chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: FLUA3, FLUA3
Symptoms: Arthralgia, Asthenia, Fatigue, Groin pain, Muscular weakness
Clinical narrative: Patient complained of debilitating muscle pain in both arms and groin area. He used to be an avid swimmer and can't swim anymore. Used to bench press 50 lbs or more and cannot even lift 25 lbs now. This started 2 days after receiving flu shot.
Age: 65.0
Sex: M
Vaccine: FLUA3, FLUA3
Symptoms: Myalgia
Clinical narrative: Patient complained of debilitating muscle pain in both arms and groin area. He used to be an avid swimmer and can't swim anymore. Used to bench press 50 lbs or more and cannot even lift 25 lbs now. This started 2 days after receiving flu shot.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced redness in a circular pattern around the injection site which grew larger as time passed. The area was swollen, warm to the touch and sensitive to pressure.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Patient came to the pharmacy on 9/22 in early afternoon with significant redness and swelling in her right arm. She stated that her arm had felt "really sore" the evening after the vaccines were administered and that after she took a shower it the area turned red and swollen. I observed the area of redness which covered most of her upper, down into the area of her elbow.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Gait disturbance, Pain in extremity, Peripheral swelling, Tachycardia
Clinical narrative: Pt reports swelling and pain in right arm the night of the injection. Slight improvements day after 9/22/17. On 9/23/17, patient reports worsening of swelling, pain, and new onset tachycardia (120 BPM) and difficulty walking. Patient checked into ER 9/23/17 and was administered IV diphenhydramine. Symptoms improved and was discharged. Now continuing on oral diphenhydramine. Swelling was localized to the right arm. No epinephrine was necessary.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth, Rash pruritic
Clinical narrative: Patient experienced a rash and swelling that started from the injection site on the deltoid muscle that extended down and anterior to the biceps area. The are was raised, red and warm to the touch. The rash was not tender but was pruritic from time to time. I offered to assist the patient with medical care but she declined and did not want to see a doctor about this issue. I advised her to use cold compresses and apply hydrocortisone cream to the affected areas and take benadryl orally. I also advised her to keep an eye out for signs of infection and to monitor her temperature for fever.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Malaise, Pyrexia, Rhinorrhoea
Clinical narrative: Patient felt "sick" ( fever, tired, runny nose) the next day after receiving vaccine.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Feeling hot, Hyperhidrosis
Clinical narrative: ABOUT 45 MINUTES AFTER SHOT, PATIENT EXPERIENCED BACKACHE, BECAME VERY HOT AND SWEATY, LASTING FOR ABOUT 10 MINUTES BEFORE SUBSIDING.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Inflammation, Injection site erythema, Injection site inflammation
Clinical narrative: Redness all over patient's left shoulder, not at injection site. from collar bone to chest area. Red and inflamed, but not itchy or rash.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Anxiety, Chills, Dizziness, Dysphonia, Neck pain
Clinical narrative: Within 5 minutes of receiving the shot became dizzy and felt anxious/restless. Voice became hoarse and neck began to hurt. After 20-30 minutes, these symptoms dissipated to be followed by chills and itching on forearms and knees. Called pharmacy and was advised to use Benadryl. Complied. The next morning awoke to an itchy, red, raised rash under arm, extending up inner arm and downward toward breast. Arm tingling down to fingers; three fingers with pins and needles (middle thru pinky fingers). As the day progressed, rash became painful; stinging more than itching. Around 8pm, tongue began burning, lime sunburn or as if exposed to too much citric acid. The next day went to urgent care wherein doctor believes the rash may be shingles. SJS not ruled out. No explanation given for burning mouth. Condition persists 48hrs. following vaccine administration.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Paraesthesia, Pruritus, Rash, Rash erythematous
Clinical narrative: Within 5 minutes of receiving the shot became dizzy and felt anxious/restless. Voice became hoarse and neck began to hurt. After 20-30 minutes, these symptoms dissipated to be followed by chills and itching on forearms and knees. Called pharmacy and was advised to use Benadryl. Complied. The next morning awoke to an itchy, red, raised rash under arm, extending up inner arm and downward toward breast. Arm tingling down to fingers; three fingers with pins and needles (middle thru pinky fingers). As the day progressed, rash became painful; stinging more than itching. Around 8pm, tongue began burning, lime sunburn or as if exposed to too much citric acid. The next day went to urgent care wherein doctor believes the rash may be shingles. SJS not ruled out. No explanation given for burning mouth. Condition persists 48hrs. following vaccine administration.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash pruritic, Restlessness, Tongue discomfort
Clinical narrative: Within 5 minutes of receiving the shot became dizzy and felt anxious/restless. Voice became hoarse and neck began to hurt. After 20-30 minutes, these symptoms dissipated to be followed by chills and itching on forearms and knees. Called pharmacy and was advised to use Benadryl. Complied. The next morning awoke to an itchy, red, raised rash under arm, extending up inner arm and downward toward breast. Arm tingling down to fingers; three fingers with pins and needles (middle thru pinky fingers). As the day progressed, rash became painful; stinging more than itching. Around 8pm, tongue began burning, lime sunburn or as if exposed to too much citric acid. The next day went to urgent care wherein doctor believes the rash may be shingles. SJS not ruled out. No explanation given for burning mouth. Condition persists 48hrs. following vaccine administration.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Mobility decreased, Nausea, Pain in extremity, Pyrexia
Clinical narrative: STARTING THE NIGHT OF THE VACCINE SHE DEVELOPED SEVERE ARM PAIN THAT RADIATED DOWN TO HER HAND. SHE WAS NOT ABLE TO MOVE HER ARM THE ENITRE NIGHT. SHE HAD CHILLS, FEVER, AND NAUSEA. THERE WAS NO REDNESS OR SWELLING AT THE INJECTION SITE.  MOTRIN MADE THE PAIN "SOMEWHAT BETTER". SHE WAS STILL SORE THE NEXT DAY, BUT WAS ABLE TO MOVE HER ARM.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, soreness, warmth and swelling at injection site.
