chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB with lot # M014925 Expiration date: 16-FEB-2019 (dose and anatomical location of administration were not reported). No concomitant therapy was provided. The temperature reported was 50.9F with a time frame of 8 hours. It was unknown if it was detected by a digital data logger. Some previous temperature excursions were reported; 49.6F for 14 hours and 34.9F for 24 hours. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Pt said his ankles were very painful right after getting the injection and the pain lasted approx. 24 hrs.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Immediate post-injection reaction, Injection site pain, Injection site reaction, Limb discomfort
Clinical narrative: After immediate administration of the flu vaccine in the deltoid, patient stated he felt dizzy and lightheaded. After a few minutes, patient left the pharmacy stating his arm hurt. Patient called the next day stating he feels "pain, burning, heaviness, and a tight feeling" in the injection area.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Skin tightness
Clinical narrative: After immediate administration of the flu vaccine in the deltoid, patient stated he felt dizzy and lightheaded. After a few minutes, patient left the pharmacy stating his arm hurt. Patient called the next day stating he feels "pain, burning, heaviness, and a tight feeling" in the injection area.
Age: 19.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Altered state of consciousness, Malaise, Posturing, Seizure, Syncope
Clinical narrative: Approx 5 mins past vaccinations with FLUARIX and BEXSERO. Patient stated she didn't feel well. She stated she felt like she was having a seizure then became syncopal with posturing. Regained consciousness within seconds. O2 Sat 100% with strong reg pulse. 911 called. Paramedics/transferred-pt declined ER visit. Fully alert, aware, stable at transfer.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with the improperly stored doses of VARIVAX lot # M006157, expiration date on 05-FEB-2018 (strength, dose number, route and anatomical location were not provided). No adverse events were reported. No product quality complaint was involved. Additional information is not expected since there was no consent for follow up.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist referring to a 63 years old male patient. The patient's medical history, concurrent condition and concomitant therapy were unknown. On 03-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 injection (lot # M024673, expiration date 17-NOV-2017, dose unknown) intramuscularly. On an unknown date in September 2016, after the administration, the patient experienced extreme pain at the injection site with inability to lift the affected arm, and also experienced fever of 102 Fahrenheit degree (F). No lab diagnosis was performed. The pain and fever resolved in 2 days without requiring treatment. The outcome of inability to lift the affect arm was unknown. The causality assessment between the events and PNEUMOVAX 23 was not reported. The pharmacist was requesting a lot check of lot # M024673. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site pain, Injection site swelling
Clinical narrative: Localized swelling, pain, cellulitis of (L) upper arm and shoulder.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: 4in circumference warm/red area near pneumovax injection site. Probably minor local reaction. 4in after 2 days - no growth after first day.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash, Scab
Clinical narrative: Pt. received MMR and Varicella (separate doses) 9/1. On 9/10 fever 102.5. 9/14 - rash on face/trunk/arms. Rash has continued and now had scabs on rash.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Blood pressure increased, Palpitations, Tremor
Clinical narrative: Pt became shaky (hands), developed increase in heart rate and blood pressure seconds after injection (BP was 234/94 and pulse was 51 after approximately 20 min). Felt better in - 30 min, went to see MD for blood pressure.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Red warm area size of half-dollar appeared at injection site at 8:00pm 9-19-16.  9-21-16 site reaction had grown to size of an orange. No pain, but it is warm to touch and itchy. patient marked the outlines and will seek care if uncomfortable or it get worse from here.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Crick in neck; no treatment, duration 4 days.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Erythema, Pallor, Papule, Rash
Clinical narrative: On 9/15, mother called to report rash on abdomen-tiny blanching red papules with no other symptoms.
