chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dizziness, Feeling hot, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Case number PHHY2015US028071 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548267) website on 05 Mar 2015. This report refers to a 30 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) intramuscularly in the right arm deltoid and PNEUMOVAX 23 (other manufacturer, batch number: not reported) intramuscularly in the right arm deltoid and PNEUMOVAX 23 (other manufacturer, batch number: not reported) intramuscularly in the left arm deltoid; both vaccines administered on 02 Oct 2014. On 02 Oct 2014, approximately one hour after vaccination, she had increasing pain. She presented in the emergency room on an unknown date for an acute visit and stated that from that morning, she had increased pain radiating to her left neck, left chest wall and left arm. She complained of dizziness, feeling hot and nausea. She noted to have a baseball sized erythematic area on her left upper arm which was very tender to touch and warm. She was unsure whether she had this vaccine in the past. The outcome of the events was reported as complete recovery. The events were reported as non-serious. Causality of the events was not reported.
Age: 30.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Musculoskeletal chest pain, Nausea, Neck pain, Pain in extremity
Clinical narrative: Case number PHHY2015US028071 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548267) website on 05 Mar 2015. This report refers to a 30 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) intramuscularly in the right arm deltoid and PNEUMOVAX 23 (other manufacturer, batch number: not reported) intramuscularly in the right arm deltoid and PNEUMOVAX 23 (other manufacturer, batch number: not reported) intramuscularly in the left arm deltoid; both vaccines administered on 02 Oct 2014. On 02 Oct 2014, approximately one hour after vaccination, she had increasing pain. She presented in the emergency room on an unknown date for an acute visit and stated that from that morning, she had increased pain radiating to her left neck, left chest wall and left arm. She complained of dizziness, feeling hot and nausea. She noted to have a baseball sized erythematic area on her left upper arm which was very tender to touch and warm. She was unsure whether she had this vaccine in the past. The outcome of the events was reported as complete recovery. The events were reported as non-serious. Causality of the events was not reported.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Case number PHHY2015US029349, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 548648) website on 05 Mar 2015. This report refers to a 65-year-old female patient. Medical history was not reported. Historical drug included anesthetics. Concomitant medication was not reported. On 15 Oct 2014, she was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) at an unspecified site along with PNEUMOVAX 23 (other manufacturer, batch number: K003074) intramuscularly in the upper left arm. On 17 Oct 2014, following the vaccination, the patient experienced redness (19 cm across by 10 cm down), pain, warmth and swelling at vaccination site. The patient applied ice in that area and was suggested to take KEFLLEX if swelling continued. The final outcome of the events was not reported. The events were reported as non-serious. The causality of the events was not reported.
Age: 69.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Arthralgia, Joint stiffness, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Case number PHHY2015US009126 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 548823) on 06 Jan 2015. This report refers to a 69 years old male patient. His current conditions included high cholesterol and high blood pressure. His concomitant medications were felodipine, bisoprolol, telmisartan and simvastatin. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm and PREVNAR (other manufacturer, batch number: K004148) in the right arm on 15 Oct 2014. On 15 Oct 2014, three hours later his arm and shoulder joint started hurting bad and he had stiffening in joint. The rest of the night, he had pain which was excruciating and he could not move or lift arm. His pain level was 9 to 10. He went to emergency room. The events outcome was unknown. The events were reported as non-serious. The causality of the event was not reported.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Urticaria
Clinical narrative: Case number PHHY2015US013022 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 549403) on 06 Jan 2015. This report refers to a 37 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unspecified date, she experienced illness. The events outcome, seriousness and causality were not reported. She further received a dose of seasonal influenza vaccine (manufacturer and batch number: not reported) on 20 Oct 2014 following which she experienced hives (see related case number; PHHY2015US013006). No further information was provided.