Age: 83.0
Sex: M
Vaccine: FLUA3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Patient called pharmacy on 9/22/17 and stated his left arm was completely numb. Patient states he feels it is due to flu shot administered on 9/13/17. Patient states he felt administration was "a little hard" and began experiencing pain and numbness 2 days after administration (9/15/17). Patient did not report any side effects to pharmacy prior to his call on 9/22/17. Patient was advised to seek medical attention due to description of symptom as "arm feeling dead".
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Headache, Injected limb mobility decreased, Injection site pain, Malaise
Clinical narrative: Patient called on 9/23/17 to report adverse events to pharmacist. Complaint of stiff neck, sore arms at injection site and cannot move her arms. She received AFLURIA 2017-2018 single dose syringe injection in left deltoid muscle and PNEMOVAX 23 in right deltoid muscle. Not feeling well, shortness of breath, terrible pain and headache. When asked on a scale of 1-10, how bad the pain was, she said 9-10. Pharmacist strongly recommended that she immediately go to the emergency room/hospital. Unknown if patient actually went to the ER or not.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Patient called on 9/23/17 to report adverse events to pharmacist. Complaint of stiff neck, sore arms at injection site and cannot move her arms. She received AFLURIA 2017-2018 single dose syringe injection in left deltoid muscle and PNEMOVAX 23 in right deltoid muscle. Not feeling well, shortness of breath, terrible pain and headache. When asked on a scale of 1-10, how bad the pain was, she said 9-10. Pharmacist strongly recommended that she immediately go to the emergency room/hospital. Unknown if patient actually went to the ER or not.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient said after shot his arm got red, swollen and very hot from the shoulder to the elbow. The patient said it got to the point he could not raise his arm. He took TYLENOL and the swelling and redness has gone away but still sore on 9/24/17. No medical attention was needed.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: Patient has an egg shaped red patch on her left arm. Patient says she's experienced itching. She used Benadryl and Hydrocortisone 1% cream over the counter. Patient stated this happened to her before a couple years ago, she went back to that doctor's office and they administered a steroid shot. Patient report event to pharmacy today 9/24/2017 around 3pm. Patient was advised to continue taking Benadryl and Hydrocortisone 1%. Pharmacy provided more OTC medication to patient at no charge.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Throat irritation, Throat tightness
Clinical narrative: Within one minute of receiving immunization, patient reported feeling closing of airway, itchy throat, and difficulty breathing. 911 was immediately called. Patient was instructed to lie down flat on her back. At the patient's request, EPIPEN was not administered, but diphenhydramine 50mg was administered. Paramedics arrived on scene. By this time, patient reported improvement in symptoms. Paramedics evaluated patient for blood pressure and blood oxygen levels. Patient declined being transported to the emergency room. Patient's parents arrived on scene and signed a release from the paramedics and went home.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site haematoma
Clinical narrative: Hematoma at injection site appearing 3 days later.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Feeling abnormal, Immediate post-injection reaction, Injection site swelling, Joint stiffness
Clinical narrative: As soon as medication was injected, the injection site swollen up. patient then complained of dizziness, tingling of the arm, not feeling right and tightness around should and neck. 911 was called .
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle tightness, Paraesthesia
Clinical narrative: As soon as medication was injected, the injection site swollen up. patient then complained of dizziness, tingling of the arm, not feeling right and tightness around should and neck. 911 was called .