Age: 0.83
Sex: M
Vaccine: FLU4
Symptoms: Crying, Hypotonia, Syncope
Clinical narrative: Pt received 1st Flu vaccine in clinic. Parents left office and shortly after called to report Pt began crying and then went limp and fainted after arriving home from office visit.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Patient develop a rash after getting chicken pox vacc. After 30 min. of getting vacc. pt's arm was itchie. Pt knew her allergic reaction to vaccine but Mom want her to get it. This date of service.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Muscular weakness, Pain in extremity, Pyrexia
Clinical narrative: Redness, tenderness to area of vaccination 6 hours after vaccination. (Rt. Deltoid). Worsening symptoms 24 hours after vaccination- Fever 102 degree F, spreading redness and pain to entire Rt. limb. Weakness to Rt. limb 36 hours after vaccination.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Vaccination site pain
Clinical narrative: Redness, tenderness to area of vaccination 6 hours after vaccination. (Rt. Deltoid). Worsening symptoms 24 hours after vaccination- Fever 102 degree F, spreading redness and pain to entire Rt. limb. Weakness to Rt. limb 36 hours after vaccination.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Dysgeusia, Dysphagia, Lymphadenopathy, Paraesthesia oral, Thyroid function test
Clinical narrative: Swallowing difficult-(subsided). Swollen glands-(subsided) (Thyroid med). Metal taste in mouth (still). Tongue tingly (still).
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 01-SEP-2016, the patient was vaccinated with an improperly stored dose of M-M-R II lot # L049316 (expiry date: 03-DEC-2017). No adverse reactions reported. No Product Quality Complain (PQC) was involved. This is one of 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 nurse refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 19-SEP-2016, the patient was vaccinated with an improperly stored PROQUAD lot # M018638 (expiry date: 11-OCT-2017). No adverse reactions reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. 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 pharmacist refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 17-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX vial, lot # L046295 (expiry date: 17-FEB-2017), subcutaneously (dosage not reported). No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information is not expected, as there is no consent to contact.
Sex: F
Vaccine: HEPA
Symptoms: Skin mass
Clinical narrative: Information has been received from a pharmacist referring to a 56 year old female patient, who was no pregnant. The patient had no drug reactions or allergies. Concurrent condition included losartan (manufacturer unknown). On 31-AUG-2016, the patient was vaccinated with a dose of VAQTA (dose unknown, frequency: reported as "once", lot # L017757, expiration date: 08-APR-2018) intramuscularly. On 31-AUG-2016, the patient had 3/4 inch nodule on left shoulder under skin which moved with palpation and was not too hard. No treatment was given for the event and no lab was performed. The outcome of the event was unknown. The causal relationship between the event and VAQTA was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication and drug allergies/reactions were not reported. On an unknown date, the patient was vaccinated with the first dose of VARIVAX (lot # and expiration date unspecified) at 11 months 3 weeks of age and a second dose of VARIVAX (lot # and expiration date unspecified) was administered at 10 years of age. No adverse effect reported. Additional information is not expected as the reporter did not wish to be contacted.
