chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Discomfort, Joint range of motion decreased, Pain in extremity
Clinical narrative: Case number PHHY2015US026898, is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 555254) website on 05 Mar 2015. This report refers to a 40-year-old female patient. Medical history included appendicitis and C-section. Current condition included IDDM and Hashimoto's thyroid. Concomitant medications included NOVOLOG, Synthroid and CYTOMEL. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number) into left arm on 20 Oct 2014. On the same day after vaccination, the patient's arm started to ache a few hours later and had discomfort. The patient had experienced discomfort with the 20 plus seasonal flu vaccinations in the past but the discomfort she experienced after the current vaccination was not of the same kind she experienced in the past. Further, she had pain in shoulder joint and profound loss of range of motion, particularly forward elevation and adduction/external rotation. On 28 Oct 2014, the patient took 600 mg ibuprofen multiple times per day and this was the worst pain of her life. The dose of ibuprofen was increased to 800 mg and the patient was started on acupuncture on 08 Nov 2014. After acupuncture, the patient motion recovered enough was able drive and perform daily activities. She was managing the pain, but she still was uncomfortable and unable to do many of the things she could (such as lifting toddler over my head) prior to the vaccination. The patient MRI scan but the results were not reported. The final outcome of the events was unknown. The events were assessed as non-serious. She felt nothing at the time of injection but thought the position of the vaccine was strange and experienced no injury or other events that lead her to believe that this could be related to something other than the flu vaccination.
Age: 85.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Case number PHHY2015US026884, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 555570) website on 05 Mar 2015. This report refers to an 85-year-old polymedicated female patient. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) intramuscularly on 03 Nov 2014. On same day after vaccination, the patient experienced shoulder pain and had restricted movement. The patient went to emergency room and had an x-ray but the results were not reported. The final outcome of the events was not reported. The events were assessed as non-serious. Causality was not reported.
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphonia
Clinical narrative: Case number PHHY2015US027959, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 555677) website on 05 Mar 2015. This report refers to a 74-year-old female patient. Her historical drugs included penicillin, statin and NEXIUM. Current conditions were none. Her concomitant medications were Aspirin, MOTRIN, DIOVAN, ZETA, Calcium plus D, Welchol and Niacin. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 21 Nov 2014. From 22 Nov 2014, she was experiencing hoarseness for 4 days (until the date of reporting). Final outcome of the event was not reported. The event was reported as non-serious. The causality of the event was not reported.
Age: 34.0
Sex: M
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injection site pain, Muscular weakness, Sensory loss
Clinical narrative: Case number PHHY2015US027885, is an initial spontaneous report from consumer received from the Vaccine Adverse Event Reporting System (VAERS reference number: 555718) website on 05 Mar 2015. This report refers to a 34 years old male patient. Historical conditions were not reported. Concomitant medication included RITALIN. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number were unknown) into the left arm on 19 Nov 2014. On 20 Nov 2014, he work up for work around 6 am and noticed a dull throbbing sensation around the injection site, like a muscle cramp. The next day (on 21 Nov 2014) it began to spread and by morning his shoulder, neck, and arm were aching and it felt like a cramp. The muscle in his bicep was tense. On 25 Nov 2014 morning, the patient noticed that his index and middle finger tips were numb on the same arm where he got the shot. He could feel pain if he poked it with a needle or bit his finger tip but when he pressed on a hard surface he had no sensation. The arm was also very weak. He was advised to submit this report by his company's employee health department. The pain was still there at the time of reporting. Outcome of events was unknown. The events were reported as non-serious. Causality of the events was not reported.
Age: 62.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site swelling, Pain
Clinical narrative: Case number PHHY2015US027985, is an initial spontaneous report received from a consumer (patient)) via the Vaccine Adverse Event Reporting System (VAERS reference number: 555726) website on 05 Mar 2015. This report refers to a 62-year-old male patient. Current condition included borderline diabetes type 2 and high cholesterol. Concomitant medication included simvastatin 20 mg. On 20 Nov 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) and pneumococcal vaccine (other manufacturer, batch number: unknown) one in each arm. On 21 Nov 2014, he developed body aches, redness and hard swelling at pneumococcal vaccine injection site. It was reported that the events worsened over 48 hours to fever and chills with intermittent shivers. The patient reported that hard red area of injection site was so painful he could not sleep on that side for 3 nights. On 24 Nov 2014, he had doctor's appointment and he was advised he might have cellulitis. He was given an antibiotic which had improved swelling, redness and pain. Final outcome of the events were reported as complete recovery. The events were reported as non-serious. Causality of the events as not reported.
