: The date (sep-2007) was added for historical condition myocardial infarction (MI) in the relevant history field of patient tab. Narrative amended accordingly.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Joint swelling, Musculoskeletal discomfort, Neck pain
Clinical narrative: This spontaneous case, reported by a health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 720425), concerns a 39-year-old adult female patient. The patient's current condition included hypothyroidism since an unspecified date. The patient's concomitant medication included levothyroxine for hypothyroidism. On 12-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml (reported as 1), route of administration: injection (reported as SYR), anatomical location: right arm, batch number: 01144621A and expiry date: not reported). On 14-Oct-2017, 2 days after vaccination, the patient experienced neck pain and soreness which was progressed to back pain (from the tailbone all the way up to the neck). Later, the pain spread all over the body with the sensation that all other joints (fingers, toes, knees, elbows, shoulders and jaws) were swollen and very painful. The patient visited emergency department for the events. At the time of this report, the outcome of the events was not recovered. The reporter assessed this case as non-serious. Significant case correction received with IRD 21-Feb-2018: The event joint swelling was made as the symptom and mapped to the diagnosis arthralgia.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: This spontaneous case, reported by a health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 720425), concerns a 39-year-old adult female patient. The patient's current condition included hypothyroidism since an unspecified date. The patient's concomitant medication included levothyroxine for hypothyroidism. On 12-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml (reported as 1), route of administration: injection (reported as SYR), anatomical location: right arm, batch number: 01144621A and expiry date: not reported). On 14-Oct-2017, 2 days after vaccination, the patient experienced neck pain and soreness which was progressed to back pain (from the tailbone all the way up to the neck). Later, the pain spread all over the body with the sensation that all other joints (fingers, toes, knees, elbows, shoulders and jaws) were swollen and very painful. The patient visited emergency department for the events. At the time of this report, the outcome of the events was not recovered. The reporter assessed this case as non-serious. Significant case correction received with IRD 21-Feb-2018: The event joint swelling was made as the symptom and mapped to the diagnosis arthralgia.
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Muscular weakness, Myositis, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 720436), concerns a 40-year-old, adult female patient. The patient's vaccination history included unspecified vaccine with adverse event, large injection site hematoma (2015). The patient's historical conditions included, chronic back and ankle pain related to staphylococcus infection in the past (unspecified dates). The patient had no known drug allergies. The current conditions included lactose intolerance and seasonal allergies. The concomitant medications included, multi-vitamins and D-3 and had no current illness. On 09-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF30506, expiry date: not reported). On 10-Oct-2017, the next day morning, the patient had sore (described as extreme) and swollen left lateral region of the arm. The patient also experienced weakness, while lifting anything. The underarm was also painful. It was reported that the injection site was normal with slight soreness. The patient had to visit emergency room and was diagnosed with myositis status post (S/P) flu shot. No other tests were performed. At the time of this report the patient had not recovered from the events (sore arm, painful underarm, muscle weakness, myositis). The reporter assessed the case as non-serious.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Discomfort, Hypoaesthesia, Injection site hypoaesthesia, Injection site pain
Clinical narrative: This spontaneous case, reported by other health care professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 720444), concerns a 53-year-old, elderly, female patient. The patient's current conditions included hypertension and was allergic to morphine, gluten and lactose. The patient's concomitant medications were not received on the vaccination day. On 06-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: WT54907 and expiry date: not reported). It was reported that vaccine was administered high 1 inch from acromion process. On 07-Oct-2017, after 1 day of vaccination, in morning the patient experienced pain (7/10) with numbness and tingling from left axilla to down the left arm and felt discomfort. On 10-Oct-2017, the patient underwent ultrasound of left axilla, the results showed 2 cm borderline of lymph nodules. On an unspecified date, the patient pain (4/10) to left axilla with numbness and tingling to fingertips. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious. Non-significant case correction received with IRD 21-Feb-2018: The event verbatim for the event injection site tingling, injection site numbness was corrected. Case comment were corrected.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site paraesthesia, Lymphadenopathy, Pain in extremity, Paraesthesia, Ultrasound scan abnormal
Clinical narrative: This spontaneous case, reported by other health care professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 720444), concerns a 53-year-old, elderly, female patient. The patient's current conditions included hypertension and was allergic to morphine, gluten and lactose. The patient's concomitant medications were not received on the vaccination day. On 06-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: WT54907 and expiry date: not reported). It was reported that vaccine was administered high 1 inch from acromion process. On 07-Oct-2017, after 1 day of vaccination, in morning the patient experienced pain (7/10) with numbness and tingling from left axilla to down the left arm and felt discomfort. On 10-Oct-2017, the patient underwent ultrasound of left axilla, the results showed 2 cm borderline of lymph nodules. On an unspecified date, the patient pain (4/10) to left axilla with numbness and tingling to fingertips. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious. Non-significant case correction received with IRD 21-Feb-2018: The event verbatim for the event injection site tingling, injection site numbness was corrected. Case comment were corrected.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 720528), concerns a 42-year-old, adult female patient. The patient had no relevant history or medications at the time of vaccine. The patient's current conditions included otitis media and allergy to erythromycin. On 13-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 1644621A, expiry date: not reported). On 14-Oct-2017, the next day of vaccination, the patient experienced pain and erythema (approximately 3 cm in diameter) at the injection site. The injected area was pruritic, warm and tender to touch. The area surrounding the injection was erythematous. At the time of this report, the patient had not recovered from the events (pain, pruritus, erythema, warm at injection site). The reporter assessed the case as non-serious. Significant case correction received with IRD 21-Feb-2018: The listedness for the event (injection site erythema) was corrected from unlisted to listed in CORE Flu Vaccine Egg Split CSL.