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist referring to a 73 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were unknown. On 07-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 (lot# M024673, expiration date 17-NOV-2017, dose unknown) intramuscularly. On the same day, 2 hours after the injection, the patient experienced extreme pain at the injection site with inability to lift the affected arm, and also experienced fever of 102 Fahrenheit degree (F). The patient was advised by pharmacist to take ADVIL and applied ice compresses. No lab diagnosis was performed. The outcome of the events was unknown. The causality assessment between the events and PNEUMOVAX 23 was not reported. The pharmacist was requesting a lot check of lot # M024673. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a pharmacist regarding his wife in late 60s (patient) as a part of market research. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date in 2010 the patient was vaccinated with one dose of ZOSTAVAX. On an unknown date in 2015, the she experienced mild case of shingles after being vaccinated with ZOSTAVAX. Shingles only lasted two days. The patient recovered with sequelae from the event, three days after the onset, on an unspecified date in approximately 2015. The action taken was reported as none. The causal relationship between the event shingles and ZOSTAVAX was unknown. Additional information is not expected, as the consent was not given for further correspondence.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to multiple patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 21-JUN-2016, multiple unspecified patients received improperly stored ROTATEQ lot # L013204, expiration date: 28-JAN-2017, via oral (concentration, dose and frequency were not reported) with a temperature of 10.2 degrees Celsius for 6 hours, 35 minutes due to digital data logger. Additionally previous excursions were reported on 09-AUG-2016 with a temperature of 1.4 degrees Celsius for 53 minutes and also on 15-AUG-2016 with a temperature of 1.5 degrees Celsius for 29 minutes. No adverse effects were reported. Information regarding concomitant medication was not reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: This solicited report was received from a physician regarding a 60 year old male patient who was a part of a market research program. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date in 2016, the subject received ZOSTAVAX (1 dose, injection, once) for Herpes zoster. It was reported that on an unspecified date in 2016, the patient came down with a 'self contained' injection site reaction and shingles. The outcome of the events was reported as recovered with sequelae 3 days after event onset (2016). The causal relationship between the events and ZOSTAVAX was unknown. Additional information is not expected due to lack of consent.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 19-SEP-2016, the patient was vaccinated with an improperly stored PROQUAD lot # M018638 (expiry date: 11-OCT-2017). No adverse reactions were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Local reaction, Skin warm
Clinical narrative: Pt called AM on 5/25/16 and then came to clinic at 16:28 on 5/25/16 with c/o red arm, swollen. Localized reaction to PNA vaccine, patient rapidly assessed with mild erythema and warmth nontender from AC fossa upward anterior bicep. Advised cool compresses, elevation, ALEVE, diphenhydramine 12.5 mg q 6 hrs PRN. And mild erythema.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot number, expiration date, dose and route were unknown). The vaccines were exposed to 30.2 F for an unspecified amount of time. No adverse effects were reported. No PQC was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot number, expiration date, dose and route were unknown). The vaccines were exposed to 30.2 F for an unspecified amount of time. No adverse effects were reported. No PQC was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored (exposed to -8 centigrade for 78 hours and previous excursion of 2 centigrade for 24 hours) VARIVAX (lot number reported as M024701, expiration date: 18-MAY-2018, route and dose were unknown). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of VAQTA (lot number, expiration date, dose and route were unknown). The vaccines were exposed to 30.2 F for an unspecified amount of time. No adverse effects were reported. No PQC was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash papular
Clinical narrative: This spontaneous report as received from a physician refers to a 65 year old female patient. The patient's medical history and concurrent conditions were not reported. On 12-FEB-2013, the patient was vaccinated with ZOSTAVAX (lot# reported as H01996) dose 2, (route: subcutaneous) to the back of left arm. Concomitant therapies included acetaminophen, aspirin, diltiazem and dronedarone hydrochloride. On 20-AUG-2016, the patient experienced papulovesicular rash on T10, T11 and T12 distribution with pain. The outcome of the events was unknown. The causality of the events were not reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. No concurrent conditions, medical history and concomitant medications were reported. On 13-MAR-2016 the patient was vaccinated with first dose of GARDASIL 9 (unspecified lot and expiration date) (dosing regimen and frequency unknown). On 14-MAR-2016 and 13-MAY-2016 the patient was vaccinated with second and third doses of GARDASIL 9 (unspecified lot and expiration date) (dosing regimen and frequency unknown). No adverse effects reported. No product quality complaint (PQC) filed. Additional information has been requested.
Age: 1.58
Sex: M
Vaccine: DTAP, FLU4, HIBV
Symptoms: Rash
Clinical narrative: Rash to back, stomach, and neck BENADRYL 25mL and TYLENOL 3.6mL given. Patient observed for 15 minutes.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Pain, Skin warm
Clinical narrative: Received Tdap Monday. Tuesday mild redness and by Wednesday it was larger. Area of redness increased an was warm to the touch. Some soreness. 12.5x7 Erythema, 4.5x3 cm induration. MOTRIN and BENADRYL w/warm compresses.
