chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Angioedema, Eyelid oedema, Hypersensitivity, Rash generalised, Urticaria
Clinical narrative: Rash (face, body, arm) puffy eyes 5 minutes after given the 3 shots and Rotavirus by mouth. Given steroid right away 2mg/kg/dose and 1 dose of TYLENOL -> VS - stable, F.U Q 5-10 min: rash improved, swollen eyes, SPO2 normal HR 130/min.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vaccination complication
Clinical narrative: Rash (face, body, arm) puffy eyes 5 minutes after given the 3 shots and Rotavirus by mouth. Given steroid right away 2mg/kg/dose and 1 dose of TYLENOL -> VS - stable, F.U Q 5-10 min: rash improved, swollen eyes, SPO2 normal HR 130/min.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Fatigue, Pyrexia
Clinical narrative: Patient described feeling weak/fatigue, having fever and joint pain starting approximately 1 day after receiving vaccination. Symptoms lasted approx 3 days. Patient did not self medicate or seek treatment.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (Medical Assistant) refers to an unspecified number of patients (age and gender unknown). The healthcare worker stated that these patients received improperly stored GARDASIL (lot# not reported, 0.5 ml, once, intramuscularly) between 17-DEC-2014 and 05-JAN-2015. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via agency refers to a 68 year old female patient. The patient's relevant medical history and past drug history were unknown. On 21-DEC-2014 the patient was vaccinated with ZOSTAVAX (lot# and expiration date not reported), a "standard dose" one time in the left arm. Concomitant medications were unknown. On 23-DEC-2014, the patient noticed golf ball sized swelling and redness at the site of injection. The patient had not had any testing or received any treatment for the golf ball sized swelling and redness. As of 23-DEC-2014, the patient would not continue on the ZOSTAVAX as it was a "one time" injection and had not recovered from the gold ball sized swelling and redness at the site of injection. The events were not potentially serious. Additional information has been requested.
Sex: U
Vaccine: HPV4, TDAP
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: With 12 hours of HPV, tetanus, and PPD developed low grade fever, vomiting, diarrhea.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker (Medical Assistant) refers to an unspecified number of patients (age and gender unknown). The healthcare worker stated that improperly stored PROQUAD (Merck) (administration/dosage details unspecified)had been possibly administered to these patients between 17-DEC-2014 and 06-JAN-2015. Concomitant medications were not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker (Medical Assistant) refers to an unspecified number of patients (age and gender unknown). The healthcare worker stated that improperly stored M-M-R II (administration/dosage details unspecified) had been possibly administered to these patients between 17-DEC-2014 and 05-JAN-2015. Concomitant medications were not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: HEPA, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No reaction reported, incorrect dose given. Given Tdap, should have been Dtap.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 30-DEC-2014, the patient was administered an expired dose of M-M-R II albumin (dose, route of administration, anatomical location were not reported) batch # J008882, lot # 0293AA expiration date 27-JUL-2014. No adverse events were reported. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Feeling abnormal, Feeling cold, Muscular weakness, Tremor
Clinical narrative: I was administered the pneumococcal vaccine (23-valent) because I have asthma. At the time when the vaccine was administered (approximately two months ago), I was 42 years old and an otherwise healthy female. About 5 minutes after getting the vaccine, I felt cold and shaky all over, and my head was spinning. I had diarrhea all of sudden. I was extremely dizzy and my thinking became very foggy. It was hard to sit up and my legs felt like jello.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Vertigo
Clinical narrative: I was administered the pneumococcal vaccine (23-valent) because I have asthma. At the time when the vaccine was administered (approximately two months ago), I was 42 years old and an otherwise healthy female. About 5 minutes after getting the vaccine, I felt cold and shaky all over, and my head was spinning. I had diarrhea all of sudden. I was extremely dizzy and my thinking became very foggy. It was hard to sit up and my legs felt like jello.
Age: 1.25
Sex: F
Vaccine: HEPA, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Incorrect dose, given Tdap, should have been DTaP. No adverse reactions reported.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: ZOSTAVAX given on 11/14/14. Patient started with rash on "1st part of December 2014".
