chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site vesicles
Clinical narrative: Case number PHHY2016US025625 is an initial spontaneous report received from a consumer (patient's friend) via Vaccine Adverse Event Reporting System (VAERS reference number: 611535) on 19 Feb 2016. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the upper arm on an unknown date. It was reported that weeks later, she had an exceptional at site response which was further specified as small blistering and persistent ache in upper arm. The events outcome, seriousness and causality was not reported.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Case number PHHY2016US024977 is an initial spontaneous report received a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 611722) on 19 Feb 2016. This report refers to a 34 year old female patient. Her current conditions included penicillin allergy. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 24 Sep 2015. The patient was given the vaccine by a fellow nursing student at a vaccine clinic. On 27 Sep 2015, the patient started having significant pain in her shoulder and inability to raise or move her shoulder. She went to emergency room and took meloxicam or ADVIL. The events continued for 2 months and it started to heal over the past few days. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Case number PHHY2016US025547 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 611820) on 19 Feb 2016. This report refers to a 41 year old female patient. She had no medical history, concurrent conditions or concomitant medications. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 23 Nov 2015. On 24 Nov 2015, the patient experienced extreme soreness which prevented the movement of her arm in all directions without causing sharp pain. She also got bruising in the area with redness and small bumps around the injection site. The events outcome was reported as condition unchanged. The events were reported as non-serious. The causality of the events was not reported.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Muscle tightness, Muscular weakness, Pain, Vaccination site pain
Clinical narrative: Case number PHHY2016US025538, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 611823) website on 19 Feb 2016. This report refers to a 53 years old female patient. Historical condition was not reported. Current condition included allergy to dairy, horse serum and penicillin. Concomitant medication included Synthroid. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly into right arm on 05 Nov 2015. On same day after vaccination, the patient's right shoulder vaccination site had been continuously sore since injection, pain and muscle tension migrated across right neck to left neck, then right neck, then right forearm, then right bicep over then days, right arm was mildly weak, any muscle movement of right shoulder causes right shoulder moderate pain. The patient visited the emergency room on an unknown date and her doctor visit was pending. The final outcome of the events was not reported. Seriousness of the events was reported as non serious and causality not reported.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Case number PHHY2016US025097 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 611925) on 19 Feb 2016. This report refers to a 25 year old female patient. She had no medical history and current condition. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on 21 Oct 2015. On 22 Oct 2015, she had pain with shoulder rotation. Some movements began with a sort of locked inhibition to move and forced motion caused a burst of pain. She could not continue her normal exercise routine and pushups exacerbation shoulder pain. The outcome of the events was reported as condition unchanged. The events were reported as non-serious. The causality of the events was not reported.
Age: 0.7
Sex: F
Vaccine: FLUX
Symptoms: Drug administered to patient of inappropriate age, Pyrexia
Clinical narrative: Case number PHHY2016US025119 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 611938) on 19 Feb 2016. This report refers to a 7 months old female patient. She had no medical history and current condition. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 20 Nov 2015. on 21 Nov 2015, she experienced consistently running fever over 101 and it continued for 7 days following vaccine and was ongoing at the time of reporting. It was reported that the source of fever was unknown. The outcome of the event was reported as condition unchanged. The event was reported as non-serious. The causality of the event was not reported.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Exercise tolerance decreased, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Case number PHHY2016US024991, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS, reference number: 611953) on 19 Feb 2016. This reports refers to a 34 years old female patient. Medical history was none. The patient had no current illness. Concomitant medications were none. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into left arm on 14 Oct 2014. On 15 Oct 2014 the patient experienced shoulder pain and limited ROM. This lasted at least a couple impacting her ability to work and exercise. Pain and limited ROM lasted for about 9 months. Final outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 64.0
Sex: F
Vaccine: DTP, FLUX
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2016US025679 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 611967) on 19 Feb 2016. This report refers to a 64 year old female patient. She had no medical history, current conditions or concomitant medications. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and DTP vaccine (other manufacturer, batch number: not reported); both vaccines administered in the right arm on 06 Oct 2015. On the same day within an hour after vaccination, a bruise appeared at the injection site and grew to a one and a half inch circle. Over the weeks, pain grew at the site and swelling appeared beneath the site. The patient still had pain in the upper arm at the time of reporting and was treated with TBA. The patient would see the doctor soon. The events outcome was reported as condition unchanged. The events were reported as non-serious. The causality of the events was not reported.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUX, IPV, MMR
