chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Injection site pain
Clinical narrative: Case number PHHY2016US172681, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 655064) website on 21 Nov 2016. This report refers to a 58 years old male patient. Past medical history was not reported. Current conditions included as allergy to penicillin (PCN), some sea food and paradichlorobenzene. Concomitant medication included as lisinopril daily. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) into left arm, intramuscularly on 21 Sep 2016. The patient also vaccinated with pneumococcal vaccine (other manufacture, batch number: not reported) (reported as pneumo vaccine) into left arm, intramuscularly on 21 Sep 2016. On the same day after vaccination, the patient experienced injection site started to be extremely painful, then chills, fever, weakness and general malaise, diarrhea and cramping along with light headedness followed. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was not reported. The causality of the events was not reported.
Age: 58.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Malaise, Muscle spasms, Pyrexia
Clinical narrative: Case number PHHY2016US172681, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 655064) website on 21 Nov 2016. This report refers to a 58 years old male patient. Past medical history was not reported. Current conditions included as allergy to penicillin (PCN), some sea food and paradichlorobenzene. Concomitant medication included as lisinopril daily. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) into left arm, intramuscularly on 21 Sep 2016. The patient also vaccinated with pneumococcal vaccine (other manufacture, batch number: not reported) (reported as pneumo vaccine) into left arm, intramuscularly on 21 Sep 2016. On the same day after vaccination, the patient experienced injection site started to be extremely painful, then chills, fever, weakness and general malaise, diarrhea and cramping along with light headedness followed. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was not reported. The causality of the events was not reported.
Age: 70.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Insomnia, Pain, Pain in extremity, Skin warm
Clinical narrative: Case number PHHY2016US171269, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 655182) on 21 Nov 2016. This report refers to a 70 years old female patient. Medical history was reported as none. Concomitant medication included levothyroxine, Metoprolol, Lisinopril and atorvastatin. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) in to left arm and first dose of pneumococcal vaccine (manufacturer unknown and batch number: not reported) in to right arm, both intramuscularly on 24 Sep 2016. On 26 Sep 2016 after vaccination, the patient's left arm became sore, as the day went on the patient's arm hurt more and hurt quite a bit when lifted, she was not able to sleep. On 27 Sep 2016, the patient noticed some redness on arm and it was warm. The patient went to pharmacy to check it and pharmacist said it was a reaction to shot. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 44.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Discomfort, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: Case number PHHY2016US171046, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 655270) website on 21 Nov 2016. This report refers to a 44-years-old female patient. Past medical history was not reported. Concomitant medications included omeprazole, sulfasalazine and VENTOLIN. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown and batch number: not reported) intramuscularly in left arm along with PNEUMOVAX vaccine (manufacturer unknown and batch number: L0174876) intramuscularly in right arm, both on 21 Sep 2016. On the same day after vaccination, the patient could not move her right arm, numbness down arm, pressure deep in axilla, could not lift arm above head. The patient received supportive care. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported.
Age: 70.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Case number PHHY2017US016329, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 655306) on 23 Jan 2017. This report refers to a 70 years old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with INN (manufacturer unknown, batch number: not reported) and PNEUMOVAX (other manufacturer), batch number: M032635) on 23 Sep 2016. On 24 Sep 2016 after vaccination, the patient complaint of pain on shoulder and arm, lack of mobility and movement of arm. The patient was prescribed TRAMADOL for pain. The outcome of the events was reported as unknown. The seriousness of the events was reported as non serious and causality was not reported.