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: ZOSTAVAX given on 11/14/14. Patient started with rash on "1st part of December 2014".
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified numbers of patients of unknown age and gender. Concomitant medication and current conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of PROQUAD (Merck) Lot number K005648, expiration date: 17-OCT-2015 (dose and route not reported). Concomitant medication was not provided. No adverse effects reported. This is one of several reports 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 as received from a pharmacist refers to a patient of unknown age and gender. On 30-DEC-3014, the patient was vaccinated with a dose of ZOSTAVAX lot # K018172, expiration date 02-DEC-2015 (route was not provided). On 30-DEC-2014, an improperly stored dose of ZOSTAVAX was administered to a patient. No adverse effects were reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report as received from a female patient refers to herself of unknown age. On 16-DEC-2014 the patient was vaccinated with M-M-R II (strength, dose, route, lot number not report) advised by her physician (form not reported). The patient reviewed her medical file from her home country. After reviewing her file the patient had already been vaccinated, and this vaccination was a monovalent for each disease measles, mumps, and rubella. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 2 month old patient of unknown gender. Medical history and current conditions were not reported. On 12-DEC-2014 the patient, who was 2 months old, was vaccinated with a dose of VARIVAX (Merck) (route, lot number and expiration date were not reported). Concomitant medication was not provided. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Concomitant medication and current conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of PROQUAD (Merck) Lot number K004712, expiration date: 02-OCT-2015, (dose and route not reported). Concomitant medication was not provided. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Tinnitus, Vision blurred
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 year old female patient with drug reactions or allergy to diethyltoluamide (product reported as DEET). The patient had no pertinent medical history. On 05-JAN-2015 the patient was vaccinated with a first dose of GARDASIL 0.5 ml, intramuscular, lot # K009482, expiry: 06-MAR-2017. There was no concomitant medication. On 05-JAN-2015 within 30 seconds to 2 minutes after receiving GARDASIL the patient experienced ringing in both of her ears, became "hot and sweaty", became dizzy and her vision was blurred. The patient was still at physician's office when the symptoms occurred. There was no treatment given for the events and no lab diagnostic studies were performed. The patient recovered from adverse events on 05-JAN-2015 within 5 to 6 minutes. Relatedness between the events and GARDASIL was not specified. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Concomitant medication and current conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX (Merck) Lot number J012375 and expiration date 03-OCT-2015 (dose and route were not reported). Concomitant medication was not provided. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old male patient. The patient's medical history included hip replacement, prostate cancer and unspecified reaction to penicillin. On 24-NOV-2014, the patient was vaccinated with ZOSTAVAX (dose, lot#, expiration date, route and site of administration were not reported). There was no concomitant medication. On 01-DEC-2014 (reported as a week after), the patient felt sick. No lab diagnostic studies were performed. The patient did not seek medical attention and no treatment was given. The outcome of event was reported as recovered/resolved on 08-DEC-2014 (reported as a week later). The relatedness between the event and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Concomitant medication and current conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL (route, dose, lot number and expiration date were not reported). Concomitant medication was not provided. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: This spontaneous report as received from a female consumer of unknown age referring to herself. Pertinent medical history, drug reactions or allergies were unspecified. The patient reported having had shingles. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. On an unknown date the patient experienced mild recurrence of shingles and post herpetic neuralgia (reported as PHN). The patient also reported that she had temporary relief after the vaccination with ZOSTAVAX. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected because no reporter details were provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Concomitant medication and current conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX (Merck) Lot number K009756 and expiration date: 09-JUL-DEC-2014 (dose and route were not reported). Concomitant medication was not provided. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.31
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Red, warm and induration starting around 6pm on 1-2-15. Tender to touch. Location site LVL.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (also reported as a licensed practical nurse) refers to unspecified patients of unknown age and gender. No medical history or concurrent condition were reported. On unknown dates, the patients were vaccinated with (Oka/Merck) VARIVAX, injection (dose, frequency, strength and lot number were not provided). Co-suspect or concomitant therapies were not provided. The VARIVAX vaccines administered to the patients underwent a supported temperature excursion. No adverse experiences reported. At the time of the report, the outcome of the event was unknown. 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 Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Concomitant medication and current conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (dose, route, lot number and expiration date were not reported). Concomitant medication was not provided. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Muscle twitching, Oedema peripheral, Weight decreased, Weight fluctuation, Weight increased
Clinical narrative: Case number PHHY2013US140526 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 506974) website on 03 Dec 2013. This report refers to a 24-year-old female patient. Her medical history included hospitalization for wisdom teeth removal in 2006. Concurrent condition included allergic to amoxicillin. Concomitant medication included PPD. She was vaccinated with FLUVIRIN (batch number: 122201A) on left arm on 01 Mar 2013. On the same day, she was also vaccinated with BOOSTRIX (other manufacturer and batch number: AC52B103BA) on right arm. On 18 Mar 2013, 17 days after vaccinations, she experienced bilateral edema of legs from knee down with 10 lb weight gain. It was also reported that the muscle twitching was noted during fluctuating weight loss period. She was still in process of weight loss. Primary medical doctor was in process of performing blood and urine testing. Outcome of the events was reported as condition unchanged as of 08 Apr 2013. Seriousness and causality of the events was not reported.