Age: 26.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Erythema, Feeling abnormal, Pruritus, Skin lesion
Clinical narrative: 25 yo healthy female who received SPV and anthrax vaccine 8 days ago with dermatitis (onset day 6) to arms, particularly flexor surface, now on anterior tibial area (R), one lesion to chest wall, popular, initially pruritic, nonpainful and feeling poorly. She was sent home from work due to health concerns. They are sending her to the ER for evaluation. I telephones the patient, received and reviewed photos, and reviewed with Medical Director. Photos demonstrate popular mildly erythematous lesions to left arm, primarily at antecubital with fewer distal lesions, one to chest wall and not particularly visible to anterior tibial. Lesions are discrete, no vesicles or pustules.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Warmness and redness further down arm from injection site. Started showing within 48 hours.
Age: 80.0
Sex: F
Vaccine: FLUX
Symptoms: Disorientation, Feeling abnormal, Laboratory test abnormal, Pain, Panic attack
Clinical narrative: Case number PHHY2016US110299, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 610684) on 11 AUG 2016. This report refers to an 80 year old female patient. Medical history was not reported. Past medications included, 625 mg cream of Premarin (conjugated estrogens tablets, batch number: J87776. expiration date: May 2016, indication: vaginal dryness) squeeze from tube onto finger nightly before bed and Prozac for depression, Paxil, lorazepam and antihypertensive and also clonazepam. Concurrent conditions included temporomadibular joint syndrome (TMJ), obsessive compulsive disorder, depression, anxiety and she had no sex in fifteen years. The patient had also received an unknown name product medication which had an applicator as well. Concomitant medications were not reported. The patient was vaccinated with Seasonal Influenza Virus vaccine (manufacturer and batch number: not reported) on an unknown date in 2016. After vaccination, the patient experienced a pain which was so bad, feeing really bad, disoriented and panic attack. Laboratory investigation includes unspecified test performed by gynecologist on an unspecified date, result reported as vaginal dryness. Corrective treatment was not reported. At the time of the report, outcome of the event was reported as unknown. Seriousness of the events were reported as non serious. Causality of the events were not reported.
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Arthritis
Clinical narrative: Case number PHHY2016US110279, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS) reference number: 610973) on 11 Aug 2016. This report refers to a 62 year old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with Seasonal Influenza Virus vaccine (manufacturer and batch number: not reported) on an unknown date. It was reported that the patient had been strenuously hiking two days before vaccination. Following vaccination, the patient experienced pain in both knees. The patient experienced sever arthritis in knees for two months. The patient had not consulted a physician. Lab details and corrective treatments were not reported. The outcome of events were recovered. Seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Case number PHHY2016US110731 is an initial spontaneous report case received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 610975) website on 11 Aug 2016. This report refers to a female patient of an unknown age. Medical history and concomitant medication was not reported. The patient was vaccinated with seasonal influenza virus vaccine (manufacturer: unknown, batch number: not reported) on an unknown date (reported as in the past year it contained some kind of aspirin product. On an unspecified date, the patient had experienced swelling of her whole arm with heat and pain. The lab investigation and corrective treatments were not reported. The patient illness at the time of vaccination, pre-existing diagnosed allergies and birth defects were not reported. The outcome of events was reported as completely recovered. The seriousness and causality of events was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Case number PHHY2016US110709 is an initial spontaneous case received from consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 610986) website on 11 Aug 2016. This report refers to a male patient of unknown age. Medical history and concomitant medication was not reported. The patient was vaccinated with seasonal influenza virus vaccine (manufacturer unknown, batch number: not reported) on an unknown date. On an unspecified date, the patient was not feeling well. The corrective treatment and laboratory test was not reported. The outcome of event was reported as unknown. The seriousness of event was reported as non serious. The causality of event was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Nasopharyngitis
Clinical narrative: Case number PHHY2016US110325 is an initial spontaneous case received from consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 611158) website on 11 Aug 2016. This report refers to a female patient of an unknown age. The patient historical drug included BETASERON, COPAXONE and AVONEX. The patient was vaccinated with seasonal influenza virus vaccine (manufacturer: unknown, batch number: not reported) on an unknown date. On an unspecified date, patient had cold like symptoms (felt sick). The patient visited emergency room on an unknown date. The corrective statement and laboratory investigations were not reported. The seriousness of event was reported as non serious. The outcome and causality was not reported.