Sex: M
Vaccine: FLUA3
Symptoms: Injection site pain, Liquid product physical issue, Myalgia
Clinical narrative: Case number PHHY2016US181572, is an initial spontaneous report received form a Vaccine Adverse Event Reporting System (VAERS reference number: 655365) website on 21 Dec 2016. This case also contains QA reference number: 1018848. This report refers to a 66 years old male patient. Past medical history was not reported. Concomitant medications included as atorvastatin, sotalol and LIMBREL. The patient was vaccinated with FLUAD (batch number: 166002) into right arm, intramuscularly on 01 Sep 2016. On the same day after vaccination, the patient experienced arm was hurting with muscle soreness upon raising arm above shoulder height or stretching the deltoid muscle. On 26 Sep 2016, the patient still experienced events. It was reported that, thickness of FLUAD was more painful was more painful than his usual flu injections on an unknown date. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported. The quality assurance department reported that, as the case was reported anonymously, it was not possible to clarify if the report of thickness referred to the needle administer the vaccine, or referred to the vaccine itself being thick (viscous. As this FLUAD batch was supplied in a needle less format (the needle is selected and attached by the administering health care professional), investigation into the interpretation. All product specifications was outside of the scope. The investigation focused on the viscous liquid interpretation. All product specifications have been met and no manufacturing events were recorded, which could have impacted on the physical characteristics of the vaccine (such as its viscosity). Based on the investigation performed, there was no evidence of a product quality issue with this batch of FLUAD. FLUAD was a milky emulsion and it was possible that the patient in this case had noticed that it had a different appearance to other influenza vaccines, and interpreted this was as meaning that the vaccine was more viscous than other products. Non significant follow up report from the QA department (QA reference number: 1018848) received on 06 Jan 2017: Updated QA reference number only. Follow up report received from a Quality Assurance Department (QA reference number: 1018848) on 17 Feb 2017: Updated event (Event Thickness of FLUAD was more painful than his usual flu injections, coding changed from product quality issue to product viscosity variable) and added investigation summary (QA investigation outcome).
Sex: M
Vaccine: FLUX, HPV4
Symptoms: Abdominal discomfort, Dizziness, Malaise, Vomiting
Clinical narrative: Case number PHHY2016US170896 is an initial spontaneous report received from consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 655415) website on 21 Nov 2016. This report refers to male patient of an unknown age. Current condition included hypersensitivity, food allergy and drug hypersensitivity. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown) and GARDASIL (other manufacturer) intramuscular on 20 Sep 2016. The patient had undergone through physical test (unspecified) and he was fine in the office and went home. He ate takeout food for dinner and went to bed. When he awoke on 21 Sep 2016, he told his mother that he felt dizzy and his stomach felt horrible. The patient threw up and then went to bed to rest. He woke up again sometime later but he was still feeling sick and dizzy. Patient received treatment (unspecified) for the events. No laboratory tests were performed. Patient had not recovered from the events. The outcome of the events was reported condition unchanged. The seriousness and causality of the events was not reported.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Injected limb mobility decreased, Injection site erythema, Musculoskeletal stiffness, Myalgia
Clinical narrative: Case number PHHY2016US170562, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 655460) on 21 Nov 2016. This report refers to a 61 years old female patient. Medical history was not reported. Concomitant medications included SYNTHROID and VIVELLE DOT. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 23 Sep 2016. On same day after vaccination, the patient experienced fever, muscle aches, stiff neck, chills, swelling and redness at vaccination site and lost use of arm. The outcome of the events was reported as complete recovery. The seriousness and causality of the events were not reported.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Vaccination site swelling
Clinical narrative: Case number PHHY2016US170562, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 655460) on 21 Nov 2016. This report refers to a 61 years old female patient. Medical history was not reported. Concomitant medications included SYNTHROID and VIVELLE DOT. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 23 Sep 2016. On same day after vaccination, the patient experienced fever, muscle aches, stiff neck, chills, swelling and redness at vaccination site and lost use of arm. The outcome of the events was reported as complete recovery. The seriousness and causality of the events were not reported.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Flushing, Headache, Hot flush, Hypoaesthesia, Pain
Clinical narrative: Case number PHHY2016US170603, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 655534) website on 21 Nov 2016. This report refers to a 25-years-old female patient. Past medical history was not reported. Current condition included seasonal allergies. Concomitant medications LO LOESTRIN and ibuprofen. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) intramuscularly in right arm on 26 Sep 2016. On the same day after vaccination, the patient experienced immediate pain in entire arm, numbing of fingers, headache, flush cheeks and hot flashes. In the afternoon later fever set in and 24 hours later body aches, headache and fever was of 102 (unspecified unit). The outcome of event headache and fever was reported as condition unchanged and for rest of events outcome was reported as complete recovery. The seriousness and causality of the events were not reported.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Case number PHHY2016US170603, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 655534) website on 21 Nov 2016. This report refers to a 25-years-old female patient. Past medical history was not reported. Current condition included seasonal allergies. Concomitant medications LO LOESTRIN and ibuprofen. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) intramuscularly in right arm on 26 Sep 2016. On the same day after vaccination, the patient experienced immediate pain in entire arm, numbing of fingers, headache, flush cheeks and hot flashes. In the afternoon later fever set in and 24 hours later body aches, headache and fever was of 102 (unspecified unit). The outcome of event headache and fever was reported as condition unchanged and for rest of events outcome was reported as complete recovery. The seriousness and causality of the events were not reported.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Contusion, Pain, Swelling
