chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Decreased appetite, Diarrhoea, Impaired work ability
Clinical narrative: Case number PHHY2014US093837, is an initial spontaneous report from Vaccine Adverse Event Reporting website (VAERS id: 516729) received on 24 JUL 2014. This report refers to a 44 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 130839) into left arm on 02 DEC 2013. On 03 DEC 2013, she developed sniffles, sore throat, loose stools, body aches, back pain, loss of appetite, fever and weakness. She was unable to work for 3 days and stayed in bed for 3 days. Upon research she reported that the flu shot contains gelatin a product of pork, which she do not eat port. She went to the emergency room. The final outcome of the events was recovered. Seriousness and causality assessment was not reported.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Case number PHHY2014US093837, is an initial spontaneous report from Vaccine Adverse Event Reporting website (VAERS id: 516729) received on 24 JUL 2014. This report refers to a 44 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 130839) into left arm on 02 DEC 2013. On 03 DEC 2013, she developed sniffles, sore throat, loose stools, body aches, back pain, loss of appetite, fever and weakness. She was unable to work for 3 days and stayed in bed for 3 days. Upon research she reported that the flu shot contains gelatin a product of pork, which she do not eat port. She went to the emergency room. The final outcome of the events was recovered. Seriousness and causality assessment was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Chills, Contusion, Erythema, Pain, Pruritus
Clinical narrative: Case number PHHY2014US094174 is an initial spontaneous report received from a  health care professional via the Vaccine Adverse Event Reporting System (VAERS reference number: 516754) website on 24 JUL 2014. This case refers to a 57 year old female patient. Her past medical history included heart problems and severe Meniere's disease. Her concomitant medications were not reported. On 26 SEP 2013, the patient was vaccinated with FLUVIRIN 2013/2014 (batch number: 13374P) intramuscularly into her left arm. On 26 SEP 2013, the patient had an arm reaction characterized by redness and itching of the arm. On the same day, in the night, she developed fever, chills and felt achy (15 mm). On 30 SEP 2013, her arm was bruised. The outcome of the events was complete recovery. The events were assessed as non serious by the Health Authority and the causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2014US094174 is an initial spontaneous report received from a  health care professional via the Vaccine Adverse Event Reporting System (VAERS reference number: 516754) website on 24 JUL 2014. This case refers to a 57 year old female patient. Her past medical history included heart problems and severe Meniere's disease. Her concomitant medications were not reported. On 26 SEP 2013, the patient was vaccinated with FLUVIRIN 2013/2014 (batch number: 13374P) intramuscularly into her left arm. On 26 SEP 2013, the patient had an arm reaction characterized by redness and itching of the arm. On the same day, in the night, she developed fever, chills and felt achy (15 mm). On 30 SEP 2013, her arm was bruised. The outcome of the events was complete recovery. The events were assessed as non serious by the Health Authority and the causality of the events was not reported.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchitis, Gastrointestinal disorder, Pain
Clinical narrative: Case number PHHY2014US091681 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 516755) website on 24 JUL 2014. This report refers to a 60-year-old female patient. Her medical history included unspecified immune system problem and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 13374P) intramuscularly in the left arm on 26 SEP 2013. On 27 SEP 2013, she experienced unspecified gastrointestinal symptoms, aching and bronchitis-like event for 3 weeks. The final outcome of the event was reported as complete recovery. The events were reported as non-serious. The causality of the event was not reported.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Joint swelling, Muscle swelling, Pyrexia, Skin warm, Tenderness
Clinical narrative: Case number PHHY2014US084386 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS reference number: 516777) website on 24 JUL 2014. This case refers to a 28 year old female patient. Her past medical history and concomitant medications were not reported. On 13 DEC 2013, the patient was vaccinated with FLUVIRIN 2013/2014 (batch number: 66521011602) intramuscularly into her arm. On 14 DEC 2013, the patient had swollen elbow and lower biceps. She was very painful to even light tough and was hot. She had high fever all day since. The outcome of the events was reported as condition unchanged. The event was assessed as non serious by the Health Authority and the causality of the event was not reported.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle tightness, Pharyngeal oedema, Tongue pruritus
Clinical narrative: Case number PHHY2014US092114 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 516809) website on 24 JUL 2014. This report refers to a 31-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2013/2014 (batch number: 13411P) intramuscularly in the left arm on 14 DEC 2013. On 14 DEC 2013, he experienced neck tightening, throat swelling, and itchy tongue which was rated as 7/10 for severity. He was treated with Benadryl liquid 10 ml which gave him immediate relief. He was given second and third dose of Benadryl 10 ml after 4 and 6 hours. The final outcome of the event was reported as complete recovery. The events as non-serious. The causality of the event was not reported.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Erythema, Flushing, Lip swelling, Pruritus