Symptoms: Asthenia, Diarrhoea, Pyrexia, Vomiting, Weight decreased
Clinical narrative: Case number PHHY2016US025788 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 611970) on 19 Feb 2016. This report refers to a 4-year-old male patient. Historical condition was not reported. Current conditions included ongoing and mild runny nose. Concomitant medication included Augmentine. The patient received seasonal influenza vaccine (manufacturer and batch number: not reported), DTAP (other manufacturer, batch number: not reported) MMR II vaccine (other manufacturer, batch number: not reported) and inactivated poilo virus vaccine (other manufacturer, batch number: not reported); all vaccines administered in the leg on 24 Nov 2015. On 25 Nov 2015, the patient experienced vomiting, diarrhea, low fever, weakness and weight loss. It was reported that the patient was experiencing weight loss for the last 4 days. The outcome was reported as complete recovery. The events were assessed as non-serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Irritability, Joint range of motion decreased, Nasal congestion, Oropharyngeal pain
Clinical narrative: Case number PHHY2016US025729 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 612019) on 19 Feb 2016. This report refers to a female patient whose age was not reported. Her vaccination history included administration of 3 doses of influenza vaccine (manufacturer and batch number: not reported) in the past and she never had a reaction. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the arm on an unknown date. On 15 Oct 2015, the patient experienced back pain, upper arm pain, sore throat, fever, stuffy nose, irritability, upper arm tenderness and decrease range of motion. The upper arm pain continued for a month. The events outcome was not reported. The events were reported as non-serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Case number PHHY2016US025729 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 612019) on 19 Feb 2016. This report refers to a female patient whose age was not reported. Her vaccination history included administration of 3 doses of influenza vaccine (manufacturer and batch number: not reported) in the past and she never had a reaction. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the arm on an unknown date. On 15 Oct 2015, the patient experienced back pain, upper arm pain, sore throat, fever, stuffy nose, irritability, upper arm tenderness and decrease range of motion. The upper arm pain continued for a month. The events outcome was not reported. The events were reported as non-serious. The causality of the events was not reported.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Muscle spasms, Pain
Clinical narrative: Case number PHHY2016US024337, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 612051) website on 19 Feb 2016. This report refers to a 48 years old female patient. Historical conditions included sciatica. Past medical history KEFLEX, clindamycin (manufacturer unknown) and codeine (manufacturer unknown). Current conditions included allergy to non-steroidal anti-inflammatory drug over the counter and prescription, tramadol and seasonal allergies. Concomitant medication included NEXIUM, gabapentin (manufacturer unknown), Synthroid, CADUET, citalopram (manufacturer unknown), ADVAIR, CLARITIN. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly in to left upper arm on 20 Oct 2015. During vaccination, the patient reported that it hurt a little as fluid injected, but seemed normal vaccination. Following day on 21 Oct 2015, patient experienced it was achy and with 01 to 02 days it continued to be nagging, had a spasms/tightness. After a couple of weeks tightness spread in shoulder, neck and incorporate left shoulder blade. The patient started taking TYLENOL 02 to 03 per day since beginning, recently tried muscle relaxants. The patient had a routine visit with chiropractor who suggested physical therapy and advised to visit primary care physician said patient should call employee health. The final outcome of the events was reported as unknown. Seriousness of the events was reported as non serious and causality not reported.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Erythema, Headache, Myalgia
Clinical narrative: Case number PHHY2016US024422 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 613279) on 19 Feb 2016. This report refers to a 50 year old female patient. Her medical history, current conditions and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the right arm on 03 Dec 2015. On 04 Dec 2015, the patient's whole shoulder was swollen and red. She was very weak and had headache, nausea and achy joints and muscles. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Peripheral swelling
Clinical narrative: Case number PHHY2016US024422 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 613279) on 19 Feb 2016. This report refers to a 50 year old female patient. Her medical history, current conditions and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the right arm on 03 Dec 2015. On 04 Dec 2015, the patient's whole shoulder was swollen and red. She was very weak and had headache, nausea and achy joints and muscles. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Pain
