chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Nausea, Tremor
Clinical narrative: This spontaneous report was received from a 78 year old female patient with multiple allergies reporting on herself. In approximately December 2015, reported as 1 month ago, the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscular into the patient's left upper arm (lot number and expiration date were not provided). Concomitant therapy information was not provided. In approximately December 2015, the patient experienced a terrible drug hypersensitivity to PNEUMOVAX 23. 5 hours after the administration of PNEUMOVAX 23, the patient experience nausea and body-shaking. The next day, on an unknown date in December 2015, the patient felt ill and her left upper arm became red, hot and swollen. It was also difficult to raise her left arm. The patient called the doctor's office and was advised to be evaluated at a local urgent care facility. The patient did not go to the facility because she felt too sick to get out of bed. No treatment was given to the patient. There were no laboratory diagnostics studies performed. The patient inquired about the ingredients on the vaccine she might have reacted to, so she could add them to her allergy list. The symptoms gradually improved and resolved within 3 days (in approximately December 2015). The patient considered the event as related to the PNEUMOVAX 23. Additional information is not expected. There was no authorization to contact physician.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-OCT-2015, the patient was vaccinated with the involved in the temperature excursion dose of VAQTA (lot # L018499, expiration date: 25-FEB-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. In approximately July 2014 (reported as approximately 18 months ago), the patient was vaccinated with the first dose of GARDXASIL (dose, lot #, route of administration were not reported). No further doses of GARDASIL were administered to the patient. On 26-JAN-2016 (on the day of the report), the patient would be switched to GARDASIL 9 (dose, lot #, route of administration were not reported). A dose of GARDASIL 9 would be administered on 26-JAN-2016  and this would be counted as dose 2 of the HPV vaccination series. No symptoms were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 26-JAN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (dose, frequency and route were not reported) lot # L004014, expiration date 04-MAR-2017. No adverse effect has been has been reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-OCT-2015, the patient was vaccinated with the involved in the temperature excursion dose of VAQTA (lot # L018499, expiration date: 25-FEB-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.05
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash on forehead 10 minutes after vaccines, BENADRYL given, patient assessed before and after BENADRYL discharged home with mother.
Age: 36.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Burning sensation, Pain, Pain in extremity
Clinical narrative: (R) arm 3rd day post vaccine - painful - hurt to move. Pain and soreness got better a little at a time. Now have a burning sensation when lifting arm up and out. No treatment. Advise to see PCP.
Age: 24.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, soreness at site ((L) deltoid).
Age: 66.0
Sex: U
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: AFLURIA 2015-2016 - given 10/29/15. Pt. went to doctor 11/25/15. Has pain says shot hit the bursa in arm.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Rash papular
Clinical narrative: Cluster of crusted papulovesicular lesions on her left anterior chest at the level of the anterior axillary line.
Age: 1.31
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Herpes zoster, Injection site reaction, Rash papular
Clinical narrative: Rash noticed on right leg (1/28/16) - three clusters of papulovesicular lesions in a dermatomal distribution on her right lower leg consistent with shingles.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Mom notice redness and swelling today morning. Patient was complaining itchiness and pain.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Face oedema, Full blood count normal, Metabolic function test normal
Clinical narrative: Facial erythema, edema within 24 hours of MENACTRA.
Age: 1.34
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Local reaction, Rash
Clinical narrative: 1/25/2016 - patient received DTaP on left thigh. 1/26/2016 - patient developed swelling, redness and rash at injection site and rash on abdomen. 1/27/2016 - visit with PCP - instructed to give TYLENOL, ice compression, recheck 1 day. 1/28/2016 - mother reported local reaction is resolving.
Age: 24.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pain, Swelling, Tenderness
Clinical narrative: Pt complained of soreness and swelling and pain to the touch.
