chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Case number PHHY2016US053377, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 623010) website on 18 Apr 2016. This report refers to 72 years old female patient. Past historical conditions included thyroid, degenerative disc disease, gastroesophageal reflux disease and high cholesterol. Concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported), on upper arm on 17 Sep 2015. On 17 Oct 2015, she had extreme pain in upper left arm sometime after Flu shot and pain in her upper arm where she got the Flu shot. On an unknown date, she had X rays of neck done (results not reported). The physician said it was from nerves coming from her neck. The physician prescribed physical therapy. On an unknown date, she had pain in the muscles and shoulder. The final outcome of the events was condition unchanged. The seriousness of the events was reported as non serious and causality was not reported.
Age: 47.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Case number PHHY2016US053089, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 623011) website on 18 Apr 2016. This report refers to a 47 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into right arm on 19 Nov 2015. On the same day after vaccination the patient experienced pain in upper arm and shoulder which had never gone away in three months. Further the patient also experienced loss in range of motion in arm. Final outcome of the events was reported as not recovered. Seriousness and causality of the events was not reported.
Age: 47.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Case number PHHY2016US053089, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 623011) website on 18 Apr 2016. This report refers to a 47 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into right arm on 19 Nov 2015. On the same day after vaccination the patient experienced pain in upper arm and shoulder which had never gone away in three months. Further the patient also experienced loss in range of motion in arm. Final outcome of the events was reported as not recovered. Seriousness and causality of the events was not reported.
Age: 65.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Case number PHHY2016US057359, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 623033) on 27 Apr 2016. This report refers to a 65 years male patient. Medical history and concurrent conditions were not reported. Concomitant medications were unknown. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into right arm on 04 Nov 2015. On the same day after vaccination the patient experienced pain at injection site (right arm). The patient was seen by his primary care doctor on 08 Jan 2016 and has been treating the arm pain with cold compress and ibuprofen as advised by his primary care physician. The case was assessed as non-serious. The outcome and causality of the events was not reported.
Age: 22.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Chills, Injection site erythema, Injection site reaction, Pyrexia, Urticaria
Clinical narrative: Case number PHHY2016US056569, is an initial spontaneous report received from the Vaccine Adverse Effect Reporting System (reference number: 623122) on 18 Apr 2016. This report refers to a 22 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date after vaccination the patient experienced itching. The outcome, seriousness and causality of the event was not reported. Further the patient was vaccinated with FLUVIRIN 2015/2016 (seasonal influenza vaccine, batch number: 1517701 at the age of 24 years old and experienced red welt at sight of injection, low grade fever and chills (see case: PHHY2016US056554).
Age: 22.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pruritus
Clinical narrative: Case number PHHY2016US056569, is an initial spontaneous report received from the Vaccine Adverse Effect Reporting System (reference number: 623122) on 18 Apr 2016. This report refers to a 22 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date after vaccination the patient experienced itching. The outcome, seriousness and causality of the event was not reported. Further the patient was vaccinated with FLUVIRIN 2015/2016 (seasonal influenza vaccine, batch number: 1517701 at the age of 24 years old and experienced red welt at sight of injection, low grade fever and chills (see case: PHHY2016US056554).
Age: 57.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2016US054695, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 623186) website on 18 Apr 2016. This report refers to a 57 year old male patient. Medical history was none. Concomitant medication was not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) in let arm on 20 Oct 2015. On 23 Oct 2015, the patient developed sore bicep and elbow. Outcome, seriousness and causality of the events were not reported.
Age: 57.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Case number PHHY2016US054695, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 623186) website on 18 Apr 2016. This report refers to a 57 year old male patient. Medical history was none. Concomitant medication was not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) in let arm on 20 Oct 2015. On 23 Oct 2015, the patient developed sore bicep and elbow. Outcome, seriousness and causality of the events were not reported.
Age: 59.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Case number PHHY2016US055926, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 623188) website on 18 Apr 2016. This report refers to a 59 year old female patient. Medical history was not reported. Concomitant medication included sertraline. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 16 Oct 2015. On 17 Oct 2015, the patient developed pain in upper arm and limited range of motion. The patient was currently performing self-prescribed exercises. The patient was still experiencing the pain. Outcome for limited range of motion was not reported. Seriousness and causality of the events were not reported.