Age: 62.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Case number PHHY2015US027985, is an initial spontaneous report received from a consumer (patient)) via the Vaccine Adverse Event Reporting System (VAERS reference number: 555726) website on 05 Mar 2015. This report refers to a 62-year-old male patient. Current condition included borderline diabetes type 2 and high cholesterol. Concomitant medication included simvastatin 20 mg. On 20 Nov 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) and pneumococcal vaccine (other manufacturer, batch number: unknown) one in each arm. On 21 Nov 2014, he developed body aches, redness and hard swelling at pneumococcal vaccine injection site. It was reported that the events worsened over 48 hours to fever and chills with intermittent shivers. The patient reported that hard red area of injection site was so painful he could not sleep on that side for 3 nights. On 24 Nov 2014, he had doctor's appointment and he was advised he might have cellulitis. He was given an antibiotic which had improved swelling, redness and pain. Final outcome of the events were reported as complete recovery. The events were reported as non-serious. Causality of the events as not reported.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Feeling abnormal, Injection site pain, Movement disorder
Clinical narrative: Case number PHHY2015US027781, is an initial spontaneous report from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 555846) website received on 05 Mar 2015. This report refers to a 48-year-old female patient. The patient's concurrent conditions included Hashimoto's disease and mild sinus congestion (but no fever, body aches, or chills, and no known illnesses). Concomitant medications included levothyroxine, flunisolide, metronidazole, OTC multi-vitamin and OTC calcium supplement. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) into the left arm on 24 Oct 2014. On the same day, during routine flu immunization, the patient felt a sharp pain at the injection site and a sensation as if something was being forced into her arm. Subsequently, and to this day, she had pain in her shoulder and difficulty moving/lifting her arm. Pain level and difficulty moving was highest upon waking in the morning. She had difficulty dressing/undressing and performing other daily tasks. The patient did report to nurse at clinic who recommended compresses. Pain level/difficulty moving showed no improvement until about 20 Nov 2014, when it began to improve but still had not cleared up completely. There was no redness, swelling, or lumps at the site. In her lifetime, she had never experienced pain or other complications from an immunization that persisted more than two days. The outcome of the events was reported as unknown. The events were reported as non-serious. Causality was not reported.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Fatigue, Pain, Pyrexia, Tremor
Clinical narrative: Case number PHHY2015US027942, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 555937) website on 05 Mar 2015. This report refers to a 54-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on 26 Nov 2014. On the same day, the patient experienced sudden fatigue and chills. By 06:30 the patient was bedridden with uncontrollable shaking with chills, body aches and fever of 102.5 degrees. The patient was treated with ibuprofen 600 mg for body aches and fever. The patient slept from 09:30 PM to 05:30 AM. Later the temperature was 98 degrees F. The outcome of the events was reported as complete recovery. The events were reported as non-serious. Causality was not reported.