Clinical narrative: Case number PHHY2016US024435 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 613294) on 19 Feb 2016. This report refers to a 58 year old female patient. She had no medical history or current conditions. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 23 Oct 2015. On the same day after vaccination, the patient's left arm was extremely painful, sore and throbbing with muscle throbbing. It was reported that days after vaccination, instead of improving, the pain in arm increased in intensity with limited range of motion. She went back to employee health in the first week of Nov 2015 due to intensity of pain and limited range of motion and she had several visits since then. The doctor ordered for a magnetic resonance imaging (MRI) of the left arm. The events outcome was not reported. The events were reported as non-serious. The causality of the events was not reported.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Immobile, Musculoskeletal stiffness, Pain, Swelling, Tenderness
Clinical narrative: Case number PHHY2016US025318, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 613304) website on 19 Feb 2016. This report refers to a 61-year-old female patient. Past medical history was not reported. Current conditions included allergies to ibuprofen. Concomitant medications included Synthroid. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 19 Nov 2015. On 20 Nov 2015, she experienced swelling, hives, extreme tenderness, immobility, pain and stiffness. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Case number PHHY2016US025318, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 613304) website on 19 Feb 2016. This report refers to a 61-year-old female patient. Past medical history was not reported. Current conditions included allergies to ibuprofen. Concomitant medications included Synthroid. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 19 Nov 2015. On 20 Nov 2015, she experienced swelling, hives, extreme tenderness, immobility, pain and stiffness. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered to patient of inappropriate age, Dysphemia
Clinical narrative: Case number PHHY2016US025114, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 613307) website on 19 Feb 2016. This report refers to a 03 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 02 Dec 2015 when she was 03 years old. The patient was highly verbal and speaking in complete sentences. On 04 Dec 2015, the patient experienced stuttering two days later, though it was just first syllables and occasionally at that time. The next day the stutter was on almost every single word to the point that she could hardly get through her sentences. Outcome of the event was reported as unknown. Seriousness of the event was reported as non-serious. The causality of the events was not reported.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Muscular weakness, Musculoskeletal pain, Nausea, Pain
Clinical narrative: Case number PHHY2016US024417, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 613570) website on 19 Feb 2016. This report refers to a 54 years old female patient. Current condition included hypertension controlled and osteoarthritis. Past medical history was not reported. Concomitant medication included clonidine and TYLENOL. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 10 Nov 2015, she experienced an aching in injection arm and shoulder, 100.4 F fever, nausea, body aches and fatigue through 14 Nov 2015 and continuing intermittent arm and shoulder pain, muscle weakness in arm and shoulder, body aches and fatigue through 07 Dec 2015. She further reported that her job performance was being adversely affected. She would consult the physician this week (unspecified date) as symptoms continuing. The final outcome of the events reported as unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Case number PHHY2016US024417, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 613570) website on 19 Feb 2016. This report refers to a 54 years old female patient. Current condition included hypertension controlled and osteoarthritis. Past medical history was not reported. Concomitant medication included clonidine and TYLENOL. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 10 Nov 2015, she experienced an aching in injection arm and shoulder, 100.4 F fever, nausea, body aches and fatigue through 14 Nov 2015 and continuing intermittent arm and shoulder pain, muscle weakness in arm and shoulder, body aches and fatigue through 07 Dec 2015. She further reported that her job performance was being adversely affected. She would consult the physician this week (unspecified date) as symptoms continuing. The final outcome of the events reported as unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Eyelid oedema, Facial pain, Lip swelling, Neuralgia, Swelling face
Clinical narrative: Case number PHHY2016US025285, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 613574) web site on 19 Feb 2016. This report refers to a 51 years old female patient. Current condition included asthma and migraines. Past medical history was not reported. Concomitant medication included amlodipine and hydrochlorothiazide. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 16 Nov 2015, intramuscularly on left arm. On 17 Nov 2015, she had swelling left side of face, left side of nose and left side of lips, left eye swelled and shut, hives by 19 Nov 2015, facial pain and pain in facial nerve. The patient went to emergency room on an unknown date. The patient was treated with prednisone taper. Outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious and causality of the events was not reported. Seriousness of the events swelling face, lip swelling, eye swelling, facial pain, neuralgia and urticarial were upgraded (medically significant) based on the information available in source document. Following an internal review done on 02 Mar 2016 for the date received on 19 Feb 2016: Significant case correction was done to upgraded the case from non serious to serious (all the events).