Age: 19.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 19 year old patient of unknown gender. The patient's concurrent conditions and medical history were not provided. On 18-AUG-2015, the patient was vaccinated with the first dose of RECOMBIVAX HB lot # L003193 (dose, route, anatomical site of vaccination and expiration date were not reported), then on 27-OCT-2015 the patient was vaccinated with the second dose of RECOMBIVAX HB lot # L003193 (dose, route, anatomical site of vaccination and expiration date were not reported). No adverse effects or product quality complain were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a currently 3 to 4 years old patient. On an unknown date, the patient was vaccinated with PEDAXHIB (2 months for dose 1, 4 months for dose 2, 6 months for dose 3, dose, frequency and lot number not provided). No adverse effects were reported. There was no product quality issue (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-OCT-2015, the patient was vaccinated with the involved in the temperature excursion dose of VAQTA (lot # L018499, expiration date: 25-FEB-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Rash, Rash erythematous, Skin irritation
Clinical narrative: This spontaneous case report was received from a pharmacist regarding a 66-year-old male patient. Patient had no pertinent medical history and no drug reactions/allergies. On 04-JAN-2016, the patient was vaccinated with PNEUMOVAX 23 (lot number L022262, expiry date 05-NOV-2016) 0.5 ml, intramuscularly in the upper right deltoid muscle. Concomitant therapy included FLOMAX. On 05-JAN-2016, the patient had an 'irritated', big red rash on his forearm. Patient sought medical attention-he contacted the pharmacist. No treatment was given for the events. No laboratory tests were done. The outcome of both the events was unknown. Causality assessment was not provided. No product quality complaint was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unknown patients of unknown age and gender. There was no concurrent condition or medical history reported. On an unknown date the patients were vaccinated with GARDASIL 9 (lot # L018351, expiration date 11-AUG-2017 and lot # L045711, expiration date 08-MAY-2017) (dosage, strength and route unknown). The vaccines were stored in temperature 1.65 degree centigrade for 15 minutes, 1.79 degree centigrade for 10 hours and 9.62 degree centigrade for 10 hours. No adverse effects was reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a currently 3 to 4 years old patient. On an unknown date, the patient was vaccinated with PEDVAXHIB (2 months for dose 1, 4 months for dose 2, 6 months for dose 3, dose, frequency and lot number not provided). No adverse effects were reported. There was no product quality issue (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a multiple unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck) lot # L004651, exp 11-FEB-2017, lot # K006135, 29-APR-2016. No adverse effects reported. Temperature of -12 degree centigrade, time frame of 94 hours and 50 minutes. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional referring to a patient of unknown age and gender. Pertinent Medical History/Drug Reactions/Allergies were not reported. On 27-JAN-2016 the patient was vaccinated with an expired dose of VAQTA (lot # K002831, expiration date: 15-JAN-2016) 1 ml, intramuscular. Concomitant medications were not reported. No adverse effects were reported. No further information was provided. Additional information has been requested (correspondence containing a request for additional information is scheduled.).
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' concurrent and historical conditions were not reported. Since 13-JAN-2016 doses of VARIVAX (Merck) (lot # L024250, expiration date 30-JUN-2017; lot # L027287, expiration date 21-JUL-2017), which were exposed to temperature outside of the recommended range (at -12.1 centigrade for 15 to 30 minutes) on 13-JAN-2016, had been administered (dose and route were unknown) to unspecified patients (Incorrect product storage). There were no temperature excursion issues previously. Concomitant therapies were not reported. No adverse experience was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' concurrent and historical conditions were not reported. Since 13-JAN-2016 doses of PROQUAD (Merck) (lot # L040412, expiration date 13-APR-2017), which were exposed to temperature outside of the recommended range (at -12.1 Centigrade for 15 to 30 minutes) on 13-JAN-2016, had been administrated (dose and route were unknown) to unspecified patients. There were no temperature excursion issues previously (incorrect product storage). Concomitant therapies were not reported. No adverse experience was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a multiple unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored PROQUAD (Merck) lot # L032760, expiry date 24-FEB-2017, L008355, 11-SEP-2016 expiry date, L031601 expiry date 18-FEB-2017. No adverse effects reported. Temperature of -12 degree Centigrade, time frame of 94 hours and 50 minutes. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy student refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, lot #, route of administration were not reported). The vaccine was stored for 72 hours at the temperature of 27 degrees Fahrenheit. No adverse effects were reported. Additional information is not expected as there is no consent to contact the reporter.
