chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: The patient erroneously received the SHINGRIX vaccine subcutaneously instead of intramuscularly. They presented with symptoms of inflamed and painful injection site. She described the site as tender and warm to touch.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Product administered at inappropriate site
Clinical narrative: The patient erroneously received the SHINGRIX vaccine subcutaneously instead of intramuscularly. They presented with symptoms of inflamed and painful injection site. She described the site as tender and warm to touch.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: FEVER BEGAN APPROXIMATELY 6 HOURS AFTER SHOT FOLLOWED BY EXTREME REDNESS AND SWELLING AT THE INJECTION SITE. IT BECAME VERY WARM TO THE TOUCH.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Borrelia test negative, Dizziness, Nuclear magnetic resonance imaging, Vision blurred
Clinical narrative: 2-4 days after immunization patient developed dizziness, blurry vision (intermittent; ophthalmologist found no abnormalities on exam), and possible POTS symptoms.
Age: 17.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity, Swelling
Clinical narrative: Significant and severe swelling, stiffness in shoulder, pain in shoulder and upper arm, limited range of motion left shoulder.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Injection site erythema, Injection site warmth
Clinical narrative: By the next day the patient had a 5" red, hot mark at the injection site. The mark moved down his arm to his elbow. He also had a stomach ache. He applied BENADRYL cream. The symptoms were gone in 3-4 days.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Communication disorder, Decreased appetite, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Large rash spreading outwards from injection site on left leg. Spread upwards toward hip and groin. Bright red rash/hive developed on hip bone of right side. Low grade fever for multiple days. Swelling of injection site. Lack of appetite for multiple days (ongoing lack of appetite). Some communicative regression for 2-3 days.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Large rash spreading outwards from injection site on left leg. Spread upwards toward hip and groin. Bright red rash/hive developed on hip bone of right side. Low grade fever for multiple days. Swelling of injection site. Lack of appetite for multiple days (ongoing lack of appetite). Some communicative regression for 2-3 days.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Erythema, Injection site swelling, Lymphadenopathy, Vaccination site pain
Clinical narrative: No pregnant. Vaccine site initially sore. Pain increase starting about 10 pm same day. Painful from injection site, around bicep and in armpit. Lymph node in armpit slightly swollen. Area on bicep below injection site swollen. Redness around the front of the arm.
Age: 62.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Erythema, Limb discomfort, Limb mass, Pain, Pain in extremity
Clinical narrative: ON THE RIGHT ARM (PNEUMOVAX SIDE) PATIENT WOKE UP NEXT MORNING WITH USUALLY SORENESS BUT AFTER 2 OR 3 DAYS HE DEVELOPED A SIGNIFICANT LUMP AND REDNESS AND STILL DISCOMFORT. NOW 2 MONTHS LATER HIS RIGHT ARM IS STILL PAINFUL UPON USE OR IF HE TRIES TO SLEEP ON RIGHT SIDE. HE IS GOING TO HIS PCP FOR REGULAR CHECKUP AND IS GOING TO DISCUSS THIS WITH HIM.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Achiness, fatigue, fever, chills-started the following day, had to go home from work to take a nap, that evening must have had a fever, went straight to bed when I got home, chills, sleeplessness great pain, redness, hotness and injection site - it is now almost exactly 5 days later, heat and soreness on arm are gone but the redness is still evident.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain, Pyrexia
Clinical narrative: Achiness, fatigue, fever, chills-started the following day, had to go home from work to take a nap, that evening must have had a fever, went straight to bed when I got home, chills, sleeplessness great pain, redness, hotness and injection site - it is now almost exactly 5 days later, heat and soreness on arm are gone but the redness is still evident.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Malaise, Musculoskeletal stiffness, Seasonal allergy
Clinical narrative: Malase, hay fever, swollen injection site and stiff arm muscle.
Age: 0.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: RN pulled Tdap from refrigerator erroneously, meaning to pull Hepatitis B vaccine. Wrong med was given, pediatrician was informed within 30 minutes, and parents were as well, once error was caught. There was no adverse reaction (as of now, baby is 32 hours old, erroneous vaccine was given at 2 hours of age. Vital signs and assessment have been WDL (normal). MD to be following up with CDC tomorrow, Monday.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Injection site warmth, Pain, Pain in extremity
Clinical narrative: Redness and swelling on the back of my arm from shoulder to elbow. Hives on front of shoulder.  Itching. Pain and heat at injection site. Severe pain in arm - hurt to move it for 3 days. Pain subsided at beginning of 3rd day but redness and hives persist.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Redness and swelling on the back of my arm from shoulder to elbow. Hives on front of shoulder.  Itching. Pain and heat at injection site. Severe pain in arm - hurt to move it for 3 days. Pain subsided at beginning of 3rd day but redness and hives persist.