Clinical narrative: Case number PHHY2014US092014, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 516810) web site on 24 Jul 2014. This report refers to an 18-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 13411P) intramuscularly on 14 Dec 2013. On the same day after vaccination, her face was red and flushed throughout the entire day. The next day when she woke up (approximately 20 hours after vaccine) her upper lip was severely swollen 7/10 for severity. Also she experienced itching and discomfort. She was treated with BENADRYL liquid 10ml and ice. There was reduced swelling over four hours time. Second dose was given four hours later for maintenance at 10ml. No further dose was required. The outcome of the events was complete recovery. The events were reported as non-serious; however the case was internally upgraded as medically significant. Causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site joint pain, Injection site joint swelling, Joint swelling, Oropharyngeal pain
Clinical narrative: Case number PHHY2014US093704 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 517029) web site on 24 Jul 2014. This case refers to a 54-year-old female patient. Her medical history included allergy to opiates and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1309801) in the left arm on 25 Nov 2013. On the same date, she had swelling and pain in the right knee and left elbow. She had increased osteoarthritic pain in all joints and slight sore throat continuing on 18 Dec 2013. The final outcome of the event was reported as condition unchanged. The events were reported as non-serious. The causality of the event was not reported.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood test, Muscular weakness, Pain in extremity
Clinical narrative: Case number PHHY2014US093764 is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 517097) website on 24 JUL 2014. This report refers to a 74-year-old male patient. His medical history included drug allergy to penicillin and Ciprofloxacin and a chronic lung disease, bronchiolitis obliterans with organizing pneumonia (BOOP). His concomitant medications were prednisone and fosinopril sodium. He was vaccinated with FLUVIRIN 2013/2014 (batch number: not reported and PNEUMOVAX23 (other manufacturer, batch number: J004747, expiry date: 20 JUL 2014) on 30 SEP 2013. On 01 OCT 2013, after vaccination, he experienced pain and muscle weakness in both arms and hands. He was treated with Tylenol and Aleve. On an unspecified date blood test was done and results were not reported. He called his physician and made an appointment for the next month. The final outcome of the event was reported as condition unchanged. The events were reported as non-serious. The causality of the event was not reported.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Dizziness, Vertigo
Clinical narrative: Case number PHHY2014US093800 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 517129) website on 24 JUL 2014. This report refers to a 29-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated  with FLUVIRIN f2013/2014 (batch number: 66521011602) intramuscularly in the left arm on 18 DEC 2013. On 19 DEC 2013, he had a mild vertigo which started at approximately 12:30 AM (hours prior to sleep). After sleeping and getting up, approximately at 5:30 AM, he had extreme vertigo and dizziness. He was not able to walk due to the events. He went to emergency room. It was reported that vertigo subsided to  moderate levels, but still remained at the time of reporting. The final outcome of the event was not reported. The events were reported as non-serious. The causality of the event was not reported.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2014US093993 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 517187) website on 24 JUL 2014. This report refers to a 42-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 13315P) intramuscularly on 22 SEP 2013. On the same day, she had pain in the arm and she was unable to lift her arm. She stated that she got injected to her tendon. The final outcome of the event was reported as unknown. The events were reported as non-serous. The causality of the event was not reported.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Limb discomfort, Pain in extremity
Clinical narrative: Case number PHHY2044US093807 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 517297) on 24 JUL 2014. This report refers to 60 years old female patient. Her medical history included chronic obstructive pulmonary disease (COPD) and upper respiratory infection. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1310301) intramuscularly in the left arm on 22 NOV 2013. On 22 NOV 2013 she experienced pain in arm causing discomfort upon use. It was also reported that it was very uncomfortable to use the arm. She visited emergency room. The outcome of the event was reported as condition unchanged. The events were reported as non-serious and causality of the events was not reported.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysgeusia, Nausea, Productive cough, Vertigo