Age: 13.0
Sex: U
Vaccine: FLUX, MMR
Symptoms: Syncope
Clinical narrative: Case number PHHY2015US029078, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 549799) website on 05 Mar 2015. This report refers to a 13-years-old patient of an unknown gender. Historical conditions and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and MMR II (other manufacturers, batch number: not reported) on an unknown date. On an unknown date, the patient experienced syncope. The outcome, seriousness and causality of the event was not reported.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Abdominal pain
Clinical narrative: Case number PHHY2015US029118, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 549935) website on 05 Mar 2015. This report refers to a male patient of an unknown age. Historical conditions and concomitant medications were not reported. Vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number: not reported) following which he had fever with a body temperature of 104 (see case: PHHY2015US029112). The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date after vaccination, the patient developed abdominal pain. The outcome, seriousness and causality of the event were not reported.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Drug administered to patient of inappropriate age, Pyrexia
Clinical narrative: Case number PHHY2015US029118, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 549935) website on 05 Mar 2015. This report refers to a male patient of an unknown age. Historical conditions and concomitant medications were not reported. Vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number: not reported) following which he had fever with a body temperature of 104 (see case: PHHY2015US029112). The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date after vaccination, the patient developed abdominal pain. The outcome, seriousness and causality of the event were not reported.
Age: 1.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Abdominal pain
Clinical narrative: Case number PHHY2015US029112, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 549935) website on 05 Mar 2015. This report refers to a 01-year-old male patient. Historical conditions and concomitant medication were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, after vaccination, the patient developed fever with a body temperature of 104 degrees. The outcome, seriousness and causality of the event were not reported. The patient also experienced abdominal pain with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date (see related case number: PHHY2015US029118).
Age: 1.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Drug administered to patient of inappropriate age, Pyrexia
Clinical narrative: Case number PHHY2015US029112, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 549935) website on 05 Mar 2015. This report refers to a 01-year-old male patient. Historical conditions and concomitant medication were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, after vaccination, the patient developed fever with a body temperature of 104 degrees. The outcome, seriousness and causality of the event were not reported. The patient also experienced abdominal pain with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date (see related case number: PHHY2015US029118).
Age: 58.0
Sex: M
Vaccine: DPP
Symptoms: Hypoaesthesia, Lymph node pain, Lymphadenopathy, Pain in extremity, Paraesthesia
Clinical narrative: Case number PHHY2015US029885, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 550036) website on 05 Mar 2015. This report refers to a 58-year-old male patient. His medical history was not reported. Concurrent conditions included adrenal insufficiency and transient ischaemic attack (TIA). Concomitant medication included CORTEF pill. He was vaccinated with influenza seasonal vaccine (manufacturer and batch number unknown) on 20 Oct 2014. He was vaccinated with diphtheria/pertussis/polio (other manufacturer and batch number: unknown) on 21 Oct 2014. On 24 Oct 2014, his lymph glands in armpit became swollen and painful. On 25 Oct 2014 at about 01:00 pm, his arm started tingling, hurting and numb. On the same date at 10.53 pm, the symptoms were just easing up. No lab data was performed, however it scared him half to death and he was afraid he would be having another TIA. The final outcome of the events was complete recovery. The events were assessed as non-serious. The causality assessment of the events was not reported.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Pain
Clinical narrative: Case number PHHY2015US007479, is an initial spontaneous report received from a consumer via vaccines adverse events reporting system (VAERS reference number: 551182) on 06 Jan 2015. This report refers to a 25 years old female patient. Her medical history included high blood pressure. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) in left arm on 23 Oct 2014. On same day post vaccination she experienced headache. She was treated with TYLENOL for headache. It was also reported that as soon as TYLENOL wore off she started to get body aches and she woke up with worse symptoms. The final outcome of the events was reported as complete recovery. The events were reported as non-serious and causality of the event was not reported.
