chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: FLUC3
Symptoms: Arthralgia, Back pain, Fatigue, Hyperhidrosis, Mobility decreased
Clinical narrative: Case number PHHY2015US168641, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 601775) on 14 Dec 2015. This report refers to a 53-year-old female patient. Historical condition was not reported. Current conditions included magnesium (manufacturer unknown), calcium (manufacturer unknown) and Vitamin D. The patient received FLUCELVAX (batch number not reported) in left arm on 19 Sep 2015. On 20 Sep 2015 the patient experienced lower back pain while sleeping, neck pain started on 21 Sep 2015, joint pain 23 Sep 2015. The neck pain and stiffness has been so severe the patient was unable to turn her neck 03 Oct 2015. The outcome of the events fatigue, joint pain, neck pain and severe stiffness, sweating (no fever) was condition unchanged and for back pain was unknown. Seriousness of the events was reported as non serious and causality was not reported.
Age: 53.0
Sex: F
Vaccine: FLUC3
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Case number PHHY2015US168641, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 601775) on 14 Dec 2015. This report refers to a 53-year-old female patient. Historical condition was not reported. Current conditions included magnesium (manufacturer unknown), calcium (manufacturer unknown) and Vitamin D. The patient received FLUCELVAX (batch number not reported) in left arm on 19 Sep 2015. On 20 Sep 2015 the patient experienced lower back pain while sleeping, neck pain started on 21 Sep 2015, joint pain 23 Sep 2015. The neck pain and stiffness has been so severe the patient was unable to turn her neck 03 Oct 2015. The outcome of the events fatigue, joint pain, neck pain and severe stiffness, sweating (no fever) was condition unchanged and for back pain was unknown. Seriousness of the events was reported as non serious and causality was not reported.
Age: 60.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Case number PHHY2015US162497 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 601851) on 24 Nov 2015. This report refers to a 60 year old female patient. Her current condition included mild asthma and allergy to penicillin. The patient's concomitant medications were PRISTIQ 50 mg daily, zolpidem extended release (ER) 12.5 mg daily PRN, CALTRATE PLUS 1800 mg daily, B complex twice daily and multivitamin BID. The patient was vaccinated with seasonal influenza virus vaccine (manufacturer and batch number: not reported) intramuscularly and ZOSTAVAX (other manufacturer, batch number: not reported) subcutaneously; both vaccines administered in the left arm on 09 Oct 2015. On 09 Oct 2015, the patient developed a 3 inch diameter swollen, red, warm area with orange peel appearance at the injection site. She had mild pain and itching to the site. Two days later, the symptoms have not changed much. The events outcome was unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 60.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site warmth
Clinical narrative: Case number PHHY2015US162497 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 601851) on 24 Nov 2015. This report refers to a 60 year old female patient. Her current condition included mild asthma and allergy to penicillin. The patient's concomitant medications were PRISTIQ 50 mg daily, zolpidem extended release (ER) 12.5 mg daily PRN, CALTRATE PLUS 1800 mg daily, B complex twice daily and multivitamin BID. The patient was vaccinated with seasonal influenza virus vaccine (manufacturer and batch number: not reported) intramuscularly and ZOSTAVAX (other manufacturer, batch number: not reported) subcutaneously; both vaccines administered in the left arm on 09 Oct 2015. On 09 Oct 2015, the patient developed a 3 inch diameter swollen, red, warm area with orange peel appearance at the injection site. She had mild pain and itching to the site. Two days later, the symptoms have not changed much. The events outcome was unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 56.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Hyperaesthesia, Hypersensitivity, Influenza A virus test, Injected limb mobility decreased, Injection site pain
Clinical narrative: Case number PHHY2015US160736, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 601908) website on 24 Nov 2015. This report refers to a 56-year-old female patient. Historical condition was not reported. Past medical history included brain aneurysm (on blood thinners: low doze aspirin and PLAVIX). Concomitant medications included PLAVIX 75 mg, Aspirin 81 mg, MYBETRIQ 25 mg and prednisone 20 mg. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into the left arm along with pneumococcal vaccine (manufacturer and batch number: not reported) into the left arm on 08 Oct 2015. On the same day after vaccination the patient's left arm/shoulder was extremely sore and it was getting hard to rise. At 05:00 PM, the patient's left arm/shoulder was extremely sensitive, hot to touch and was immobile. The patient's whole body was feverish. The patient took ALEVE for pain and hot baths/cold compresses all the night. On the next day in the morning the patient went to a doctor and was told allergic reaction possibly due to the pneumonia shot and strep throat. The patient was tested for flu and Streptococcus (results not reported). Final outcome of the events was recovered. Events were reported as non-serious. Causality was not reported.