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Case number PHHY2013US127761 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 498308) website on 11 Nov 2013. This reports refers to a male patient of an unknown age. His medical history included diabetes mellitus 2, hyperlipidemia and current condition included benign prostatic hyperplasia (BPH). He was vaccinated with FLUVIRIN (batch number: 123204) intramuscularly, PNEUMOVAX (batch number: 1786AA) intramuscularly into right arm and ADACEL (batch number: C4009BA) intramuscularly into left arm on 14 May 2012. It was reported that the vaccine (unspecified) was administered to a patient of an inappropriate age. No other information was provided.
Sex: F
Vaccine: FLU3
Symptoms: Headache, Vertigo
Clinical narrative: Case number PHHY2013US127857 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 500429) web site on 11 Nov 2013. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1307601) intramuscularly in arm on 22 Aug 2013. On the same day, she experienced headache, head spinning and can see straight. The outcome of the events was reported as complete recovery on the same day. The seriousness and causality were not reported.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypersensitivity, Inflammation, Injection site inflammation, Pyrexia, White blood cell count increased
Clinical narrative: Case number PHHY2013US127884 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 501198) web site on 11 Nov 2013: This report refers to a 72 year old female patient. She used to take Iodine in the past. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1307601) intramuscularly in the right ar along with PNEUNOVAX (other manufacturer, batch number: H017759) intramuscularly in to the left arm on 27 AUG 2013. Three hours after receiving the vaccine she began to feel fever, and inflammation that spread across the top of her arm where the shot was given. She visited the physician who began treatment as an allergic reaction and ordered laboratory tests. Diagnostic test revealed increased white blood cell count (no values were reported) Treatment medication included Augmentin 500 mg. Final outcome of the events was reported as complete recovery. No further information about seriousness and causality was reported.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Insomnia, Pruritus
Clinical narrative: Case number PHHY2013US127887 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 501218) web site on 11 NOV 2013: This report refers to a 20 year old female patient. Her medical history was not reported and her concomitant medications included unspecified tuberculosis medications. She was vaccinated with FLUVIRIN 2013/2014 (batch number 1307601) intramuscularly in to the right ar on 23 AUG 2013. Within 48 hours of the vaccine being administered she complained of extreme itchiness, insomnia and coughing. She was recommended to try hydrocortisone cream and ZYRTEC for five days. Final outcome of the events was reported as condition unchanged as on 23 AUG 2013. No further information about seriousness and causality was reported.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Local swelling, Mobility decreased, Pyrexia
Clinical narrative: Case number PHHY2013US127900 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 501523) web site on 11 NOV 2013. This report refers to a 63-year-old male patient. His medical history and concomitant medications were not reported. HE was vaccinated with FLUVIRIN 2013/2014 (batch number not reported) and PNEUMOVAX (batch number not reported) on 04 SEP 2013. On the same day, he experienced fever more than 102.He also experienced right arm and armpit swelling. It was reported that he had to use his left hand to pick up his right arm. The event outcome was condition unchanged as of 05 SEP 2013. The seriousness and causality were not reported. No additional information was available.