Age: 1.0
Sex: M
Vaccine: FLUX
Symptoms: Product use issue, Respiratory disorder
Clinical narrative: Case number PHHY2015US029194, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 551677) website on 05 Mar 2015. This report refers to a 01-year-old male patient. The patient's concurrent condition included heart defects. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date in 2013. On an unknown date after vaccination, the patient had slight upper respiratory complications. It was reported that such reaction did not occur until more than 72 hours after the vaccine was given. The outcome, seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Case number PHHY2015US029898, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 551993) website on 05 Mar 2015. This report refers to a female patient of an unknown age. Her historical condition included mitral valve prolapse. Current condition included seasonal allergies. Concomitant medications were not reported. On unknown date, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown). On an unknown date, the patient experienced pain (site not specified). Outcome, seriousness and causality of the event were not reported. The patient was further vaccinated with FLUZONE (other manufacturer, batch number: U5036AA) on 10 Oct 2014 and experienced events.
Age: 69.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Neuralgia
Clinical narrative: Case number PHHY2015US028266, is an initial spontaneous report received from a consumer (patient's wife) via the Vaccine Adverse Event Reporting System (VAERS, reference number: 552422) website on 05 Mar 2015. This report refers to a 69 year old male patient. His medical history included shingles, during 1997 and on an other unspecified year. He had no drug allergies. On 26 Jan 2008, the patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) via unknown route at a dose of 1 DF and ZOSTAVAX (other manufacturer, batch number: not reported) subcutaneously at a dose of 0.65 ml. On 12 Oct 2014, the patient experienced shingles rash which stretched from the back of his neck going up over his ear, face and onto the eyelid. The patient was also experiencing nerve pain. A medical attention was sought in Oct 2014. He was prescribed with few medications including an eye drop as treatment. The outcome of the event was condition unchanged. Events were reported as non-serious. Causality was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHHY2015US029394, is an initial spontaneous report received from a pharmacist via Vaccine Adverse Event Reporting System (VAERS reference number: 553332) website on 05 Mar 2015. This report refers to a patient of unknown age and gender. Medical history and concomitant medications were not reported. On an unknown date in Apr 2013 (reported as about 18 months ago), the patient was vaccinated with the first dose of ZOSTAVAX (other manufacturer, batch number: not reported) at a dose 0.65 ml subcutaneously. On 13 Oct 2014, the patient was accidentally vaccinated with a second dose of ZOSTAVAX at a dose of 0.65 ml subcutaneously instead of seasonal influenza (unknown manufacturer, batch number: not reported). No adverse effect was reported following this administration error.
Age: 1.0
Sex: U
Vaccine: FLUX, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site nodule, Rash
Clinical narrative: Case number PHHY2015US029853, is an initial spontaneous report received from a physician via Vaccine Adverse Event Reporting System (VAERS reference number: 553382) website on 05 Mar 2015. This report refers to a 01-year-old patient of an unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) along with MMR II (batch number J014875, other manufacturer), VARIVAX (batch number: unknown, other manufacturer), PREVNAR (batch number: unknown, other manufacturer) and HIB vaccine (batch number: unknown, other manufacturer) on an unknown date. On 10 Oct 2014 the patient experienced nodule at the injection site, MMR like rash over the back and trunk area (not specified if the patient rash resembled measles, mumps, or rubella specifically). The patient consulted physician on an unknown date. The outcome of events was reported as condition unchanged. The reporter considered the events as non serious. The causality was not reported.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal distension, Constipation, Decreased appetite, Gastrointestinal pain, Headache
Clinical narrative: Case number PHHY2015US028807, is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS, reference number: 553829) on 05 Mar 2015. This report refers to a 41 year old female patient. Medical history was not reported. Concurrent condition included mitral valve regurgitation and seasonal allergies. No concomitant medication was reported. Her vaccination history included administration of flu shots (seasonal influenza vaccine) in the past which were tolerated well. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 11 Nov 2014. On the same day after vaccination, she experienced massive headache and pain. She took maximum dose of ALEVE each day. She experienced nausea and had no appetite. Patient forced herself to eat but she felt bloated and experienced gastrointestinal pain. The patient also developed constipation and sore throat. She was drinking herbal tea to soothe her throat, additional water and clear broth. As per patient the events were very severe and she would not like to receive this vaccine in future. Final outcome of the events was not reported. Events were reported as non-serious. Causality was not reported.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Oropharyngeal pain, Pain