Clinical narrative: Case number PHHY2014US093874 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 517358 on 24 JUL 2014. This report refers to a 56 years old female patient. Her medical history included allergy to Lyrica, diabetes and hypertension. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309701) intramuscularly in the left arm on 21 DEC 2013. It was reported that on 22 DEC 2013 after breakfast and church she had multiple episodes of nausea, vomiting, light headedness, dizziness and vertigo. She also experienced metallic taste and excessive phlegm in the throat. The outcome of the event was reported as unknown. The events were reported as non-serious and the causality of the events was not reported.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Case number PHHY2014US093874 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 517358 on 24 JUL 2014. This report refers to a 56 years old female patient. Her medical history included allergy to Lyrica, diabetes and hypertension. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309701) intramuscularly in the left arm on 21 DEC 2013. It was reported that on 22 DEC 2013 after breakfast and church she had multiple episodes of nausea, vomiting, light headedness, dizziness and vertigo. She also experienced metallic taste and excessive phlegm in the throat. The outcome of the event was reported as unknown. The events were reported as non-serious and the causality of the events was not reported.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain, Pain in extremity
Clinical narrative: Case number PHHY2014US093659 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 517584) website on 24 Jul 2014. This report refers to a 61-year-old male patient. Past medical history and concomitant medications were not provided. He received FLUVIRIN (batch number: 1309101) into left arm on 01 Nov 2013. On the same day, post vaccination, he experienced pain which was radiating down left arm from site of injection upon certain movements. He also experienced bruise at the site of injection which lasted 8-10 days and then pain didn't get better. These events were reported as non-serious. Final outcome of the events was reported as condition unchanged as of 24 Dec 2013. Causality of the events was not reported.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain, Limb discomfort, Musculoskeletal disorder, Pain
Clinical narrative: Case number PHHY2014US093661 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 517622) website on 24 Jul 2014. This report refers to a 40-year-female patient. Her concurrent condition included asthma flare up. Concomitant medications were not reported. She received FLUVIRIN (batch number: 1308001) into left arm on 07 Nov 2013. On the same day, post vaccination, she experienced pain at injection site. The pain has worsened since the vaccination where she has difficulty using her left arm. She also experienced discomfort and pain while lifting the arm. She describes the pain to be at 10 on the pain scale of 10. She has been icing the area and taking ibuprofen and acetaminophen for pain relief. She has not seeked medical attention as of yet but intends to. She reports there was slight bruising at the injection site which was no longer visible. These events were reported as non-serious. Outcome of the event of bruising at the injection site was reported as recovered and other events as condition unchanged as of 24 Dec 2013. Causality of the events was not reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Case number PHHY2014US094086, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 517712) web site on 24 July 2014. This report refers to a 62-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1206401) on 12 Nov 2013. On 13 Nov 2013, 24 hours after vaccination she experienced swelling. The outcome of the event reported as recovered. The event reported as non-serious. The causality of the event was not reported.
Age: 60.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Case number PHHY2014US094103, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 517742) website on 24 Jul 2014. This report refers to a 60-year-old male patient. On 18 Dec 2013, he was vaccinated with FLUVIRIN (batch number: 13465P) intramuscularly in the right arm along with ZOSTAVAX (other manufacturer, batch number: J008433) subcutaneously in the right arm. On 19 Dec 2013, one day after vaccination he experienced swelling, redness, itchiness and warm to touch. On 22 Dec 2013, the events were improving. The final outcome of the events reported as recovered. The events reported as non-serious. The causality of the event was not reported.
Age: 54.0
Sex: M
Vaccine: FLU3, HEP, MMR
Symptoms: Abdominal discomfort, Activities of daily living impaired, Diarrhoea, Fatigue, Influenza like illness
Clinical narrative: Case number PHHY2014US056660 is an initial spontaneous report received from a consumer who is a physician via the vaccine adverse event reporting system (VAERS reference number: 522675) web site on 06 May 2014. This report refers to a 54 year old male patient. His medical history included lumbar spine fusion at 02 years of his age. His current conditions included allergy to verapamil and CIPRO, hypertension, irritable bowel syndrome, fibromyalgia, neuropathy, cervical spine nerve room compression (C5 to 6), high cholesterol, "GEDs" anxiety and depression. His vaccination history included adverse reaction in the previous year which was similar to the events after FLUVIRIN shot. On 13 Feb 2014, he was vaccinated with FLUVIRIN (batch number: 13403P, expiry date: 01 Mar 2014) via unknown route, hepatitis b vaccine (batch number: AHBVC200AA, expiry date: 06 Feb 2015) via unknown route and MMR II (batch number: H020257, expiry date: 08 Nov 2014) subcutaneously all into left deltoid on 13 Feb 2014. On the same day after vaccination he experienced, left deltoid pain, mild flu like symptoms, gastrointestinal upset, mild diarrhea, fatigue, drowsiness and lethargy. Later in the evening, the symptoms became more severe and included left arm and hand pain. The pain was severe enough to take analgesics and also resulted in the loss of sleep. He could sleep only for 02 hours. On 14 Feb 2014, he was feeling better but due to lack of sleep fatigue and other symptoms persisted and he could not attend office. The reporter stated that the symptoms were not acute. The outcome and causality were not reported.