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Case number PHHY2016US025285, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 613574) web site on 19 Feb 2016. This report refers to a 51 years old female patient. Current condition included asthma and migraines. Past medical history was not reported. Concomitant medication included amlodipine and hydrochlorothiazide. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 16 Nov 2015, intramuscularly on left arm. On 17 Nov 2015, she had swelling left side of face, left side of nose and left side of lips, left eye swelled and shut, hives by 19 Nov 2015, facial pain and pain in facial nerve. The patient went to emergency room on an unknown date. The patient was treated with prednisone taper. Outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious and causality of the events was not reported. Seriousness of the events swelling face, lip swelling, eye swelling, facial pain, neuralgia and urticarial were upgraded (medically significant) based on the information available in source document. Following an internal review done on 02 Mar 2016 for the date received on 19 Feb 2016: Significant case correction was done to upgraded the case from non serious to serious (all the events).
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Case number PHHY2016US025702 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 613714) on 19 Feb 2016. This report refers to a 55 year old female patient. She had no illness. Her current condition included allergy to VICODIN and amoxillin. Her concomitant medications included ranitidine 300 mg. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 15 Oct 2015. On the same day she had several shoulder and arm pain. It was reported that the pain had continued in the shoulder and arm since the day of the vaccine. It was not as severe as the first week, but was continuous. No laboratory tests were performed. The events outcome was reported as condition unchanged. The events were reported as non-serious. The causality of the events was not reported.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Malaise, Muscular weakness, Musculoskeletal pain, Myalgia
Clinical narrative: Case number PHHY2016US025392, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 613829) website on 19 Feb 2016. This report refers to a 67-years-old male patient. Past medical history was not reported. Concomitant medications included Dorzolamide/timolol for glaucoma. He was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 23 Nov 2016. On the same day, he experienced general sickness, pain in deltoid muscle and shoulder joint, painful to lift arm, physician weakness and arm weakness. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Case number PHHY2016US025392, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 613829) website on 19 Feb 2016. This report refers to a 67-years-old male patient. Past medical history was not reported. Concomitant medications included Dorzolamide/timolol for glaucoma. He was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 23 Nov 2016. On the same day, he experienced general sickness, pain in deltoid muscle and shoulder joint, painful to lift arm, physician weakness and arm weakness. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Speech disorder
Clinical narrative: Case number PHHY2016US027690, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 614232) on 19 Feb 2016. This report refers to a 68 years old male patient. Past medical history was not reported. Current conditions included hypersensitivity and unspecified allergies. Concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 25 Nov 2015 and also received fluticasone propionate (manufacturer unknown) and ADVAIR inhalation powder (batch number 5ZP9982, expiry date 2016) for an unknown indication and at an unknown dose started in 2015. After vaccination, on an unknown date in 2015, less than a month after receiving influenza vaccine and an unknown time after starting ADVAIR, she experienced feeling unwell and speech disorder, she could hardly talk and thought that was may be from allergies. The outcome of the events was unknown. It was unknown if the reporter considered the feeling unwell and speech disorder to be related to influenza vaccine and ADVAIR. The events were assesses as non serious and causality was not reported.