Sex: U
Vaccine: FLUX
Symptoms: Dyspnoea
Clinical narrative: Case number PHHY2016US110286, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 611181) on 11 Aug 2016. This report refers to a patient of unknown age and gender. Medical history and concomitant medications were not reported. The patient was vaccinated with Seasonal Influenza Virus vaccine (manufacturer and batch number: not reported) on an unknown date. On an unspecified date after vaccination, the patient could not breathe. Laboratory investigations and corrective treatments were not reported. At the time of this report the outcome of event was reported as unknown. Seriousness of the event was reported as non serious and causality of the event was not reported. Seriousness of the event dyspnoea was upgraded based on available information in the source document.
Sex: U
Vaccine: FLUX
Symptoms: Dyspnoea, Feeling hot
Clinical narrative: Case number PHHY2016US110292, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 611188) on 11 Aug 2016. This report refers to a patient of unknown age and gender. Medical history and concomitant medications were not reported. The patient was vaccinated with Seasonal Influenza Virus vaccine (manufacturer and batch number: not reported) on an unknown date. On an unspecified date after vaccination, the patient experienced difficulty in breathing and felt warm. Laboratory investigations and corrective treatments were not reported. At the time of this report the outcome of events was reported as complete recovery. Seriousness of the events was reported as non serious and causality of the events were not reported. Seriousness assessment of the event dyspnoea was upgraded based on available information in the source document.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Arthritis, Influenza, Vaccination failure
Clinical narrative: Case number PHHY2016US110459, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 611191) website on 11 Aug 2016. This report refers to an unknown age of male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date (two years ago). Two months after the vaccination, the patient got the flu. The patient did not have any testing to determine the strain and was treated with TAMIFLU. The patient had arthritis in the shoulder (pointed to his left shoulder). The outcome, seriousness and causality of the events were not reported. Seriousness assessment of the events influenza and vaccination failure was upgraded to serious (medically significant) based on the information available in the source document.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Arthritis, Drug administered at inappropriate site, Influenza, Mobility decreased
Clinical narrative: Case number PHHY2016US110459, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 611191) website on 11 Aug 2016. This report refers to an unknown age of male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date (two years ago). Two months after the vaccination, the patient got the flu. The patient did not have any testing to determine the strain and was treated with TAMIFLU. The patient had arthritis in the shoulder (pointed to his left shoulder). The outcome, seriousness and causality of the events were not reported. Seriousness assessment of the events influenza and vaccination failure was upgraded to serious (medically significant) based on the information available in the source document.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Arthritis, Influenza, Vaccination failure
Clinical narrative: Case number PHHY2016US110385, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 611191) website on 11 Aug 2016. This report refers to an elderly old male patient. Prior to vaccination history included as, the patient vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) two years ago and experienced two months flu two months later and experienced arthritis (Refer case ID: PHHY2016US110459). Past medical history was not reported. Current condition included as arthritis. Concomitant medications was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into arm on an unspecified date two weeks ago. It was stated that, influenza vaccine was administered it too high, right into the joint. The patient could not move his arm and had been going to physician for therapy. Corrective treatment and laboratory data were not reported. The outcome of events was reported as unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Arthritis, Drug administered at inappropriate site, Influenza, Mobility decreased
Clinical narrative: Case number PHHY2016US110385, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 611191) website on 11 Aug 2016. This report refers to an elderly old male patient. Prior to vaccination history included as, the patient vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) two years ago and experienced two months flu two months later and experienced arthritis (Refer case ID: PHHY2016US110459). Past medical history was not reported. Current condition included as arthritis. Concomitant medications was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into arm on an unspecified date two weeks ago. It was stated that, influenza vaccine was administered it too high, right into the joint. The patient could not move his arm and had been going to physician for therapy. Corrective treatment and laboratory data were not reported. The outcome of events was reported as unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Bone pain, Musculoskeletal stiffness