Age: 56.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site warmth, Pain in extremity, Pharyngitis streptococcal, Pyrexia, Streptococcus test
Clinical narrative: Case number PHHY2015US160736, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 601908) website on 24 Nov 2015. This report refers to a 56-year-old female patient. Historical condition was not reported. Past medical history included brain aneurysm (on blood thinners: low doze aspirin and PLAVIX). Concomitant medications included PLAVIX 75 mg, Aspirin 81 mg, MYBETRIQ 25 mg and prednisone 20 mg. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into the left arm along with pneumococcal vaccine (manufacturer and batch number: not reported) into the left arm on 08 Oct 2015. On the same day after vaccination the patient's left arm/shoulder was extremely sore and it was getting hard to rise. At 05:00 PM, the patient's left arm/shoulder was extremely sensitive, hot to touch and was immobile. The patient's whole body was feverish. The patient took ALEVE for pain and hot baths/cold compresses all the night. On the next day in the morning the patient went to a doctor and was told allergic reaction possibly due to the pneumonia shot and strep throat. The patient was tested for flu and Streptococcus (results not reported). Final outcome of the events was recovered. Events were reported as non-serious. Causality was not reported.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Impaired work ability, Injected limb mobility decreased, Injection site bruising, Injection site haemorrhage
Clinical narrative: Case number PHHY2015US162013, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 601916) website on 24 Nov 2015. This report refers to a 36 years old female patient. Past medical history included as asthma, hypertension (HTN), seasonal and environmental allergies, abdominal discomfort and bloating. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into left arm on 29 Sep 2015. On the same day after vaccination, the patient experienced pain, felt like nurse buried the needle, felt like fire when vaccine was injected. It was stated that, pain was steadily worsened throughout the evening and night despite, taking naproxen and ibuprofen. In the morning, trying to get ready for work, she literally could not move arm without crying, could not get dressed or lift her arm above head. It was stated that, she was forced to call off work that day because of the excruciating pain. The patient was contacted to the physician office, explained the situation, she was advised to ice the area and come back to the office if it did not get any better. It was stated that, there was much more dried blood on the bandage when she removed it, than with other previous vaccine (normally just a speck if any at all). This bandage was almost totally saturated- the site bled quite a bit. The patient arm feels better, but still tender and weak. The patient stated that, she sought advice from a medical professional at her job who think she may have hit my nerve, and/or vaccine, itself actually attacked my muscle tissue. The injection site is still bruised. The patient can honestly say this was the worst pain she have ever experienced in her life next to childbirth. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non-serious. The causality of the events was not reported. Following an internal review done for the data received on 24 Nov 2015, the following significant correction was done: Event coding, vaccination site bleeding instead of vaccination site haemorrhage and could not move arm should be coded as injected limb mobility decreased instead of movement disorder.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Muscular weakness, Pain, Vaccination site bruising, Vaccination site pain
Clinical narrative: Case number PHHY2015US162013, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 601916) website on 24 Nov 2015. This report refers to a 36 years old female patient. Past medical history included as asthma, hypertension (HTN), seasonal and environmental allergies, abdominal discomfort and bloating. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into left arm on 29 Sep 2015. On the same day after vaccination, the patient experienced pain, felt like nurse buried the needle, felt like fire when vaccine was injected. It was stated that, pain was steadily worsened throughout the evening and night despite, taking naproxen and ibuprofen. In the morning, trying to get ready for work, she literally could not move arm without crying, could not get dressed or lift her arm above head. It was stated that, she was forced to call off work that day because of the excruciating pain. The patient was contacted to the physician office, explained the situation, she was advised to ice the area and come back to the office if it did not get any better. It was stated that, there was much more dried blood on the bandage when she removed it, than with other previous vaccine (normally just a speck if any at all). This bandage was almost totally saturated- the site bled quite a bit. The patient arm feels better, but still tender and weak. The patient stated that, she sought advice from a medical professional at her job who think she may have hit my nerve, and/or vaccine, itself actually attacked my muscle tissue. The injection site is still bruised. The patient can honestly say this was the worst pain she have ever experienced in her life next to childbirth. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non-serious. The causality of the events was not reported. Following an internal review done for the data received on 24 Nov 2015, the following significant correction was done: Event coding, vaccination site bleeding instead of vaccination site haemorrhage and could not move arm should be coded as injected limb mobility decreased instead of movement disorder.
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Erythema, Pain, Pain in extremity, Pyrexia
Clinical narrative: Case number PHHY2015US162185 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 601946) website on 24 Nov 2015. This report refers to a 50 year old female patient. Past medications included Penicillin, Sulfa drugs, CECLOR, BIAXIN and Prednisone. Her concurrent condition included asthma. Concomitant medications were XYZAL, PULMICORT and Albuterol. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into left arm on 08 Oct 2015. On 09 Oct 2015, the patient experienced dizziness, light-headedness, body aches, fever, vomiting, and sore/red arm. The outcome of the events was reported as condition unchanged. The events were reported to be non-serious and causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Case number PHHY2015US162185 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 601946) website on 24 Nov 2015. This report refers to a 50 year old female patient. Past medications included Penicillin, Sulfa drugs, CECLOR, BIAXIN and Prednisone. Her concurrent condition included asthma. Concomitant medications were XYZAL, PULMICORT and Albuterol. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into left arm on 08 Oct 2015. On 09 Oct 2015, the patient experienced dizziness, light-headedness, body aches, fever, vomiting, and sore/red arm. The outcome of the events was reported as condition unchanged. The events were reported to be non-serious and causality was not reported.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: Case number PHHY2015US162115, is an initial spontaneous report received from consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 601956) website on 24 Nov 2015. This report refers to a 46-year-old female patient. Historical condition included hypothyroidism. Patient had no current illness. Concomitant medications included levothyroxine (manufacturer unknown), CLARITIN and fluoxetine (manufacturer unknown). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) into left arm on 08 Oct 2015. On 09 Oct 2015 after vaccination, the patient experienced pain in left shoulder and neck, as the day went on patient noticed a knot that was red where she was vaccinated (in left arm), pain shoots through shoulder and neck when the patient made certain movements and even sometimes when she took a deep breath, over the course of the weekend, the knot became more noticeable, red and warm to touch, had numbness and tingling in fingers on left hand. The site of vaccination was itchy with a burning sensation. On Monday (date unspecified) the pain does not seem to be getting better even though the vaccination site does not seem to be as irritated. The final outcome of the events was reported as non serious. Seriousness and causality of the events were not reported.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site warmth, Neck pain, Paraesthesia, Vaccination site pain
Clinical narrative: Case number PHHY2015US162115, is an initial spontaneous report received from consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 601956) website on 24 Nov 2015. This report refers to a 46-year-old female patient. Historical condition included hypothyroidism. Patient had no current illness. Concomitant medications included levothyroxine (manufacturer unknown), CLARITIN and fluoxetine (manufacturer unknown). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) into left arm on 08 Oct 2015. On 09 Oct 2015 after vaccination, the patient experienced pain in left shoulder and neck, as the day went on patient noticed a knot that was red where she was vaccinated (in left arm), pain shoots through shoulder and neck when the patient made certain movements and even sometimes when she took a deep breath, over the course of the weekend, the knot became more noticeable, red and warm to touch, had numbness and tingling in fingers on left hand. The site of vaccination was itchy with a burning sensation. On Monday (date unspecified) the pain does not seem to be getting better even though the vaccination site does not seem to be as irritated. The final outcome of the events was reported as non serious. Seriousness and causality of the events were not reported.