Age: 74.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Body temperature fluctuation, Chills, Fatigue, Palpitations, Somnolence
Clinical narrative: TDAP - 3 - but type not known given at same time. Severe shivering -- teeth chattering; low body temperature; racing heart that night. Body temperature remains subject to random fluctuations -- mostly chills --  temp. drops to 95.8 erratically to this day. Severe tiredness -- desire to sleep if not fully engaged.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Injection site erythema, Injection site induration, Injection site inflammation, Injection site pruritus
Clinical narrative: Patient experienced hives that were isolated to the arm in which the vaccination was given. Area involved included shoulder, upper arm, and forearm to the wrist (no hand involvement). Additionally, the area surrounding the injection site about 2 inches in diameter also became hot, red, itchy, and hard (inflamed). PharmD did not personally witness the reaction. Per patient, her friend did personally observe the patient's reaction. Per patient, no other abnormal symptoms other than diarrhea the first two days following vaccination. Reaction was delayed until 6/16/2018 at approximately noon.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site urticaria, Injection site warmth, Urticaria
Clinical narrative: Patient experienced hives that were isolated to the arm in which the vaccination was given. Area involved included shoulder, upper arm, and forearm to the wrist (no hand involvement). Additionally, the area surrounding the injection site about 2 inches in diameter also became hot, red, itchy, and hard (inflamed). PharmD did not personally witness the reaction. Per patient, her friend did personally observe the patient's reaction. Per patient, no other abnormal symptoms other than diarrhea the first two days following vaccination. Reaction was delayed until 6/16/2018 at approximately noon.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had Swelling, Redness and tenderness at injection site.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue
Clinical narrative: Tiredness, lack of energy.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Dyspnoea, Fatigue
Clinical narrative: Within 3 hours, full body aches, chills, shivering, aching joints, tender skin, hive-like full body itching but without hive bumps, sore muscles, sore neck, headache, extreme fatigue, weakness, shortness of breath, nausea. It lasted at that severe stage for 32 hours and then subsided SLOWLY over the next week. It finally left after 10 days. I was super weak.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Nausea, Neck pain, Pain
Clinical narrative: Within 3 hours, full body aches, chills, shivering, aching joints, tender skin, hive-like full body itching but without hive bumps, sore muscles, sore neck, headache, extreme fatigue, weakness, shortness of breath, nausea. It lasted at that severe stage for 32 hours and then subsided SLOWLY over the next week. It finally left after 10 days. I was super weak.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Pruritus generalised
Clinical narrative: Within 3 hours, full body aches, chills, shivering, aching joints, tender skin, hive-like full body itching but without hive bumps, sore muscles, sore neck, headache, extreme fatigue, weakness, shortness of breath, nausea. It lasted at that severe stage for 32 hours and then subsided SLOWLY over the next week. It finally left after 10 days. I was super weak.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Pain, swelling, heat at injection site the evening of the injection. In addition, fever of 101.2 and headache later that night and through the next morning. Treated with TYLENOL.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Blood pressure increased, Confusional state, Disorientation, Fatigue, Heart rate increased
Clinical narrative: The morning after the vaccination was given- I had confusion, fatigue, swollen arm at injection site, elevated blood pressure, elevated heart rate, Disorientation, Extreme pain in left arm where injection was given that sharply radiated throughout the rest of the arm.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: The morning after the vaccination was given- I had confusion, fatigue, swollen arm at injection site, elevated blood pressure, elevated heart rate, Disorientation, Extreme pain in left arm where injection was given that sharply radiated throughout the rest of the arm.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Anxiety, Chest discomfort, Confusional state, Contusion, Disturbance in attention
Clinical narrative: The morning after the vaccination was given- I had confusion, fatigue, swollen arm at injection site, elevated blood pressure, elevated heart rate, Disorientation, Extreme pain in left arm where injection was given that sharply radiated throughout the rest of the arm.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Dry mouth, Fatigue, Limb discomfort, Nausea, Pain
Clinical narrative: The morning after the vaccination was given- I had confusion, fatigue, swollen arm at injection site, elevated blood pressure, elevated heart rate, Disorientation, Extreme pain in left arm where injection was given that sharply radiated throughout the rest of the arm.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Pain in extremity, Palpitations
Clinical narrative: The morning after the vaccination was given- I had confusion, fatigue, swollen arm at injection site, elevated blood pressure, elevated heart rate, Disorientation, Extreme pain in left arm where injection was given that sharply radiated throughout the rest of the arm.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Night sweats, Pyrexia, Rash
Clinical narrative: Severe night sweats, fever > 101 F, rash on back, cough} all on evening after vaccine.