Age: 59.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2016US055926, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 623188) website on 18 Apr 2016. This report refers to a 59 year old female patient. Medical history was not reported. Concomitant medication included sertraline. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 16 Oct 2015. On 17 Oct 2015, the patient developed pain in upper arm and limited range of motion. The patient was currently performing self-prescribed exercises. The patient was still experiencing the pain. Outcome for limited range of motion was not reported. Seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUR3, FLUX
Symptoms: Anxiety, Cardiac monitoring, Electrocardiogram normal, Heart rate increased, Palmar erythema
Clinical narrative: Case number PHHY2016US055890 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (reference number: 623208) on 18 Apr 2016. This report refers to a female patient whose age was not reported. Past medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unspecified date after vaccination, the patient experienced bruising, nausea and high heart rate (no values reported). The outcome, seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUR3, FLUX
Symptoms: Palpitations
Clinical narrative: Case number PHHY2016US055890 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (reference number: 623208) on 18 Apr 2016. This report refers to a female patient whose age was not reported. Past medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unspecified date after vaccination, the patient experienced bruising, nausea and high heart rate (no values reported). The outcome, seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUR3, FLUX
Symptoms: Contusion, Heart rate increased, Nausea
Clinical narrative: Case number PHHY2016US055890 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (reference number: 623208) on 18 Apr 2016. This report refers to a female patient whose age was not reported. Past medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unspecified date after vaccination, the patient experienced bruising, nausea and high heart rate (no values reported). The outcome, seriousness and causality of the events were not reported.
Age: 46.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site paraesthesia, Injection site swelling
Clinical narrative: Case number PHHY2016US053328, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 623223) website on 18 Apr 2016. This report refers to 46 years old female patient. Past historical condition and concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported), on arm on 23 Sep 2015. On 24 Sep 2015, it was swollen at injection area, red, pain dull ache, tingling, limited range of motion and sore. Physical therapy was assigned. On an unknown date, she went to an emergency room. On an unknown date she underwent magnetic resonance imaging (results not reported). The final outcome of the events was condition unchanged. The seriousness of the events was reported as non serious and causality was not reported.
Age: 46.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Case number PHHY2016US053328, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 623223) website on 18 Apr 2016. This report refers to 46 years old female patient. Past historical condition and concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported), on arm on 23 Sep 2015. On 24 Sep 2015, it was swollen at injection area, red, pain dull ache, tingling, limited range of motion and sore. Physical therapy was assigned. On an unknown date, she went to an emergency room. On an unknown date she underwent magnetic resonance imaging (results not reported). The final outcome of the events was condition unchanged. The seriousness of the events was reported as non serious and causality was not reported.
Age: 46.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased, Nuclear magnetic resonance imaging normal
Clinical narrative: Case number PHHY2016US053328, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 623223) website on 18 Apr 2016. This report refers to 46 years old female patient. Past historical condition and concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported), on arm on 23 Sep 2015. On 24 Sep 2015, it was swollen at injection area, red, pain dull ache, tingling, limited range of motion and sore. Physical therapy was assigned. On an unknown date, she went to an emergency room. On an unknown date she underwent magnetic resonance imaging (results not reported). The final outcome of the events was condition unchanged. The seriousness of the events was reported as non serious and causality was not reported.
Age: 46.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain, Paraesthesia
Clinical narrative: Case number PHHY2016US053328, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 623223) website on 18 Apr 2016. This report refers to 46 years old female patient. Past historical condition and concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported), on arm on 23 Sep 2015. On 24 Sep 2015, it was swollen at injection area, red, pain dull ache, tingling, limited range of motion and sore. Physical therapy was assigned. On an unknown date, she went to an emergency room. On an unknown date she underwent magnetic resonance imaging (results not reported). The final outcome of the events was condition unchanged. The seriousness of the events was reported as non serious and causality was not reported.