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Insomnia, Pain in extremity
Clinical narrative: Case number PHHY2013US137901 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 501689) web site on 11 NOV 2013: This report refers to a 65-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1307701) intramuscularly in to the left arm on 03 SEP 2013. On 04 SEP 2013, her arm was very sore which prevented her from sleeping that night and there was a slight discoloration at the injection site. Final outcome of the events was reported as condition unchanged as on 06 SEP 2013. No further information about seriousness and causality was reported.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose normal, Headache, Hot flush, Hyperhidrosis, Vision blurred
Clinical narrative: Case number PHHY2013US127914, in an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 501851) web site on 11 NOV 2013. This report refers to a 60-year-old female patient. Her medical history was not reported. Her concomitant medications included clonazepam. She had no known drug allergies. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1307801) intramuscularly in the right arm on 09 SEP 2013. On the same day of vaccination, she experienced sweating, headache, blurred vision, hot flash. Her blood pressure and sugar levels were normal. The event outcome was condition unchanged as of 09 SEP 2013. The seriousness and causality were not reported.
Age: 22.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Night sweats
Clinical narrative: Case number PHHY2013US137673 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 502006) web site on 11 NOV 2013: This report refers to a 22-year-old female patient. Her medical history included asthma.  Her concomitant medications included Symbicort. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1308101) in to the right arm along with PNEUMOVAX (other manufacturer, batch number: H021941) in to the left arm on 07 SEP 2013. On the same night after vaccinations, she experienced night sweat. Final outcome of the event was reported as condition unchanged as on 10 SEP 2013. No further information about seriousness and causality was reported.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Case number PHHY2013US127700 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 502221) web site on 11 NOV 2013: This report refers to a female patient of unknown age. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number 307601) intramuscularly on 11 SEP 2013. On 12 SEP 2013, she returned to the pharmacy because there was swelling, redness and tenderness of about 2 inches in size, that started the same day after vaccination. Final outcome of the event was reported as condition unchanged as on 12 SEP 2013. No further information about seriousness and causality was reported.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Influenza like illness, Nausea, Tenderness, Vomiting
Clinical narrative: Case number PHHY2013US127725 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 502324) web site on 11 NOV 2013. This report refers to a 66-year-old female patient. Her medical history included allergic to Sulfa. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1307601) intramuscularly into right arm and PNEUNMOVAX (other manufacturer, batch number: H009825) intramuscularly into left arm on 03 SEP 2013. On the same day after vaccination, she experienced flu like symptoms including nausea and vomiting and left arm tenderness. On 05 SEP 2013, she experienced shortness of breath. She visited the emergency room due to these events. Outcome of the events was reported as recovered as of 10 SEP 2013. Seriousness and causality were not reported for the events.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Fatigue, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Case number PHHY2013US127727 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 502351) web site on 11 NOV 2013. This report refers to a 44-year-old female patient. She was an immune- suppressed patient. Her concomitant medication included HUMIRA. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1307601) into left arm and PNEUMOVAX (other manufacturer, batch number: unknown) into left arm on 10 SEP 2013. On 11 SEP 2013, she complained of severe pain at injection site. Her left upper arm was red, swollen, and tender. She also complained of fatigue, chills and flu like symptoms. Outcome of the events was reported as recovered. No seriousness and causality was reported for the events.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Case number PHHY2013US127727 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 502351) web site on 11 NOV 2013. This report refers to a 44-year-old female patient. She was an immune- suppressed patient. Her concomitant medication included HUMIRA. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1307601) into left arm and PNEUMOVAX (other manufacturer, batch number: unknown) into left arm on 10 SEP 2013. On 11 SEP 2013, she complained of severe pain at injection site. Her left upper arm was red, swollen, and tender. She also complained of fatigue, chills and flu like symptoms. Outcome of the events was reported as recovered. No seriousness and causality was reported for the events.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Muscle spasms, Myalgia, Thyroid disorder