Sex: U
Vaccine: FLUX, PPV, VARZOS
Symptoms: Injection site pain, Lethargy
Clinical narrative: Case number PHHY2015US027867, is an initial spontaneous report from a pharmacist via Vaccine Adverse Event Reporting System (VAERS reference number: 555953) web site on 05 Mar 2015. This report refers to a patient of unspecified age and gender. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown), PNEUMOVAX (other manufacturer, batch number: unknown) and ZOSTAVAX (other manufacturer, batch number: unknown) into the arm on an unknown date. On an unknown date after the vaccination, the patient had extreme lethargy and injection site arm pain. The patient sought medical attention with the pharmacist. No product complaint was reported for ZOSTAVAX, PNEUMOVAX and flu vaccine. The final outcome of the events was recovered. The events were reported as non serious.  Causality of the events was not reported.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Joint crepitation, Joint range of motion decreased, Pain in extremity
Clinical narrative: Case number PHHY2015US027754, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556036) website on 05 MAR 2015. This report refers to a 31-year-old female patient. Her medical history and concomitant medication details was not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) intramuscularly into the left arm on 20 NOV 2014. On 21 NOV 2014, she had pain in left shoulder area that radiated to left hand. Further she had limited range of motion and popping feeling upon movement. The events were reported as non-serious. Outcome and causality of the events was not reported.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Fatigue, Musculoskeletal pain, Myalgia, Throat irritation
Clinical narrative: Case number PHHY2015US027798, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556037) website on 05 Mar 2015. This report refers to a 65 years old female patient. Her medical history included Lyme disease (2007) and had hip replacement in 2010 and 2013. The patient also had reaction to intravenous pyelogram (IVP) dye, when she had a test for kidney. Her concurrent conditions included osteoarthritis, irritable bowel syndrome (IBS), allergies to metal (nickel), animal dander and pollens. Concomitant medication details were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 17 Nov 2014. On 27 Nov 2014, she felt fatigue and went to bed with hot throat. She woke up with shoulder pain and joint pain on shoulders and knees. The pain was worst on the back of her upper thighs when she walked or hiked (severe muscle pain to the touch). She had no fever. She had pain which spread all over especially the shoulders, elbows and knees. So, far she had not visited the physician but would if not better. The final outcome of the events was unknown. The events were reported as non-serious. The causality assessment of the events was not reported.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Case number PHHY2015US027910, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556056) website on 05 Mar 2015. This report to a 62-years-old male patient. His medical history details were not reported. Concomitant medications included simvastatin, omeprazole and finasteride. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 14 Oct 2014. On the same day, after vaccination, the patient had shoulder pain which got worsens over time. Further the patient had loss of mobility in shoulder, difficulty raising arm and lifting things with that arm. He went to the emergency room, two weeks after shot and was given cortisone prescription and referred physical therapy. He had three visits for physical therapy and has been assigned various exercises for shoulder. The final outcome of the events was condition unchanged. The events were reported as non-serious. The causality assessment of the events was not reported.
Age: 55.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Activities of daily living impaired, Contusion, Erythema, Gait disturbance, Hyperaesthesia
Clinical narrative: Case number PHHY2015US027945, is an initial spontaneous report from received via consumer from the Vaccine Adverse Events Reporting System (VAERS reference number: 556069) website on 05 Mar 2015. This report refers to a 55 years old female patient. Historical conditions included pneumonia with collapsed lung, sickness and shaking in Sep 2014 and she took a day off. Concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 23 Nov 2014. She was also vaccinated with pneumococcal vaccine (other manufacturer, batch number: unknown) on 23 Nov 2014. On 23 Nov 2014, her point of vaccine on upper arm to elbow was severe red with burning pain and the events lasted for several days. Approximately 11 hours later, she woke up with severe flu symptoms, shaking profusely and she had a body temperature of 103 and could barely walk. This lasted severely 3 days and the temperature did not reach 100 at the time of this report (continued a week). She was treated with TAMIFLU on 24 Nov 2014. On 26 Nov 2014, she went to the pharmacist and she was advised to see her doctor. On the same day, she slept a lot after reaching home. A week later redness was gone, and it looked like large circular bruise about 4 inches in diameter and continued to be sensitive. The patient could not have a sheet on it because it hurt so much to touch for several nights. She took two days off from work as she was so sick. Patient felt a little better but was lethargic and she believed that fever went away. The final outcome of the event was reported as complete recovery. The events were reported as non-serious. Causality was not reported.