Clinical narrative: Case number PHHY2015US028807, is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS, reference number: 553829) on 05 Mar 2015. This report refers to a 41 year old female patient. Medical history was not reported. Concurrent condition included mitral valve regurgitation and seasonal allergies. No concomitant medication was reported. Her vaccination history included administration of flu shots (seasonal influenza vaccine) in the past which were tolerated well. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 11 Nov 2014. On the same day after vaccination, she experienced massive headache and pain. She took maximum dose of ALEVE each day. She experienced nausea and had no appetite. Patient forced herself to eat but she felt bloated and experienced gastrointestinal pain. The patient also developed constipation and sore throat. She was drinking herbal tea to soothe her throat, additional water and clear broth. As per patient the events were very severe and she would not like to receive this vaccine in future. 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 swelling
Clinical narrative: Case number PHHY2015US0264310, is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 5553843) website on 05 Mar 20155. This report refers to a 07-year-old female patient. Medical history included swelling the size of a softball at injection area. Concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) into her left arm on 14 Nov 2014. On the same date after vaccination, she had large swelling at injection area. The final outcome of the event was unknown. The event was reported as non serious. Causality of the event was not reported.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Erythema, Local swelling, Pain, Pyrexia
Clinical narrative: Case number PHHY2015US026433, is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 553845) website on 05 Mar 2015. This report refers to a 59-year-old female patient. Medical history included Sjogren's disease, fibromyalgia, chronic fatigue, stage III kidney disease, common variable immunodeficiency, myositis, sicca syndrome and unspecified retinal disorder. This poly medicated patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) into her left arm on 14 Nov 2014. On the same date after vaccination, she had fever/chills, body aches and large red swollen area below the injection site. She took ibuprofen for fever and body aches. The final outcome of the events was unknown. The events were reported as non serious. Causality of the events was not reported.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Biopsy brain, Dermatitis allergic, Dizziness, Hot flush, Neuropathy peripheral
Clinical narrative: Case number PHHY2015US028677, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 553858) on 05 Mar 2015. This report refers to a 57 year old female patient. Medical history was not reported. Concurrent condition included sulfonamide allergy. Concomitant medication included FLONASE. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 24 Oct 2014. On 25 Oct 2014, she experienced itching and tingling skin, which later turned into allergic rash on arms, neck, chest and back. She also experienced symptoms of dizziness, brain fog, neuropathy and hot flashes. Final outcome of the events was condition unchanged. Events were reported as non-serious. Causality was not reported.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Tinea capitis
Clinical narrative: Case number PHHY2015US028677, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 553858) on 05 Mar 2015. This report refers to a 57 year old female patient. Medical history was not reported. Concurrent condition included sulfonamide allergy. Concomitant medication included FLONASE. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 24 Oct 2014. On 25 Oct 2014, she experienced itching and tingling skin, which later turned into allergic rash on arms, neck, chest and back. She also experienced symptoms of dizziness, brain fog, neuropathy and hot flashes. Final outcome of the events was condition unchanged. Events were reported as non-serious. Causality was not reported.
Age: 63.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Blood test normal, Burning sensation, Computerised tomogram normal, Electrocardiogram normal, Hyperacusis
Clinical narrative: Case number PHHY2015US028191 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 553996) website on 05 Mar 2015. This reports refers to a 63 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) intramuscularly in the left arm and ZOSTAVAX (other manufacturer, batch number: not reported) intramuscularly in the right arm; both vaccines administered on 03 Oct 2014. On 03 Oct 2014, she had tingling in legs, hyper hearing, inner burn and shaking. She went to emergency room. Her blood tests, electrocardiogram and computerized tomogram (CAT) scan was negative. The outcome of the events was reported as condition unchanged. The events were reported as non-serious. Causality of the events was not reported. Following an internal review of the data received in 05 Mar 2015. It was identified that the event verbatim hyper hearing was erroneously coded as hearing impaired and hence it was recoded as hyperacusis.