Clinical narrative: Case number PHHY2016US110269, is an initial spontaneous report received from consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 611217) website on 11 Aug 2016. This report refers to a female patient of unknown age. Medical history and concomitant medication was not reported. The patient was vaccinated with Seasonal Influenza Virus Vaccine quadrivalent (manufacturer unknown, batch number not reported) on an unknown date. Following the vaccination, the patient experienced a lot of stiffness and her bones ached. The patient was treated with antibiotics for another condition. Lab data and corrective treatments were not provided. Outcome of the events was reported as complete recovery. Seriousness of the event was reported as non serious and causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHHY2016US111977 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 611449) on 11 Aug 2016. This report refers to a 49-year-old female patient. Medical history was not reported. Concomitant medications was not reported. The patient was vaccinated with Seasonal Influenza Virus Vaccine (manufacturer unknown, batch number not reported) on an unknown date. After vaccination experienced swelling an itching at site injection. The patient had not received any vaccine within 4 weeks prior to vaccination. Illness at the time of vaccination and adverse event following prior vaccination, adverse event prior vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were reported as none. At the time of this report, patient had recovered form events on an unspecified date. Seriousness of the event was reported as non serious. Causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Pain in extremity, Temperature intolerance
Clinical narrative: Case number PHHY2016US110289 is an initial spontaneous report received from consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 611455) website on 11 Aug 2016. This report refers to a female patient of an unknown age. Historical condition was not reported. Past medications included AVONEX on 01 Jan 1995, COPAXONE on 02 Jan 2000 and natalizumab on 01 Jan 2003. Current conditions included hypertension, diabetes and high cholesterol. Concomitant medications included Aspirin, JANUMENT and multiple medications for hypertension and high cholesterol. The patient was vaccinated with Influenza Virus Vaccine Seasonal (manufacturer unknown, batch number not reported) on an unknown date. It was reported that the patient legs were hurt and she was moved to south due to her intolerance to cold. On an unspecified date, the patient had experienced allergy. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of events was unknown. Seriousness of the events was reported as non serious and causality was not reported.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Nausea, Swelling
Clinical narrative: Case number PHHY2016US110306 is an initial spontaneous report received from another healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 614467) website on 11 Aug 2016. This report refers to a 21 year old female patient. Medical history was not reported. The patient's current condition included type 1 diabetes mellitus. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine (manufacturer: unknown, batch number: not reported) in left deltoid and PNEUMOVAX 23 (batch number: L014420) in the right deltoid on 06 Nov 2016. On 06 Nov 2016, after vaccination the patient developed pain in the right deltoid where patient received the shot had injection site pain, limited swelling and nausea. The patient visited physician in emergency room for medical attention and received ibuprofen as treatment. The patient recovered from the injection site pain, nausea and injection site swelling on 12 Nov 2015. All this events lasted for five days after treatment. The therapy with PNEUMOVAX 23 was not discontinued. The outcome of event nausea was reported as completely recovered. Seriousness of event was reported as non serious and causality of event was not reported.
Age: 13.0
Sex: U
Vaccine: FLUX, HEPA
Symptoms: Headache, Injection site pain, Ocular hyperaemia, Oropharyngeal pain, Pyrexia
Clinical narrative: Case number PHHY2016US110403, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 616057) website on 11 Aug 2016. This report refers to a 13 years old patient of unknown gender. Past medical history included drug reaction. Current condition included drug hypersensitivity and penicillin allergy. Concomitant medications were not reported. The patient was vaccinated with Seasonal Influenza vaccine (manufacturer unknown and batch number: not reported) along with VAQTA (other manufacturer, batch number: L015460, expiry date: 20 Jul 2017) in arm, both on 18 Nov 2015. On the same day after vaccination, the patient experienced sore arm at injection site, red eyes later in the day of vaccination. The patient also had additional symptoms including a fever of 102F, sore throat and headache. No treatment was given for the events. No lab diagnostics studies were performed. The patient visited the emergency room. The outcome of the events was unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported. The seriousness assessment of the event fever was upgraded based on information available in the source document.