Age: 63.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site warmth
Clinical narrative: BOOSTRIX and SHINGRIX given left arm about 2 and 1/2 inches apart (vertical) on Friday June 15th 3:11PM. Fatigue (moderate) on Sat with no visible reaction or weakness of muscle. Sunday woke up in morning and variable shaped red, hot area around injection site was evident, irregular shape (approximate 4inches vertical by 2 and 1/2 inches horizontal approx), larger on top (SHINGRIX on top) than on bottom injection site. Patient complains of heat on that area but still no muscle weakness or pain. Feeling ok energy-wise and happy that she was able to get the shot. Read that the effects she was having were expected and relatively common.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Myalgia, Pain
Clinical narrative: Burning pain and sore to touch all along deltoid muscle that is progressively getting worse 2 weeks following injection. Bruise apparent 2 weeks after, as well. Bruise appeared 6/17/18.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Eye swelling, Facial paralysis, Lacrimation increased, Pharyngitis, Rhinitis allergic
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 via Vaccine Adverse Event Reporting System (VAERS 669560) was reported by other non-health professional and concerns an 40 years old male patient. Administration of Company suspect drug: On 15-Oct-2016 the patient was administered with AFLURIA QUADRIVALENT (dosage: 0.5 ml, duration: not reported, batch number: WT54807, route of administration: intramuscular). Adverse reactions/events and outcomes: On 17-Oct-2016 after administration of AFLURIA QUADRIVALENT, the patient experienced eye swelling, facial paralysis, lacrimation increased, pharyngitis and rhinitis allergic. Treatment medications: It was reported that patient's physician prescribed him prednisone 20 mg, valacyclovir 500 mg and natural tears (0.1%-0.3%) drops. The patient received 2015 influenza with no reaction. Action taken with AFLURIA QUADRIVALENT was not reported and outcome of the events was reported as recovered. Reporter's Assessment: The other non-health professional had not provided any causality assessment between the events and AFLURIA QUADRIVALENT. This report was non-serious. Non-significant case correction received on 19-Apr-2017.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Burning sensation, Lymph node pain, Lymphadenopathy, Tonsillar hypertrophy
Clinical narrative: This Spontaneous case, initially received on 12-Apr-2017, was reported by other non-health professional via regulatory authority (VAERS ID: 669597) and concerns a 33-years-old male patient. Patient's medical history included Lyme disease. Administration of Company suspect drug: On 17-Oct-2016, the patient was administered with AFLURIA QUADRIVALENT (dose: 12 of unspecified unit, batch number: 13349221A, route of administration: intramuscular and anatomical location: left arm). Adverse reactions/events and outcomes: On 18-Oct-2016, after administration of influenza vaccine, the patient awoke the day after with swollen tonsils and upper body lymph-nodes. The lymph nodes under the arms were particularly sore for three days after vaccination and persisted for 6 days. Patient's Tonsils reduced in swelling after 4 days, but left fingertips experienced a persistent burning sensation for 10 days. This was the first non-single dose flu vaccination after being diagnosed with Lyme disease. Tonsils and lymph nodes were confirmed swollen by certificate nurse. Action taken with influenza vaccine was not reported. The outcome of the events was recovered. Reporter's Assessment: The reporter did not provide the causality between influenza vaccine and events. This report was not serious.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Fatigue, Malaise, Muscular weakness
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 via Vaccine Adverse Event Reporting System (VAER - 669684) was reported by a other non-health professional and concerns a 12 years old male patient. The patient's concomitant medication included amitriptyline. On 02-Nov-2016 the patient was administered with AFLURIA QUADRIVALENT (dose and duration: not reported, batch number: WT58508, route of administration: intramuscular). The patient's mother stated that on 03-Nov-2016 after administration of AFLURIA QUADRIVALENT, the patient felt fatigued, lower leg weakness and he felt unwell and stayed in bed from 03-Nov-2016 to 04-Nov-2016 due to the weakness. On 02-Nov-2016 the patient aged 12 years was administered with AFLURIA QUADRIVALENT characterised by "Inappropriate age at vaccine administration". Action taken with AFLURIA QUADRIVALENT was not reported and outcome of the events fatigue, malaise and muscular weakness was reported as recovered and outcome of the event inappropriate age at vaccine administration was unknown. Reporter's Assessment: The other non-health professional had not provided any assessment between the events and AFLURIA QUADRIVALENT. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Middle insomnia, Musculoskeletal pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by an other-non health professional via regulatory authority (VAERS ID: 669744) and concerns a 56 years old female patient. Patient's medical history was not reported. Administration of Company suspect drug(s): On 28-Oct-2016 AFLURIA QUADRIVALENT was administered (dose: 0.5 ml) via intramuscular route of administration, batch number: WT54707. Adverse reactions/events and outcomes: On 28-Oct-2016 after administration of AFLURIA QUADRIVALENT the patient experienced sore arm on the same day after vaccine was given. Two days later the patient felt more pain in her arm which woke her up in her sleep. The treatment for the events include BIOFREEZE, ibuprofen (800 mg every 8 hours) and muscle exercise and still complains of soreness around her shoulder. Patient had no adverse reaction to past flu shots. Outcome of the events was recovered. Reporter's Assessment: The Other Non-Health Professional considered the causality between the AFLURIA QUADRIVALENT and events were related. This report is not serious.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by an other non-health professional via regulatory body (VAERS ID: 670054) and concerns a 62 years old female patient. Administration of Company suspect drug: On 11-Oct-2016, patient was administered with AFLURIA QUADRIVALENT (dosage: 0.5 ml, batch number: WT59707, route of administration: intramuscular, anatomical location: left arm). Adverse reactions/events and outcomes: On 11-Oct-2016, after administration of AFLURIA QUADRIVALENT, the patient experienced extreme pain at the site of injection, arm was very sore and pain in her arm when moving up and down. Action taken with the suspect product was not reported. Outcome was reported as not recovered. Reporter also mentioned that her arm was very sore for couple of days. Treatment medications: It was reported that after rubbing with MYOFLEX she felt relief for pain. Reporter's Assessment: The other health authority did not provide any causality for the events in relation to the suspect product. This report is not serious.