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse via a company representative and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with PEDVAXHIB (route, lot number and expiration date were not provided. Concomitant therapy information was not provided. On unknown dates, an extra dose was administered to the patients, the patients received a fourth dose of PEDVAXHIB. No adverse events were reported. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. On 21-JAN-2016, an unspecified number of patients were vaccinated with improperly stored doses of ZOSTAVAX Lot # L032184, expiration date 25-NOV-2016 (route, dose and anatomical location were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to multiple unspecified patients of unknown age and gender. Patients concurrent conditions, medical history and concomitant medications were unknown. It was reported that doses of PNEUMOVAX 23 Lot # L019836, expiry date 24-MAR-2017 (dose and route were not reported) that had been exposed to 34.4F for 2 hours and then back in the range, were given to unspecified patients on unspecified dates. It was also confirmed that the vaccine had no previous temperature excursion. It was unknown if the patients sought medical attention. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Keratitis
Clinical narrative: This spontaneous report was received from an Internet article, via Sanofi Pasteur MSD, concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. The article stated that, studying case reports from national and international registries, it was found at least 20 cases of patients, children and adults, that were vaccinated with Zoster vaccine (manufacturer unknown) (reported as "chickenpox and shingles vaccine") (dose, dose number, route, anatomical location, lot # and expiration dates were unspecified). On an unknown date, within a month after vaccination, the unspecified patients experienced corneal inflammation. The outcome of the event was unknown. The article stated that there was a link between the event and Zoster vaccine (manufacturer unknown). Additional information is not expected, no contact details were provided.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, and hot feeling at site of ZOSTAVAX injection.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a currently 3 to 4 years old patient. On an unknown date, the patient was vaccinated with PEDVAXHIB (2 months for dose 1, 4 months for dose 2, 6 months for dose 3, dose, frequency and lot number not provided). No adverse effects were reported. There were no product quality issue (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV, VARZOS, FLUX, PPV, VARZOS
Symptoms: Pain, Rash pruritic, Urticaria
Clinical narrative: Case number PHHY2015US147035 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 587765) on 02 NOV 2015. This report refers to a 65 year old female patient. Her current condition included seasonal allergies and sensitivity to LEVAQUIN. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported), pneumococcal polyvalent vaccine (other manufacturer, batch number: not reported) and 0.65 ml ZOSTAVAX (other manufacturer, batch number: not reported) subcutaneously; all vaccines administered on 31 OCT 2007. On 02 NOV 2007, she developed hives that were of the width of human hand and hives were all over her body. She stated that this was recurring since 2007 and she would be seeing a dermatologist in few days. She was treated with doxepin hydrochloride 25 mg. The final outcome of events was reported as condition unchanged. The events were reported as non-serious, but the event was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported
Age: 65.0
Sex: F
Vaccine: FLUX, PPV, VARZOS, FLUX, PPV, VARZOS
Symptoms: Urticaria
Clinical narrative: Case number PHHY2015US147035 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 587765) on 02 NOV 2015. This report refers to a 65 year old female patient. Her current condition included seasonal allergies and sensitivity to LEVAQUIN. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported), pneumococcal polyvalent vaccine (other manufacturer, batch number: not reported) and 0.65 ml ZOSTAVAX (other manufacturer, batch number: not reported) subcutaneously; all vaccines administered on 31 OCT 2007. On 02 NOV 2007, she developed hives that were of the width of human hand and hives were all over her body. She stated that this was recurring since 2007 and she would be seeing a dermatologist in few days. She was treated with doxepin hydrochloride 25 mg. The final outcome of events was reported as condition unchanged. The events were reported as non-serious, but the event was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Epistaxis, Rhinorrhoea
Clinical narrative: Case number PHHY2014US155382, is an initial spontaneous report received from the vaccines adverse events reporting system (VAERS reference number: 541841) on 13 Nov 2014. This report refers to a 3 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with AGRIFLU (batch number: not reported) on unspecified date. She was also vaccinated with Nasal FLUMIST (batch number: not reported) intranasal spray on unspecified date. It was reported that she had a blood clot with nasal mucous coming from nose. The outcome of the events was reported as complete recovery. The events were reported as non-serious by reporter. The causality of the events was not reported.