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased, Myalgia
Clinical narrative: Redness, excessive swelling pain at injection site. Muscles in my left arm, shoulder, and at times to the base of left neck experience sharp pain and limited movement. About 2 weeks later, redness began to fade and swelling began to decrease. Now, about 4-1/2 weeks later I still have the sharp muscle pains if I move my left arm a certain way or pick things up.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient received the both immunizations on 9/23. She came back to the pharmacy on 9/24. Her arm was swollen some, very red and hot to the touch. She also reported a good deal of pain.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Premature labour
Clinical narrative: Woman went into preterm labor. Had to be hospitalized to stop labor progression and contractions.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: Shoulder paid in left shoulder: -8/28/17 Mon night bf school started around 9pm I got flu shot in upper left arm from pharmacy; it hurt the muscle upon injection and that night I had lots of pain in my arm that woke me up while sleeping -8/29/17 I had limited range of motion from my left shoulder (couldn't really lift my arm from the shoulder (elbow down fine)) and had similar sleeping pain, cannot dress myself with anything over head and barely with button down shirt -8/30/17-9/3/17 had pain and range of motion issues but range of motion slowly was getting better (like down to 20-30% issue) -9/4/17 went for a short 20 mins run of stairs at stadium and range of motion from shoulder worsened significantly over next 24 hours and had similar night pain so called for doc apt -9/7/17 went to clinic for appt, doc 'heard of this ailment, nurse had once for woman who had lifted weights after flu shot, was told not to exercise, to get a heating pad, and to take low dose med that's like ALEVE for 5-7 days -9/8/17-9/14/17 took all medicine and getting better but still not right (pain while dressing, showering washing hair, etc) -9/15/17 came back from store and carried 4 bags from street to dorm and shoulder got a bit worse -9/19/17 saw physician again and he said range of motion improved from first time but still clearly something wrong so prescribed PT -9/20/17 called PT but first available appt not until 10/11 -9/24/17 today: still hurts when raise arm to shave, while washing hair sometimes, while taking off shirt, and when putting on backpack; friend found article which corresponds extremely closely with what I'm experiencing! Also, regarding where I got the vaccine: pharmacy. Received: FLUARIX QUAD 2017-108 Syringe, GlaxoSmithKline NDC: 58160-0907-52 Qty 0.5 ML Exp Date: 03/2018.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Sleep disorder
Clinical narrative: Shoulder paid in left shoulder: -8/28/17 Mon night bf school started around 9pm I got flu shot in upper left arm from pharmacy; it hurt the muscle upon injection and that night I had lots of pain in my arm that woke me up while sleeping -8/29/17 I had limited range of motion from my left shoulder (couldn't really lift my arm from the shoulder (elbow down fine)) and had similar sleeping pain, cannot dress myself with anything over head and barely with button down shirt -8/30/17-9/3/17 had pain and range of motion issues but range of motion slowly was getting better (like down to 20-30% issue) -9/4/17 went for a short 20 mins run of stairs at stadium and range of motion from shoulder worsened significantly over next 24 hours and had similar night pain so called for doc apt -9/7/17 went to clinic for appt, doc 'heard of this ailment, nurse had once for woman who had lifted weights after flu shot, was told not to exercise, to get a heating pad, and to take low dose med that's like ALEVE for 5-7 days -9/8/17-9/14/17 took all medicine and getting better but still not right (pain while dressing, showering washing hair, etc) -9/15/17 came back from store and carried 4 bags from street to dorm and shoulder got a bit worse -9/19/17 saw physician again and he said range of motion improved from first time but still clearly something wrong so prescribed PT -9/20/17 called PT but first available appt not until 10/11 -9/24/17 today: still hurts when raise arm to shave, while washing hair sometimes, while taking off shirt, and when putting on backpack; friend found article which corresponds extremely closely with what I'm experiencing! Also, regarding where I got the vaccine: pharmacy. Received: FLUARIX QUAD 2017-108 Syringe, GlaxoSmithKline NDC: 58160-0907-52 Qty 0.5 ML Exp Date: 03/2018.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site pain, Peripheral coldness, Skin discolouration
Clinical narrative: 09/20/2017 evening pt went to work and experience numbness in arms, cold to touch, and bluish color to the arm. 9/21/17 called pharmacy and reported her symptoms. 9/22/17 Pt said her symptoms were better and she only had soreness near the injection site-MD told pt if she did not get better to go to the ER. But pt did feel better on 9/22/17.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Dizziness, Headache, Pain in extremity
Clinical narrative: Fever - headache - pain, back and legs, weakness 4 plus days - dizziness. Shot on Monday - symptoms Tues, Wed, Thurs, Fri and Sat.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever - headache - pain, back and legs, weakness 4 plus days - dizziness. Shot on Monday - symptoms Tues, Wed, Thurs, Fri and Sat.