Age: 54.0
Sex: M
Vaccine: FLU3, HEP, MMR
Symptoms: Injection site pain, Insomnia, Lethargy, Pain in extremity, Somnolence
Clinical narrative: Case number PHHY2014US056660 is an initial spontaneous report received from a consumer who is a physician via the vaccine adverse event reporting system (VAERS reference number: 522675) web site on 06 May 2014. This report refers to a 54 year old male patient. His medical history included lumbar spine fusion at 02 years of his age. His current conditions included allergy to verapamil and CIPRO, hypertension, irritable bowel syndrome, fibromyalgia, neuropathy, cervical spine nerve room compression (C5 to 6), high cholesterol, "GEDs" anxiety and depression. His vaccination history included adverse reaction in the previous year which was similar to the events after FLUVIRIN shot. On 13 Feb 2014, he was vaccinated with FLUVIRIN (batch number: 13403P, expiry date: 01 Mar 2014) via unknown route, hepatitis b vaccine (batch number: AHBVC200AA, expiry date: 06 Feb 2015) via unknown route and MMR II (batch number: H020257, expiry date: 08 Nov 2014) subcutaneously all into left deltoid on 13 Feb 2014. On the same day after vaccination he experienced, left deltoid pain, mild flu like symptoms, gastrointestinal upset, mild diarrhea, fatigue, drowsiness and lethargy. Later in the evening, the symptoms became more severe and included left arm and hand pain. The pain was severe enough to take analgesics and also resulted in the loss of sleep. He could sleep only for 02 hours. On 14 Feb 2014, he was feeling better but due to lack of sleep fatigue and other symptoms persisted and he could not attend office. The reporter stated that the symptoms were not acute. The outcome and causality were not reported.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pain in extremity, Pain of skin, Peripheral swelling, Pyrexia
Clinical narrative: Case number PHHY2014US056454, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 523006) website on 06 May 2014. This report refers to a 39-year-old female patient. Her medical history included stage 1 breast cancer and hypothyroidism. She had no known drug allergies. Concomitant drugs included levothyroxine, AUGMENTIN, ARIMIDEX and ASA. She was vaccinated with FLUVIRIN (batch number: 1309501) and PNEUMOVAX (batch number: J005068) intramuscularly in the left arm on 06 Feb 2014. On 07 Feb 2014, she experienced body aches, arm pain and swelling, fever and skin tenderness of affected arm. The patient visited the emergency room. The final outcome of the events reported as recovered. The seriousness and causality of the events were not reported.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary mass, Mammogram, Vaccination site pain
Clinical narrative: Case number PHHY2014US056419 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 523389) website on 06 May 2014. This report refers to a 67-year-old female patient. Her medical history was not reported and concomitant medications were SPIRIVA and losartan. She was vaccinated with FLUVIRIN (batch number: 13471P) in the left arm on 07 Jan 2014. On 17 Jan 2014, post vaccination, she had lump under her left arm which was the size of lima bean. She underwent a mammogram and results were not reported. She also had soreness at the site of vaccination which continued even at the time of reporting. The lump went away on an unknown date. The final outcome of the lump under her arm was reported as complete recovery and that of vaccination site soreness was condition unchanged. The event was reported as non-serious. The causality of the event was not reported.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Mobility decreased, Pain, Paraesthesia
Clinical narrative: Case number PHHY2014US056043 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 523517) web site on 06 May 2014. This report refers to a 27 year old female patient who was 23 weeks of pregnant. Her concomitant medication included prenatal vitamins. She was vaccinated with FLUVIRIN (batch number: 131111) intramuscularly into right arm on 15 Jan 2014. On the same day, post vaccination, she experienced tingling and deep soreness after injection. Soreness increased and caused limited mobility. The treatment was rendered with ibuprofen and physical therapy. Tingling lasted for 24 hours but outcome for rest of the events were condition unchanged. The events were reported as non-serious and causality was not reported. 18 Jun 2014: Reporter was anonymous and therefore due diligence cannot be pursued. This case is considered lost to follow up.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Pain, Pain in extremity
Clinical narrative: Case number PHHY2014US055732, is an initial spontaneous report from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 524150) website on 06 May 2014. This report refers to a 56-year-old female patient. Past medical history included very sore; achy and nausea. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 1347) intramuscularly into the left upper arm on 07 Dec 2013. On 10 Dec 2013, her left arm was hurting when she lifts up and out. Her arm was sore and achy all the time. Also she feels discomfort in the arm all the time. The final outcome of the events was condition unchanged. The events were reported as non-serious. Causality was not reported.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza
Clinical narrative: Case number PHHY2014US055975 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 524330) website on 06 May 2014. This report refers to a 57-year-old female patient. Her medical history and concomitant medications were not reported. On 27 Sep 2013, she was vaccinated with FLUVIRIN (batch number: 1308501) intramuscularly in the right arm. It was reported that at the same time, she was also vaccinated with PNEUMOVAX (other manufacturer, and batch number: not reported). Following vaccination, four to five days later she experienced flu. Due to the event, on an unspecified date, she visited the emergency room. The final outcome was reported as complete recovery. The causality of the events was not reported. The events were reported as non-serious.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal disorder, Neuralgia, Pain in extremity