Sex: F
Vaccine: HEP, FLUX
Symptoms: Diarrhoea, Headache, Injection site pain, Nausea, Vomiting
Clinical narrative: Case number PHHY2016US090513 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 626439) website on 20 Jun 2016. This report refers to a 28-year-old female patient. Historical condition included allergy to sulfa. Concomitant medication was not reported. The patient was vaccinated with Seasonal Influenza vaccine (manufacturer unknown, batch number; not reported) on an unknown date. After vaccination the patient experienced hives/swelling. Outcome of the events was not reported. Seriousness of the events was reported as non serious. Causality was not reported.
Sex: F
Vaccine: HEP, FLUX
Symptoms: Swelling, Urticaria
Clinical narrative: Case number PHHY2016US090513 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 626439) website on 20 Jun 2016. This report refers to a 28-year-old female patient. Historical condition included allergy to sulfa. Concomitant medication was not reported. The patient was vaccinated with Seasonal Influenza vaccine (manufacturer unknown, batch number; not reported) on an unknown date. After vaccination the patient experienced hives/swelling. Outcome of the events was not reported. Seriousness of the events was reported as non serious. Causality was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Discomfort, Hypersensitivity, Lymphadenopathy, Urticaria
Clinical narrative: Case number PHHY2016US086052, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 630006) website on 20 Jun 2016. This report refers to a female patient of unknown age. Past medical history was not reported. Current condition include allergy to chicken feathers. Concomitant medications were not reported. The patient was vaccinated with influenza vaccine seasonal (manufacturer unknown and batch number: not reported) on an unknown date. After vaccination, the patient experienced extreme allergic reaction: lymph nodes very swollen in neck/upper body with hives and significant discomfort for several days with much suffering. The outcome of the events extreme allergic reaction, lymph nodes very swollen in neck/upper body, discomfort and hives was unknown. The seriousness of the events were reported as non serious. The causality of the events were not reported.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain, Insomnia, Nuclear magnetic resonance imaging
Clinical narrative: Case number PHHY2016US084637, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 630233) website on 20 Jun 2016. This report refers to a 61-year-old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with Seasonal Influenza Virus Vaccine Inn (manufacturer unknown, batch number: not reported) in left arm (left shoulder) on 20 Oct 2015. On 21 Oct 2015 after vaccination the patient left shoulder was very painful, limited mobility and lost strength and sleepless night. The patient went to urgent care on 22 Oct 2015. X ray and magnetic resonance imaging (MRI) was performed (no result reported). The outcome of the events were condition unchanged. Seriousness of the cases was reported as non-serious and causality was not reported.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: X-ray
Clinical narrative: Case number PHHY2016US084637, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 630233) website on 20 Jun 2016. This report refers to a 61-year-old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with Seasonal Influenza Virus Vaccine Inn (manufacturer unknown, batch number: not reported) in left arm (left shoulder) on 20 Oct 2015. On 21 Oct 2015 after vaccination the patient left shoulder was very painful, limited mobility and lost strength and sleepless night. The patient went to urgent care on 22 Oct 2015. X ray and magnetic resonance imaging (MRI) was performed (no result reported). The outcome of the events were condition unchanged. Seriousness of the cases was reported as non-serious and causality was not reported.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Asthenia, Injection site pain, Insomnia, Mobility decreased, Nuclear magnetic resonance imaging
Clinical narrative: Case number PHHY2016US084637, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 630233) website on 20 Jun 2016. This report refers to a 61-year-old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with Seasonal Influenza Virus Vaccine Inn (manufacturer unknown, batch number: not reported) in left arm (left shoulder) on 20 Oct 2015. On 21 Oct 2015 after vaccination the patient left shoulder was very painful, limited mobility and lost strength and sleepless night. The patient went to urgent care on 22 Oct 2015. X ray and magnetic resonance imaging (MRI) was performed (no result reported). The outcome of the events were condition unchanged. Seriousness of the cases was reported as non-serious and causality was not reported.