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This initial spontaneous caser was received from an other medical assistant via health authority (VAERS ID: 681480) on 10-Jul-2017, concerns a male patient of unspecified age. On an unspecified date, patient was vaccinated with INN flu vaccine seasonal, (route of administration: syringe (as reported), dose, anatomical location, batch number, expiry date, indication, trade name and manufacturer: not reported) and PNEUMOVAX 23 (route of administration: syringe (as reported), anatomical location: arm, dose, batch, number, expiry date: not reported). On an unspecified date, the patient developed severe redness and swelling at the injection site after being vaccinated with PNEUMOVAX 23 and flu shot. It was not specified if the patient received the flu shot in the same arm where the PNEUMOVAX 23 was administered. The patient was advised by the physician to go for an urgent care, but it was unknown if the patient went for it. The outcome of the events was not reported. Reporter's comments: Health authority did not provide the casual relationship between the events and suspect vaccine (INN flu vaccine seasonal) and assessed the report as non-serious.
Age: 51.0
Sex: M
Vaccine: FLUX, VARCEL, FLUX, VARCEL
Symptoms: Chills, Depression, Fatigue, Feeling cold, Injection site rash
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional via health authority (VAERS ID: 683017) on 10-Jul-2017, concerning a 51-year-old male patient. The patient's medical history and concurrent conditions were not reported. The patient was receiving unspecified concomitant medications. The patient was under prophylaxis for an unspecified indication at an unspecified time. On 03-Feb-2017, the patient was vaccinated with INN flu vaccine (route of administration: syringe (as reported), anatomical location: right arm, batch number, indication, dose, trade name, manufacturer: not reported) and varicella zoster vaccine (route of administration: subcutaneous, anatomical location: left arm, dose, batch number and indication: not reported). On same day, the patient developed an injection site rash in the arm, where the VARIVAX was administered. Later, the patient felt chilled, cold and tired. The rash persisted for three days, and subsided after getting treated with BENADRYL. The patient felt better however he was tired. The patient suspected that, he felt tired because of depression. The patient reported that, he never experienced chicken pox before or received any vaccine against chicken pox. He even suspected that why he was administered VARIVAX and not ZOSTAVAX (wrong vaccine administered). The patient still considered to take second dose of VARIVAX, but not decided yet. The outcome of the events Chills, feeling cold and fatigue was recovering, depression was not recovered and injection site rash was recovered. Reporter's comment: The health authority assessed the report as non-serious. Significant case correction received on 26-Jul-2017: Listedness of the event injection site rash was corrected.
Age: 51.0
Sex: M
Vaccine: FLUX, VARCEL, FLUX, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional via health authority (VAERS ID: 683017) on 10-Jul-2017, concerning a 51-year-old male patient. The patient's medical history and concurrent conditions were not reported. The patient was receiving unspecified concomitant medications. The patient was under prophylaxis for an unspecified indication at an unspecified time. On 03-Feb-2017, the patient was vaccinated with INN flu vaccine (route of administration: syringe (as reported), anatomical location: right arm, batch number, indication, dose, trade name, manufacturer: not reported) and varicella zoster vaccine (route of administration: subcutaneous, anatomical location: left arm, dose, batch number and indication: not reported). On same day, the patient developed an injection site rash in the arm, where the VARIVAX was administered. Later, the patient felt chilled, cold and tired. The rash persisted for three days, and subsided after getting treated with BENADRYL. The patient felt better however he was tired. The patient suspected that, he felt tired because of depression. The patient reported that, he never experienced chicken pox before or received any vaccine against chicken pox. He even suspected that why he was administered VARIVAX and not ZOSTAVAX (wrong vaccine administered). The patient still considered to take second dose of VARIVAX, but not decided yet. The outcome of the events Chills, feeling cold and fatigue was recovering, depression was not recovered and injection site rash was recovered. Reporter's comment: The health authority assessed the report as non-serious. Significant case correction received on 26-Jul-2017: Listedness of the event injection site rash was corrected.
Sex: M
Vaccine: FLUX, VARZOS, FLUX, VARZOS
Symptoms: Herpes virus infection
Clinical narrative: This initial non-serious spontaneous case was received from an consumer via health authority (VAERS ID: 683100) on 10-Jul-2017, concerning a 70-year-old male patient. The patient's current included herpes simplex type II (since an unspecified date on 1975) which had plagues him for nearly 40 years. The patient was under prophylaxis for an unknown indication. On an unspecified date in 2013, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacture: not reported). On the same day, the patient received ZOSTAVAX (dose: 1 DF (one shot), route of administration: intramuscular (SYR) (reported incorrect route of drug administration), anatomical location, batch number, expiry date: not reported). Bot the vaccines were administered within a couple of minutes. It was reported that, within 36 hours after the vaccination with INN Flu Vaccine Seasonal and ZOSTAVAX, the patient developed one "major" herpes attack. The patient did not received any treatment but visited his physician for medical attention. On an unspecified date patient's blood count was performed during his annual physical exam but no results were provided. The patient thought that the ZOSTAVAX somehow suppressed or possible caused his herpes type 2 virus in his body. The outcome of the event "major" herpes attack was recovered. Reporter's comments: The health authority the case as non-serious.