Clinical narrative: Case number PHHY2016US178863, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 655623) on 21 Dec 2016. This report refers to a 67 years old female patient. Historical condition was not reported. Current condition included diabetes. Concomitant medication was not reported. The patient was vaccinated with first dose of FLUAD (batch number: 165703) intramuscularly into the right arm on 22 Sep 2016. On 23 Sep 2016 after vaccination, the patient had swelling, painful and big bruise (black and purple). The outcome of the events was reported as unknown. The seriousness was reported as non serious and causality was not reported.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Injection site inflammation, Injection site pain
Clinical narrative: Case number PHHY2016US172959, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 655744) on 21 Nov 2016. This report refers to a 41 year old female patient. Medical history and current illness was not reported. Concomitant medication included levothyroxine. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into right arm on 16 Sep 2016. It was reported that the pharmacist injected the shot into her upper arm and directly into the bursa sac which resulted in tremendous pain and inflammation on the same day of injection. Following the events the patient visited emergency room. The patient was treated with medication, potential cortisone shots, "PT (reported like this)" and other methods. The patient had additional testing and appointments with surgeon on 30 Sept 2016. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported.
Age: 75.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Fatigue, Headache, Hypersomnia
Clinical narrative: Case number PHHY2016US174844, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 655747) on 21 Nov 2016. This report refers to a 75 year old female patient. Medical history was not reported. Her current condition included hypertension. Concomitant medication included doxazosin. No lab testing was reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into left arm on 19 Sep 2016. On the same day, the patient experienced chills, headache, weakness, unusual tiredness and nausea. He was sleeping for 12 hours or more daily. Following the events the patient was called to the pharmacy with the prescription. On 26 Sep 2016, the physician prescribed her medication and she improved on 28 Sep 2016. The final outcome of the events was reported as complete recovery. Seriousness of the events was not reported. The reporter stated that absolutely without doubt this illness was brought on by the injection of flu vaccination as she was healthy without any symptoms just hours before the injection.
Age: 75.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea
Clinical narrative: Case number PHHY2016US174844, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 655747) on 21 Nov 2016. This report refers to a 75 year old female patient. Medical history was not reported. Her current condition included hypertension. Concomitant medication included doxazosin. No lab testing was reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into left arm on 19 Sep 2016. On the same day, the patient experienced chills, headache, weakness, unusual tiredness and nausea. He was sleeping for 12 hours or more daily. Following the events the patient was called to the pharmacy with the prescription. On 26 Sep 2016, the physician prescribed her medication and she improved on 28 Sep 2016. The final outcome of the events was reported as complete recovery. Seriousness of the events was not reported. The reporter stated that absolutely without doubt this illness was brought on by the injection of flu vaccination as she was healthy without any symptoms just hours before the injection.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Ear pain, Local swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: Case reference PHHY2016US174846, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 655781) on 21 Nov 2016. This report refers to a 53 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into right arm 26 Sep 2016. On 27 Sep 2016, the patient developed enlarged painful lymph clavicular lymph node, neck swelling and mild ear pain (same side as flu shot). The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: Case number PHHY2016US172668 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 656005) on 21 Nov 2016. This report refers to a 52 year old female patient. She had no medical history or current conditions. Her concomitant medication included ARMOUR THYROID. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 27 Sep 2016. On the same day after vaccination, the patient had shoulder pain that just kept getting worse as time went on. She went to emergency room, took ADVIL, but it did not help much. The next day, she could even lift arm up without extreme pain. It was reported that two days later the pain worsened. She went to emergency room. The event outcome was reported as condition unchanged. The seriousness and causality of the event was not reported.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Insomnia, Nausea, Pain, Pain in extremity
Clinical narrative: Case number PHHY2016US172692, is an initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 656006) website on 21 Nov 2016. This report refers to 41 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown) on 15 Sep 2016. On the same day, the patient experienced ached all over, nausea, insomnia, fatigue, and extremely sore arm. Patient arm was still very sore and it had been two weeks since the vaccination. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Case number PHHY2016US172267 is an initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 656243) website on 21 Nov 2016. This report refers to 37 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown) into right arm on 21 Sep 2016. On the same day, the patient developed extreme pain in shoulder. The patient had unable to move shoulder or lift arm. It was stated that 10 days later pain still present. On an unknown date, the patient visited emergency room/doctor visit. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported.