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Case number PHHY2015US162192 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 601961) website on 24 Nov 2015. This report refers to a 66 year old female patient. Medical history was not reported. Her concurrent condition included allergies to CIPRO, CELEBREX, FELDINE and AUGMENTIN.  Concomitant medications included SYNTHROID, LIPITOR, and NEURONTIN (gabapentin). The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into left arm on 07 Oct 2015. On the same day, the patient developed pain in left arm, pain in shoulder and side of neck. Next day she also experienced headache. The patient's treatment included ice and ADVIL. It was reported that her headache was gone but she still had pain. Final outcome of the events was reported as unknown. The events were reported to be non-serious and causality was not reported.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Case number PHHY2015US162780 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 601979) website on 24 Nov 2015. This report refers to a 25 year 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) intramuscularly into left arm on 30 Sep 2015. One hour following vaccination, patient developed ache in left arm that progressed into a sharp pain throughout her muscle. It was reported that she had extreme difficulty in moving her arm side to side or up and down and had decreased strength in that arm as well. Following the events the patient visited emergency room. The outcome of the events was reported as unknown. The events were reported to be non-serious and causality was not reported.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Nausea, Pain, Respiratory tract congestion, Retching
Clinical narrative: Case number PHHY2015US158252, is an initial spontaneous report from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 601992) website on 24 Nov 2015. This report refers to a 29-year-old female patient. Medical history was none. The patient had no current illness. Concomitant medication included ALEVE. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into the left arm intramuscularly on 08 Oct 2015. On the same day after vaccination approximately at 11:45, the patient was congested and nauseated. The patient vomited four times and spent the rest of the night dry heaving. The nausea subsided with PHENERGAN around 08:00 to 09:00 on 09 Oct 2015. On 12 Oct 2015, early morning, the patient experienced cough, congestion and body aches. Final outcome of the events was unknown. Events were reported as non-serious. Causality was not reported.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Case number PHHY2015US158252, is an initial spontaneous report from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 601992) website on 24 Nov 2015. This report refers to a 29-year-old female patient. Medical history was none. The patient had no current illness. Concomitant medication included ALEVE. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into the left arm intramuscularly on 08 Oct 2015. On the same day after vaccination approximately at 11:45, the patient was congested and nauseated. The patient vomited four times and spent the rest of the night dry heaving. The nausea subsided with PHENERGAN around 08:00 to 09:00 on 09 Oct 2015. On 12 Oct 2015, early morning, the patient experienced cough, congestion and body aches. Final outcome of the events was unknown. Events were reported as non-serious. Causality was not reported.
Age: 57.0
Sex: F
Vaccine: FLUC3
Symptoms: Malaise, Mouth ulceration, Pain, Pain in extremity, Pyrexia
Clinical narrative: Case number PHHY2015US164791, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 602030) website on 14 Dec 2015. This report refers to a 57-year-old female patient. Historical condition was not reported. Current conditions included allergies to penicillin, codeine and latex. The patient had no current illness. Concomitant medications included cetirizine (manufacturer unknown), Multi Vitamin. The patient was vaccinated with FLUCELVAX (batch number: 173991) intramuscularly in to left arm on 21 Sep 2015. On the same day after vaccination, the patient experienced fever with body temperature 101, body aches, malaise. On 22 Sep 2015, the patient experienced pain at vaccination site, large ulcer on roof of mouth and arm was sore for 12 days. The patient's fever was persisted for 48 hours, body aches and malaise for several days. Ulcer was healing slowly but was not completely resolved after 20 days. The final outcome of the event large ulcer on roof of mouth was reported as condition improving, outcome of the event pain at vaccination site was not reported and outcome of other events was reported as complete recovery. Seriousness of the events was reported as non serious and causality not reported.