Age: 63.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Paraesthesia, Tremor
Clinical narrative: Case number PHHY2015US028191 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 553996) website on 05 Mar 2015. This reports refers to a 63 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) intramuscularly in the left arm and ZOSTAVAX (other manufacturer, batch number: not reported) intramuscularly in the right arm; both vaccines administered on 03 Oct 2014. On 03 Oct 2014, she had tingling in legs, hyper hearing, inner burn and shaking. She went to emergency room. Her blood tests, electrocardiogram and computerized tomogram (CAT) scan was negative. The outcome of the events was reported as condition unchanged. The events were reported as non-serious. Causality of the events was not reported. Following an internal review of the data received in 05 Mar 2015. It was identified that the event verbatim hyper hearing was erroneously coded as hearing impaired and hence it was recoded as hyperacusis.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Vaccination site swelling
Clinical narrative: Case number PHHY2015US026561, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 554008) website on 05 Mar 2015. This report refers to a 30-year-old female patient. Medical history and concomitant medications were not reported. On 14 Nov 2014, she was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported), intramuscularly. On the same date, (14 Nov 2014), following the vaccination the patient experienced vaccination site swelling. The final outcome of the event was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Inflammation, Joint swelling, Pain in extremity
Clinical narrative: Case number PHHY2015US028923, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554083) website on 05 Mar 2015. This report refers to a 27 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on left arm on 11 Nov 2014. On 14 Nov 2014, the patient developed swelling in wrist and pain in arm of injection. The patient was treated with TYLENOL for two days but the problems remained. The patient consulted doctor who was told that her lymphoids were inflamed. The outcome of the events was condition unchanged. The events were reported as non-serious. Causality of the events was not reported.
Age: 45.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Cough, Pain, Pyrexia
Clinical narrative: Case number PHHY2015US026514, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 544089) website on 05 Mar 2015. This report refers to a 45-year-old male patient. Medical history was not reported. Concomitant medications included lisinopril, FLONASE. On 06 Nov 2014, he was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported), intramuscularly in the left arm. On 07 Nov 2014, following the vaccination the patient experienced fever with a body temperature of 39 degree Celsius along with achiness, weakness and occasional coughing. The patient had completely recovered from fever by 12 Nov 2014. The patient took a whole week to regain normal energy level. The patient also reported that he did not even have a significant cold in the prior 6 months. The final outcome of the events was complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 11.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Pallor, Paraesthesia
Clinical narrative: Case number PHHY2015US028386, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 554102) website on 05 Mar 2015. This report refers to an 11 year old male patient. Concomitant medication included DIMETAP. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number were unknown) on 17 Nov 2014. On 18 Nov 2014, the patient developed extreme paleness. He also developed tingling sensation in head and had chills. Outcome of the events was reported as unknown. The events were reported as non-serious. Causality was not reported.
Age: 4.0
Sex: F
Vaccine: FLUX, FLUX, FLU3
Symptoms: Nausea, Peripheral swelling, Vomiting
Clinical narrative: Case number PHHY2015US034581, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554128) website on 16 Mar 2015. This report refers to a 4-year-old female patient. Her medical history and concomitant medications was not reported. Vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number: not reported) and experienced events (See case: PHHY2015US034583). She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on an unspecified date. On an unknown date, she developed nausea, vomiting and swollen arm. The outcome, seriousness and causality assessment of the events was not reported. She was further vaccinated with FLUVIRIN (batch number 014031A) and experienced events (see case: PHHY2015US033903).
Age: 4.0
Sex: F
Vaccine: FLUX, FLUX, FLU3
Symptoms: Arthralgia, Burning sensation, Headache, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Case number PHHY2015US034581, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554128) website on 16 Mar 2015. This report refers to a 4-year-old female patient. Her medical history and concomitant medications was not reported. Vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number: not reported) and experienced events (See case: PHHY2015US034583). She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on an unspecified date. On an unknown date, she developed nausea, vomiting and swollen arm. The outcome, seriousness and causality assessment of the events was not reported. She was further vaccinated with FLUVIRIN (batch number 014031A) and experienced events (see case: PHHY2015US033903).