Age: 71.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Case number PHHY2016US181787, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 656293) website on 21 Dec 2016. This report refers to a 71 years old female patient. Medical history was not reported. Concomitant medications included Simvastatin, PRO AIR, Latanoprost and Mometasone. The patient was vaccinated with FLUAD (batch number: 165803) into left arm on 18 Sep 2016. The patient was also vaccinated with PNEUMOVAX (manufacturer unknown, batch number: M012156) into right arm on 18 Sep 2016. After vaccination on 20 Sep 2016, the patient right arm got significantly red and was swollen (from the injection site to below the elbow) and was painful to touch. Following the events the patient visited emergency room/urgent care. The outcome of the events was reported as unknown. The seriousness of the events was reported as non-serious and causality was not reported.
Age: 71.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Tenderness
Clinical narrative: Case number PHHY2016US181787, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 656293) website on 21 Dec 2016. This report refers to a 71 years old female patient. Medical history was not reported. Concomitant medications included Simvastatin, PRO AIR, Latanoprost and Mometasone. The patient was vaccinated with FLUAD (batch number: 165803) into left arm on 18 Sep 2016. The patient was also vaccinated with PNEUMOVAX (manufacturer unknown, batch number: M012156) into right arm on 18 Sep 2016. After vaccination on 20 Sep 2016, the patient right arm got significantly red and was swollen (from the injection site to below the elbow) and was painful to touch. Following the events the patient visited emergency room/urgent care. The outcome of the events was reported as unknown. The seriousness of the events was reported as non-serious and causality was not reported.
Sex: M
Vaccine: DTAP, FLUX, HIBV
Symptoms: Crying, Gait disturbance, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Case number PHHY2016US173340, is an initial spontaneous report received from Vaccine Averse Event Reporting System (VAERS reference number: 656390) on 21 Nov 2016. This report refers to a 1 year old (reported as 1.6 years) male patient. Past medications history and concomitant medications were not reported. He was vaccinated with first dose of seasonal influenza vaccine INN (unknown manufacturer, batch number: not reported), third dose of HIB unknown manufacturer, batch number: not reported): all the vaccines into the right leg on 28 Sep 2016. After vaccination, on the same day, he experienced swollen leg, limping, pain, he was crying to be held and refused to walk and had a fever of 99 degrees. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported.
Age: 55.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHHY2016US173241, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 656481) website on 21 Nov 2016. This report refers to a 55 years old female patient. Past medical history was not reported. Current condition included as sulfa drugs allergy, seasonal allergies and hypertension. Concomitant medications included as TOPROL, valsartan, lovastatin, triamcinolone acetonide (reported as Triamcinolone), azelastine and ALLEGRA. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) into left arm on 26 Sep 2016. The patient also vaccinated with varicella zoster vaccine (other manufacture, batch number: not reported) (reported as zoster vaccine) into left arm, subcutaneous on 26 Sep 2016. On 28 Sep 2016, the patient experienced bright red itchy patch at site of injection with lump and swelling around it. Next day patient had larger area of redness, itching and swelling. On an unknown date, the patient suffered with redness to her elbow with swelling and itching. The outcome of the events was reported as condition unchanged. The seriousness of the events was not reported. The causality of the events was not reported.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2016US173181, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 656486) website on 21 Nov 2016. This report refers to a 73 years old female patient. Past medical history was not reported. Concomitant medications included levoxothyrine and TOVIAZ. The patient was vaccinated with seasonal influenza vaccine inn (manufacturer unknown and batch number: not reported) on 26 Sep 2016. On the same after vaccination, the patient experienced swelling, redness and pain incorporating whole girth of upper arm and not at injection site. It was reported that, initially it lasted 48 hours and took another 48 hours for symptoms to subside to the point the patient did not needed pain medication. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal chest pain, Pain in extremity
Clinical narrative: Case number PHHY2016US172771 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 656515) on 21 Nov 2016. This report refers to a 44 year old female patient. Her current condition included stage IV metastatic breast cancer. Her concomitant medications included morphine, PERCOCET, lisinopril, carvedilol, sertraline, CELBREX and ZANTAC 150. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the right arm on 30 Sep 2016. On 01 Oct 2016, the patient had severe body aches in all extremities included feet and ribs. The event outcome was reported as condition unchanged. The seriousness and causality of the event was not reported.