Age: 84.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2016US053397, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 623248) website on 18 Apr 2016. This report refers to an 84 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) for flu and pneumonia in right arm on 11 Sep 2015. On 12 Sep 2015, the patient reported pain in right when lying on left arm and need to change to right side to relieve pain. The outcome of the event was reported as condition unchanged (as on 03 Nov 2015). The seriousness of the event was reported as non serious. The causality of the event was not reported.
Age: 42.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Disturbance in attention, Dizziness, Immediate post-injection reaction, Injection site erythema, Injection site haematoma
Clinical narrative: Case number PHHY2016US053261, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 623343) website on 18 Apr 2016. This report refers to a 42 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) (reported as inactivated influenza vaccine) in deltoid of right arm on 22 Feb 2016. On the same day after vaccination, the patient experienced immediate pain, local erythema, pruritus, edema and nodule formation at the injection site, with brief systemic symptoms of mild lightheadedness and loss of focus to events and lump in throat. It was reported that, clinical history and clinical exam were not consistent with immunoglobulins E mediated event (results unspecified) as the symptoms were localized and not urticarial. The reporter suspected the systemic symptoms were in response to pain and stress. The patients presentation of events was most consistent with formation of a hematoma secondary to vaccination. It was also reported that, the patient was educated on self care of continued ice, followed by heat in 1 to 2 days, rest (with caution to maintain range of motion in the shoulder to prevent freezing), and ibuprofen (manufacturer unknown) TID (to take with food). The final outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious and causality was not reported.
Age: 42.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site nodule, Injection site oedema, Injection site pain, Injection site pruritus, Sensation of foreign body
Clinical narrative: Case number PHHY2016US053261, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 623343) website on 18 Apr 2016. This report refers to a 42 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) (reported as inactivated influenza vaccine) in deltoid of right arm on 22 Feb 2016. On the same day after vaccination, the patient experienced immediate pain, local erythema, pruritus, edema and nodule formation at the injection site, with brief systemic symptoms of mild lightheadedness and loss of focus to events and lump in throat. It was reported that, clinical history and clinical exam were not consistent with immunoglobulins E mediated event (results unspecified) as the symptoms were localized and not urticarial. The reporter suspected the systemic symptoms were in response to pain and stress. The patients presentation of events was most consistent with formation of a hematoma secondary to vaccination. It was also reported that, the patient was educated on self care of continued ice, followed by heat in 1 to 2 days, rest (with caution to maintain range of motion in the shoulder to prevent freezing), and ibuprofen (manufacturer unknown) TID (to take with food). The final outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious and causality was not reported.
Age: 42.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Stress
Clinical narrative: Case number PHHY2016US053261, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 623343) website on 18 Apr 2016. This report refers to a 42 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) (reported as inactivated influenza vaccine) in deltoid of right arm on 22 Feb 2016. On the same day after vaccination, the patient experienced immediate pain, local erythema, pruritus, edema and nodule formation at the injection site, with brief systemic symptoms of mild lightheadedness and loss of focus to events and lump in throat. It was reported that, clinical history and clinical exam were not consistent with immunoglobulins E mediated event (results unspecified) as the symptoms were localized and not urticarial. The reporter suspected the systemic symptoms were in response to pain and stress. The patients presentation of events was most consistent with formation of a hematoma secondary to vaccination. It was also reported that, the patient was educated on self care of continued ice, followed by heat in 1 to 2 days, rest (with caution to maintain range of motion in the shoulder to prevent freezing), and ibuprofen (manufacturer unknown) TID (to take with food). The final outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious and causality was not reported.