Age: 55.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Influenza, Lethargy, Pain, Pyrexia, Tremor
Clinical narrative: Case number PHHY2015US027945, is an initial spontaneous report from received via consumer from the Vaccine Adverse Events Reporting System (VAERS reference number: 556069) website on 05 Mar 2015. This report refers to a 55 years old female patient. Historical conditions included pneumonia with collapsed lung, sickness and shaking in Sep 2014 and she took a day off. Concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 23 Nov 2014. She was also vaccinated with pneumococcal vaccine (other manufacturer, batch number: unknown) on 23 Nov 2014. On 23 Nov 2014, her point of vaccine on upper arm to elbow was severe red with burning pain and the events lasted for several days. Approximately 11 hours later, she woke up with severe flu symptoms, shaking profusely and she had a body temperature of 103 and could barely walk. This lasted severely 3 days and the temperature did not reach 100 at the time of this report (continued a week). She was treated with TAMIFLU on 24 Nov 2014. On 26 Nov 2014, she went to the pharmacist and she was advised to see her doctor. On the same day, she slept a lot after reaching home. A week later redness was gone, and it looked like large circular bruise about 4 inches in diameter and continued to be sensitive. The patient could not have a sheet on it because it hurt so much to touch for several nights. She took two days off from work as she was so sick. Patient felt a little better but was lethargic and she believed that fever went away. The final outcome of the event was reported as complete recovery. The events were reported as non-serious. Causality was not reported.
Age: 45.0
Sex: M
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Case number PHHY2015US028040, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556101) website on 05 Mar 2015. This report refers to a 45-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 22 Oct 2014. On the same day, after vaccination, he experienced shoulder pain and stiffness. Further he was unable to move his shoulder or sleep on his shoulder without pain. Following the events, he visited emergency room. The events were reported as non-serious. Outcome and causality of the events was not reported.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Burning sensation, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: Case number PHHY2015US027797, is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 556104) website on 05 Mar 2015. This report refers to a 43 year old female patient. The patient was healthy and had penicillin allergy. She was not on any other medications at the time of vaccination. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number were unknown) on 16 Oct 2015. On 17 Oct 2014, the patient woke up with ankles and wrists hurting and the pain was there over a month later. She also experienced a burning sensation in her muscles. Her legs and arms felt weird and she was tired and cold all the time. She did not have an appetite and had lost 10 to 20 pounds in that time period. She was also having difficulty to pick things up. The outcome of the events was reported as condition unchanged. The event was reported as non-serious and causality was not reported.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling cold, Grip strength decreased, Weight decreased
Clinical narrative: Case number PHHY2015US027797, is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 556104) website on 05 Mar 2015. This report refers to a 43 year old female patient. The patient was healthy and had penicillin allergy. She was not on any other medications at the time of vaccination. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number were unknown) on 16 Oct 2015. On 17 Oct 2014, the patient woke up with ankles and wrists hurting and the pain was there over a month later. She also experienced a burning sensation in her muscles. Her legs and arms felt weird and she was tired and cold all the time. She did not have an appetite and had lost 10 to 20 pounds in that time period. She was also having difficulty to pick things up. The outcome of the events was reported as condition unchanged. The event was reported as non-serious and causality was not reported.
Sex: U
Vaccine: FLUX
Symptoms: Pharyngeal oedema
Clinical narrative: Case number PHHY2015US027935, is an initial spontaneous report received from a pharmacy student via the Vaccine Adverse Event Reporting System (VAERS reference number: 556160) website on 05 Mar 2015. This report refers to a patient of unknown gender and age. Historical condition was not reported. The patient was vaccinated with influenza vaccine (manufacturer and batch number were unknown) on an unknown date. On an unknown date after vaccination, the patient experienced throat swelling. Outcome of the event was reported as unknown. The event was reported as non-serious. Causality was not reported.
Age: 77.0
Sex: M
Vaccine: FLUX
Symptoms: Gait disturbance, Joint swelling, Peripheral swelling
Clinical narrative: Case number PHHY2015US027946, is an initial spontaneous report from received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556227) website on 05 Mar 2015. This report refers to a 77 years old male patient. Historical conditions were not reported. Current conditions included non-specified low back pain radiating into leg. Concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 05 Nov 2014 (date of vaccination was approximate; as per patient it was three weeks ago as of 01 Dec 2014). Two days after vaccination, on 07 Nov 2014, he experienced bilateral swelling of ankle and subsequently the lower legs. This was accompanied by difficulty in climbing stairs. He stated that for the first two steps, his foot did not begin the movement correctly, but once he started going, he was fine. It was also difficult to raise foot high (est. 45-60 degree. hip flexion). He had no prior episodes of this condition. The events outcome was unknown. The events were reported as non-serious. Causality of the events was not reported.