Age: 53.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Headache, Herpes zoster, Injection site erythema, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Case number PHHY2014US162472 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS ID: 543963) on 28 Nov 2014. This report refers to a 53 years old female patient. Her medical history included fibromyalgia. Her vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number: not reported) which were tolerated. Her concomitant medications were lisinopril, PROZAC, ESTRANORETH and trazadone. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and pneumococcal vaccine (other manufacturer, batch number: not reported) on 12 Sep 2014. On 13 Sep 2014, she was nauseated and her lungs to take a breath. She experienced headache with a red bump at the vaccination site. On 14 Sep 2014 the bump turned to 8x3 raised bump and was very hot to touch with a very stiff neck. She went to urgent care with a differential diagnosis of either shingles or an adverse reaction to the vaccination. It was reported that the rash grew and the site was still very hot to touch. The outcome of the events was reported as condition unchanged. The events were reported as non-serious. The causality of the events was not reported.
Age: 53.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Nausea, Painful respiration, Vaccination complication
Clinical narrative: Case number PHHY2014US162472 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS ID: 543963) on 28 Nov 2014. This report refers to a 53 years old female patient. Her medical history included fibromyalgia. Her vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number: not reported) which were tolerated. Her concomitant medications were lisinopril, PROZAC, ESTRANORETH and trazadone. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and pneumococcal vaccine (other manufacturer, batch number: not reported) on 12 Sep 2014. On 13 Sep 2014, she was nauseated and her lungs to take a breath. She experienced headache with a red bump at the vaccination site. On 14 Sep 2014 the bump turned to 8x3 raised bump and was very hot to touch with a very stiff neck. She went to urgent care with a differential diagnosis of either shingles or an adverse reaction to the vaccination. It was reported that the rash grew and the site was still very hot to touch. The outcome of the events was reported as condition unchanged. The events were reported as non-serious. The causality of the events was not reported.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Discomfort, Injection site erythema, Pain, Pyrexia
Clinical narrative: Case number PHHY2014US159698, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544321) website on 28 Nov 2014. This report refers to a 66-year-old female patient. Concurrent conditions included rheumatoid arthritis. Concomitant medications included methotrexate and RITUXAN. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 16 Sep 2014. On the same day after vaccination, the patient experienced high fever, aching body, general overall discomfort and developed a red patch below injection site about 3 inches square. She still had some fever two days later. The final outcome of the events was unknown. The events were reported as non-serious; Causality was not reported.
Age: 36.0
Sex: M
Vaccine: FLUX
Symptoms: Vertigo
Clinical narrative: Case number PHHY2014US159551, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 544395) website on 28 Nov 2014. This report refers to a 36-year-old male patient. His current conditions included hypothyroidism and depression. Concomitant drugs included reclipsen, WELLBUTRIN, meloxicam and Armour Thyroid. He was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) in the right arm on 17 Sep 2014. On 18 Sep 2014, he experienced vertigo which was first noticed when he bent down. The event continued for 2 days whenever he moved his head quickly. The outcome of the event was unknown. The event reported as non-serious. The causality of the event was not reported.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Injection site erythema, Joint swelling, Pain, Pain in extremity
Clinical narrative: Case number PHHy2014US159562, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544421) website on 28 Nov 2014. This report refers to a 42-year-old female patient. It was reported that no other vaccines were given to the patient during months prior to influenza vaccine and she did not receive any other medications. She was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on 16 Sep 2014. On the same date, after vaccination she experienced sore arm and approximately 1 cm in diameter of redness developed around injection site. On 17 Sep 2014 at approximately 06:00 am, her knees, elbows and other major joints started feeling sore, swollen and achy. She took 800 mg ibuprofen at 8:00 am and after 30-40 minutes, her pain level was still rising to the point where it was extremely painful to stand and walk. She went home from work at 9:00 am and rested, elevated legs and iced her knees. She took naproxen at 03:00pm. There was no significant pain relief. She could not stand for any significant time period without extreme pain. On 18 Sep 2014, her knees and elbows felt a little better in the morning. She took naproxen at 05:30 am and she was unable to determine whether it helped or not. The events swelling and aching at joints gradually felt better throughout day. On 19 Sep 2014, she almost felt 90-100% normal and anticipated feeling gradually better throughout today. The final outcome of the events reported as recovered. The events reported as non-serious. The causality of the events was not reported.