Sex: F
Vaccine: FLU4, PPV
Symptoms: Paraesthesia oral
Clinical narrative: This Spontaneous case, initially received on 12-Apr-2017, which was reported by an other-health professional via regulatory body (VAERS ID: 670297) and concerns a 69 years old female patient. At the time of the event the patient had diabetes and high blood pressure. Concomitant medication included: amlodipine, aspirin, gabapentin, atorvastatin, metformin, atenolol and baclofen. Administration of company suspect drug: On 23-Nov-2016, patient was administered with AFLURIA QUADRIVALENT (dosage: 0.5 ml, batch number: WT56808A, route of administration: intramuscular, anatomical location: right arm). Administration of non-company suspect drug: On 23-Nov-2016, patient was administered with PNEUMOVAX (dosage: unknown, batch number: M040004, route of administration: intramuscular, anatomical location: left arm). Adverse reactions/events and outcomes: On 23-Nov-2016, after administration of AFLURIA QUADRIVALENT and PNEUMOVAX, the patient experienced tingling of tongue within 15 min. Action taken with the suspect product was not reported. Outcome was reported as recovered/resolved. The patient was treated with BENADRYL for tingling of the tongue. Reporter's Assessment: The other non-health care professional considered event was related. This report was non serious.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Lumbar puncture, Nerve conduction studies, Nuclear magnetic resonance imaging
Clinical narrative: This serious initial spontaneous case, was received via health authority (VAERS ID: 671461) on 12-Apr-2017, concerning a 47-year-old adult male patient. The patient's medical history included diabetes mellitus, hypertension and hypercholesterolemia. The patient's concomitant medication included Aspirin, CRESTOR, INVOKANA and Krill oil (fish oil). On 05-Oct-2016, the patient was administered with AFLURIA (TIV) (reported as AFLURIA QUADRIVALENT) (dose: 0.5 ml (reported as 3), route of administration: intramuscular, anatomical location: left arm, batch number: WT52406, expiry date: not reported). On 11-Nov-2016, the patient experienced Guillain-Barre syndrome and was hospitalised for 14 days. On unspecified date, the patient's lab test included spinal tap (lumbar puncture), multiple MRI (nuclear magnetic resonance imaging) and nerve conduction study. The outcome of the event was not recovered/not resolved. Health authority assessed the report as serious due to hospitalisation and permanent disability. Significant case correction received on 11-Aug-2017: Corrected suspect product coding from AFLURIA QUADRIVALENT to AFLURIA (TIV) with reference to batch number and listedness of the event Guillain-Barre syndrome was corrected from unlisted to listed. The narrative was amended accordingly.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Diplopia, Immediate post-injection reaction, Impaired work ability, Injection site reaction, Laboratory test
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, was reported by an other non-health professional and concerns a 38 years old female patient. The patient's medical history Included: Asthma, GERD. Patient has year-round allergies seasonal and environmental. The patient's concomitant medication included: SINGULAIR, ALLEGRA, FLONASE, Iron. Administration of Company suspect drug: On 13-Oct-2015, the patient administered with AFLURIA QUADRIVALENT, Dose, route and batch number: not reported) on left arm. Adverse reactions/events and outcomes: The patient reported that, she received AFLURIA QUADRIVALENT through Nurse at a Wellness Fair through her job. She felt the medicine go up her shoulder and up into her neck. She set around for 15 minutes and was allowed to leave. After getting back to her desk, she started to have double vision within 30 minutes of receiving the vaccine. It was bad to the point she was not able to drive, do her job, watch TV or function normally. It was ongoing for about 4 months. She currently still having a little effect from it. She was diagnosed with antibodies attacking my thyroid. She never had any issues with her thyroid. This diagnosis was given after her description of the reaction of the flu shot. She had to see a neurologist, eye doctor, and eye doctor specialist for the double vision. They ran a battery of tests. Action taken with AFLURIA QUADRIVALENT was not reported. Outcome for events was not recovered. Reporter's Assessment: The reporter implied the causality between AFLURIA QUADRIVALENT and events was related. Company causality between AFLURIA QUADRIVALENT and events was assessed as not related. Health Authority did not provide the causality of the events. This report was not serious.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of personal independence in daily activities, Thyroid disorder