Age: 18.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Chest X-ray normal, Computerised tomogram normal, Eye contusion, Eye swelling, Haemorrhage
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 720579), concerning an 18-year-old, adult female patient. The patient's historical conditions included cold (from 25-Sep-2017 to 29-Sep-2017), achalasia gastroparesis, IBS-C (since an unspecified date). The patient was not administered with any concomitant medications. On 04-Oct-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5 ml (dose: reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On the same day, the patient was administered with non-company suspect drug GARDASIL 9 (dose: 3 (as reported), route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On the same day, after receiving both vaccines on left arm, the patient walked out for 2 minutes and sat on a post as she felt nauseous, and then she fainted on her right side. She woke up in a pile of blood after 20-30 seconds. The emergency team took her to the hospital, after an hour of the incident. CT (computed tomography) scan and chest X-ray were performed, which were normal. She got 7 stitches inside and outside the mouth, had a swollen, black eye, neck pain on left side, constant migraines and messed up front right tooth. She left out of the hospital after 5 hours. On 11-Oct-2017, sutures outside the lip were removed. On 12-Oct-2017, neck X-ray was performed which was normal. The patient had not yet recovered from the events. The reporter assessed this case as non-serious.
Age: 18.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Lip injury, Migraine, Mouth injury, Nausea, Neck pain
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 720579), concerning an 18-year-old, adult female patient. The patient's historical conditions included cold (from 25-Sep-2017 to 29-Sep-2017), achalasia gastroparesis, IBS-C (since an unspecified date). The patient was not administered with any concomitant medications. On 04-Oct-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5 ml (dose: reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On the same day, the patient was administered with non-company suspect drug GARDASIL 9 (dose: 3 (as reported), route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On the same day, after receiving both vaccines on left arm, the patient walked out for 2 minutes and sat on a post as she felt nauseous, and then she fainted on her right side. She woke up in a pile of blood after 20-30 seconds. The emergency team took her to the hospital, after an hour of the incident. CT (computed tomography) scan and chest X-ray were performed, which were normal. She got 7 stitches inside and outside the mouth, had a swollen, black eye, neck pain on left side, constant migraines and messed up front right tooth. She left out of the hospital after 5 hours. On 11-Oct-2017, sutures outside the lip were removed. On 12-Oct-2017, neck X-ray was performed which was normal. The patient had not yet recovered from the events. The reporter assessed this case as non-serious.
Age: 18.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Spinal X-ray normal, Suture insertion, Syncope, Tooth injury
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 720579), concerning an 18-year-old, adult female patient. The patient's historical conditions included cold (from 25-Sep-2017 to 29-Sep-2017), achalasia gastroparesis, IBS-C (since an unspecified date). The patient was not administered with any concomitant medications. On 04-Oct-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5 ml (dose: reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On the same day, the patient was administered with non-company suspect drug GARDASIL 9 (dose: 3 (as reported), route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On the same day, after receiving both vaccines on left arm, the patient walked out for 2 minutes and sat on a post as she felt nauseous, and then she fainted on her right side. She woke up in a pile of blood after 20-30 seconds. The emergency team took her to the hospital, after an hour of the incident. CT (computed tomography) scan and chest X-ray were performed, which were normal. She got 7 stitches inside and outside the mouth, had a swollen, black eye, neck pain on left side, constant migraines and messed up front right tooth. She left out of the hospital after 5 hours. On 11-Oct-2017, sutures outside the lip were removed. On 12-Oct-2017, neck X-ray was performed which was normal. The patient had not yet recovered from the events. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Foetal death, Ultrasound antenatal screen abnormal
Clinical narrative: This is spontaneous case, reported by other non-health care professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 720605), concerns a 27-year-old, adult female patient. The patient's concomitant medication included prenatal vitamin. On 08-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT dose: 0.5ml, batch number: xf30306, anatomical location: right arm, route of administration: injection (reported as SYR). On 08-Sep-2017, after administration of AFLURIA QUADRIVALENT. The patient went for her first prenatal check-up on the same day, ultrasound showed baby as 7 weeks 2 days. On 30-Sep-2017, the patient felt something was not right and got admitted in ER (emergency room). Ultrasound on the same day showed baby was 7 weeks 5 days. It was reported that, approximate date of death would be 12-Sep-17 and the baby might have been around 11 weeks. The reporter assessed the case as non-serious. The outcome of the events "exposure during pregnancy" and "ultrasound antenatal screen abnormal" was unknown.