Age: 1.0
Sex: M
Vaccine: FLUX, MMR
Symptoms: Drug administered to patient of inappropriate age, Pyrexia, Rash
Clinical narrative: Case number PHHY2014US159584, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544507) website on 28 Nov 2014. This report refers to a 01-year-old male patient. On 09 Sep 2014, he was vaccinated with Seasonal Influenza vaccine (manufacturer and batch number: not reported) in the left arm along with MMR live vaccine (other manufacturer, batch number: not reported) in the right arm. This patient received influenza vaccine which should be given to persons more than 04 years of age. On 16 Sep 2014, he experienced fever more than 102 and rash covering face and chest. The final outcome of the events reported as not recovered. The events reported as non-serious. The causality of the events was not reported.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Headache, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Case number PHHY2014US163267 is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS ID: 544529) website on 28 Nov 2014. This report refers to a 49 year old male patient. His current conditions included high blood pressure and HIV. His concomitant medications included lisinopril, trazodone and ATRIPIA. On 18 Sep 2014, he was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into his right arm. On the same day after the vaccination, he developed sore throat, persistent cough, headache and runny nose. The outcome of the events was condition unchanged. The events were reported as non serious and causality of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Heart rate increased
Clinical narrative: Case number of PHHY2014US163294 is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS ID: 544556) website on 28 Nov 2014. This report refers to a 40 year old female patient. Her current conditions included sulfa allergy and concomitant medications included atenolol and levothyroxine. On 20 Sep 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported). On the same day after the vaccination, she had a rapid heartbeat and dizziness. The outcome of the events was complete recovery. The events were reported as non serious and causality of the events was not reported.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Pain
Clinical narrative: Case number PHHY2014US160795, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544557) website on 28 Nov 2014. This report refers to a 53 year old female patient. Her medical history included Meniere's disease and Ceclor allergy. She also had shingles several weeks prior and was on treatment with antiviral. She had no symptoms of shingles at the time of vaccine. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) intramuscularly into right arm on 17 Sep 2014. On 20 Sep 2014, she started to feel burning sensation at previous shingles site which progressed to very painful for 9 hours. The following day it was less painful. Events were reported as non-serious. Final outcome of the events was unknown. Causality assessment was not reported.
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Hypoaesthesia, Insomnia, Musculoskeletal pain, Swelling
Clinical narrative: Case number PHHY2014160830, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544558) website on 28 Nov 2014. This report refers to a 68 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 19 Sep 2014. On the same day he also received PNEUOVAX 23 (batch number: unknown, other manufacturer) into right arm. On the same day post vaccination he developed right shoulder soreness and could not sleep. The next morning he developed soreness, redness and severe swelling of bicep and tricep and also numbness in right hand first day after which did pass. Events were reported as non-serious. Final outcome of the events was condition unchanged as of 21 Sep 2014. Causality assessment was not reported.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Blister, Pruritus generalised, Rash generalised
Clinical narrative: Case number PHHY2014US156166, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544577) website on 28 Nov 2014. This report refers to a 65-year-old female patient. Medical history included congestive heart failure (2003). Concurrent conditions included penicillin allergy, diabetes and high blood pressure. This polymedicated patient received seasonal influenza vaccine (manufacturer and batch number: not reported) on 19 Sep 2014. On the same day after vaccination, she experienced itching on legs, armpits, back, head, arms and groin which progressed to a rash in the same areas. The itching and rash was more pronounced the next morning along with small blisters scattered around. She started taking 50mg BENADRYL every 4 hours which provided some relief. It was reported that the itching and blisters were very annoying. She was going to see a doctor. The outcome of the events was condition unchanged. Seriousness was not reported. Causality was not reported.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Dysgeusia, Erythema, Flushing, Palpitations
Clinical narrative: Case number PHHY2014US161238, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544686) website on 28 Nov 2014. This report refers to a 40 year old female patient. Her medical history was not reported. Concomitant medication included multivitamin. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) intramuscular into right arm on 22 Sep 2014. On the same day post vaccination she developed dizziness, heart palpitations, different taste in throat, lump feeling in throat, face was red and flushed and was seeing spots. Events were reported as non-serious. Final outcome of the events was completely recovered. Causality assessment was not reported.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Sensation of foreign body, Visual impairment