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, was reported by an other non-health professional and concerns a 38 years old female patient. The patient's medical history Included: Asthma, GERD. Patient has year-round allergies seasonal and environmental. The patient's concomitant medication included: SINGULAIR, ALLEGRA, FLONASE, Iron. Administration of Company suspect drug: On 13-Oct-2015, the patient administered with AFLURIA QUADRIVALENT, Dose, route and batch number: not reported) on left arm. Adverse reactions/events and outcomes: The patient reported that, she received AFLURIA QUADRIVALENT through Nurse at a Wellness Fair through her job. She felt the medicine go up her shoulder and up into her neck. She set around for 15 minutes and was allowed to leave. After getting back to her desk, she started to have double vision within 30 minutes of receiving the vaccine. It was bad to the point she was not able to drive, do her job, watch TV or function normally. It was ongoing for about 4 months. She currently still having a little effect from it. She was diagnosed with antibodies attacking my thyroid. She never had any issues with her thyroid. This diagnosis was given after her description of the reaction of the flu shot. She had to see a neurologist, eye doctor, and eye doctor specialist for the double vision. They ran a battery of tests. Action taken with AFLURIA QUADRIVALENT was not reported. Outcome for events was not recovered. Reporter's Assessment: The reporter implied the causality between AFLURIA QUADRIVALENT and events was related. Company causality between AFLURIA QUADRIVALENT and events was assessed as not related. Health Authority did not provide the causality of the events. This report was not serious.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Eye pruritus, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 was reported by other non-health professional via Vaccine Adverse Event Reporting System (VAERS: 674719) and concerns a 61 years old female patient. The patient's historical condition included osteoporosis. Administration of Company suspect drug: On 26-Dec-2016, the patient received AFLURIA QUADRIVALENT (dose of 0.5 ml, expiry date: not reported, batch no: WT53206) at left arm via intramuscular route. Non-company suspect drug: On an 26-Dec-2016, the patient also received ZOSTAVAX (dose, expiry date, batch no, route of administration: not reported). Adverse reactions/events and outcomes: On 26-Dec-2016 after administration of influenza vaccine and varicella zoster vaccine, the patient experienced rash at site of injection with mild itch and mild itch over right eye with no rash. The patient took 20 ml of BENADRYL generic liquid as a treatment drug for the events. Action taken with the vaccine was not reported. The outcome of the events was unknown. Reporter's Assessment: The other non-health professional did not provide the causality of the events in relation to the AFLURIA QUADRIVALENT. This case was non-serious.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 from Vaccine Adverse Events Reporting System (VAERS reference number: 677743) as reported by a other non healthcare professional and concerns a 60 years old male patient. On 04-Jan-2017, the patient was administered by AFLURIA QUADRIVALENT (dosage: 0.5 ml, batch number: WT57108, route of administration: intramuscular). On 04-Jan-2017, after administration of AFLURIA QUADRIVALENT, the patient experienced hard to lift, rotate arm and to lift arm over her head. The outcome of event hard to life, rotate arm and to lift arm over her head was recovered/resolved. Current illness was reported as left arm soreness more than 7 days. Reporter's Assessment: The other non healthcare professional assessed the event hard to lift, rotate arm and to lift arm over her head as non serious and the causality of the events was not reported. This case report was non serious.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: This initial serious spontaneous case, was received via VAERS (ID: 678561) on 12-Apr-2017, reported by other non-health professional and concerns a 45 years old male adult patient. The patient's medical history included: hypertension, depression, anxiety, anemia, GERD (gastroesophageal reflux disorder), coronary artery disease, hyperlipidemia. The patient's current condition included upper respiratory tract infection (URI). The patient's concomitant medications included lisinopril, iron, fluoxetine, metoprolol, NTG, buspirone, ASA, NEXIUM, Atorvastatin, carvedilol. On 28-Dec-2016, the patient received 0.5ml intramuscular AFLURIA QUADRIVALENT of batch number: 14049222A on left arm. On 09-Jan-2017, after 11 days (as reported) of administration of AFLURIA QUADRIVALENT, the patient was diagnosed with Guillain-Barre syndrome. The patient was hospitalised at the time of report. The outcome of the event was reported as not recovered. Health authority assessed the report as serious (life threatening, hospitalization and medically significant). Significant case-correction received on 11-Aug-2017: The listedness of the event Guillain-Barre syndrome was corrected from unlisted to listed.