Age: 42.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Disturbance in attention, Dizziness, Erythema, Immediate post-injection reaction, Injection site nodule
Clinical narrative: Case number PHHY2016US053261, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 623343) website on 18 Apr 2016. This report refers to a 42 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) (reported as inactivated influenza vaccine) in deltoid of right arm on 22 Feb 2016. On the same day after vaccination, the patient experienced immediate pain, local erythema, pruritus, edema and nodule formation at the injection site, with brief systemic symptoms of mild lightheadedness and loss of focus to events and lump in throat. It was reported that, clinical history and clinical exam were not consistent with immunoglobulins E mediated event (results unspecified) as the symptoms were localized and not urticarial. The reporter suspected the systemic symptoms were in response to pain and stress. The patients presentation of events was most consistent with formation of a hematoma secondary to vaccination. It was also reported that, the patient was educated on self care of continued ice, followed by heat in 1 to 2 days, rest (with caution to maintain range of motion in the shoulder to prevent freezing), and ibuprofen (manufacturer unknown) TID (to take with food). The final outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious and causality was not reported.
Age: 42.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Oedema, Pruritus
Clinical narrative: Case number PHHY2016US053261, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 623343) website on 18 Apr 2016. This report refers to a 42 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) (reported as inactivated influenza vaccine) in deltoid of right arm on 22 Feb 2016. On the same day after vaccination, the patient experienced immediate pain, local erythema, pruritus, edema and nodule formation at the injection site, with brief systemic symptoms of mild lightheadedness and loss of focus to events and lump in throat. It was reported that, clinical history and clinical exam were not consistent with immunoglobulins E mediated event (results unspecified) as the symptoms were localized and not urticarial. The reporter suspected the systemic symptoms were in response to pain and stress. The patients presentation of events was most consistent with formation of a hematoma secondary to vaccination. It was also reported that, the patient was educated on self care of continued ice, followed by heat in 1 to 2 days, rest (with caution to maintain range of motion in the shoulder to prevent freezing), and ibuprofen (manufacturer unknown) TID (to take with food). The final outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious and causality was not reported.
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Injection site pain, Lymph node pain, Lymphadenopathy, Neck pain
Clinical narrative: Case number PHHY2016US054605, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 623357) website on 18 Apr 2016. This report refers to an adult female patient. Current condition include allergic to AVELOX, seasonal allergies, asthma and allergic reactions due to fluoroquinolones. Past historical condition and concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on an unknown date. On an unknown date, after vaccination she experienced pain at the injection site that radiates to her neck, swollen lymph node about 1 cm in size which was soft, movable, tender to touch. The final outcome, seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Injection site pain, Lymphadenopathy, Neck pain, Tenderness
Clinical narrative: Case number PHHY2016US054605, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 623357) website on 18 Apr 2016. This report refers to an adult female patient. Current condition include allergic to AVELOX, seasonal allergies, asthma and allergic reactions due to fluoroquinolones. Past historical condition and concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on an unknown date. On an unknown date, after vaccination she experienced pain at the injection site that radiates to her neck, swollen lymph node about 1 cm in size which was soft, movable, tender to touch. The final outcome, seriousness and causality of the events were not reported.
Age: 72.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2016US056062, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 623404) website on 18 Apr 2016. This report refers to a 72 year old male patient. Medical history and concurrent condition were none. Concomitant medication was not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 01 Oct 2015. On 11 Oct 2015, the patient developed pain in left arm. The pain did not go away by the time of reporting. Seriousness and causality of the event were not reported.
Age: 80.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal stiffness, Neck pain
Clinical narrative: Case number PHHY2016US053310, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 623411) website on 18 Apr 2016. This report refers to an 80 years old female patient. Past medical history included as Vitamin B 12 deficiency, coagulation (COGN) and gout. Current condition included as anemia in chronic kidney disease, hypertension (HTN) and diabetic. Concomitant medications was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) split suspension at a dose of 0.5 ml into right arm (right deltoid) on 25 Sep 2015. The patient was also vaccinated with PREVNAR 13 vaccine (other manufacture, batch number: not reported) into left arm on 25 Sep 2015. On the same day after vaccination, the patient experienced right deltoid became swollen and felt warm to touch, very sore from elbow to clavicle neck area, site is still sore and stiff from elbow to shoulder. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the event was not reported.