Age: 21.0
Sex: M
Vaccine: FLUX
Symptoms: Bedridden, Influenza
Clinical narrative: Case number PHHY2015US027907, is an initial spontaneous report from a consumer (patient) received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556293) website on 05 Mar 2015. This report refers to a 21 year old male patient. His medical history and concomitant medications were not reported. On an unspecified date, he was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown). On an unknown date, he experienced the flu and was in bed for two weeks. Outcome of the event was unknown. Event was reported as non-serious. Causality of the event was not reported. No further information was available at the time of reporting.
Age: 0.5
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Case number PHHY2015US027961, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556319) website on 05 Mar 2015. This report refers to a 6-months-old male patient. His current condition included chronic otitis media and had ventilator tube placement in 2013. His food allergy testing was negative in 2013. Concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) in Dec 2013. On an unspecified date, he experienced rash. He was treated with BENADRYL. The outcome, seriousness and causality assessment of the event was not reported.
Age: 66.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Arthralgia, Diplopia, Myalgia
Clinical narrative: Case number PHHY2015US027916, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556358) website on 05 Mar 2015. This report refers to a 66 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) and PREVNAR 13 (other manufacturer, batch number: unknown) on 25 Nov 2014. On 26 Nov 2014, he experienced slight generalized muscle pain. Symptoms increased to severe muscle and joint pain and 27 Nov 2014. He also developed double vision on 29 Nov 2014 and 30 Nov 2014. The event double vision resolved by 01 Dec 2014. The outcome of muscle pain and joint pain was reported as condition unchanged. Events were reported as non-serious. Causality assessment was not reported.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Case number PHHY2015US027920, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 556435) website on 05 Mar 2015. This report refers to a 66 years old male patient. He had no medical history. His concomitant medications include OSTEO BI-FLEX and fish oil. On 25 Nov 2014, he was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) into left arm. On 28 Nov 2014, he experienced extensive shoulder pain starting in the middle of his shoulders making it difficulty to raise his arms and the events lasted for three days. Outcome of the events was reported as complete recovery. Events were reported as non-serious. Causality assessment of the events was not reported.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Skin mass, Urticaria
Clinical narrative: Case number PHHY2015US027702, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 556469) website on 05 Mar 2015. This report refers to a 67-year-old female patient. Medical history and concomitant medication were not reported. Current condition of the patient included allergies to some medicine including sulfa and penicillin. On 07 Oct 2014, she was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) intramuscularly in the left arm. On the same day (07 Oct 2014), following the vaccination she experienced events which began as itching, turned into hives and lumps and bumps under the skin. She reported that she was still being treated for them, and they were under control with Antihistamines during the first to third week. There was no sign of the improvement of the symptoms and she was discussing the issues with physician. She was being treated with Vitamin B12 shots and was (results not reported). On an unknown date, she visited the emergency room. The final outcome of the events was however not reported. The events were reported as non-serious. The causality of the events was not reported.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, X-ray
Clinical narrative: Case number PHHY2015US027741, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 556472) website on 05 Mar 2015. This report refers to a 26-year-old female patient. Medical history was not reported. Concomitant medications included birth control pills. On 16 Oct 201, she was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) in the left arm. On the same day (16 Oct 2014), following the vaccination, she experienced shoulder pain and limited mobility in left shoulder. On an unknown date, she visited the emergency room. She was prescribed medications and physical therapy. She also underwent X-ray (lab data: not provided). The final outcome of the events was not reported. The events were reported as non-serious. The causality of the events was not reported.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Local swelling, Malaise, Swelling
Clinical narrative: Case number PHHY2015US028010, is an initial spontaneous report received from the consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 556719) website on 05 Mar 2015: This report refers to a 54 year old female patient. Current conditions included hypertension, nausea and a headache. Concomitant medication included lisinopril-HCTZ, metoprolol and Lo-orgestrel. Her vaccination history included administration of tetanus toxoid vaccine (manufacturer and batch number unknown) and experienced severe swelling and malaise for three days. She was vaccinated with seasonal influenza virus vaccine (manufacturer and batch number unknown) into left arm on 01 Dec 2014. On 02 Dec 2014, the patient had swelling in the armpit of the vaccination arm. The swelling was so severe that it was visible from the outside. When she holds up both of her arms, it looked like she had a little pillow in her left armpit. There was no redness. She had treated it with ibuprofen and warm compresses. The final outcome of the event was unknown. The event was reported as non-serious. Causality was not reported.