Sex: F
Vaccine: FLUX, PNC13, PPV
Symptoms: Feeling abnormal
Clinical narrative: Case number PHHY2016US025944, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 614427) website on 19 Feb 2016. This report refers to female patient of an unknown age (over 65 years old or might be in her seventies). Past medical history and concomitant medication were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported), PNEUMOVAX 23 (manufacturer: other manufacturer and batch number: not reported) probably in the deltoid region and PREVNAR 13 (manufacturer: other and batch number: not reported) in the arm on an unknown date. Next day of vaccination, she complained of feeling really crappy and horrible. She was mad at the pharmacy because she claimed that it was pharmacy's fault that she felt that way. Filed representative stated that he did not know the dates of when the events occurred, but he knew that it was longer than five days ago. It was not reported if the patient required an emergency room or doctor visit. The events lasted for five days and the patient was fine at the time of reporting. Outcome of the event was reported as complete recovery (recovered). Seriousness of the event was reported as non serious and causality of the event was not reported.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site inflammation, Injection site pain, Mobility decreased
Clinical narrative: Case number PHHY2016US026008, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 614441) website on 19 Feb 2016. This report refers to a 46-years-old female patient. Past medical history was not reported. Current conditions included penicillin allergy and asthma. Concomitant medications included EFFEXOR and Albuterol. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly in right arm on 01 Oct 2015. On 02 Oct 2015, she experienced burning pain in deltoid and trapezius muscle, limited range of motion in neck, inflammation and pain at the site of administration (reported as 10 weeks post shot). She visited the emergency room. The outcome of the events was not reported. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Headache, Injection site erythema, Nausea
Clinical narrative: Case number PHHY2016US026316, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 614559) on 19 Feb 2016. This report refers to a 22 years old female patient. Past medical history included pregnancy (details unspecified). Concomitant medication was not reported. She was vaccinated with first dose of seasonal influenza vaccine (manufacturer and batch number: not reported) into the left arm on 08 Dec 2015. After vaccination, on 09 Dec 2015, she experienced major headache resulting in dizziness, nausea, vomiting, weakness, itching all over body and redness around injection site larger than a quarter. Outcome of the events was reported as complete recovery on an unknown date. Seriousness of the events was reported as non serious and causality was not reported. Seriousness of the events pruritus generalized, nausea, vomiting and dizziness was upgraded (medically significant) based on the information available in the source document.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus generalised, Vomiting
Clinical narrative: Case number PHHY2016US026316, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 614559) on 19 Feb 2016. This report refers to a 22 years old female patient. Past medical history included pregnancy (details unspecified). Concomitant medication was not reported. She was vaccinated with first dose of seasonal influenza vaccine (manufacturer and batch number: not reported) into the left arm on 08 Dec 2015. After vaccination, on 09 Dec 2015, she experienced major headache resulting in dizziness, nausea, vomiting, weakness, itching all over body and redness around injection site larger than a quarter. Outcome of the events was reported as complete recovery on an unknown date. Seriousness of the events was reported as non serious and causality was not reported. Seriousness of the events pruritus generalized, nausea, vomiting and dizziness was upgraded (medically significant) based on the information available in the source document.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Insomnia, Joint range of motion decreased, Musculoskeletal pain, Pain
Clinical narrative: Case number PHHY2016US024304 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 614659) on 19 Feb 2016. This report refers to a a 57 year old male patient. Medical history was not reported. Concomitant medications included Hydrochlorothiazide 25 mg, Pravastatin 40 mg and BENICAR (olmesaratan, 20 mg). The patient was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported, site of vaccination: not reported) on 07 Oct 2015. On 09 Oct 2015, the patient experienced significant shoulder pain and restricted range of motion in shoulder and arm. The pain radiated down through arm to thumb. It was reported that he had lack of sleep at night due to pain. Following the events the he visited emergency room and was prescribed Naproxen for pain, but no results were seen. The outcome of the events was not reported. Events were reported as non-serious. Causality of the events was not reported.
Age: 5.0
Sex: M
Vaccine: DTAP, FLUX, IPV
Symptoms: Chest pain, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2016US024426, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 614836) website on 19 Feb 2016. This report refers to a 05 year old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported), DTAP and IPV (manufacturer unknown and batch number: not reported) on 29 Oct 2015. On the same day after vaccination experienced extreme painful, tender, swelling and redness at the site of shot and beyond down to wrist and across to chest. Pain and swelling lasted for 5 days. He reported that, this was worse than the reaction of previous year, which was similar but not quite extensive or long lasting. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the event was reported as non serious. The causality of the event was not reported. The event chest pain was upgraded to medically significant based on the information available in the source document.