Clinical narrative: Case number PHHY2014US055880, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 524426) web site on 06 May 2014. This report refers to a 34-year-old female patient. Concomitant drug included ADIPEX-P. She was vaccinated with FLUVIRIN (batch number: 13374P) intramuscularly on 22 Jan 2014. On the same date, her arm was sore when given the immunization to the point where she cannot hardly use the arm. She visited the emergency room and the pain was described as a nerve pain that was relieved partially when she was on steroids. Her doctor prescribed medications (unspecified) on 17 Feb 2014 for pain. It was told that if it did not resolve an MRI would be the next step. The final outcome of the events reported as not recovered. The seriousness and causality of the events were not reported.
Age: 61.0
Sex: F
Vaccine: FLU3, MMR, MNQ
Symptoms: Fatigue, Lip ulceration, Tongue ulceration
Clinical narrative: Case number PHHY2014US056571 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 525499) website on 06 May 2014. This report refers to 61 year old female patient. Her medical history and concomitant medication was not reported included. She was vaccinated with FLUVIRIN (batch number: 1310201) into right arm on 20 Feb 2014. On the same day she received MMR II (batch number: J006994, other manufacturer) subcutaneous and MENACTRA (batch number: UH314AA, other manufacturer) subcutaneous. On 03 Mar 2014, she experienced fatigue and ulcers lower lip and tongue for 2 to 3 days. The physician called on 06 Mar 2014, and reported that the patient presented to their clinic complaining of the events. Physician did not think that the symptoms were related to vaccines, but will do additional testing and blood work (results not reported) and also hydrate the patient. She visited the emergency room. The outcome of the events and seriousness was not reported. Physician assessed the events as not related to vaccination.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Crying, Fatigue, Feeling cold, Musculoskeletal stiffness
Clinical narrative: Case number PHHY2014US071332 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 526008) web site on 09 Jun 2014. This report refers to a 14-year-old male patient. His current condition included pollen allergy. His concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 1346P) intramuscularly into left arm on 17 Mar 2014. On the same day, one and a half an hour after vaccination, he experienced pain in left arm which extended up into neck. His arm was getting stiff and experienced excruciating pain upon movement. He cried, felt cold and developed nausea, abdominal pain and fatigue. The patient was taken to emergency room for medical support. The final outcome was not reported. The event was reported as non serious and causality was not reported.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Neck pain, Pain, Pain in extremity
Clinical narrative: Case number PHHY2014US071332 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 526008) web site on 09 Jun 2014. This report refers to a 14-year-old male patient. His current condition included pollen allergy. His concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 1346P) intramuscularly into left arm on 17 Mar 2014. On the same day, one and a half an hour after vaccination, he experienced pain in left arm which extended up into neck. His arm was getting stiff and experienced excruciating pain upon movement. He cried, felt cold and developed nausea, abdominal pain and fatigue. The patient was taken to emergency room for medical support. The final outcome was not reported. The event was reported as non serious and causality was not reported.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Acoustic stimulation tests normal, Immediate post-injection reaction, Tinnitus
Clinical narrative: Case number PHHY2014US071342 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 526043) web site on 09 Jun 2014. This report refers to a 42-year-old female patient. Her current condition included allergy to shellfish, tuna, FLAGYL, Erythromycin, MACROBID, BACTRIM, NOVOCAINE and Fentanyl. Her concomitant medications included AXID and NASONEX. She was vaccinated with FLUVIRIN (batch number: 1308201) intramuscularly into right arm on 21 Nov 2013. On the same day, immediately after vaccination (within seconds), she experienced acute tinnitus in the right ear which, within 01-week, moved to both ears. On an unknown date, hearing test showed normal results. The final outcome was reported as condition unchanged. The event was reported as non serious and causality was not reported.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Case number PHHY2014US071360 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 526144) web site on 09 Jun 2014. This report refers to a 37-year-old female patient. She had a history of allergic reaction (unspecified). She was vaccinated with FLUVIRIN (batch number: 1308701) intramuscularly into left arm on 26 Sep 2013. On the same day after vaccination, she experienced swelling (unspecified). Treatment was rendered with BENADRYL. No epinephrine was administered. The final outcome was reported as complete recovery. The event was reported as non serious and causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Chapped lips, Dry skin, Lip swelling, Mouth swelling, Skin fissures