Age: 57.0
Sex: F
Vaccine: FLUC3
Symptoms: Vaccination site pain
Clinical narrative: Case number PHHY2015US164791, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 602030) website on 14 Dec 2015. This report refers to a 57-year-old female patient. Historical condition was not reported. Current conditions included allergies to penicillin, codeine and latex. The patient had no current illness. Concomitant medications included cetirizine (manufacturer unknown), Multi Vitamin. The patient was vaccinated with FLUCELVAX (batch number: 173991) intramuscularly in to left arm on 21 Sep 2015. On the same day after vaccination, the patient experienced fever with body temperature 101, body aches, malaise. On 22 Sep 2015, the patient experienced pain at vaccination site, large ulcer on roof of mouth and arm was sore for 12 days. The patient's fever was persisted for 48 hours, body aches and malaise for several days. Ulcer was healing slowly but was not completely resolved after 20 days. The final outcome of the event large ulcer on roof of mouth was reported as condition improving, outcome of the event pain at vaccination site was not reported and outcome of other events was reported as complete recovery. Seriousness of the events was reported as non serious and causality not reported.
Age: 52.0
Sex: F
Vaccine: FLUC3
Symptoms: Oral mucosal eruption, Oral pruritus, Pruritus, Rash, Throat irritation
Clinical narrative: Case number PHHY2015US169071, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602099) website on 14 Dec 2015. This report refers to a 52 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173537) into left arm on 05 Oct 2015. On the same day after vaccination the patient experienced itching and rash on both arms/legs and back mouth. Further the patient experienced throat itching. Outcome of the events was unknown. The cause was assessed as non-serious. Causality of the events was not reported.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Local swelling, Pain
Clinical narrative: Case number PHHY2015US162082 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 602175) on 24 Nov 2015. This report refers to a 41 year old female patient. Her current condition included systemic lupus erythematosus (SLE). The patient's concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine (manufacturer and batch number: not reported) subcutaneously in the right arm on 13 Oct 2015. She stated that the vaccine was administered subcutaneously in the back of her arm which was large and it was not put in deltoid. The nursing professional was asked about the route and he said that it was supposed to be intramuscular, but he continued to give the vaccine subcutaneously and rubbed the site vigorously after injecting it. On the same day the patient had localized swelling and pain. The outcome of the events was unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Eye pain, Ocular hyperaemia
Clinical narrative: Case number PHHY2015US162650, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 602176) website on 24 Nov 2015. This report refers to a 33-year-old female patient. The patient had no medical history and current illness. Concomitant medication included LO LOESTRIN FE. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into the right arm intramuscularly on 09 Oct 2015. On 11 Oct 2015, the patient experienced bloodshot veiny eyes and sore eyes. Final outcome of the events was not reported. Events were reported as non-serious. Causality was not reported.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Insomnia, Pain in extremity, Vaccination site pain
Clinical narrative: Case number PHHY2015US162651, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 602230) website on 24 Nov 2015. This report refers to a 42-year-old female patient. Historical condition included congenital nerve deafness. Concomitant medications included TREXIMET and EFFEXOR for migraine. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 07 Oct 2015. On the same day after vaccination, the patient's site of vaccination was hurting/pain where the patient got the shot and the pain was radiating down the arm. The patient felt this way for several days. Further, the patient noticed redness in the shot area. After a while, the symptoms went away. A week later, the patient's site of vaccination was hurting so much and the patient had trouble sleeping. The patient planned to call the doctor today. Final outcome of the events was unknown. Events were reported as non-serious. Causality was not reported.