Sex: M
Vaccine: FLUX, VARZOS, FLUX, VARZOS
Symptoms: Blood count, Condition aggravated, Herpes virus infection
Clinical narrative: This initial non-serious spontaneous case was received from an consumer via health authority (VAERS ID: 683100) on 10-Jul-2017, concerning a 70-year-old male patient. The patient's current included herpes simplex type II (since an unspecified date on 1975) which had plagues him for nearly 40 years. The patient was under prophylaxis for an unknown indication. On an unspecified date in 2013, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacture: not reported). On the same day, the patient received ZOSTAVAX (dose: 1 DF (one shot), route of administration: intramuscular (SYR) (reported incorrect route of drug administration), anatomical location, batch number, expiry date: not reported). Bot the vaccines were administered within a couple of minutes. It was reported that, within 36 hours after the vaccination with INN Flu Vaccine Seasonal and ZOSTAVAX, the patient developed one "major" herpes attack. The patient did not received any treatment but visited his physician for medical attention. On an unspecified date patient's blood count was performed during his annual physical exam but no results were provided. The patient thought that the ZOSTAVAX somehow suppressed or possible caused his herpes type 2 virus in his body. The outcome of the event "major" herpes attack was recovered. Reporter's comments: The health authority the case as non-serious.
Age: 17.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Anxiety, Crying, Diarrhoea, Fatigue, Influenza like illness
Clinical narrative: This initial spontaneous case, was received on 10-Jul-2017 was reported by physician via health authority (VAERS ID: 683251) and concerns a 17-year-old, adolescent, female patient. The patient's current illness included prophylaxis for an unspecified condition since an unspecified date. The patient's medical history, concomitant medications, drug reactions, or allergies were not reported. On 01-Oct-2014, the patient was vaccinated with the INN Flu Vaccine, (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacture name: not reported). On the same day, the patient was also administered with first dose of GARDASIL (route of administration: syringe (as reported), dose, anatomical location, batch number, expiry date: not reported). After 3 to 4 days of vaccine administration (reported as approximately 04-Oct-2014), the patient experienced diarrhoea, which lasted for one day. On an unspecified date, a few months after the vaccination, the patient felt anxious, tired and crying very often, these symptoms lasted for 1 year. On an unspecified date, additional to the above events, the patient experienced flu like symptoms and felt unwell which last for few months. The patient also had personality changes. The outcome of the event flu like symptoms was not reported and remaining all the events were recovered. The health authority assessed the report as not serious. Significant case correction received on 26-Jul-2017: Listedness of the event diarrhoea was corrected.
Age: 17.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Malaise, Personality change
Clinical narrative: This initial spontaneous case, was received on 10-Jul-2017 was reported by physician via health authority (VAERS ID: 683251) and concerns a 17-year-old, adolescent, female patient. The patient's current illness included prophylaxis for an unspecified condition since an unspecified date. The patient's medical history, concomitant medications, drug reactions, or allergies were not reported. On 01-Oct-2014, the patient was vaccinated with the INN Flu Vaccine, (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacture name: not reported). On the same day, the patient was also administered with first dose of GARDASIL (route of administration: syringe (as reported), dose, anatomical location, batch number, expiry date: not reported). After 3 to 4 days of vaccine administration (reported as approximately 04-Oct-2014), the patient experienced diarrhoea, which lasted for one day. On an unspecified date, a few months after the vaccination, the patient felt anxious, tired and crying very often, these symptoms lasted for 1 year. On an unspecified date, additional to the above events, the patient experienced flu like symptoms and felt unwell which last for few months. The patient also had personality changes. The outcome of the event flu like symptoms was not reported and remaining all the events were recovered. The health authority assessed the report as not serious. Significant case correction received on 26-Jul-2017: Listedness of the event diarrhoea was corrected.
Age: 17.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Anxiety, Crying, Diarrhoea, Dizziness, Fatigue
Clinical narrative: This initial spontaneous case, was received on 10-Jul-2017 was reported by physician via health authority (VAERS ID: 683251) and concerns a 17-year-old, adolescent, female patient. The patient's current illness included prophylaxis for an unspecified condition since an unspecified date. The patient's medical history, concomitant medications, drug reactions, or allergies were not reported. On 01-Oct-2014, the patient was vaccinated with the INN Flu Vaccine, (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacture name: not reported). On the same day, the patient was also administered with first dose of GARDASIL (route of administration: syringe (as reported), dose, anatomical location, batch number, expiry date: not reported). After 3 to 4 days of vaccine administration (reported as approximately 04-Oct-2014), the patient experienced diarrhoea, which lasted for one day. On an unspecified date, a few months after the vaccination, the patient felt anxious, tired and crying very often, these symptoms lasted for 1 year. On an unspecified date, additional to the above events, the patient experienced flu like symptoms and felt unwell which last for few months. The patient also had personality changes. The outcome of the event flu like symptoms was not reported and remaining all the events were recovered. The health authority assessed the report as not serious. Significant case correction received on 26-Jul-2017: Listedness of the event diarrhoea was corrected.