Clinical narrative: Case number PHHY2014US0707855, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number 526316) website on 09 JUN 2014. This report refers to a 69-year-old female patient. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309401) via subcutaneous route in the left arm on 17 JAN 2014. On an unknown date, after vaccination she experienced swelling of the lips and parts of the area around the mouth. She also experienced dry, chapped skin around the lips and mouth. She went to physician and dermatologist but still had the symptoms from JAN 2014. She already took steroid pack as a treatment. She had an appointment with allergist next week (unspecified date). The outcome of the events reported as not recovered. The events were reported as non-serious. The causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Stomatitis
Clinical narrative: Case number PHHY2014US0707855, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number 526316) website on 09 JUN 2014. This report refers to a 69-year-old female patient. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309401) via subcutaneous route in the left arm on 17 JAN 2014. On an unknown date, after vaccination she experienced swelling of the lips and parts of the area around the mouth. She also experienced dry, chapped skin around the lips and mouth. She went to physician and dermatologist but still had the symptoms from JAN 2014. She already took steroid pack as a treatment. She had an appointment with allergist next week (unspecified date). The outcome of the events reported as not recovered. The events were reported as non-serious. The causality of the events was not reported.
Age: 0.7
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2014US071044 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 526475) web site on 09 Jun 2014. This report refers to a 08-months-old female neonate who was vaccinated with FLUVIRIN (batch number: 1309601) intramuscularly in the left arm on 14 Mar 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: Case number PHHY2014US071284 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS, reference number: 527032) website on 09 Jun 2014. This report refers to a 58-year-old polymedicated male patient. His medical history included supraventricular tachycardia, post-traumatic stress disorder, depression, anxiety with panic; tinnitus, obsessive-compulsive disorder, hypertension, chronic pain and allergy to A-TAC. He was vaccinated with FLUVIRIN (batch number: 1309101) intramuscularly into left arm on 10 Jan 2014. On 11 Jan 2014, one day after vaccination, his tinnitus became extremely worse and has not getting better. He visited emergency room due to this event. The event was reported as non-serious. Outcome of the event was reported as condition unchanged. Causality of the event was not reported.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Fatigue, Headache, Nausea
Clinical narrative: Case number PHHY2014US070864 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 527418) web site on 09 Jun 2014. This report refers to a 30-year-old male patient. His current illness included sore throat and some minor cough. On 02 Feb 2014, he was vaccinated with FLUVIRIN (batch number: 1308701) intramuscularly in the right arm. Following the vaccination, on 02 Apr 2014, he had uncontrollable cough, some minor headaches, fatigue, itchy throat, some nausea symptom, and some difficulties in taking deep breaths. The final outcome of the events was not reported. The causality of the events was not reported. The events were reported as non-serious.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Case number PHHY2014US070864 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 527418) web site on 09 Jun 2014. This report refers to a 30-year-old male patient. His current illness included sore throat and some minor cough. On 02 Feb 2014, he was vaccinated with FLUVIRIN (batch number: 1308701) intramuscularly in the right arm. Following the vaccination, on 02 Apr 2014, he had uncontrollable cough, some minor headaches, fatigue, itchy throat, some nausea symptom, and some difficulties in taking deep breaths. The final outcome of the events was not reported. The causality of the events was not reported. The events were reported as non-serious.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discharge, Injection site vesicles
Clinical narrative: Case number PHHY2014US071533 is an initial spontaneous report received from vaccine adverse event reporting system web site (VAERS reference number: 527675) on 09 Jun 2014. This spontaneous report refers to a 52 year old female patient. Her past medical history and concomitant medications were not reported. On 08 Oct 2013, she was vaccinated with FLUVIRIN (batch number: 1308501) intramuscularly into her left arm. On an unspecified date after vaccination, her arm was blistered and liquid came out of the injection site. The outcome of the events was not reported. The events were reported as non serious and the causality of the events was not reported.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fall, Pallor
Clinical narrative: Case number PHHY2014US081205 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 529226) web site on 01 Jul 2014. This report refers to a 14-year-old female patient. Her medical history and concomitant medications were not reported. Her vaccination history included administration of flu shot (unknown manufacturer, batch number: not reported) after which she experienced marked light headedness (see related case number: PHHY2014US081320). She was vaccinated with FLUVIRIN (batch number: 1310301) intramuscularly in the left arm on 16 Jan 2014. On same day 5 minutes after vaccination she started to slide down. Pharmacy staff and her mom took her to waiting room. After 5 to 10 minutes she started feeling better and was given little sip of water. Her color came back after another 10 minutes. The outcome of the event was reported as completely recovered. The event was reported as non-serious. The causality of the event was not reported.