Clinical narrative: Case number PHHY2013US127736 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 502365) web site on 11 NOV 2013: This report refers to a 57 year-old-male patient. His medical history and concomitant medications were not reported. He was not taking any other medications or received any other vaccinations other than annual influenza vaccination; however no adverse events were reported following these vaccinations. He was vaccinated with FLURVIRN 2012/2013 (batch number 123203 and expiry date: June 2013) in to the left arm on 31 OCT 2012. On 14 NOV 2012, he developed myalgia, weakness and musculature cramping. The symptoms progressed over two week period after vaccination. These symptoms persisted and only slightly improved after receiving a course of high dose prednisone prescribed by his local physician. Unfortunately the symptoms returned shortly after stopping the prednisone treatment. The local physician also determined slight thyroid dysfunction and SYNTHROID supplementation was initiated. Myalgia and weakness improved some but still persisted. Final outcome of the events was reported as condition unchanged as on 12 SEP 2013. No further information about seriousness and causality was reported.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Vision blurred
Clinical narrative: Case number PHHY2013US127767 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 502527) web site on 11 NOV 2013: This report refers to a 24-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1307901) intramuscularly in to the right arm on 15 SEP 2013. On the same day after vaccination she was not able to see and that her vision was blurry. She sat down and began to sweat intensely. At the tie 911 was called. Her vision became normal and she stopped sweating once paramedics arrived. Final outcome of the events was reported as complete recovery on the same day. No further information abut seriousness and causality was reported.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin discolouration
Clinical narrative: Case number PHHY2013US127654 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 502568) web site on 11 NOV 2013 with a follow up report from QA department (NVD QA reference number 265756) received on 14 JAN 2014. This report refers to a 63-year-old female patient. Her historical drug included cephalosporins. Concomitant drugs included PRO AIR and fluconazole. The patient was vaccinated with FLUVIRIN 2013/2014, bot intramuscularly in the left arm on 04 SEP 2013. On 06 SEP 2013, her arm became sore and red. On day 4 after vaccination , her arm was warm to touch, swollen, itchy and sore with whitish patch. Upon visiting, her doctor prescribed antibiotics and steroids. The outcome of the events reported as not recovered. The seriousness and causality of the events were not reported. The QA department reported the investigation summary as "based on the review performed the batch was manufactured in accordance with the approved internal procedures and in compliance with cGMP requirements".  Follow up report from QA department received on 14 JAN 2014: Updated the batch review report.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: Case number PHHY2013US127654 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 502568) web site on 11 NOV 2013 with a follow up report from QA department (NVD QA reference number 265756) received on 14 JAN 2014. This report refers to a 63-year-old female patient. Her historical drug included cephalosporins. Concomitant drugs included PRO AIR and fluconazole. The patient was vaccinated with FLUVIRIN 2013/2014, bot intramuscularly in the left arm on 04 SEP 2013. On 06 SEP 2013, her arm became sore and red. On day 4 after vaccination , her arm was warm to touch, swollen, itchy and sore with whitish patch. Upon visiting, her doctor prescribed antibiotics and steroids. The outcome of the events reported as not recovered. The seriousness and causality of the events were not reported. The QA department reported the investigation summary as "based on the review performed the batch was manufactured in accordance with the approved internal procedures and in compliance with cGMP requirements".  Follow up report from QA department received on 14 JAN 2014: Updated the batch review report.
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Malaise, Mobility decreased, Muscle tightness, Musculoskeletal pain
Clinical narrative: Case number PHHY2013US127674 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 502658) web site on 11 NOV 2013: This report refers to a 63-year-old female patient. Her medical history included hypothyroidism and allergy to penicillin. This poly medicated patient was vaccinated with FLUVIRIN 2013/2014 (batch number: 1307801) intramuscularly in to the right arm on 09 SEP 2013. On the same day after vaccination, her arm was achy. Two to three days after vaccination she felt "under the weather", on day four she had muscle tightness and pain in neck, bilateral shoulder and bilateral chest. She could hardly lift her arms and on day five she experienced vomiting in the morning. She felt better in the afternoon. Final outcome of the events was reported as complete recovery. No further information about serious and causality was reported.