Age: 5.0
Sex: M
Vaccine: DTAP, FLUX, IPV
Symptoms: Pain in extremity, Peripheral swelling, Swelling, Tenderness
Clinical narrative: Case number PHHY2016US024426, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 614836) website on 19 Feb 2016. This report refers to a 05 year old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported), DTAP and IPV (manufacturer unknown and batch number: not reported) on 29 Oct 2015. On the same day after vaccination experienced extreme painful, tender, swelling and redness at the site of shot and beyond down to wrist and across to chest. Pain and swelling lasted for 5 days. He reported that, this was worse than the reaction of previous year, which was similar but not quite extensive or long lasting. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the event was reported as non serious. The causality of the event was not reported. The event chest pain was upgraded to medically significant based on the information available in the source document.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHHY2016US024547, is an initial spontaneous report received from a non-health care professional via a company representative and Vaccine Adverse Event Reporting System (VAERS, reference number: 61525) on 19 Feb 2016. This report refers to a patient of an unknown age and gender. The patient was vaccinated with GARDASIL (batch number: K010215) instead of seasonal influenza vaccine (manufacturer and batch number: not reported) on 29 Oct 2015. The case was assessed as non-serious. No adverse effects were reported.
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Case number PHHY2016US029417, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS 616582) website on 29 Feb 2016. This report refers to a female patient of an unknown age. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unknown date. After vaccination on an unknown date, the patient experienced syncope. The outcome, seriousness and causality of the events were not reported. Seriousness of the events "syncope" was upgraded based on information available in the source document.
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Syncope
Clinical narrative: Case number PHHY2016US029417, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS 616582) website on 29 Feb 2016. This report refers to a female patient of an unknown age. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unknown date. After vaccination on an unknown date, the patient experienced syncope. The outcome, seriousness and causality of the events were not reported. Seriousness of the events "syncope" was upgraded based on information available in the source document.
Age: 64.0
Sex: F
Vaccine: FLUX, VARZOS, FLUX, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal pain, Neck pain
Clinical narrative: Case number PHHY2016US032427 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 617015) on 08 Mar 2016. This report refers to a 64 year old female patient. It was reported that the patient has just got over slight cold. Current illness was reported as none. Concomitant medication included Synthroid (levothyroxine, 0.05 mg). The patient was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) into left arm and Zoster vaccine (other manufacturer, batch number: not reported) into left leg on 04 Dec 2015. On 05 Dec 2015, the patient developed swelling and redness at site-3 x 5" area that was hard and painful to touch. She experienced pain in shoulder and neck like a pinched nerve which has not gone away. The outcome of the events was not reported. Events were reported as non-serious. Causality of the events was not reported.
Age: 33.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Blood test, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Case number PHHY2016US031470, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 617021) on 08 Mar 2016. This report refers to a 33 years old male patient. Medical history and concurrent conditions were none. Concomitant medications were none. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into left arm on 30 Oct 2015. On 17 Dec 2015 the patient experienced numbness and pins and needles sensation in legs that progressed upward. Further the patient was diagnosed with Guillain-Barre syndrome and received plasmapheresis. The patient was hospitalized for 7 days due to these events. The patient underwent magnetic resonance imaging (MRI), spinal tap and blood tests (further not specified). Outcome of the events was recovered. Causality of the events was not reported.
Age: 33.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Paraesthesia, Plasmapheresis
Clinical narrative: Case number PHHY2016US031470, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 617021) on 08 Mar 2016. This report refers to a 33 years old male patient. Medical history and concurrent conditions were none. Concomitant medications were none. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into left arm on 30 Oct 2015. On 17 Dec 2015 the patient experienced numbness and pins and needles sensation in legs that progressed upward. Further the patient was diagnosed with Guillain-Barre syndrome and received plasmapheresis. The patient was hospitalized for 7 days due to these events. The patient underwent magnetic resonance imaging (MRI), spinal tap and blood tests (further not specified). Outcome of the events was recovered. Causality of the events was not reported.
Age: 37.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Axillary pain, Oedema peripheral
Clinical narrative: Case number PHHY2016US033293 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 617041) on 08 Mar 2016. This report refers to a 37 year old female patient. Medical history was not reported. It was reported that the patient might have some seasonal allergies. Concomitant medication included Sertraline (50 mg), QUASENSE, FLONASE and PROAIR INHALER (when needed). The patient was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) into arm on 31 Dec 2015. On 01 Jan 2016, her armpit of the vaccinated arm was swollen and sore. It was reported that on 03 Jan 2016 also her armpit was swollen and sore. The outcome of the events was reported as unknown. Events were reported as non-serious. Causality of the events was not reported.