Age: 54.0
Sex: U
Vaccine: FLUC3
Symptoms: Fatigue, Lethargy, Pruritus
Clinical narrative: Case number PHHY2015US167149, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602285) website on 14 Dec 2015. This report refers to a 54 years old patient of an unknown gender. Medical history and concurrent illness were none. Concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 174273) intramuscularly into right arm on an unknown date. On the same day after vaccination the patient developed itching and continued to feel tired and lethargic. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Influenza, Nasal congestion, Nasopharyngitis
Clinical narrative: Case number PHHY2015US162508, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 602291) website on 24 Nov 2015. This report refers to a 60 years old female patient. Past medical history was not reported. Concurrent medical conditions included as systemic lupus erythematosus. Concomitant medications included as fish oil (manufacturer unknown), PLAQUENIL, Vitamin B12, Vitamin D and LIVING GREEN Multivitamin. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into left arm on 04 Oct 2015. On the same day after vaccination, the patient experienced cold and flu symptoms. On 06 Oct 2015, the patient suffered nasal congestion and feelings of weakness. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non-serious and causality was reported as suspected. Following an internal review done for the data received on 24 Nov 2015, the following Non-significant correction was done: Event Asthenia, labeling (CDS) was changed from unlisted to listed.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injection site abscess, Pain in extremity, Skin tightness
Clinical narrative: Case number PHHY2015US162652 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 602357) website on 24 Nov 2015. This report refers to a 44-year-old female patient. The patient had no medical history and current illness. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer batch number: not reported) into the left arm intramuscularly on 04 Oct 2015. On the same day after vaccination, the patient's left shoulder down to fingers continued to feel sore. The patient's arm feels like she slept on it and the arm persists tightness and have a little numbing at times. Final outcome of the events was not reported. Events were reported as non-serious. Causality was not reported.
Age: 61.0
Sex: F
Vaccine: FLUC3
Symptoms: Musculoskeletal stiffness
Clinical narrative: Case number PHHY2015US167127, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602403) website on 14 Dec 2015. This report refers to a 61 years old female patient. Concurrent condition included hypertension. Concomitant medications included LEXAPRO and metoprolol. The patient was vaccinated with FLUCELVAX (batch number: 174273) intramuscularly into right arm on 05 Oct 2015. On the same day after vaccination the patient developed stiff neck in the evening. Outcome of the event was recovered. The case was assessed as non-serious. Causality of the event was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Burning sensation, Chills, Cold sweat
Clinical narrative: Case number PHHY2015US162025, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 602412) website on 24 Nov 2015. This report refers to a 33 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into left arm on 13 Oct 2015. On the same day after vaccination the patient experienced chills, cold sweat and whole body shivers. Further the patient felt like burning up but no fever was recorded. The case was assessed as non-serious. Outcome and causality of the events was not reported.