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity, Vomiting
Clinical narrative: Case number PHHY2013US127674 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 502658) web site on 11 NOV 2013: This report refers to a 63-year-old female patient. Her medical history included hypothyroidism and allergy to penicillin. This poly medicated patient was vaccinated with FLUVIRIN 2013/2014 (batch number: 1307801) intramuscularly in to the right arm on 09 SEP 2013. On the same day after vaccination, her arm was achy. Two to three days after vaccination she felt "under the weather", on day four she had muscle tightness and pain in neck, bilateral shoulder and bilateral chest. She could hardly lift her arms and on day five she experienced vomiting in the morning. She felt better in the afternoon. Final outcome of the events was reported as complete recovery. No further information about serious and causality was reported.
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Cough, Gait disturbance, Joint swelling, Pyrexia
Clinical narrative: Case number PHHY2013US127684, is an initial spontaneous report received from the consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 502693) web site on 11 NOV 2013. This report refers to a 57-year-old female patient. Her medical history included asthma, celiac, high blood pressure and thyroid which were controlled by medication. Concomitant drugs included levothyroxine, montelukast, valsartan and hydrochlothiazide, meloxicam, potassium chloride and zolpidem. She was vaccinated with FLUVIRIN 2013/2013 (batch number: 1308401) intramuscularly in the left arm on 11 SEP 2013. On the same date, in the evening she noticed aching in joints. It was reported that the swelling and pain in joints grew worse each day. On 14 SEP 2013 at 10:20 AM, she went to the emergency room and she had fever of 101, she could barely walk and could not put weight on hands. On the same date, urine analysis showed negative result and she had no  nausea but had mild cough which was related to her asthma. It was reported that the pain was extreme. She was given a DEMEROL shot and was prescribed BENADRYL and TYLENOL. On 15 SEP 2013, at night she had a fever of 99.9 but at the time of reporting she did not have one. On 16 SEP 2013, the swelling and pain have decreased so that she could move around but it was still very swollen and painful. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLU3
Symptoms: Urine analysis normal, Weight bearing difficulty
Clinical narrative: Case number PHHY2013US127684, is an initial spontaneous report received from the consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 502693) web site on 11 NOV 2013. This report refers to a 57-year-old female patient. Her medical history included asthma, celiac, high blood pressure and thyroid which were controlled by medication. Concomitant drugs included levothyroxine, montelukast, valsartan and hydrochlothiazide, meloxicam, potassium chloride and zolpidem. She was vaccinated with FLUVIRIN 2013/2013 (batch number: 1308401) intramuscularly in the left arm on 11 SEP 2013. On the same date, in the evening she noticed aching in joints. It was reported that the swelling and pain in joints grew worse each day. On 14 SEP 2013 at 10:20 AM, she went to the emergency room and she had fever of 101, she could barely walk and could not put weight on hands. On the same date, urine analysis showed negative result and she had no  nausea but had mild cough which was related to her asthma. It was reported that the pain was extreme. She was given a DEMEROL shot and was prescribed BENADRYL and TYLENOL. On 15 SEP 2013, at night she had a fever of 99.9 but at the time of reporting she did not have one. On 16 SEP 2013, the swelling and pain have decreased so that she could move around but it was still very swollen and painful. The seriousness and causality of the events were not reported.