Age: 35.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Dizziness, Granulocyte count increased, Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2016US165332, is an initial spontaneous report received through Vaccine Adverse Event Reporting System (VAERS) web site (VAERS reference number: 656531) on 21 Nov 2016. This report refers to a 35 year old female patient. Historical condition was not reported. Current condition included high blood pressure. Concomitant medication included amlodipine 10 mg, bupropion 150 mg, prenatal vitamins, labetalol 300 mg, omeprazole 20 mg and sertraline 200 mg. The patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number was not reported) in her left arm from 27 Sep 2016, intramuscularly. The patient was also vaccinated with pneumococcal vaccine (manufacturer unknown) from 27 Sep 2016 in her left arm, intramuscularly. On 28 Sep 2016, the patient woke up with fever of 102 degrees F (normal range not reported), severe body aches and weakness with intermittent dizziness. After treatment with TYLENOL and rest, the fever dropped to 101 degrees, but again went up to 102 after a few hours. Around 01 PM, the patient took ADVIL and the temperature dropped to 99 degrees. By approximately 05 PM, the temperature was back to 102 degrees. Other symptoms persisted throughout the day. On 29 Sep 2016, the patient woke up with a fever of 102 degrees and continued aches and weakness. On the same date (around 7:30 AM), the patient noticed a large, raised, red bump that was hot to the touch and approximately 2 inches below the injection site with the size of a golf ball. The patient's fever went down with ADVIL but began to raise back to 101 degrees around 1 PM. The red lump continued to spread and was now to the size of a large softball. The patient returned to the physician at 3 PM, where temperature was 101 degrees. The physician recommended icing the arm and monitoring to see if it spread. Blood was also drawn to determine if infection was present. On 30 Sep 2016, the patient woke up to a normal temperature but was weak. The rash had spread very little but began to itch. As of 02 Oct 2016, the patient was waiting to hear back from the physician as to whether an allergy pill could help. On an unknown date, the patient's blood work was done which revealed that her white blood cells and granulocytes (grans) came back high (result, normal range and unit were not reported) and lymphocytes (lymphs) came back low (result, normal range and unit were not reported). The outcome of the event fever of 102 degrees F (101 degrees, 99 degrees) was complete recovery, while the outcome of the events severe body aches, weakness and intermittent dizziness was condition unchanged, while the outcome of the events vaccination site mass and injection site erythema was condition deteriorated and the outcome of the other events was not reported. The seriousness and causality of the events were not reported.