Age: 80.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Case number PHHY2016US053310, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 623411) website on 18 Apr 2016. This report refers to an 80 years old female patient. Past medical history included as Vitamin B 12 deficiency, coagulation (COGN) and gout. Current condition included as anemia in chronic kidney disease, hypertension (HTN) and diabetic. Concomitant medications was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) split suspension at a dose of 0.5 ml into right arm (right deltoid) on 25 Sep 2015. The patient was also vaccinated with PREVNAR 13 vaccine (other manufacture, batch number: not reported) into left arm on 25 Sep 2015. On the same day after vaccination, the patient experienced right deltoid became swollen and felt warm to touch, very sore from elbow to clavicle neck area, site is still sore and stiff from elbow to shoulder. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the event was not reported.
Age: 73.0
Sex: U
Vaccine: FLU3, FLUX
Symptoms: Injection site pain, Mobility decreased, Myalgia
Clinical narrative: Case number PHHY2016US057565, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 623427) web site on 18 Apr 2016. This report refers to 73 years old patient of an unknown age. Past historical conditions and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported), on 10 Oct 2014. On an unknown date, the patient's flu shot hurt. On an unknown date (given as by December), the arm muscles hurt so much and now 15 months later the patient had half of movement back but still limited. The patient received cortisone shot (manufacturer unknown) but it did not help. On an unknown date, the patient went to emergency room. The final outcome of the events was condition unchanged. The seriousness of the events was reported as non serious and causality was not reported.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2016US052851 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (reference number: 623458) on 18 Apr 2016. This report refers to a 66 year old female patient. Her historical drugs included penicillin, amoxicillin, BACTRIM, cephalexin, statins, epinephrine, LORATAB, and PERCOCET (she had problems with LORATAB and PERCOCET). Her concomitant medications include enalapril maleate 20 mg two dosage form per day, metformin 500 mg two dosage form per day, amlodipine besylate 5 mg one dosage form per day, oxybutynin 5 mg two dosage form per day, levothyroxine 50 mg one dosage form per day, COUMADIN 4 mg one dosage form per day, multivitamin one dosage form per day and magnesium 250 mg one dosage form per day. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and pneumococcal vaccine (other manufacturer, batch number: not reported); both vaccines administered on 20 Oct 2015. On 21 Nov 2015, the patient experienced high heat at the injection site with soreness and swelling of whole upper arm. The outcome of the events was reported as complete recovery. The seriousness and causality of the events was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Device malfunction, Injection site pain, Nuclear magnetic resonance imaging, Pain in extremity, X-ray
Clinical narrative: Case number PHHY2016US053113 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 623537) on 18 Apr 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 influenza vaccine (manufacturer and batch number: not reported) on an unknown date. It was reported that after vaccination, the patient experienced soreness. The outcome, seriousness and causality of the events were not reported. The patient was further vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the arm on 21 Oct 2015 following which she experienced shoulder pain (see related case number: PHHY2016US053119). No further information was provided.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain
Clinical narrative: Case number PHHY2016US053113 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 623537) on 18 Apr 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 influenza vaccine (manufacturer and batch number: not reported) on an unknown date. It was reported that after vaccination, the patient experienced soreness. The outcome, seriousness and causality of the events were not reported. The patient was further vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the arm on 21 Oct 2015 following which she experienced shoulder pain (see related case number: PHHY2016US053119). No further information was provided.