Age: 57.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Injected limb mobility decreased, Limb discomfort, Pain in extremity, Sleep disorder
Clinical narrative: Case number PHHY2016US084701, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 630352) on 20 Jun 2016. This report refers to 57 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with Seasonal Influenza Virus Vaccine Inn (manufacturer unknown, batch number: not reported) in upper right arm from 26 Oct 2015. On the same day, the patient's upper arm had been sore and it was still there till April, 2016. The patient also could not raise an arm high, the prick-insert was rather high on the upper arm, could not sleep on right side, discomfort while changing shirts and discomfort in upper arm. The outcome of the events were condition unchanged. Seriousness of the events were reported as non serious and causality of the events were not reported.
Age: 57.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Discomfort, Drug administered at inappropriate site, Limb discomfort, Mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2016US084701, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 630352) on 20 Jun 2016. This report refers to 57 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with Seasonal Influenza Virus Vaccine Inn (manufacturer unknown, batch number: not reported) in upper right arm from 26 Oct 2015. On the same day, the patient's upper arm had been sore and it was still there till April, 2016. The patient also could not raise an arm high, the prick-insert was rather high on the upper arm, could not sleep on right side, discomfort while changing shirts and discomfort in upper arm. The outcome of the events were condition unchanged. Seriousness of the events were reported as non serious and causality of the events were not reported.
Age: 57.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Sleep disorder
Clinical narrative: Case number PHHY2016US084701, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 630352) on 20 Jun 2016. This report refers to 57 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with Seasonal Influenza Virus Vaccine Inn (manufacturer unknown, batch number: not reported) in upper right arm from 26 Oct 2015. On the same day, the patient's upper arm had been sore and it was still there till April, 2016. The patient also could not raise an arm high, the prick-insert was rather high on the upper arm, could not sleep on right side, discomfort while changing shirts and discomfort in upper arm. The outcome of the events were condition unchanged. Seriousness of the events were reported as non serious and causality of the events were not reported.
Sex: F
Vaccine: FLUX, HEP, HEPA, FLUX, FLUX
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2016US085029, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 630361) website on 20 Jun 2016. This report refers to a 40 year old female patient. Past historical condition included irritable bowel syndrome and prior vaccine history of influenza (refer case: PHHY2016US085113) and patient experienced sore and Hepatitis A and Hepatitis B. Current conditions included allergies, mental illness. No concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer: unknown, batch number: not reported) on 28 Jan 2016 into arm. On the same day after vaccination the patient developed soreness at site of injection and surrounding area for some days no treatment. The outcome of event was reported as completely recovered. The seriousness of event was reported as non serious. The causality of event was not reported.
Sex: F
Vaccine: FLUX, HEP, HEPA, FLUX, FLUX
Symptoms: Hepatitis A, Hepatitis B, Injection site pain
Clinical narrative: Case number PHHY2016US085029, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 630361) website on 20 Jun 2016. This report refers to a 40 year old female patient. Past historical condition included irritable bowel syndrome and prior vaccine history of influenza (refer case: PHHY2016US085113) and patient experienced sore and Hepatitis A and Hepatitis B. Current conditions included allergies, mental illness. No concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer: unknown, batch number: not reported) on 28 Jan 2016 into arm. On the same day after vaccination the patient developed soreness at site of injection and surrounding area for some days no treatment. The outcome of event was reported as completely recovered. The seriousness of event was reported as non serious. The causality of event was not reported.