Age: 4.0
Sex: F
Vaccine: FLUX, FLUX, FLU3
Symptoms: Impaired work ability, Induration, Nausea, Pain in extremity, Skin warm
Clinical narrative: Case number PHHY2015US034581, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554128) website on 16 Mar 2015. This report refers to a 4-year-old female patient. Her medical history and concomitant medications was not reported. Vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number: not reported) and experienced events (See case: PHHY2015US034583). She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on an unspecified date. On an unknown date, she developed nausea, vomiting and swollen arm. The outcome, seriousness and causality assessment of the events was not reported. She was further vaccinated with FLUVIRIN (batch number 014031A) and experienced events (see case: PHHY2015US033903).
Sex: F
Vaccine: FLUX, FLUX, FLU3
Symptoms: Nausea, Peripheral swelling, Vomiting
Clinical narrative: Case number PHHY2015US034583, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554128) website on 16 Mar 2015. This report refers to a female patient of unspecified age. Her medical history and concomitant medications was not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number details unknown) on an unspecified date. On an unknown date, she developed nausea, vomiting and swollen arm. The outcome, seriousness and causality assessment of the events was not reported. She was further vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and experienced events (See cases: PHHY2015US034583) and FLUVIRIN (batch number 014031A) and experienced events (see case: PHHY2015US033903).
Sex: F
Vaccine: FLUX, FLUX, FLU3
Symptoms: Arthralgia, Burning sensation, Headache, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Case number PHHY2015US034583, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554128) website on 16 Mar 2015. This report refers to a female patient of unspecified age. Her medical history and concomitant medications was not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number details unknown) on an unspecified date. On an unknown date, she developed nausea, vomiting and swollen arm. The outcome, seriousness and causality assessment of the events was not reported. She was further vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and experienced events (See cases: PHHY2015US034583) and FLUVIRIN (batch number 014031A) and experienced events (see case: PHHY2015US033903).
Sex: F
Vaccine: FLUX, FLUX, FLU3
Symptoms: Impaired work ability, Induration, Nausea, Pain in extremity, Skin warm
Clinical narrative: Case number PHHY2015US034583, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554128) website on 16 Mar 2015. This report refers to a female patient of unspecified age. Her medical history and concomitant medications was not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number details unknown) on an unspecified date. On an unknown date, she developed nausea, vomiting and swollen arm. The outcome, seriousness and causality assessment of the events was not reported. She was further vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and experienced events (See cases: PHHY2015US034583) and FLUVIRIN (batch number 014031A) and experienced events (see case: PHHY2015US033903).
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Case number PHHY2015US028423, is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 554155) website on 05 Mar 2015. This report refers to a 36 years old male patient. She had no medical history. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscularly into the left arm on 11 Oct 2014. On 11 Oct 2014, she experienced pain in the left shoulder and left arm and tingling in the left hand. The events continued six weeks post injection. She went to emergency room. Electrocardiogram (EMG) and other lab tests were to be performed. Outcome of the events was not reported. The events were reported as non-serious. Causality of the events was not reported.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Gait disturbance, Insomnia, Muscle spasms, Musculoskeletal disorder
Clinical narrative: Case number PHHY2015US028544, is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 554190) website on 05 Mar 2015. This report refers to a 45 years old female patient. Current conditions included asthma. Concomitant medications included DEPAKOTE, SEROQUEL, clonazepam, trazodone, levothyroxine and omeprazole. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number were unknown) intramuscularly into the left arm on 05 Nov 2014. On 05 Nov 2014, she experienced severe joint and muscle pain with muscle spasms in legs. Her vaccination she was swollen and painful and it could not be touched and she could not sleep on it for 4 days. She could barely walk or use her hands and could not sleep on 05 Nov 2014 due to the pain. She went to emergency room on 06 Nov 2014 or 07 Nov 2014. Joint and muscle pain as well as muscle spasms in legs lasted through 07 Nov 2014. Lab data was not reported. Outcome of the events was reported as complete recovery. The events were reported as non-serious. Causality of the events was not reported.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2015US028544, is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 554190) website on 05 Mar 2015. This report refers to a 45 years old female patient. Current conditions included asthma. Concomitant medications included DEPAKOTE, SEROQUEL, clonazepam, trazodone, levothyroxine and omeprazole. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number were unknown) intramuscularly into the left arm on 05 Nov 2014. On 05 Nov 2014, she experienced severe joint and muscle pain with muscle spasms in legs. Her vaccination she was swollen and painful and it could not be touched and she could not sleep on it for 4 days. She could barely walk or use her hands and could not sleep on 05 Nov 2014 due to the pain. She went to emergency room on 06 Nov 2014 or 07 Nov 2014. Joint and muscle pain as well as muscle spasms in legs lasted through 07 Nov 2014. Lab data was not reported. Outcome of the events was reported as complete recovery. The events were reported as non-serious. Causality of the events was not reported.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Hypoaesthesia, Injection site pain, Pain, Pyrexia