Sex: M
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash erythematous, Rash generalised
Clinical narrative: Case number PHHY2013US135791 is an initial spontaneous report from a consumer via Vaccine Adverse Event Reporting System (reference number: 502937) received on 25 NOV 2013 with a follow up information received from a consumer via vaccine adverse event reporting system on 24 JUL 2014. This report refers to a 71-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2012/2013 (batch number: 1206701) on 14 SEP 2013. On 15 SEP 2013, 01 day after vaccination, he started with a bright red rash and very severe itching which started with face and neck eventually going all the way to his toes over 10 days. He was told after getting flu shot by the county nurse that he would have problems with this vaccine due to having a preservative in it. He had a visit to emergency room due to these events. Outcome of the events was reported as recovered. The event was reported as non-seriousness and causality of the events was not reported.  Follow up information received from the vaccine adverse event reporting system on 24 JUL 2014. Suspect vaccine batch number and reported seriousness updated.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Joint stiffness, Mobility decreased
Clinical narrative: Case number PHHY2013US140161 is an initial spontaneous report received from the Vaccine Event Reporting System (VAERS reference number: 502989) website on 03 DEC 2013. This report refers to a female patient of an unknown age. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1308601)intramuscularly on 16 SEP 2013. On the same day, she was also vaccinated with PNEUMOVAX (other manufacturer, batch number: H013399) intramuscularly. On the same day, post vaccinations, she experienced stiffness of  joints in hands. Mainly in right hand in middle of pointer finger. It was reported that it was hard to close hand. Outcome of the events was reported as recovered. Seriousness and causality of the event was not reported.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site mass, Injection site swelling, Malaise
Clinical narrative: Case number PHHY2013US140170 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 502990) website on 03 DEC 2013. This report refers to a 58-year-old female patient. Her concurrent conditions included allergic to iodine and adrenaline. She had no vaccine allergies. Concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1302601) intramuscularly on left arm on 09 SEP 2013. On the same day, she was also vaccinated with PNEUNOVAX (other manufacturer, batch number H014561) intramuscularly on right arm. On the same day, post vaccinations, she started feeling sick (flu like) the event of shots and progressively developed a fever that peaked at 103. Also she experienced red lumpy swelling at pneumonia site. Outcome of the events was reported as condition unchanged as of 11 SEP 2013. Seriousness and causality of the event was not reported.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2013US140170 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 502990) website on 03 DEC 2013. This report refers to a 58-year-old female patient. Her concurrent conditions included allergic to iodine and adrenaline. She had no vaccine allergies. Concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1302601) intramuscularly on left arm on 09 SEP 2013. On the same day, she was also vaccinated with PNEUNOVAX (other manufacturer, batch number H014561) intramuscularly on right arm. On the same day, post vaccinations, she started feeling sick (flu like) the event of shots and progressively developed a fever that peaked at 103. Also she experienced red lumpy swelling at pneumonia site. Outcome of the events was reported as condition unchanged as of 11 SEP 2013. Seriousness and causality of the event was not reported.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Rash erythematous, Swelling
Clinical narrative: Case number PHHY2013US140178 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 503030) website on 30 DEC 2013. This report refers to a 62-year-old poly medicated female patient. Her concurrent conditions included anxiety, depression, chest pain, hypercholesteremia; hypertension and chronic pain. She was vaccinated with FLUVIRIN 2013/2014 (batch number 13392P) intramuscularly on right arm on 12 SEP 2013. On the same day, she was also vaccinated with ZOSTAVAX (other manufacturer and batch number: J003806) subcutaneously on left arm. On 13 SEP 2013, 01 day after vaccinations, she experienced swelling and red rash. It was reported that the vaccination site was not painful or hot but it was just red and itchy and that symptoms had improved. Final outcome of the events was reported as recovered. Seriousness and causality of the events was not reported.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Dizziness, Hyperhidrosis, Muscle contractions involuntary
Clinical narrative: Case number PHHY2013US140325 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 503429) website on 03 DEC 2013. This case refers to a 56-year-old patient of unspecified gender. The patient's medical history included treatment with Macrodantin and non-steroidal anti-inflammatory drugs (NSAIDS). Concomitant medications included SINGULAIR. She was vaccinated with FLUVIRIN 2013/2014 (batch number 1308601) and PNEUMOVAX (other manufacturer, batch number H013399) in left arm on 21 SEP 2013. The same day after vaccination the patient ws feeling faint, sweating, laid down and began having multiple back and abdominal contractions that lasted a total of 15 to 20 minutes. The patient refused trip to hospital. The outcome of the events was reported as complete recovery as of 21 SEP 2013. The seriousness and causality assessment of the events was not reported.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Feeling hot, Injection site hypoaesthesia, Injection site pain, Injection site warmth