Age: 37.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Case number PHHY2016US033293 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 617041) on 08 Mar 2016. This report refers to a 37 year old female patient. Medical history was not reported. It was reported that the patient might have some seasonal allergies. Concomitant medication included Sertraline (50 mg), QUASENSE, FLONASE and PROAIR INHALER (when needed). The patient was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) into arm on 31 Dec 2015. On 01 Jan 2016, her armpit of the vaccinated arm was swollen and sore. It was reported that on 03 Jan 2016 also her armpit was swollen and sore. The outcome of the events was reported as unknown. Events were reported as non-serious. Causality of the events was not reported.
Age: 74.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Dyspnoea, Eyelid function disorder, VIIth nerve paralysis
Clinical narrative: Case number PHHY2016US031471, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 617192) on 08 Mar 2016. This report refers to a 74 years old female patient. Medical history included high blood pressure (HBP). Concurrent conditions were none. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 29 Oct 2015. On 09 Nov 2015 the patient had difficulty breathing, difficulty spitting and was unable to blink eye. The patient was diagnosed with Bell's palsy. The patient was treated with methylprednisolone, famciclovir, erythromycin and ofloxacin for eye. Outcome of the events was not recovered. Causality of the events was not reported. Seriousness assessment of "Bell's palsy" was upgraded based on the NVD key event list and "difficulty breathing" was upgraded based on the information in the source document.
Age: 74.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Dyspnoea, Eyelid function disorder, Facial paralysis
Clinical narrative: Case number PHHY2016US031471, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 617192) on 08 Mar 2016. This report refers to a 74 years old female patient. Medical history included high blood pressure (HBP). Concurrent conditions were none. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 29 Oct 2015. On 09 Nov 2015 the patient had difficulty breathing, difficulty spitting and was unable to blink eye. The patient was diagnosed with Bell's palsy. The patient was treated with methylprednisolone, famciclovir, erythromycin and ofloxacin for eye. Outcome of the events was not recovered. Causality of the events was not reported. Seriousness assessment of "Bell's palsy" was upgraded based on the NVD key event list and "difficulty breathing" was upgraded based on the information in the source document.
Age: 52.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Joint range of motion decreased, Nuclear magnetic resonance imaging, Pain, X-ray
Clinical narrative: Case number PHHY2016US031765 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 617243) on 08 Mar 2016. This report refers to a 52 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) on 21 Sep 2015. On an unknown date, the patient experienced chronic pain and limited range of motion in left arm and shoulder. Following the events the patient visited a chiropractic/orthopedics for treatment and also had MRI and X-ray lab tests. The outcome of the events was reported as condition unchanged. Events were reported as non-serious. Causality of the events was not reported.
Age: 52.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Case number PHHY2016US031765 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 617243) on 08 Mar 2016. This report refers to a 52 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) on 21 Sep 2015. On an unknown date, the patient experienced chronic pain and limited range of motion in left arm and shoulder. Following the events the patient visited a chiropractic/orthopedics for treatment and also had MRI and X-ray lab tests. The outcome of the events was reported as condition unchanged. Events were reported as non-serious. Causality of the events was not reported.
Age: 1.3
Sex: F
Vaccine: DTAP, FLUX, HIBV, VARCEL, FLUX, HIBV, TDAP, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Case number PHHY2016US031965, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 617596) on 08 Mar 2016. This report refers to 15 months old female patient. Medical history included eczema. The patient had no current illness. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported), DTAP (batch number: not reported, other manufacturer), haemophilus B conjugate vaccine (batch number: not reported, other manufacturer) and VARIVAX (batch number: not reported, other manufacturer); all vaccinations into left leg on 04 Jan 2016. On 05 Jan 2016 the patient experienced rash and fever. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, FLUX, HPV4, MNQ, TDAP
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Case number PHHY2016US035361 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 617812) on 15 Mar 2016. This report refers to a 13 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with GARDASIL (other manufacturer, batch number: L023230) into right arm, MENVEO (other manufacturer, batch number: M15032) into right arm and BOOSTRIX (other manufacturer, batch number: 2224P) into left arm, all intramuscularly on 06 Jan 2016. It was reported that the patient received Tdap instead of seasonal influenza vaccine (manufacturer and batch number: not reported) and hence two Tdaps were given to patient in the same arm. The outcome of the event was not reported. The case was assessed as non-serious. No adverse effects were reported after this maladministration.