Clinical narrative: Case number PHHY2015US026417, is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 554402) website on 05 Mar 2015. This reports refers to a 48 years old female patient. Current condition included mild sinus congestion without fever. Concomitant medications were TOPROL XL and LEXAPRO. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) in he left arm on 17 Oct 2014. On the same date, the patient experienced extreme pain in her left arm injection site and her arm and fingers went numb for approximately 24 hours. She woke up at 11:00 pm the night of the vaccine with chills, fever and all over body aches. She was still experiencing extreme pain when she tried to raise her left arm. The outcome of the events was not reported. The events were reported as non-serious. Causality of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Hypoaesthesia, Malaise, Nausea, Paraesthesia
Clinical narrative: Case number PHHY2015US028613, is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 5544050) website on 05 Mar 2013. This report refers to a 43 years old female patient. She had no allergies. Current conditions included high blood pressure, chronic obstructive pulmonary disease (COPD), fibromyalgia, high cholesterol, hypothyroidism, irritable bowel syndrome (IBS) and fatigue. Concurrent medications included levothyroxine 50 mg one a day, LOPRESSOR 50 mg one a day, Hydrocodeine 10/325 every 8 hours, CELEXA 20 mg one a day and NUVIGIL 150 mg one a day. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number were unknown) intramuscularly in to the left arm on 12 Nov 2014, On 13 Nov 2014, she experienced extreme fatigue and malaise. She stated that the fatigue was severe since the flu shot (when compared to the past). She was in bed for 6 days and she felt that taking shower was exhausting. She also experienced nausea and worsening of numbness and tingling in hands and legs. Outcome of the events was not reported. The events were reported as non-serious. Causality of the events was not reported.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHHY2015US028686, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 554408) website on 05 Mar 2015. This report refers to a 25-year-old female patient. Historical conditions were none. No concomitant medication was reported. The patient vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 17 Nov 2014. On 18 Nov 2014, the patient experienced red, itchy, painful and large swelling in the arm where the injection was administered. The swelling was about the size of a small fist. Given the description by the patient to the doctor, the patient was advised to take allergy medicine like BENADRYL as the doctor felt the patient was having an allergic reaction. Further, the patient was asked to keep an eye on the events and was told the arm would be back to normal within a day or two. The final outcome of the events was not reported. The events was reported as non-serious. Causality was not reported.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus
Clinical narrative: Case number PHHY2015US027737, is an initial spontaneous report from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 554409) website on 05 Mar 2015. This report refers to a 57-year-old female patient. Medical history included diabetes (type 2), high blood pressure, myotonia and hives with sulfa drugs, KEFLEX, pork derived Hepaarin, codeine, ZOLOFT and WELLBUTRIN. This poly medicated patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) into his left arm on 05 Nov 2014. On 08 Nov 2014 after the vaccination, she had itching which was severe for 3 days then lighter for each day thereafter. It intensified in the evenings. The final outcome of the event was not reported. The event was reported as non serious. Causality of the event was not reported.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Heart rate increased, Influenza like illness, Pyrexia, Sleep disorder due to a general medical condition
Clinical narrative: Case number PHHY2015US028995, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554430) website on 05 Mar 2015: This report refers to a 56 years old female patient. Current condition includes diabetes, Wolff-Parkinson-White (WPW) syndrome and sleep apnea (all events under control). Concomitant medication included LEVEMIR, NOVOLOG and metformin. On 18 Nov 2014, the patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscularly in the right arm. On the same day, she had fever, chills and flu-like symptoms. In the middle of the night (4 AM) she woke up with rapid heart rate. Outcome of the events was reported as complete recovery. The events were reported as non-serious. Causality of the events was not reported.