Clinical narrative: Case number PHHY2013US137027 is an initial report received from vaccine adverse event reporting system (VAERS reference  number: 503463) on 25 NOV 2013. This report refers to a 55-year-old female patient. Concomitant medications include LEXAPRO, ,PROTONIX, Calcium w/s Vitamin D and ESTRADERM. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 13373P, expiry date; not reported) to left arm in 16 SEP 2013. The nurse was unable to local deltoid properly, hence the flu vaccine was erroneously given in left shoulder joint. Within 30 minutes she has developed warmth, numbness and pain at injection site. She has also developed warmth, stiffness in left face and axillary area. Outcome of the events were not reported. Seriousness and causality were not reported.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness
Clinical narrative: Case number PHHY2013US137027 is an initial report received from vaccine adverse event reporting system (VAERS reference  number: 503463) on 25 NOV 2013. This report refers to a 55-year-old female patient. Concomitant medications include LEXAPRO, ,PROTONIX, Calcium w/s Vitamin D and ESTRADERM. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 13373P, expiry date; not reported) to left arm in 16 SEP 2013. The nurse was unable to local deltoid properly, hence the flu vaccine was erroneously given in left shoulder joint. Within 30 minutes she has developed warmth, numbness and pain at injection site. She has also developed warmth, stiffness in left face and axillary area. Outcome of the events were not reported. Seriousness and causality were not reported.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site reaction, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: Case number PHHY2013US140372 is an initial report received from vaccine adverse event reporting systems (VAERS reference number: 503645) on 03 DEC 2013. This report refers to a 43-year-old female patient. She was vaccinated with FLUVIRIN 2011/2012 (batch number: 1101201; expiry date: not reported) intramuscularly to right arm on 04 OCT 2013. On the same day of vaccination there was a pinching sensation in the right arm about 2-3 inches below the shoulder. She could not reach all the way up and extending the arm out caused stiffness and pain. She reporting having a sore muscle the first day and then the pinching pain since then. She did not seek the care of a physician but tried to treat with ibuprofen, aspirin, cream, heat patches and a brace. Outcome of the events were reported as condition unchanged. Seriousness and causality were not reported.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Sensory disturbance
Clinical narrative: Case number PHHY2013US140372 is an initial report received from vaccine adverse event reporting systems (VAERS reference number: 503645) on 03 DEC 2013. This report refers to a 43-year-old female patient. She was vaccinated with FLUVIRIN 2011/2012 (batch number: 1101201; expiry date: not reported) intramuscularly to right arm on 04 OCT 2013. On the same day of vaccination there was a pinching sensation in the right arm about 2-3 inches below the shoulder. She could not reach all the way up and extending the arm out caused stiffness and pain. She reporting having a sore muscle the first day and then the pinching pain since then. She did not seek the care of a physician but tried to treat with ibuprofen, aspirin, cream, heat patches and a brace. Outcome of the events were reported as condition unchanged. Seriousness and causality were not reported.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Mobility decreased
Clinical narrative: Case number PHHY2013US139953 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 503712) website on 03 DEC 2013. This report refers to a 70-year-old female patient. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1308501) subcutaneously and PNEUMOVAX (batch number: 1947AA) both subcutaneously on 17 SEP 2013. On 20 SEP 2013, she had a big red patch 12 x 9 cm wide spreading entire upper arm. It was reported to the physician. She got both the shots in same arm and stated that other arm could not be used anymore. Seriousness and causality of the events were not reported.
Age: 28.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: Case number PHHY2013US139963 is an initial spontaneous report received via vaccine adverse event reporting system (VAERS reference number: 503714) on 03 Dec 2013. This report refers to a 28-year-old female patient. Her medical history included lupus, multiple sclerosis and epilepsy. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN, (batch number: 1308601) intramuscularly in the right arm and PNEUMOVAX, (batch number: J004747) intramuscularly in the left arm on 22 Sep 2013. On the same day, several hours after vaccination, her arm started to swell and become tender. The outcome of the event reported as condition unchanged. The seriousness and causality were not reported.