Age: 39.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Dehydration, Mobility decreased, Pain, Pyrexia, White blood cell count increased
Clinical narrative: Case number PHHY2015US171346, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 602575) website on 29 Dec 2015. This report refers to a 39-year-old male patient. Historical conditions included seasonal allergies and asthma. The patient had no current illness. Concomitant medication was none. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into the left arm on 13 Oct 2015. On 14 Oct 2015, the patient had experienced fever with a temperature spike to 103.8 and generalized body aches. The patient received ADVIL. The patient was unable to even get out of bed and fever continued despite receiving ADVIL. The patient became dehydrated. The patient's complete blood count showed WBC were 14,000. The patient requested intravenous fluid and antibiotics and steroids were started by MD. Final outcome of the events was not reported. Events were reported as non-serious. Causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Case number PHHY2015US173036 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 602800) on 29 Dec 2015. This report refers to a 62 year old female patient. She had no medical history or current conditions. Her concomitant medications were NORVASC, Simvastatin and ASA. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) subcutaneously in the left arm on 06 Oct 2015. On 06 Oct 2015, her left arm was painful in the area of shot. Nine days after the shot, she could not put any pressure on it or sleep on it. She stated that the arm was very sore and there was weakness in the arm to lift. The events outcome was reported as unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Nausea, Tremor
Clinical narrative: Case number PHHY2015US172464, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 602905) on 29 Dec 2015. This report refers to 71 years old female patient. Past medical history was not reported. Past medications included penicillin (manufacturer unknown) and aspirin (manufacturer unknown). Concomitant medications included  Methylphenidate ER 20 mg in the morning, Methylphenidate (manufacturer unknown) 10 mg in the evening, atenolol (manufacturer unknown) 100 mg in the morning, amlodipine Besylate (manufacturer unknown) 2.5 mg in the evening, prednisolone acetate (manufacturer unknown) 15 ml in the morning and evening and timolol maleate (manufacturer unknown) ophthalmic formulation. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number and expiry: not reported) on 15 Oct 2015. On the same day after vaccination, she experienced mild nauseas, severe shakes and chills and weakness. The outcome of the events was reported as complete recovery on an unknown date. These events were assessed as non serious. Causality of the events was not reported.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Abnormal behaviour, Aggression, Screaming
Clinical narrative: Case number PHHY2015US173034, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602952) website on 29 Dec 2015. This report refers to a 3 years old female patient. Medical history was none. The patient had no current illnesses. Concomitant medications included PRILOSEC and Vitamin D. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 15 Oct 2015. On 16 Oct 2015 the patient presented with behavior changes described as rage, screaming, kicking walls and hitting. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Cough, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Case number PHHY2015US172219, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602951) website on 29 Dec 2015. This report refers to a 69 years 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) on 07 Oct 2015. On the same day, he experienced fever, chills, muscle ache, sore throat, chest congestion, cough and temperature few days later reached 100.0 Fahrenheit. He was treated with cough medicines (unspecified) and decongestant pills (unspecified). It was reported that, symptoms continued over a week and were ongoing. The final outcome of the events was unknown. he seriousness of the events was reported as non serious and causality was not reported.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Respiratory tract congestion
Clinical narrative: Case number PHHY2015US172219, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602951) website on 29 Dec 2015. This report refers to a 69 years 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) on 07 Oct 2015. On the same day, he experienced fever, chills, muscle ache, sore throat, chest congestion, cough and temperature few days later reached 100.0 Fahrenheit. He was treated with cough medicines (unspecified) and decongestant pills (unspecified). It was reported that, symptoms continued over a week and were ongoing. The final outcome of the events was unknown. he seriousness of the events was reported as non serious and causality was not reported.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Case number PHHY2015US173060. is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 603004) website on 29 Dec 2015. This report refers to a 54-year-old female patient. Medical history and current illness was none. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 24 Sep 2015. On 25 Sep 2015, the patient experienced pain in shoulder area that just got progressively worse to the extent that the patient could not lift the arm. The patient did not see a healthcare provider and was trying ice, ibuprofen and stretching. Further, the patient had range of motion but still had pain while lifting pain. Final outcome of the events was not recovered. Events were reported as non-serious. Causality was not reported.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2015US173059, is an initial spontaneous report received the Vaccine Adverse Event Reporting System (VAERS reference number: 603110) on 29 Dec 2015. This report refers to a 34 year old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and bath number: not reported) intramuscularly on 16 Oct 2015. On the same day 17 Oct 2015, the patient developed bruising, swelling, redness of injection site. The outcome of the events was not reported. Events were reported as non-serious and causality was not reported.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Confusional state, Crying, Mental disorder, Nervousness
Clinical narrative: Case number PHHY2015US172756, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 603116) website on 29 Dec 2015. This report refers to a 57 years old polymedicated female patient. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into left arm on 03 Oct 2015. On 12 Oct 2015 the patient presented with extreme confusion, mental breakdown, nervousness and crying that lasted for 3 days. Final outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 3.0
Sex: F
Vaccine: DTAP, FLUX, MMR
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site extravasation, Injection site pruritus, Vaccination site pain
Clinical narrative: Case number PHHY2015US173544, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 603117) on 29 Dec 2015. This report refers to a 3 years old female patient. Past medical history and concomitant medications were not reported. This 3 years old female patient was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number and expiry: not reported), Dtap (unknown manufacturer; batch number and expiry: not reported) and Measles-Mumps-Rubella Virus Vaccine (unknown manufacturer, batch number and expiry: not reported); subcutaneously on 15 Oct 2015,. It was reported that the immunization was possibly given in the subcutaneous tissues, closer to inner thigh. On 16 Oct 2015, she experienced large red, painful, itchy and raised area which was approximately 3 inches in diameter and large part leaked out of site when vaccine was administered. The outcome of the events large red, painful, itchy and raised area which was approximately 3 inches in diameter was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious and causality was not reported.