Age: 17.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Influenza like illness, Personality change
Clinical narrative: This initial spontaneous case, was received on 10-Jul-2017 was reported by physician via health authority (VAERS ID: 683251) and concerns a 17-year-old, adolescent, female patient. The patient's current illness included prophylaxis for an unspecified condition since an unspecified date. The patient's medical history, concomitant medications, drug reactions, or allergies were not reported. On 01-Oct-2014, the patient was vaccinated with the INN Flu Vaccine, (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacture name: not reported). On the same day, the patient was also administered with first dose of GARDASIL (route of administration: syringe (as reported), dose, anatomical location, batch number, expiry date: not reported). After 3 to 4 days of vaccine administration (reported as approximately 04-Oct-2014), the patient experienced diarrhoea, which lasted for one day. On an unspecified date, a few months after the vaccination, the patient felt anxious, tired and crying very often, these symptoms lasted for 1 year. On an unspecified date, additional to the above events, the patient experienced flu like symptoms and felt unwell which last for few months. The patient also had personality changes. The outcome of the event flu like symptoms was not reported and remaining all the events were recovered. The health authority assessed the report as not serious. Significant case correction received on 26-Jul-2017: Listedness of the event diarrhoea was corrected.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Breast pain, Erythema, Musculoskeletal pain, Pain in extremity, Peripheral swelling
Clinical narrative: This non-serious initial, spontaneous case, was reported by a pharmacist via health authority (VAERS Id: 683543) received on 10-Jul-2017, concerning a female patient of unspecified age (reported as 20's). The patient had an increased risk of pneumococcal disease due to smoking. At the time of this report, the patient was under prophylaxis for an unknown indication. On 01-Oct-2016, the patient was administered with INN Flu Vaccine (route of administration, anatomical location, trade name, batch number, manufacturer, expiry date: not reported). On same day, the patient was administered with PNEUMOVAX 23 (route of administration: intramuscular, dose, batch number and anatomical location: not reported). On an unspecified date, the patient experienced redness, swelling, and soreness from the shoulder to the elbow and soreness in the breast. The outcome of the events was not reported. Reporter's comment: The health authority assessed the events as non-serious.
Age: 29.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Breast pain, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This non-serious initial spontaneous case, was received on 10-Jul-2017 and reported by other health professional (pharmacist) via health authority (VAERS ID: 684235) concerning a 29-year-old female adult patient. The patient's current condition included asthma and prophylaxis for an unspecified condition from an unspecified time. The patient had no relevant concomitant medications. On 01-Oct-2016, the patient was vaccinated with the INN Flu Vaccine (dose, anatomical location: arm, route of administration, batch number, expiry date, trade name, manufacture name: not reported). On the same day, the patient was also vaccinated with PNEUMOVIX (dose, anatomical location: arm, route of administration: intramuscular, batch number, expiry date, trade name, manufacture name: not reported). On an unspecified date, after vaccination, the patient experienced redness, swelling, and soreness from the shoulder to the elbow, and had soreness in the breast. It was reported that, the reporter could not verify whether either of the vaccines had been administered in the affected arm. It was reported that the reporter had no information regarding patient's lab diagnostics studies and treatment medication. The outcome of the events was not reported. The health authority assessed the reporter as not serious. Significant case correction received on 26-Jul-2017: Coding of the event "swelling from the shoulder to the elbow" was corrected from swelling to peripheral swelling and listedness was changed accordingly.
Age: 76.0
Sex: M
Vaccine: FLUX, PPV, VARZOS, FLUX, PPV, VARZOS
Symptoms: Erythema, Joint swelling, Muscular weakness, Myalgia, Pruritus
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional via health authority (VAERS ID: 684299) on 10-Jul-2017, concerning a 76-year-old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. The vaccination history included Zoster vaccine and the current illness included prophylaxis. On 11-Sep-2016, the patient was administered with INN Flu Vaccine (dose, route of administration (SYR, as reported), anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the patient was administered with PNEUMOVAX 23 (dose, route of administration, anatomical location, batch number, expiry date: not reported) and ZOSTAVAX (dose: 2 (as reported), route of administration: subcutaneous, anatomical location, batch number, expiry date: not reported). On an unspecified date, the patient had swollen elbow on the right arm, that was also itchy, red and muscle ache. The patient also experienced muscle pain from his elbow to shoulder and around the neck and weakness in the legs. The patient did not receive any treatment for the adverse events, but had monthly follow-up appointments with the physician. The outcome of the events was not recovered. Reporter's comment: The health authority assessed the case as non-serious.