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (vaccine adverse event reporting system: 679158) and concerns a 45-years-old adult female patient. The patient's medication history included: Upper respiratory tract infection, diabetes mellitus, GERD, bilateral carpal tunnel syndrome. The patient's concomitant medication included: Ranitidine, B12, iron, hydroxyzine, omeprazole, ibuprofen. Administration of Company suspect drug: On 20-Jan-2017, the patient was administered with AFLURIA QUADRIVALENT (Batch number: WT54607) via intramuscular route on left arm. Non-company suspect drug: On unspecified date the patient was administered with PNEUMOVAX (batch number: M006141) on left arm. Adverse reactions/events and outcomes: On 20-Jan-2017 the patient experienced left arm swelling, redness, tender to touch and low grade fever, cellulitis. Lab data: Cellulitis of left arm. Reporter's Assessment: The reporter did not provide the causality between influenza vaccine and the events. This case is non serious. Revision to the information on 12-Apr-2017: Upon review the following correction was made. The seriousness criteria of the event cellulitis was upgraded from non serious to serious. This case was upgraded to serious (medically significant).    This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (vaccine adverse event reporting system: 679158) and concerns a 45-years-old adult female patient. The patient's medication history included: Upper respiratory tract infection, diabetes mellitus, GERD, bilateral carpal tunnel syndrome. The patient's concomitant medication included: Ranitidine, B12, iron, hydroxyzine, omeprazole, ibuprofen for unknown indication. Administration of Company suspect drug: On 20-Jan-2017, the patient was administered with AFLURIA QUADRIVALENT (0.5 ml, Batch number: WT54607) via intramuscular route on left arm. Non-company suspect drug: On unspecified date the patient was administered with PNEUMOVAX (batch number: M006141) on left arm. Adverse reactions/events and outcomes: On 20-Jan-2017 the patient experienced left arm swelling, redness, tender to touch and low grade fever, cellulitis. Lab data: Cellulitis of left arm. Reporter's Assessment: The reporter did not provide the causality between influenza vaccine and the events. This case is non serious. Revision to the information received on 12-Apr-2017: Upon review the following correction was made. The seriousness criteria of the event cellulitis was upgraded from non serious to serious. This case was upgraded to serious (medically significant).
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by an other non health professional via Health Authority (FDA VAERS number: 679378) and concerns a 51 years old male patient. On 27-Dec-2016, the patient was administered with one dose of AFLURIA QUADRIVALENT (dosage: 0.5ml, batch number: WY52205, route of administration: intramuscular, anatomical location: left arm). On 27-Dec-2016, after administration of AFLURIA QUADRIVALENT, the patient's arm was still sore from vaccination. Action taken with the suspect product was not reported. Outcome was reported as unknown. Reporter's Assessment: Health Authority did not provide any causality assessment and considered the report as non-serious.
Age: 18.0
Sex: F
Vaccine: FLU4, IPV, MNQ, TDAP
Symptoms: Malaise, Type IV hypersensitivity reaction
Clinical narrative: This spontaneous case, initially received on 05-May-2017 was reported by other non-health professional via health authority (VAERS ID: 683047) and concerns an 18-years-old female patient. The patient was allergic to egg. Administration of Company suspect drug: On 16-Feb-2017, the subject received AFLURIA QUADRIVALENT (batch number: WT58508, dose, expiry date: not reported) at left arm via intramuscular route. Non-company suspect drugs: On 16-Feb-2017, the patient also received MENACTRA (batch number: U5523BA, dose, expiry date: not reported) at left arm via intramuscular route, IPOL (batch number: N1A46, dose, expiry date: not reported) and BOOSTRIX (batch number: 3457Y, dose, expiry date: not reported) at right arm via intramuscular route. Adverse reactions/events and outcomes: On 16-Feb-2017 after administration of influenza vaccine, meningococcal vaccine, iodinated glycerol and Tdap vaccine, the patient was continuously monitored for more than 30 minutes. During the time, the patient was admitted for not feeling well and was continuously monitored but showed no serious signs of adverse reaction at that time. The patient was left with rest of her group. Later in the day, the patient was looked for the medical attention to her instructor who released her for medical care and her symptoms had developed into a delayed allergic response at the urgent care clinic. Action taken with the suspect vaccines was not reported. The outcome of the events was recovered. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the influenza vaccine. This case was serious (life-threatening).