Clinical narrative: Case number PHHY2014US161238, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544686) website on 28 Nov 2014. This report refers to a 40 year old female patient. Her medical history was not reported. Concomitant medication included multivitamin. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) intramuscular into right arm on 22 Sep 2014. On the same day post vaccination she developed dizziness, heart palpitations, different taste in throat, lump feeling in throat, face was red and flushed and was seeing spots. Events were reported as non-serious. Final outcome of the events was completely recovered. Causality assessment was not reported.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Headache, Joint stiffness, Pyrexia
Clinical narrative: Case number PHHY2014US159626, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544694) website on 28 Nov 2014. This report refers to a 56 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 21 Sep 2014. On the same day post vaccination he experienced headache, fever and stiff hips, lower and upper back pain. Events were reported as non-serious. Outcome of the events was condition unchanged as on 23 Sep 2014. Causality assessment was not reported.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dizziness, Ear discomfort, Hyperhidrosis, Myalgia
Clinical narrative: Case number PHHY2014US159402, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 544839) website on 28 Nov 2014. This report refers to a 34 years old female patient. Medical history was not reported. Concomitant medications included Omega 3 fish oil, spironolactone and JUNEL FE. Her vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number unknown) on an unknown date and experienced sore arm (see case: PHHY2014US159403). She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) into right arm on 22 Sep 2014. On 23 Sep 2014, the patient experienced sore throat, dizziness, nausea, chills, sweating, muscle aches and felt like a cotton ball in her left ear. The events were reported as non-serious. Outcome and causality of the events was not reported.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Oropharyngeal pain
Clinical narrative: Case number PHHY2014US159402, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 544839) website on 28 Nov 2014. This report refers to a 34 years old female patient. Medical history was not reported. Concomitant medications included Omega 3 fish oil, spironolactone and JUNEL FE. Her vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number unknown) on an unknown date and experienced sore arm (see case: PHHY2014US159403). She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) into right arm on 22 Sep 2014. On 23 Sep 2014, the patient experienced sore throat, dizziness, nausea, chills, sweating, muscle aches and felt like a cotton ball in her left ear. The events were reported as non-serious. Outcome and causality of the events was not reported.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test, Bruxism, Excessive eye blinking, Grimacing, Muscle contractions involuntary
Clinical narrative: Case number PHHY2014US158289, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544859) website on 28 Nov 2014. This report refers to a 03-year-old female patient. Her concomitant drug included children multivitamin. She was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the right arm on 28 Oct 2013. On 31 Oct 2013, she experienced tic disorder with cringing, clenched jaw, hands balled into fists, excessive blinking and grimacing. It was reported that the disorder would change in frequency, at worse it occurred every 15 seconds and at best, a few times per day and for sometimes disappeared for weeks. The disorder has continued off and on for almost a year. The patient underwent blood and urine tests (results: not provided). She underwent neurology evaluation with two separate neurologists, not associated with each other and neurology evaluation and observation were ongoing. It was not known whether the disorder would increase, decrease or remain permanent. The outcome of the events reported as not recovered. The events reported as non-serious. The causality of the events was not reported.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Neurological examination, Tic, Urine analysis
Clinical narrative: Case number PHHY2014US158289, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544859) website on 28 Nov 2014. This report refers to a 03-year-old female patient. Her concomitant drug included children multivitamin. She was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the right arm on 28 Oct 2013. On 31 Oct 2013, she experienced tic disorder with cringing, clenched jaw, hands balled into fists, excessive blinking and grimacing. It was reported that the disorder would change in frequency, at worse it occurred every 15 seconds and at best, a few times per day and for sometimes disappeared for weeks. The disorder has continued off and on for almost a year. The patient underwent blood and urine tests (results: not provided). She underwent neurology evaluation with two separate neurologists, not associated with each other and neurology evaluation and observation were ongoing. It was not known whether the disorder would increase, decrease or remain permanent. The outcome of the events reported as not recovered. The events reported as non-serious. The causality of the events was not reported.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cold sweat, Fatigue, Headache, Pain