Sex: U
Vaccine: DTAP, FLUX, MMR, VARCEL, DTAP, FLUX, MMR, VARCEL
Symptoms: Cough, Fatigue, Feeling hot
Clinical narrative: This initial spontaneous case was received from nurse via health authority (VAERS ID: 685526) on 10-Jul-2017, concerns a patient of unspecified gender and age. The patient's concurrent condition, concomitant medication and medical history was not reported. The patient was under prophylaxis for an unknown indication. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (trade name, manufacture, dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unspecified date subject was administered with DTaP (dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unspecified date, the subject was administered with MMR II (dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unspecified date, the subject was administered with VARIVAX (dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unspecified date, after the administration of all vaccines the patient developed sporadic cough, fatigue and felt hot without fever. The outcome of the events was not reported. Reporter's comments: Health authority assessed the report as non-serious and reported the causality as unknown.
Age: 56.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Eye swelling, Headache, Paraesthesia oral, Speech disorder, Swelling face
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional via health authority (VAERS ID: 686029) on 10-Jul-2017, concerning a 56-year-old, adult, female patient. The patient had no medical history. On 10-Jan-2017, the patient was vaccinated with INN Flu Vaccine (anatomical location: right arm, dose, batch number, route of administration, indication, trade name, manufacturer: not reported). On same day, two hours after the vaccination, the patient had severe headache, noticed swelling on the right side of the face which extended to the left. She was unable to close the right eye and talk clearly. The patient felt heaviness on the tongue. No laboratory tests were performed. The patient consulted doctor for a check-up. The outcome for the events was not recovered. The health authority assessed the case as non-serious. Significant case correction received on 26-Jul-2017: Listedness of the events swelling face and eye swelling were corrected.
Age: 56.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Eyelid function disorder, Headache, Speech disorder, Swelling face, Tongue discomfort
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional via health authority (VAERS ID: 686029) on 10-Jul-2017, concerning a 56-year-old, adult, female patient. The patient had no medical history. On 10-Jan-2017, the patient was vaccinated with INN Flu Vaccine (anatomical location: right arm, dose, batch number, route of administration, indication, trade name, manufacturer: not reported). On same day, two hours after the vaccination, the patient had severe headache, noticed swelling on the right side of the face which extended to the left. She was unable to close the right eye and talk clearly. The patient felt heaviness on the tongue. No laboratory tests were performed. The patient consulted doctor for a check-up. The outcome for the events was not recovered. The health authority assessed the case as non-serious. Significant case correction received on 26-Jul-2017: Listedness of the events swelling face and eye swelling were corrected.
Age: 57.0
Sex: M
Vaccine: FLUX, FLU4, FLUX
Symptoms: Pain in extremity
Clinical narrative: This initial spontaneous case, was received from an other non-health professional via health authority (VAERS ID: 686150) on 10-Jul-2017, concerning a 57-year-old male adult patient. The patient had no current illness and medical history. On 02-Nov-2016, the patient was vaccinated with the INN Flu Vaccine (anatomical location: left arm, dose 2 (as reported), batch number, expiry date, trade name, manufacture name, route of administration: not reported). On 25-Dec-2016, 1 month 24 days after vaccination, the patient experienced pain in upper arm (serious), when he moved his arm in certain directions and was reported that the pain worsened with the time. The outcome of the events was not reported. Reporter's comment: The health authority assessed the report as non-serious. Significant case correction received on 19-Jul-2017: As determined causality was corrected from unassessable to not related.
Age: 57.0
Sex: M
Vaccine: FLUX, FLU4, FLUX
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain, Pain in extremity
Clinical narrative: This initial spontaneous case, was received from an other non-health professional via health authority (VAERS ID: 686150) on 10-Jul-2017, concerning a 57-year-old male adult patient. The patient had no current illness and medical history. On 02-Nov-2016, the patient was vaccinated with the INN Flu Vaccine (anatomical location: left arm, dose 2 (as reported), batch number, expiry date, trade name, manufacture name, route of administration: not reported). On 25-Dec-2016, 1 month 24 days after vaccination, the patient experienced pain in upper arm (serious), when he moved his arm in certain directions and was reported that the pain worsened with the time. The outcome of the events was not reported. Reporter's comment: The health authority assessed the report as non-serious. Significant case correction received on 19-Jul-2017: As determined causality was corrected from unassessable to not related.