Age: 35.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site warmth, Lymphocyte count decreased, Pain, Pyrexia, Rash pruritic
Clinical narrative: Case number PHHY2016US165332, is an initial spontaneous report received through Vaccine Adverse Event Reporting System (VAERS) web site (VAERS reference number: 656531) on 21 Nov 2016. This report refers to a 35 year old female patient. Historical condition was not reported. Current condition included high blood pressure. Concomitant medication included amlodipine 10 mg, bupropion 150 mg, prenatal vitamins, labetalol 300 mg, omeprazole 20 mg and sertraline 200 mg. The patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number was not reported) in her left arm from 27 Sep 2016, intramuscularly. The patient was also vaccinated with pneumococcal vaccine (manufacturer unknown) from 27 Sep 2016 in her left arm, intramuscularly. On 28 Sep 2016, the patient woke up with fever of 102 degrees F (normal range not reported), severe body aches and weakness with intermittent dizziness. After treatment with TYLENOL and rest, the fever dropped to 101 degrees, but again went up to 102 after a few hours. Around 01 PM, the patient took ADVIL and the temperature dropped to 99 degrees. By approximately 05 PM, the temperature was back to 102 degrees. Other symptoms persisted throughout the day. On 29 Sep 2016, the patient woke up with a fever of 102 degrees and continued aches and weakness. On the same date (around 7:30 AM), the patient noticed a large, raised, red bump that was hot to the touch and approximately 2 inches below the injection site with the size of a golf ball. The patient's fever went down with ADVIL but began to raise back to 101 degrees around 1 PM. The red lump continued to spread and was now to the size of a large softball. The patient returned to the physician at 3 PM, where temperature was 101 degrees. The physician recommended icing the arm and monitoring to see if it spread. Blood was also drawn to determine if infection was present. On 30 Sep 2016, the patient woke up to a normal temperature but was weak. The rash had spread very little but began to itch. As of 02 Oct 2016, the patient was waiting to hear back from the physician as to whether an allergy pill could help. On an unknown date, the patient's blood work was done which revealed that her white blood cells and granulocytes (grans) came back high (result, normal range and unit were not reported) and lymphocytes (lymphs) came back low (result, normal range and unit were not reported). The outcome of the event fever of 102 degrees F (101 degrees, 99 degrees) was complete recovery, while the outcome of the events severe body aches, weakness and intermittent dizziness was condition unchanged, while the outcome of the events vaccination site mass and injection site erythema was condition deteriorated and the outcome of the other events was not reported. The seriousness and causality of the events were not reported.
Age: 35.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: White blood cell count increased
Clinical narrative: Case number PHHY2016US165332, is an initial spontaneous report received through Vaccine Adverse Event Reporting System (VAERS) web site (VAERS reference number: 656531) on 21 Nov 2016. This report refers to a 35 year old female patient. Historical condition was not reported. Current condition included high blood pressure. Concomitant medication included amlodipine 10 mg, bupropion 150 mg, prenatal vitamins, labetalol 300 mg, omeprazole 20 mg and sertraline 200 mg. The patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number was not reported) in her left arm from 27 Sep 2016, intramuscularly. The patient was also vaccinated with pneumococcal vaccine (manufacturer unknown) from 27 Sep 2016 in her left arm, intramuscularly. On 28 Sep 2016, the patient woke up with fever of 102 degrees F (normal range not reported), severe body aches and weakness with intermittent dizziness. After treatment with TYLENOL and rest, the fever dropped to 101 degrees, but again went up to 102 after a few hours. Around 01 PM, the patient took ADVIL and the temperature dropped to 99 degrees. By approximately 05 PM, the temperature was back to 102 degrees. Other symptoms persisted throughout the day. On 29 Sep 2016, the patient woke up with a fever of 102 degrees and continued aches and weakness. On the same date (around 7:30 AM), the patient noticed a large, raised, red bump that was hot to the touch and approximately 2 inches below the injection site with the size of a golf ball. The patient's fever went down with ADVIL but began to raise back to 101 degrees around 1 PM. The red lump continued to spread and was now to the size of a large softball. The patient returned to the physician at 3 PM, where temperature was 101 degrees. The physician recommended icing the arm and monitoring to see if it spread. Blood was also drawn to determine if infection was present. On 30 Sep 2016, the patient woke up to a normal temperature but was weak. The rash had spread very little but began to itch. As of 02 Oct 2016, the patient was waiting to hear back from the physician as to whether an allergy pill could help. On an unknown date, the patient's blood work was done which revealed that her white blood cells and granulocytes (grans) came back high (result, normal range and unit were not reported) and lymphocytes (lymphs) came back low (result, normal range and unit were not reported). The outcome of the event fever of 102 degrees F (101 degrees, 99 degrees) was complete recovery, while the outcome of the events severe body aches, weakness and intermittent dizziness was condition unchanged, while the outcome of the events vaccination site mass and injection site erythema was condition deteriorated and the outcome of the other events was not reported. The seriousness and causality of the events were not reported.