Sex: M
Vaccine: FLU4
Symptoms: Influenza
Clinical narrative: This serious initial spontaneous case, was received from other non-health professional via health authority (VAERS ID: 693653) on 21-Jul-2017, concerning a 61-year-old adult male patient. The patient's historical condition included flu (influenza). The patient historical drugs included Aspirin, indomethacin and ibuprofen which caused urticaria, irregular heart rate, simvastatin caused muscle pain, atorvastatin caused rash, rosuvastatin caused tremor and minocycline caused an unspecified reaction. The patient's current conditions included obstructive sleep apnoea syndrome, chronic pain syndrome, pancreatitis, depressive disorder, shoulder bone unspecified abnormalities (reported as shoulder bone abno), cervical radiculopathy, carpal tunnel syndrome, lumbar radiculopathy, alcohol abuse, esophagitis, gastro-duodenitis, polyp of colon, gastroesophageal reflux disease, adrenal hypertrophy or hyperplasia, diaphragmatic hernia, type 2 diabetes mellitus without complications, arteriosclerotic heart disease, benign essential hypertension, cataract and unspecified problems (reported as unspecified pos). On 09-Mar-2017, the patient was administered with AFLURIA (dose: 1 (as reported), batch number: WT56007, anatomical location: right arm, route of administration: not reported). On 17-Mar-2017, 9 days after vaccination, the patient developed flu symptoms (influenza) with associated flu like symptoms. It was reported that, the patient had complained this response every time when he got the flu and entered it as adverse response. The patient was treated with loratadine (10 mg, every day) for the event. At the time of this report, the patient's condition was improving.
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Eyelid oedema, Lip swelling, Nausea, Pharyngeal oedema
Clinical narrative: This initial spontaneous case, received on 05-Dec-2017, reported by other health professional via regulatory authority (VAERS ID: 713424) concerns a 55-year-old female patient. Patient's medical history and concomitant medications were not reported. It was stated that, the patient had never reacted to flu vaccine before. On 15-Sep-2017, at 08:30 hours, the patient received AFLURIA QUADRIVALENT (dose: 0.5ml, anatomical location: left arm, batch number, route of administration: SYR as reported). On the same day, about 15 minutes after administration of AFLURIA QUADRIVALENT, the patient experienced throat swelling, nose swelling, unable to breath and had severe nausea. The patient reported to her PMD at the clinic and took EPIPEN (epipren as reported). At about 13:00 hours, the patient had reoccurrence of symptoms with no relief from oral BENADRYL. The patient had nausea (another episode), vomiting, throat swelled shut, upper lip swelled and eyes were puffy. The patient reported the symptoms to her PMD at the clinic and got EPIPEN injection and prednisone. At 20:30 hours, the patient had second episode of reoccurrence of symptoms (reported as more severe than the last episode) with no relief on oral medication. It was reported that, the symptoms were persisting and admitted to ED on 15-Sep-2017 and discharged on 16-Sep-2017. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the case as serious (hospitalization and life threatening).
Sex: F
Vaccine: FLU4
Symptoms: Swelling, Vomiting
Clinical narrative: This initial spontaneous case, received on 05-Dec-2017, reported by other health professional via regulatory authority (VAERS ID: 713424) concerns a 55-year-old female patient. Patient's medical history and concomitant medications were not reported. It was stated that, the patient had never reacted to flu vaccine before. On 15-Sep-2017, at 08:30 hours, the patient received AFLURIA QUADRIVALENT (dose: 0.5ml, anatomical location: left arm, batch number, route of administration: SYR as reported). On the same day, about 15 minutes after administration of AFLURIA QUADRIVALENT, the patient experienced throat swelling, nose swelling, unable to breath and had severe nausea. The patient reported to her PMD at the clinic and took EPIPEN (epipren as reported). At about 13:00 hours, the patient had reoccurrence of symptoms with no relief from oral BENADRYL. The patient had nausea (another episode), vomiting, throat swelled shut, upper lip swelled and eyes were puffy. The patient reported the symptoms to her PMD at the clinic and got EPIPEN injection and prednisone. At 20:30 hours, the patient had second episode of reoccurrence of symptoms (reported as more severe than the last episode) with no relief on oral medication. It was reported that, the symptoms were persisting and admitted to ED on 15-Sep-2017 and discharged on 16-Sep-2017. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the case as serious (hospitalization and life threatening).
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Burning sensation, Chest discomfort, Chills, Dehydration
Clinical narrative: This serious initial spontaneous case, received on 05-Dec-2017, reported by other health professional via regulatory authority (VAERS ID: 713978) and concerns 31-year-old female patient. Patient did not have medical history (current illness, allergies and concomitant medications). On 21-Sep-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5ml (1 as reported), anatomical location: left arm, batch number, route of administration: syr (as reported). On the same day, after vaccination, the patient had tightness in chest, burning lungs, tingling of lips, sensation of throat closing up, difficulty breathing, dizziness, weakness, hives near injection site, swollen itchy eyes, face numbing, chills, mild fever, reduced oxygen saturation, wheezing & hoarseness, pale face. The patient took two BENADRYL, drank a ton of water, and got monitored on vital signs at home. It was reported that, the subject had severe chills in the middle of the night, extreme dizziness and dehydration. Probably she might have gone to the hospital, but the patient's husband was a nurse so he was monitoring her at home instead of going to the hospital. The outcome of the events was recovered.