Age: 1.3
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 16-moth-old female patie t who receivedFLUARIX (batch number 527X7, expiry date 17th June 2015). On an unknown date, the patient received FLUARIX. On an nknown date, an unknown time after receiving FLUARIX, the patient experienced inappropriate age at vaccine administration was unknown. Additional information received: FLUARIX QIV given to a 16 months old patient.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site discolouration, Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 30-year-old female patient who received FLUARIX 2014/2015 (batch number 45HX7, expiry date unknown).  On 3rd November 2014, the patient received FLUARIX 2014-2015 season (intramuscular) .5 ml. On 3rd November 2014, the patient experienced pain in extremity. On an unknown date, the outcome of pain in extremity was not recovered/not resolved.   The reporter considered the pain in extremity to be related to FLUARIX 2014-2015 season.   Additional details provided: Nurse reported that a patient was administered the vaccine in the deltoid on November 3, 2014. Later in the day on November 3, her arm became sore. Seven days after the injection , it started to hurt more. The patient now complains that it hurts from her shoulder to her elbow. There is no swelling or bruising. The patient describes the pain as a deep ache and as a "7" on a scale from 1 to 10. The patient says that it is not getting better and today the pain is worse than it was yesterday.  Follow up information received on 13 November 2014 from the consumer. The patient received FLUARIX Trivalent 2014-2015 season in left arm. Previously administered products included flu vaccine (with no reactions).  All previous vaccination went uncomplicated. On 3rd November 2014, less than a day after receiving FLUARIX Trivalent 2014-2015 season, the patient experienced injection site pain. On 4th November 2014, the patient experienced injected limb mobility decreased (limited range of motion that has deteriorated). The patient said that it was bad, as far as soreness and pain in her left arm; she described that she was having trouble lifting her purse or turning the steering wheel to drive. The patient said that she experienced pain and soreness that prevented her from sleeping. When she rubs the injection site, she does not feel any knots, but the area was tender and there was still a little white mark were the vaccination was given.  At the time of the follow-up reporting, the outcome of the injected limb mobility decreased injection site pain, sleep problem, pain in arm and injection site discoloration, pain in arm were not recovered/not resolved. It was unknown if the reporter considered the injected limb mobility decreased, sleep problem, pain in arm and injection site discoloration to be related to FLUARIX Trivalent 2014-2015 season. The reporter considered the injection site pain and pain in arm to be related to FLUARIX Trivalent 2014-2015 season. Additional details provided: Patient reported that she felt the flu vaccine was given at an injection site that seemed higher than she usually remembered getting vaccines. The patient reported the event to a doctor.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 30-year-old female patient who received FLUARIX 2014/2015 (batch number 45HX7, expiry date unknown).  On 3rd November 2014, the patient received FLUARIX 2014-2015 season (intramuscular) .5 ml. On 3rd November 2014, the patient experienced pain in extremity. On an unknown date, the outcome of pain in extremity was not recovered/not resolved.   The reporter considered the pain in extremity to be related to FLUARIX 2014-2015 season.   Additional details provided: Nurse reported that a patient was administered the vaccine in the deltoid on November 3, 2014. Later in the day on November 3, her arm became sore. Seven days after the injection , it started to hurt more. The patient now complains that it hurts from her shoulder to her elbow. There is no swelling or bruising. The patient describes the pain as a deep ache and as a "7" on a scale from 1 to 10. The patient says that it is not getting better and today the pain is worse than it was yesterday.  Follow up information received on 13 November 2014 from the consumer. The patient received FLUARIX Trivalent 2014-2015 season in left arm. Previously administered products included flu vaccine (with no reactions).  