Clinical narrative: Case number PHHY2014US159659 is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 544916) website on 28 Nov 2014. This report refers to a 41 years old female patient. Her medical history included thyroid cancer and she had complete thyroidectomy in Mar 2013. Her concomitant medications included Synthroid 175 mcg daily. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on 22 Sep 2014. On 22 Sep 2014, the night of vaccination, she had chills, unexplained and significant fatigue and aches. She also had periodic headaches and was unusually thirsty. It was reported that fatigue, chills, and aches lasted through the following day. Two days after vaccination, on 24 Sep 2014, she had slight runny nose and cold sweats. She stated that her thyroid cancer and complete thyroidectomy might or might not have contributed to the after effects. The final outcome of events was reported as condition unchanged. The events were reported as non-serious. The causality of the events was not reported.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Rhinorrhoea, Thirst
Clinical narrative: Case number PHHY2014US159659 is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 544916) website on 28 Nov 2014. This report refers to a 41 years old female patient. Her medical history included thyroid cancer and she had complete thyroidectomy in Mar 2013. Her concomitant medications included Synthroid 175 mcg daily. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on 22 Sep 2014. On 22 Sep 2014, the night of vaccination, she had chills, unexplained and significant fatigue and aches. She also had periodic headaches and was unusually thirsty. It was reported that fatigue, chills, and aches lasted through the following day. Two days after vaccination, on 24 Sep 2014, she had slight runny nose and cold sweats. She stated that her thyroid cancer and complete thyroidectomy might or might not have contributed to the after effects. The final outcome of events was reported as condition unchanged. The events were reported as non-serious. The causality of the events was not reported.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Injection site bruising, Malaise, Pain
Clinical narrative: Case number PHHY2014US159752, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 545344) website on 28 Nov 2014. This report refers to a 53-year-old female patient. Medical history included glaucoma. Concurrent conditions included Graves Disease and hypertension. Concomitant medications included SYNTHROID and Aspirin. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 24 Sep 2014. On the same day after vaccination, she experienced headache, general malaise and had diffuse aching. The patient had 3 into 3 bruise at injection site. The final outcome of the events was recovered. The events were reported as non-serious; Causality was not reported.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Injected limb mobility decreased, Joint stiffness, Pain, Pain in extremity
Clinical narrative: Case number PHHY2014US160820 is an initial spontaneous report from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 545388) website on 28 Nov 2014. This report refers to a 38-year-old female patient. Historical conditions were not reported. Concomitant medications included EFFEXOR, WELLBUTRIN, PHENERGAN and ZOFRAN. Vaccination history included administration of influenza vaccine (manufacturer and batch number: not reported) and experienced pain (See case: PHHY2014US160849). She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into the left arm on 24 Sep 2014. On the same day after vaccination, she experienced localized pain. At approximately on 05:40 PM, she experienced throbbing pain in the area surrounding the joint and severe pain and stiffness in the joint itself. On 25 Sep 2014, in the morning her left arm was in severe pain and was unable to move her left arm to any appreciable degree. On 25 Sep 2014, the patient went to a general practitioner. She was prescribed acetaminophen and codeine along with instructions for follow up in a few days. No tests were performed. On 26 Sep 2014, the pain and lack of motion in left arm has not subsided and were with same intensity as on 25 Sep 2014. The final outcome of the events was unknown. The events were reported as non-serious; Causality was not reported.
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness postural, Fatigue, Impaired work ability, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: Case number PHHY2014US160994, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 545412) website on 28 Nov 2014. This report refers to a 37-year-old male patient. Medical history included astigmatism. Concomitant medications included BETAINE PLUS HP and digestive supplements. Vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number: not reported) and experienced events (See case: PHHY2014US161002). He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into the left arm on 22 Sep 2014. On the 23 Sep 2014, the patient experienced general aches which are most intense around neck and high on shoulders with stiffness. The patient had fatigue and severe dizziness with change of head position up or down from neutral. He woke with symptoms and they worsened slightly over 24 hours. They symptoms faded over next 24 hours. He missed work on 2nd day and by 3rd day only general fatigue, dizziness with change of head position up or down from neutral (faint/dizziness postural) and achiness remained. After 72 hours no symptoms remained except minor, localized tight spots at neck and shoulder trigger points. The outcome of the events was complete recovery. The events were reported as non-serious; Causality was not reported.