Age: 62.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Acupuncture, Mobility decreased, Muscular weakness, Pain in extremity, X-ray limb
Clinical narrative: Case number PHHY2016US052956 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 623701) on 18 Apr 2016. This report refers to a 62 year old female patient. Her current condition included allergy to sulfa. She had no concomitant medications. She was vaccinated with annual seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the left arm on 30 Oct 2015. She felt that the vaccine was given too low in the arm. On 11 Dec 2015, she experienced severe upper arm pain and she felt like hitting the funny bone after reaching around and hugging another individual. The severe pain in upper arm was accompanied by decreased ability to move freely, pain and weakness of left arm. She had x-ray of the left upper arm on 21 Jan 2016 and results were not reported. She had physical therapy consultation on 04 Feb 2016 and acupuncture treatment consultation and treatment on 22 Feb 2016. The events outcome was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 62.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Acupuncture, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: Case number PHHY2016US052956 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 623701) on 18 Apr 2016. This report refers to a 62 year old female patient. Her current condition included allergy to sulfa. She had no concomitant medications. She was vaccinated with annual seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the left arm on 30 Oct 2015. She felt that the vaccine was given too low in the arm. On 11 Dec 2015, she experienced severe upper arm pain and she felt like hitting the funny bone after reaching around and hugging another individual. The severe pain in upper arm was accompanied by decreased ability to move freely, pain and weakness of left arm. She had x-ray of the left upper arm on 21 Jan 2016 and results were not reported. She had physical therapy consultation on 04 Feb 2016 and acupuncture treatment consultation and treatment on 22 Feb 2016. The events outcome was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 62.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain, Pain in extremity, X-ray limb
Clinical narrative: Case number PHHY2016US052956 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 623701) on 18 Apr 2016. This report refers to a 62 year old female patient. Her current condition included allergy to sulfa. She had no concomitant medications. She was vaccinated with annual seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the left arm on 30 Oct 2015. She felt that the vaccine was given too low in the arm. On 11 Dec 2015, she experienced severe upper arm pain and she felt like hitting the funny bone after reaching around and hugging another individual. The severe pain in upper arm was accompanied by decreased ability to move freely, pain and weakness of left arm. She had x-ray of the left upper arm on 21 Jan 2016 and results were not reported. She had physical therapy consultation on 04 Feb 2016 and acupuncture treatment consultation and treatment on 22 Feb 2016. The events outcome was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 28.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Fatigue, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Case number PHHY2016US054596, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 623707) website on 18 Apr 2016. This report refers to a 28 year old pregnant female patient. Medical history was not reported. Concomitant medication included prenatal vitamin. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 22 Feb 2016. On the same day after vaccination the patient experienced extreme physical exhaustion. The patient also developed redness, rash, and swelling at injection site on the same day. Outcome, seriousness and causality of the events were not reported. This case was lost to follow up at initial.
Age: 28.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Exposure during pregnancy, Fatigue, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Case number PHHY2016US054596, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 623707) website on 18 Apr 2016. This report refers to a 28 year old pregnant female patient. Medical history was not reported. Concomitant medication included prenatal vitamin. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 22 Feb 2016. On the same day after vaccination the patient experienced extreme physical exhaustion. The patient also developed redness, rash, and swelling at injection site on the same day. Outcome, seriousness and causality of the events were not reported. This case was lost to follow up at initial.
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2016US051793, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 623737) website on 18 Apr 2016. This report refers to a 48 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on unknown date. Post vaccination the patient experienced severe pain in arm. The outcome, seriousness and causality of the event was not reported. Further the patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 07 Sep 2015. On 08 Sep 2015 the patient experienced severe pain in arm and could not raise her arm (see case: PHHY2016US051834).
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2016US051793, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 623737) website on 18 Apr 2016. This report refers to a 48 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on unknown date. Post vaccination the patient experienced severe pain in arm. The outcome, seriousness and causality of the event was not reported. Further the patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 07 Sep 2015. On 08 Sep 2015 the patient experienced severe pain in arm and could not raise her arm (see case: PHHY2016US051834).