Age: 11.0
Sex: F
Vaccine: FLUX, HPV4, MNQ, TDAP
Symptoms: Posture abnormal, Syncope
Clinical narrative: Case number PHHY2015US028550, is an initial spontaneous report received from a physician via the Vaccine Adverse Event Reporting System (VAERS reference number: 554444) website on 05 Mar 2015. This report refers to an 11-years-old female patient. Current condition included unspecified prophylaxis. Concomitant medication included tuberculin purified protein derivative. On 23 Oct 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown), DTaP vaccine (other manufacturer, batch number: unknown), meningococcal vaccine (manufacturer and batch number: unknown; hence conservatively taken as meningococcal ACYW-1355 vaccine INN); all vaccines given on 23 Oct 2014. She also received GARDASIL (other manufacturer, batch number: K004205, expiry date: 12 Jan 2017) at a dose of 0.5 ml intramuscularly on the same date. The GARDASIL was the last vaccine that was given on 23 Oct 2014. On 23 Oct 2014, 5 minutes after being vaccinated with GARDASIL, the patient fainted. She was in sitting position and her head went back as she fainted. No other symptoms were reported. She did not seek medical attention and no treatment was given. The outcome of events was unknown. The events were reported as non-serious. Causality of the events was not reported.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2015US026419, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554476) website on 05 Mar 2015. This report refers to a 54 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 07 Oct 2014. On the same date, the patient experienced arm pain which she still had 5 weeks after shot. The outcome of the event was not reported. The event was reported as non-serious. Causality of the event was not reported.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2015US029163, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 554525) website on 05 Mar 2015. This report refers to a 48-year-old male patient. The patient's concurrent condition included IDDM-insulin controlled (insulin-dependent diabetes mellitus). Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into left arm on 22 Oct 2014. The patient was vaccinated with PNEUMOVAX 23 (other manufacturer, batch number: K009809) intramuscularly into left deltoid on 28 Oct 2014. On 29 Oct 2014, the patient developed redness and some swelling with pain in left upper bicep to antecubital. On 30 Oct 2014, the patient called PCP's (primary care physician) office and reported having this reaction. The patient visited emergency room due to the events. Redness to upper forearm was noted by PCP during examination. The outcome of the events was reported as unknown. The events was reported as non-serious. Causality of the events was not reported.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Joint swelling, Pain, Pain in extremity
Clinical narrative: Case number PHHY2015US028996, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 554719) website on 05 Mar 2015. This report refers to a 67 year old female patient. Current condition included food allergy to soft shelled crabs. Concomitant medication was not reported. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) in left arm on 11 Nov 2014. On the same day, she experienced chills and body aches. Approximately 28 hours after vaccination, severe pain began in right wrist and swelling of top of the hand. Pain and swelling began to subside after 24 hours. She started experiencing pain and swelling behind right knee. After another 24 hours, the pain moved into right hip. The pain in hip subsided about five days after vaccination but she again developed pain and swelling in right wrist and hand. She also experienced pain in right hand fingers. As of the date of reporting the right hand remained painful and swollen. Outcome of right wrist swelling/swelling behind right knee, right wrist pain/pain behind right knee/pain into right hip, pain in right hand fingers, swelling of top of the hand was reported as condition unchanged. Outcome for body ache and chills was not reported. The events were reported as non-serious. Causality was not reported.