Age: 64.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Asthenia, Mobility decreased, Pain, Pain in extremity, Weight bearing difficulty
Clinical narrative: Case number PHHY2015US027017, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556826) website on 05 MAR 2015. This report refers to a 64 year old female patient. Concomitant medications included Toviaz, Vitamin D, Elmiron, and Claritin. On 11 OCT 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) along with shingles vaccine/zoster live vaccine (other manufacturer, batch number: not reported). The shingles vaccine was administered in the right arm. On 11 NOV 2014, the patient experienced soreness in left arm, unable to life or carry weight, pain at night, unable to lift arm straight up or bend it backwards, loss of strength and flexibility, hurts when running (back and forth motion) and visited emergency room. She was treated with Aspirin, received heat and rest. Events were reported as non-serious. Final outcome of the events was condition unchanged. Causality assessment was not reported.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Headache, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Case number PHHY2015US027026, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556979) website on 05 Mar 2015. This report refers to a 56 year old female patient. She was allergic to silicone, pet dander, EXCEDRIN and Novocain. She had seasonal allergies. Concomitant medications included levocetirizine 5mg, NEXIUM 40 mg and TRICOR 145 mg. On 01 Dec 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscularly. On the same date, after vaccination she experienced redness of the eyes, sore throat, chills and vomiting. Later on after the chills subsided, she had fever, achy joints and severe headaches. Events were reported as non-serious. Final outcome of the events was recovered. Causality assessment was not reported.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Vomiting
Clinical narrative: Case number PHHY2015US027026, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556979) website on 05 Mar 2015. This report refers to a 56 year old female patient. She was allergic to silicone, pet dander, EXCEDRIN and Novocain. She had seasonal allergies. Concomitant medications included levocetirizine 5mg, NEXIUM 40 mg and TRICOR 145 mg. On 01 Dec 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscularly. On the same date, after vaccination she experienced redness of the eyes, sore throat, chills and vomiting. Later on after the chills subsided, she had fever, achy joints and severe headaches. Events were reported as non-serious. Final outcome of the events was recovered. Causality assessment was not reported.
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Feeling abnormal, Headache, Injection site induration, Injection site swelling, Lethargy
Clinical narrative: Case number PHHY2015US026949, is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 557334) website on 05 Mar 2015. This report refers to a 46-year-old male patient. Historical conditions were not reported. This polymedicated patient vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) into the left arm on 04 Dec 2014. On 05 Dec 2014, the patient experienced tennis ball circumference hardened swelling around injection site (upper left arm). He also had significantly swollen left armpit lymph node, significant neck pain, headache, general lethargy and he was also feeling as if blood was cut off to the left arm. It was reported that still a significant issue was there and symptoms remained. However final outcome of the events was unknown. Seriousness of the events were reported as non serious. Causality of the events were not reported.
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Lymphadenopathy, Neck pain
Clinical narrative: Case number PHHY2015US026949, is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 557334) website on 05 Mar 2015. This report refers to a 46-year-old male patient. Historical conditions were not reported. This polymedicated patient vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) into the left arm on 04 Dec 2014. On 05 Dec 2014, the patient experienced tennis ball circumference hardened swelling around injection site (upper left arm). He also had significantly swollen left armpit lymph node, significant neck pain, headache, general lethargy and he was also feeling as if blood was cut off to the left arm. It was reported that still a significant issue was there and symptoms remained. However final outcome of the events was unknown. Seriousness of the events were reported as non serious. Causality of the events were not reported.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Joint swelling, Pruritus, Urticaria
Clinical narrative: Case number PHHY2015US026865, is an initial spontaneous report from a healthcare professional Vaccine Adverse Event Reporting System (VAERs reference number: 557403) website on 05 Mar 2015. This report refers to a 58-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 19 Sep 2014. On the same date after the vaccination, she had urticarial, pruritus and swelling of arm. The final outcome of the events was unknown. The events were reported as non serious. Causality of the events was not reported.