Age: 57.0
Sex: M
Vaccine: FLUX, FLU4, FLUX
Symptoms: Nuclear magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: This initial spontaneous case, was received from an other non-health professional via health authority (VAERS ID: 686150) on 10-Jul-2017, concerning a 57-year-old male adult patient. The patient had no current illness and medical history. On 02-Nov-2016, the patient was vaccinated with the INN Flu Vaccine (anatomical location: left arm, dose 2 (as reported), batch number, expiry date, trade name, manufacture name, route of administration: not reported). On 25-Dec-2016, 1 month 24 days after vaccination, the patient experienced pain in upper arm (serious), when he moved his arm in certain directions and was reported that the pain worsened with the time. The outcome of the events was not reported. Reporter's comment: The health authority assessed the report as non-serious. Significant case correction received on 19-Jul-2017: As determined causality was corrected from unassessable to not related.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Arthralgia, Chills, Decreased appetite, Erythema, Headache
Clinical narrative: This non-serious spontaneous case, received from other non-health professional via health authority (VAERS ID: 686217) on 10-Jul-2017, reported by other non-health professional concerning an 82-year-old male patient. The patient had no current illness. The subject's concomitant medication included SPIRIVA 18MCG CP-handihaler, amlodipine, simvastatin, Lisinopril, Triamterene HCTZ. On 15-Mar-2017, patient was vaccinated with INN Flu Vaccine Seasonal (dose, trade name, manufacturer, batch number, route of administration, anatomical location: not reported). On 16-Mar-2017, after one day of vaccination, the patient experienced chills, red around arm, joint pain, headache, muscle pain decreased appetite. The outcome of the events was not recovered. Reporter's assessment: The health authority assessed the case as non-serious.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Myalgia
Clinical narrative: This non-serious spontaneous case, received from other non-health professional via health authority (VAERS ID: 686217) on 10-Jul-2017, reported by other non-health professional concerning an 82-year-old male patient. The patient had no current illness. The subject's concomitant medication included SPIRIVA 18MCG CP-handihaler, amlodipine, simvastatin, Lisinopril, Triamterene HCTZ. On 15-Mar-2017, patient was vaccinated with INN Flu Vaccine Seasonal (dose, trade name, manufacturer, batch number, route of administration, anatomical location: not reported). On 16-Mar-2017, after one day of vaccination, the patient experienced chills, red around arm, joint pain, headache, muscle pain decreased appetite. The outcome of the events was not recovered. Reporter's assessment: The health authority assessed the case as non-serious.
Age: 44.0
Sex: F
Vaccine: FLUX, TDAP, FLUX, TDAPIPV
Symptoms: Injection site joint movement impairment, Injection site pain
Clinical narrative: This initial spontaneous case, was received on 10-Jul-2017 and reported via health authority (VAERS: 686299) concerning a 44-year-old female adult patient. The patient's had no relevant medical history. At the age of 44, the patient experienced Pain, limited motion after Tdap vaccination. The patient's concomitant medication included WERA for birth control. On 01-Feb-2016, the patient was vaccinated with the INN Flu Vaccine (route of administration: syringe (as reported), anatomical location: left arm, dose, batch number, expiry date, trade name, manufacture name: not reported). On the same day, the patient was also vaccinated with TDaP IPV (route of administration: syringe (as reported), anatomical location: left arm, dose, batch number, expiry date, trade name, manufacture name: not reported). On the same day, in evening after vaccination of TDaP and flu shot, the patient experienced sharp pain in his left shoulder where shots were administered and he had no range of motion of his shoulder and pain continued to date. It was reported that the treatment continued to date. On an unspecified date, the patient went to consult the specialist, and then he was going to PT (physical therapy) thrice a week for 3 weeks. The outcome of the events was not reported. Reporter's comment: The health authority assessed the report as not serious.
Age: 44.0
Sex: F
Vaccine: FLUX, TDAP, FLUX, TDAPIPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This initial spontaneous case, was received on 10-Jul-2017 and reported via health authority (VAERS: 686299) concerning a 44-year-old female adult patient. The patient's had no relevant medical history. At the age of 44, the patient experienced Pain, limited motion after Tdap vaccination. The patient's concomitant medication included WERA for birth control. On 01-Feb-2016, the patient was vaccinated with the INN Flu Vaccine (route of administration: syringe (as reported), anatomical location: left arm, dose, batch number, expiry date, trade name, manufacture name: not reported). On the same day, the patient was also vaccinated with TDaP IPV (route of administration: syringe (as reported), anatomical location: left arm, dose, batch number, expiry date, trade name, manufacture name: not reported). On the same day, in evening after vaccination of TDaP and flu shot, the patient experienced sharp pain in his left shoulder where shots were administered and he had no range of motion of his shoulder and pain continued to date. It was reported that the treatment continued to date. On an unspecified date, the patient went to consult the specialist, and then he was going to PT (physical therapy) thrice a week for 3 weeks. The outcome of the events was not reported. Reporter's comment: The health authority assessed the report as not serious.