All previous vaccination went uncomplicated. On 3rd November 2014, less than a day after receiving FLUARIX Trivalent 2014-2015 season, the patient experienced injection site pain. On 4th November 2014, the patient experienced injected limb mobility decreased (limited range of motion that has deteriorated). The patient said that it was bad, as far as soreness and pain in her left arm; she described that she was having trouble lifting her purse or turning the steering wheel to drive. The patient said that she experienced pain and soreness that prevented her from sleeping. When she rubs the injection site, she does not feel any knots, but the area was tender and there was still a little white mark were the vaccination was given.  At the time of the follow-up reporting, the outcome of the injected limb mobility decreased injection site pain, sleep problem, pain in arm and injection site discoloration, pain in arm were not recovered/not resolved. It was unknown if the reporter considered the injected limb mobility decreased, sleep problem, pain in arm and injection site discoloration to be related to FLUARIX Trivalent 2014-2015 season. The reporter considered the injection site pain and pain in arm to be related to FLUARIX Trivalent 2014-2015 season. Additional details provided: Patient reported that she felt the flu vaccine was given at an injection site that seemed higher than she usually remembered getting vaccines. The patient reported the event to a doctor.
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Chills, Nausea, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report as received from a agency refers to a female patient of unknown age. On 17-NOV-2014, the patient was vaccinated with PNEUMOVAX 23, (lot# K009876, expiration date 19-MAR-2016), (dose was not reported) intramuscularly in the left arm's deltoid muscle. On 17-NOV-2014, in the afternoon, the patient experienced fever, pain on left arm, chills and nauseas. Claimant required immediate medical attention and treatment. The outcome of pain on left arm, chills, nauseas and fever was unknown. The relatedness between the event and therapy with PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Abdominal discomfort, Abdominal pain, Back pain, Cellulitis, Laboratory test abnormal
Clinical narrative: This spontaneous report as received from a agency refers to a female patient of unknown age. On 17-NOV-2014, the patient was vaccinated with PNEUMOVAX 23, (lot# K009876, expiration date 19-MAR-2016), (dose was not reported) intramuscularly in the left arm's deltoid muscle. On 17-NOV-2014, in the afternoon, the patient experienced fever, pain on left arm, chills and nauseas. Claimant required immediate medical attention and treatment. The outcome of pain on left arm, chills, nauseas and fever was unknown. The relatedness between the event and therapy with PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report as received from a agency refers to a female patient of unknown age. On 17-NOV-2014, the patient was vaccinated with PNEUMOVAX 23, (lot# K009876, expiration date 19-MAR-2016), (dose was not reported) intramuscularly in the left arm's deltoid muscle. On 17-NOV-2014, in the afternoon, the patient experienced fever, pain on left arm, chills and nauseas. Claimant required immediate medical attention and treatment. The outcome of pain on left arm, chills, nauseas and fever was unknown. The relatedness between the event and therapy with PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cyst, Injection site rash, Injection site vesicles
Clinical narrative: Information was received from a pharmacist regarding a 63 year old female patient, who on 17-NOV-2014, was vaccinated with ZOSTAVAX, 0.65 ml (lot #K010967, expiration date 06-NOV-2015) (route of administration not provided). On an unknown date, the patient then developed a yellow "cyst type" of a blistering rash at the injection site. No treatment was given. The outcome of the yellow "cyst type" of blistering rash at the injection site was reported as not recovered. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: FLUX
Symptoms: Aphasia, Feeling abnormal, Injected limb mobility decreased, Somnolence
Clinical narrative: This serious spontaneous consumer report (initial receipt 09-Jan-2015) concerns a female patient. On an unspecified date, years ago, the patient received unspecified flu vaccine (manufacturer and batch number not reported). On an unspecified date, after vaccination, the patient could not lift her arm where the injection was administered. Soon afterwards, she felt like "she was getting surgery, where she felt sleepy, but could hear people's voices but could not speak." She somehow made it to an emergency room and was administered epinephrine and her symptoms resolved. The patient stated that she now had low tolerance towards the swine in the flu vaccines. The outcome was reported as resolved. Reporter comments: The reporter assessed the events as related to the use of flu vaccine.