Age: 79.0
Sex: F
Vaccine: FLUX
Symptoms: Tinnitus
Clinical narrative: Case number PHHY2015US026874, is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 557768) website on 05 Mar 2015. This report refers to a 79-year-old female patient. Medical history was not reported. Concomitant medication included lorazepam. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) into her left arm on 24 Sep 2014. On 25 Sep 2014 after the vaccination, she had ringing in her ears. The final outcome of the event was recovered. The event was reported as non serious. Causality of the event was not reported.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Limb discomfort, Pain in extremity, Paraesthesia
Clinical narrative: Case number PHHY2015US027080, is an initial spontaneous report from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 557934) website on 05 Mar 2015. This report refers to a 33-year-old female patient. Medical history was not reported. This polymedicated patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) into his right arm on 02 Dec 2014. On the same date after the vaccination, around the site it felt like her upper arm was heavy/asleep, and as the day went by the rest of her arm felt the same way. She thought it would be gone by the next day. Later that night, around 11 pm she woke up with my entire right hand feeling numb, tingling and a little painful. It did not matter how she laid in bed or the position of her arm/hand. It would only somewhat go away if she was sitting up/standing. This happened throughout the night, every night since the shot. She also get some of the numbness/tingling during the day (most part of the day my arm/hand feels heavy and asleep), but was worse at night and keeps me up all night. She went to the employee health doctor with her concern on 05 Dec 2014 since this has not gone away. Following the events she visited emergency room. The final outcome of the events was not recovered. The events were reported as non serious. Causality of the events was not reported.
Age: 2.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Chest X-ray abnormal, Cough, Pyrexia
Clinical narrative: Case number PHHY2015US026909, is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 558049) website on 05 Mar 2015. This report refers to a 02-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) into her right leg and DTAP vaccine (manufacturer and batch number unknown) into her left leg on 27 Oct 2014. On the same date after the vaccination she had dry nighttime cough followed by fever 3 days later. It was reported that cough became chronic (6+ weeks) with no other symptoms. Multiple examinations have shown nothing. Chest X-ray was done (results not reported). The final outcome of the events were not recovered. The events were reported as non serious. Causality of the events was not reported.
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Incorrect route of drug administration, Pain, Paraesthesia
Clinical narrative: Case number PHHY2015US026925, is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 558116) website on 05 Mar 2015. This report refers to a 74-year-old female patient. Medical history included multiple allergies, but none to eggs or to previous flu vaccines, possible bladder and respiratory infection. This poly medicated patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) into her right arm subcutaneously (off label use) on 10 Dec 2014. On the same date after the vaccination, she had pins and needles in right foot, acute severe pain, with no previous nerve pain or diagnosis of neuropathy. She did not take any medication after vaccination before pain started. The final outcome of the events was recovered. The events were reported as non serious. Causality of the events was not reported.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Paraesthesia
Clinical narrative: Case number PHHY2015US027041, is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 558117) website on 05 Mar 2015. This report refers to a 50-year-old male patient. Medical history included SLE (systemic lupus erythematosus), depression, eye dryness and relapsing polychondritis. This poly medicated patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) into his right arm on 07 Nov 2014. On the same date after the vaccination, he had severe pain right upper arm/shoulder spreading around area of injection. He had difficulty lifting arm and moving arm certain directions and tingling skin on forearm/hand. It was worsening as time went by. He scheduled an orthopedic appointment for 15 Dec 2014. The final outcome of the events was not recovered. The events were reported as non serious. Causality of the events was not reported.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Ocular hyperaemia
Clinical narrative: Case number PHHY2015US026930, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 558126) website on 05 Mar 2015. This report refers to a 35-year-old female patient. Medical history and concomitant medications were not reported. On 12 Dec 2014, she was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported). On the same date (12 Dec 2014), following the vaccination, she developed redness in eyes without drainage or crusting. The final outcome of the event was not reported. On an unknown date, she visited the emergency room. The event was reported as non-serious. The causality of the event was not reported.