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Extra dose administered, Fatigue, Impaired work ability, Influenza
Clinical narrative: Case number PHHY2016US174160, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 656553) on 21 Nov 2016. This report refers to a 51 years old female patient. Past vaccination history included she received the unspecified flu shot 15 years out of 18 and within 8 hours she came down with severe cases of the flu (details unspecified). Current condition included asthma. Concomitant medication was not reported. She was vaccinated with tenth dose of seasonal influenza vaccine INN (unknown manufacturer, batch number: not reported) into the left arm on 23 Oct 2010 and fifth dose of influenza vaccine INN (batch number: not reported) into the right arm on an unknown date. After vaccination, on the same day, she experienced full blown flu, fever, chills, body aches and fatigue for 5 to 7 days. She required doctor visit in order to avoid patients and hence she was off work. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pyrexia
Clinical narrative: Case number PHHY2016US174160, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 656553) on 21 Nov 2016. This report refers to a 51 years old female patient. Past vaccination history included she received the unspecified flu shot 15 years out of 18 and within 8 hours she came down with severe cases of the flu (details unspecified). Current condition included asthma. Concomitant medication was not reported. She was vaccinated with tenth dose of seasonal influenza vaccine INN (unknown manufacturer, batch number: not reported) into the left arm on 23 Oct 2010 and fifth dose of influenza vaccine INN (batch number: not reported) into the right arm on an unknown date. After vaccination, on the same day, she experienced full blown flu, fever, chills, body aches and fatigue for 5 to 7 days. She required doctor visit in order to avoid patients and hence she was off work. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported.
Age: 61.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Headache, Injection site pain, Malaise
Clinical narrative: Case number PHHY2016US166139, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 656654) website on 21 Nov 2016. This report refers to a 61-years-old female patient. Past medical history was not reported. Current condition included sulfa and codeine allergy. Concomitant medication included melatonin, venlafaxine HCL, multivitamin and glucosamine/chondroitin. The patient's previous vaccination history included seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) on an unspecified date (last year) and experienced headache, malaise, and injection site aching (see case PHHY2016US166144). The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) subcutaneously in left arm on 28 Sep 2016. On 01 Oct 2016, the patient experienced numbness in area of injection and sharp shooting pain and increased, prolonged numbness in upper arm when raised overhead also, aching in injection location and headache experienced on day 01 after flu shot. On 03 Oct 2016, the symptoms were reported as ongoing and increasing. The outcome of the events was reported as condition unchanged. The seriousness and causality of events were not reported.
Age: 61.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Headache, Injection site hypoaesthesia, Injection site pain
Clinical narrative: Case number PHHY2016US166139, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 656654) website on 21 Nov 2016. This report refers to a 61-years-old female patient. Past medical history was not reported. Current condition included sulfa and codeine allergy. Concomitant medication included melatonin, venlafaxine HCL, multivitamin and glucosamine/chondroitin. The patient's previous vaccination history included seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) on an unspecified date (last year) and experienced headache, malaise, and injection site aching (see case PHHY2016US166144). The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) subcutaneously in left arm on 28 Sep 2016. On 01 Oct 2016, the patient experienced numbness in area of injection and sharp shooting pain and increased, prolonged numbness in upper arm when raised overhead also, aching in injection location and headache experienced on day 01 after flu shot. On 03 Oct 2016, the symptoms were reported as ongoing and increasing. The outcome of the events was reported as condition unchanged. The seriousness and causality of events were not reported.