Age: 3.0
Sex: F
Vaccine: DTAP, FLUX, MMR
Symptoms: Vaccination site swelling
Clinical narrative: Case number PHHY2015US173544, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 603117) on 29 Dec 2015. This report refers to a 3 years old female patient. Past medical history and concomitant medications were not reported. This 3 years old female patient was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number and expiry: not reported), Dtap (unknown manufacturer; batch number and expiry: not reported) and Measles-Mumps-Rubella Virus Vaccine (unknown manufacturer, batch number and expiry: not reported); subcutaneously on 15 Oct 2015,. It was reported that the immunization was possibly given in the subcutaneous tissues, closer to inner thigh. On 16 Oct 2015, she experienced large red, painful, itchy and raised area which was approximately 3 inches in diameter and large part leaked out of site when vaccine was administered. The outcome of the events large red, painful, itchy and raised area which was approximately 3 inches in diameter was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious and causality was not reported.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Headache, Hyperhidrosis, Pallor, Tremor
Clinical narrative: Case number PHHY2015US171278, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 603131) website on 29 Dec 2015. This report refers to a 39 years old female patient. Past medical history included gluten sensitivity and current conditions included as seasonal allergies. The patient's vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date and experienced fainting. Concomitant medication included as FLONASE, CLARITIN and hydrochlorothiazide (manufacturer unknown). The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into left arm on 08 Oct 2015. On the same day after vaccination, the patient experienced headache, sweating, shaking, paleness and fatigue. The patient was taken to the emergency room. 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.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Palpitations, Pruritus, Rash, Swelling face, Urticaria
Clinical narrative: Case number PHHY2015US172757, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 603143) website on 29 Dec 2015. This report refers to a 37 years old female patient. Concurrent conditions included allergy to erythromycin, contrast dyes and sulfa drugs. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 16 Oct 2015. On the same day after vaccination the patient experienced hives, swollen face, rash, itching and racing heart. The patient went to emergency room due to these events. The patient was treated with BENADRYL and steroids. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "hives, swollen face, rash, itching, racing heart" was upgraded based on information in the source document.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Disorientation, Dizziness, Erythema, Influenza like illness
Clinical narrative: Case number PHHY2015US173571 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 603169) on 29 Dec 2015. This report refers to a 68 year old female patient. She had no medical history or current conditions. Her concomitant medications included escitalopram 15 mg. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on 05 Oct 2015. On the same day after vaccination, she experienced chills, nausea, flu like symptoms, disorientation and dizziness that lasted for 5 to 6 days. Her arm was red for 6 days and she still had a knot at injection site. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Nodule
Clinical narrative: Case number PHHY2015US173571 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 603169) on 29 Dec 2015. This report refers to a 68 year old female patient. She had no medical history or current conditions. Her concomitant medications included escitalopram 15 mg. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on 05 Oct 2015. On the same day after vaccination, she experienced chills, nausea, flu like symptoms, disorientation and dizziness that lasted for 5 to 6 days. Her arm was red for 6 days and she still had a knot at injection site. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.