Age: 60.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pruritus, Rash, Skin discolouration
Clinical narrative: Case number PHHY2015US027004, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 558239) web site on 05 Mar 2015. This report refers to a 60-year-old female patient. Medical history and concomitant medications were not reported. On 06 Dec2014, she was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) along with ZOSTAVAX (other manufacturer, batch number: K009771). On 07 Dec 2014, following the vaccination, the patient developed circular colouration along with bumps and massive itching. On 11 Dec 2014, she discussed the events with her doctor, who advised her to wait and watch. The final outcome of the events was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Computerised tomogram, Fall, Fatigue, Gait disturbance
Clinical narrative: Case number PHHY2015US164850, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 596826) website on 14 Dec 2015. This report refers to a 53 years old female patient. Past medical history included codeine allergy, type II diabetes and hypertension. Concomitant medications were included unspecified dental numbing medications. She was vaccinated with FLUVIRIN (batch number: 015011A) on 03 Oct 2014. On 10 Oct 2014, she felt very weak, fatigued, trouble walking, leg weakness and falling, she dragged for about 2 months and more until she experienced leg paralysis. She experienced transverse myelitis on an unknown date. She was hospitalized for 20 days on an unknown date. Laboratory data included magnetic resonance imaging (MRI), computed tomography scan (CT scan), spinal taps and X rays (results unspecified). The outcome of the events was not reported. The seriousness of the events was reported as serious (permanent disability). The causality of the events was not reported. The quality assurance department stated that, the case was reported as FLUVIRIN, however without a valid FLUVIRIN batch number. Therefore, as this was a standard request, we would not investigate further. Following an internal review done for the data received on 14 Dec 2015, significant case correction was done: The suspect drug coding was changed to FLUVIRIN vaccine from influenza vaccine. Follow up report received from Quality Assurance Department on 01 Feb 2016: Added standard batch summary report.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture, Monoplegia, Muscular weakness, Myelitis transverse, Nuclear magnetic resonance imaging
Clinical narrative: Case number PHHY2015US164850, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 596826) website on 14 Dec 2015. This report refers to a 53 years old female patient. Past medical history included codeine allergy, type II diabetes and hypertension. Concomitant medications were included unspecified dental numbing medications. She was vaccinated with FLUVIRIN (batch number: 015011A) on 03 Oct 2014. On 10 Oct 2014, she felt very weak, fatigued, trouble walking, leg weakness and falling, she dragged for about 2 months and more until she experienced leg paralysis. She experienced transverse myelitis on an unknown date. She was hospitalized for 20 days on an unknown date. Laboratory data included magnetic resonance imaging (MRI), computed tomography scan (CT scan), spinal taps and X rays (results unspecified). The outcome of the events was not reported. The seriousness of the events was reported as serious (permanent disability). The causality of the events was not reported. The quality assurance department stated that, the case was reported as FLUVIRIN, however without a valid FLUVIRIN batch number. Therefore, as this was a standard request, we would not investigate further. Following an internal review done for the data received on 14 Dec 2015, significant case correction was done: The suspect drug coding was changed to FLUVIRIN vaccine from influenza vaccine. Follow up report received from Quality Assurance Department on 01 Feb 2016: Added standard batch summary report.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Case number PHHY2015US164850, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 596826) website on 14 Dec 2015. This report refers to a 53 years old female patient. Past medical history included codeine allergy, type II diabetes and hypertension. Concomitant medications were included unspecified dental numbing medications. She was vaccinated with FLUVIRIN (batch number: 015011A) on 03 Oct 2014. On 10 Oct 2014, she felt very weak, fatigued, trouble walking, leg weakness and falling, she dragged for about 2 months and more until she experienced leg paralysis. She experienced transverse myelitis on an unknown date. She was hospitalized for 20 days on an unknown date. Laboratory data included magnetic resonance imaging (MRI), computed tomography scan (CT scan), spinal taps and X rays (results unspecified). The outcome of the events was not reported. The seriousness of the events was reported as serious (permanent disability). The causality of the events was not reported. The quality assurance department stated that, the case was reported as FLUVIRIN, however without a valid FLUVIRIN batch number. Therefore, as this was a standard request, we would not investigate further. Following an internal review done for the data received on 14 Dec 2015, significant case correction was done: The suspect drug coding was changed to FLUVIRIN vaccine from influenza vaccine. Follow up report received from Quality Assurance Department on 01 Feb 2016: Added standard batch summary report.