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dysphonia, Dyspnoea, Eye pruritus, Eye swelling
Clinical narrative: This serious initial spontaneous case, received on 05-Dec-2017, reported by other health professional via regulatory authority (VAERS ID: 713978) and concerns 31-year-old female patient. Patient did not have medical history (current illness, allergies and concomitant medications). On 21-Sep-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5ml (1 as reported), anatomical location: left arm, batch number, route of administration: syr (as reported). On the same day, after vaccination, the patient had tightness in chest, burning lungs, tingling of lips, sensation of throat closing up, difficulty breathing, dizziness, weakness, hives near injection site, swollen itchy eyes, face numbing, chills, mild fever, reduced oxygen saturation, wheezing & hoarseness, pale face. The patient took two BENADRYL, drank a ton of water, and got monitored on vital signs at home. It was reported that, the subject had severe chills in the middle of the night, extreme dizziness and dehydration. Probably she might have gone to the hospital, but the patient's husband was a nurse so he was monitoring her at home instead of going to the hospital. The outcome of the events was recovered.
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site urticaria, Oxygen saturation decreased, Pallor, Paraesthesia oral
Clinical narrative: This serious initial spontaneous case, received on 05-Dec-2017, reported by other health professional via regulatory authority (VAERS ID: 713978) and concerns 31-year-old female patient. Patient did not have medical history (current illness, allergies and concomitant medications). On 21-Sep-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5ml (1 as reported), anatomical location: left arm, batch number, route of administration: syr (as reported). On the same day, after vaccination, the patient had tightness in chest, burning lungs, tingling of lips, sensation of throat closing up, difficulty breathing, dizziness, weakness, hives near injection site, swollen itchy eyes, face numbing, chills, mild fever, reduced oxygen saturation, wheezing & hoarseness, pale face. The patient took two BENADRYL, drank a ton of water, and got monitored on vital signs at home. It was reported that, the subject had severe chills in the middle of the night, extreme dizziness and dehydration. Probably she might have gone to the hospital, but the patient's husband was a nurse so he was monitoring her at home instead of going to the hospital. The outcome of the events was recovered.
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Throat tightness, Wheezing
Clinical narrative: This serious initial spontaneous case, received on 05-Dec-2017, reported by other health professional via regulatory authority (VAERS ID: 713978) and concerns 31-year-old female patient. Patient did not have medical history (current illness, allergies and concomitant medications). On 21-Sep-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5ml (1 as reported), anatomical location: left arm, batch number, route of administration: syr (as reported). On the same day, after vaccination, the patient had tightness in chest, burning lungs, tingling of lips, sensation of throat closing up, difficulty breathing, dizziness, weakness, hives near injection site, swollen itchy eyes, face numbing, chills, mild fever, reduced oxygen saturation, wheezing & hoarseness, pale face. The patient took two BENADRYL, drank a ton of water, and got monitored on vital signs at home. It was reported that, the subject had severe chills in the middle of the night, extreme dizziness and dehydration. Probably she might have gone to the hospital, but the patient's husband was a nurse so he was monitoring her at home instead of going to the hospital. The outcome of the events was recovered.
Sex: M
Vaccine: FLU4
Symptoms: Angioedema, Hypersensitivity, Injection site cellulitis, Injection site swelling
Clinical narrative: This initial serious spontaneous case, was received on 05-Dec-2017, from other health professional via health authority (VAERS ID: 714678), concerning a 16-year-old adolescent male patient. The patient had no known drug, food or any product allergies and was healthy overall. On 25-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: U1838AB (as reported), expiry date: not reported). On the same day, the patient developed moderate swelling at the injection site associated with cellulitis. It was reported that the patient had angioedema, which was considered as allergic reaction. The patient had to visit the physician for consultation. At the time of the report, the patient had not recovered from the events.
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Influenza, Malaise, Pain in extremity
Clinical narrative: This initial serious spontaneous case, was received on 05-Dec-2017, was reported by other health professional via health authority (VAERS ID: 717937) and concerns a 41-year-old adult female patient. The patient's current condition included mild hypertension. The patient's concomitant medication included: losartan potassium, HCTZ, citalopram. On 28-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml (1 as reported), anatomical location: left arm, patient route of administration: (syringe as reported), batch number, expiry date: not reported). On 29-Sep-2017, one day after vaccination, the patient experienced left arm sore, which was painful and slightly numbness since vaccination. It was reported that, the patient also experienced general malaise and extended but mild flu symptoms. At the time of this report, the outcome of the events was not recovered.