Age: 48.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2016US051834, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 623737) website on 18 Apr 2016. This report refers to a 48 years old female patient. Medical history was not reported. Her vaccination included administration of seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date and experienced severe pain in arm (see case: PHHY2016US051793). Concurrent conditions and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 07 Sep 2015. On 08 Sep 2015 the patient experienced severe pain in arm. Further the patient could not raise her arm for over a month after the vaccine was given. Final outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 48.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2016US051834, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 623737) website on 18 Apr 2016. This report refers to a 48 years old female patient. Medical history was not reported. Her vaccination included administration of seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date and experienced severe pain in arm (see case: PHHY2016US051793). Concurrent conditions and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 07 Sep 2015. On 08 Sep 2015 the patient experienced severe pain in arm. Further the patient could not raise her arm for over a month after the vaccine was given. Final outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Discomfort, Middle insomnia, Nuclear magnetic resonance imaging abnormal, Pain, Pain in extremity
Clinical narrative: Case number PHHY2016US053056, is an initial spontaneous report received from a consumer (patient's wife) from the Vaccine Adverse Event Reporting System (VAERS reference number: 623900) on 18 Apr 2016. This report refers to a male patient of unspecified age. Vaccination history included influenza vaccine tolerated in the past. Concomitant medication was not reported. He was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) into the left arm on 03 Oct 2015. When a pharmacist gave him a shot, blood dripped down his arm and the pharmacist was slow to do anything about it. They had the cotton ball ready to do and the band aid, but the pharmacist was klutzy. The event outcome, seriousness and causality were not reported.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Rotator cuff syndrome, Ultrasound Doppler normal, X-ray limb
Clinical narrative: Case number PHHY2016US053056, is an initial spontaneous report received from a consumer (patient's wife) from the Vaccine Adverse Event Reporting System (VAERS reference number: 623900) on 18 Apr 2016. This report refers to a male patient of unspecified age. Vaccination history included influenza vaccine tolerated in the past. Concomitant medication was not reported. He was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) into the left arm on 03 Oct 2015. When a pharmacist gave him a shot, blood dripped down his arm and the pharmacist was slow to do anything about it. They had the cotton ball ready to do and the band aid, but the pharmacist was klutzy. The event outcome, seriousness and causality were not reported.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site haemorrhage
Clinical narrative: Case number PHHY2016US053056, is an initial spontaneous report received from a consumer (patient's wife) from the Vaccine Adverse Event Reporting System (VAERS reference number: 623900) on 18 Apr 2016. This report refers to a male patient of unspecified age. Vaccination history included influenza vaccine tolerated in the past. Concomitant medication was not reported. He was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) into the left arm on 03 Oct 2015. When a pharmacist gave him a shot, blood dripped down his arm and the pharmacist was slow to do anything about it. They had the cotton ball ready to do and the band aid, but the pharmacist was klutzy. The event outcome, seriousness and causality were not reported.
Age: 62.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Case number PHHY2016US056004 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 624000) on 18 Apr 2016. This report refers to a 62 year old female patient. Medical history was not reported. Concomitant medication included PREMPRO. Her lab data included PT (physiotherapy) records. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into right arm on 10 Oct 2014. On 11 Oct 2014, the patient experienced pain at injection site, somewhat limited range of motion and pain up into shoulder. It was reported that she underwent PT (physiotherapy), but still some pain was there during some motions and positions. The outcome of the events was reported as condition unchanged. Events were reported as non-serious. Causality of the events was not reported.
Age: 16.0
Sex: M
Vaccine: FLUX, HPVX, MENB, FLUX, HPVX, MENB
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Case number PHHY2016US056508, is an initial spontaneous report received from a physician via sales representative and Vaccine Adverse Reporting System (reference number: 624108) website on 18 Apr 2016. This report refers to a 16 years old male patient. Medical history was not reported. Concurrent conditions were unknown. The patient had no concomitant medications. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) at 1 DF single in the left arm on 20 Nov 2015. On the same day the patient was also vaccinated with TRUMENBA (other manufacturer) at 0.5 ml single in the right arm and HPV (other manufacturer) at 1 DF single in the right arm. On 21 Nov 2015 the patient experienced fever with body temperature of 101 degrees Fahrenheit, muscle pain and body ache with outcome of unknown. Seriousness and causality of the events was not reported.
Age: 17.0
Sex: F
Vaccine: FLUX, MENB, FLUX, MENB
Symptoms: Back pain, Headache, Myalgia
Clinical narrative: Case number PHHY2016US053870 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 624111) on 18 Apr 2016. This report refers to a 17 year old female patient. Medical history and concomitant medication was not reported. It was reported that the patient did not have any other medical condition and did not underwent any kind of lab work. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and TRUMENBA (other manufacturer, batch number: not reported), both at a dose of 0.5 ml on 02 Dec 2015. On the same day, the patient experienced severe muscle ache of the arms and leg, headache and lower back pain. The patient was given MOTRIN as a treatment. The outcome of the events was reported as unknown. Events were reported as non-serious. Causality of the events was not reported.