Age: 67.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Back pain, Pain in extremity, Sciatica
Clinical narrative: Case number PHHY2016US179451, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 656720) website on 21 Dec 2016. This report refers to a 67 years old female patient. Past medical history was not reported. Concomitant medications included losartan, metformin and atorvastatin. The patient was vaccinated with FLUAD (batch number: 165803) in left arm along with PREVNAR 13 (Pfizer/Wyeth, batch number: N16561) in right arm, both on 20 Sep 2016. On 22 Sep 2016, the patient experienced sciatica type pain radiating from lower back down to the calf/feet. The outcome of the events was unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Burning sensation, Injected limb mobility decreased, Injection site pain, Insomnia, Pain
Clinical narrative: Case number PHHY2016US172574, is an initial spontaneous report received from via Vaccine Adverse Event Reporting System (VAERS reference number: 656871) website on 21 Nov 2016. This report refers to a 51-years-old female patient. Past medication history was not reported. Concomitant medication included SYNTHROID, CRESTOR, and metformin. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) in right arm on 16 Sep 2016. The patient was also vaccinated with trivalent inactivated influenza virus split vinon or surface antigen (subunit), influenza vaccine (unknown manufacturer, batch number: not reported) in left arm on 16 Sep 2016. On the same day after vaccination, the patient experienced intense burning upon injection that ran down her arm and since then there was an intense pain in upper arm and shoulder. The patient was unable to move right arm and shoulder and was unable to sleep due to pain and had throbbing pain constant. The patient received treatment with muscle relaxants, anti-inflammatory medications and TYELNOL (manufacturer unknown) and now was going for physical therapy. On an unspecified date the patient had a normal X ray. The outcome of event was reported as condition unchanged. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUX, TDAP
Symptoms: X-ray normal
Clinical narrative: Case number PHHY2016US172574, is an initial spontaneous report received from via Vaccine Adverse Event Reporting System (VAERS reference number: 656871) website on 21 Nov 2016. This report refers to a 51-years-old female patient. Past medication history was not reported. Concomitant medication included SYNTHROID, CRESTOR, and metformin. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) in right arm on 16 Sep 2016. The patient was also vaccinated with trivalent inactivated influenza virus split vinon or surface antigen (subunit), influenza vaccine (unknown manufacturer, batch number: not reported) in left arm on 16 Sep 2016. On the same day after vaccination, the patient experienced intense burning upon injection that ran down her arm and since then there was an intense pain in upper arm and shoulder. The patient was unable to move right arm and shoulder and was unable to sleep due to pain and had throbbing pain constant. The patient received treatment with muscle relaxants, anti-inflammatory medications and TYELNOL (manufacturer unknown) and now was going for physical therapy. On an unspecified date the patient had a normal X ray. The outcome of event was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 33.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Axillary pain, Swelling, Tenderness
Clinical narrative: Case number PHHY2016US164878, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 656894) on 21 Nov 2016. This report refers to a 34 years old male patient. Historical condition included gout. Vaccination history included administration of seasonal influenza vaccine Inn (manufacturer unknown, batch number: not reported) a year ago when the patient was 33 year old and experienced pain and swelling in right axilla in less than 24 hours after vaccination in right deltoid (see case PHHY2016US164989). Current conditions included hypertension, diabetes mellitus (type 2), hyperlipidemia, obesity and epilepsy. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine Inn (manufacturer unknown, batch number: not reported) intramuscularly in to right deltoid on 01 Oct 2016. On same day after vaccination within 24 hours, the patient experienced swelling and pain in right axilla. On examination, it was found that the patient's right axilla was tender and diffusely swollen encompassing an area of approximately 10 cm diameter, without palpable lymphadenopathy. No erythema at vaccination site nor in axilla. The patient was recommended symptomatic treatment with Ibuprofen. The patient went to emergency room. The outcome of the events was reported as condition unchanged. Seriousness and causality of the events was not reported.
Age: 33.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Axillary pain, Swelling
Clinical narrative: Case number PHHY2016US164878, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 656894) on 21 Nov 2016. This report refers to a 34 years old male patient. Historical condition included gout. Vaccination history included administration of seasonal influenza vaccine Inn (manufacturer unknown, batch number: not reported) a year ago when the patient was 33 year old and experienced pain and swelling in right axilla in less than 24 hours after vaccination in right deltoid (see case PHHY2016US164989). Current conditions included hypertension, diabetes mellitus (type 2), hyperlipidemia, obesity and epilepsy. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine Inn (manufacturer unknown, batch number: not reported) intramuscularly in to right deltoid on 01 Oct 2016. On same day after vaccination within 24 hours, the patient experienced swelling and pain in right axilla. On examination, it was found that the patient's right axilla was tender and diffusely swollen encompassing an area of approximately 10 cm diameter, without palpable lymphadenopathy. No erythema at vaccination site nor in axilla. The patient was recommended symptomatic treatment with Ibuprofen. The patient went to emergency room. The outcome of the events was reported as condition unchanged. Seriousness and causality of the events was not reported.