chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2014US055822, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 523377) website on 06 MAY 2014. This report refers to 16 year old male patient. On 10 DEC 2013, he was vaccinated with FLUCELVAX (batch number: 010031A) intramuscularly into left arm. No adverse event was reported following this maladministration  (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014 of the data received on 06 MAY 2014, it was identified that the BPI labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
Age: 15.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2014US055829 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 523513) website on 06 MAY 2014. This report refers to 15 year old male patient. On 27 NOV 2013, he was vaccinated with FLUCELVAX (batch number: 010031A) intramuscularly into left arm. No adverse event was reported following this maladministration (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014 of the date received on 06 MAY 2014, it was identified that the BPI labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
Age: 15.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Off label use
Clinical narrative: Case number PHHY2014US055878 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 524263) website on 06 MAY 2014. This report refers to a 15 year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX (batch number: 010011A) intramuscularly on 20 JAN 2014. He did not experience any adverse event following the maladministration (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 06 MAY 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "Drug use in unapproved population".
Age: 15.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Off label use
Clinical narrative: Case number PHHY2014US055833 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 524320) website on 06 MAY 2014. This report refers to 15 year old male patient. On 20 JAN 2014, he was vaccinated with FLUCELVAX (batch number: 010011A) intramuscularly. No adverse event was reported following this maladministration (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 06 MAY 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Caesarean section, Exposure during pregnancy, Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2013US023311 is an initial spontaneous report received from a pharmacist on 05 NOV 2013 and a follow up report from the Vaccine Adverse Event Reporting System (VAERS reference number: 525217) website on 06 MAY 2014, with a combined follow up received from  nurse on 28 OCT 2014 and 04 NOV 2014. This report refers to a 33-year-old pregnant female patient. Past medical history included ovarian cyst removal. Current condition included allergies. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1308501) intramuscularly into the right arm at a dose of 0.5 ml on 13 OCT 2013 at 34 weeks of gestation. On 21 OCT 2013, she again received FLUVIRIN 2013/2014 (batch number: 1308501) intramuscularly into the right arm at a dose of 0.5 ml at 35 weeks of gestation. The patient was pregnant when she received both the vaccines. The nurse reported that no drugs were discontinued due to pregnancy and there was no contraception failure and it was unknown if the patient had undergone any prenatal tests. The patient underwent caesarean section. No adverse event was experienced due to the medication error (inappropriate schedule of vaccine administered).  Follow up report from the Vaccine Adverse Event Reporting System (VAERS reference number: 525217) website on 06 MAY 2014: Updated VAERS ID. Added event (inappropriate schedule of vaccine administered) and another dose of FLUVIRIN.  Combined follow up received from nurse on 28 OCT 2014 and 04 NOV 2014: updated patient demographics, medical history, current condition, dose and site of vaccination of FLUVIRIN and other clinically relevant information in the narrative.
Age: 14.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2014US055683 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 525397) website on 06 MAY 2014. This report refers to a 14 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX (batch number: 010031A) intramuscularly in the left arm on 04 JAN 2014. The seriousness of the case was reported as non-serious. No adverse event was reporting following this administration error.  Following an internal review on 18 AUG 2014 of the data received on 06 MAY 2014, it was identified that the BPI labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
Age: 10.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Off label use
Clinical narrative: Case number PHHY2014US055714 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 525409) website on 06 MAY 2014. This report refers to a 10 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 010031A) intramuscularly in the left arm on 04 JAN 2014. The seriousness of the case was reported as non-serious. No adverse event was reporting following the administration error.   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 06 MAY 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "adult product administered to child".
Age: 10.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Off label use
Clinical narrative: Case number PHHY2014US055723 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 525410) website on 06 MAY 2014. This report refers to a 10 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 010031A) intramuscularly in the left arm on 05 JAN 2014. The seriousness of the case was reported as non-serious. No adverse event was reporting following this administration error.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 06 MAY 2014: The BPI labeling of the event "In appropriate age of vaccine administration" changed from listed to unlisted and added second indication as "Adult product administered to child".
Age: 8.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2014US056511, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 525411) website on 06 MAY 2014. This report refers to an 8 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUCELVAX (batch number: 010031A) intramuscular into right arm on 05 JAN 2014. No adverse event was reported following this maladministration (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014 of the data received on 06 MAY 2014, it was identified that the BPI labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
Age: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Off label use
Clinical narrative: Case number PHHY2014US056517, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 525413) website on 06 MAY 2014. This report refers to 16 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUCELVAX (batch number: 010031A) intramuscular into left arm on 31 DEC 2013. No adverse event was reported following this maladministration (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 06 MAY 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 7.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Off label use
Clinical narrative: Case number PHHY2014US056432 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 525415) website on 06 MAY 2014. This report refers to a 7-year-old female patient. Her medical history and concomitant medications were not reported. This patient under 18-years of age was inadvertently vaccinated with FLUCELVAX (batch number: 010031A) intramuscularly in the left arm on 04 JAN 2014. The event was reported as non-serious. No adverse events were reported following the maladministration.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 06 MAY 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added indication as "Adult product administered to child".
Age: 16.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Off label use
Clinical narrative: Case number PHHY2014US056514, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 525417) website on 06 MAY 2014. This report refers to a 16-year-old female patient who was accidentally vaccinated with FLUCELVAX (batch number: 010031A) intramuscularly in the right arm on 14 DEC 2013. No adverse event reported following this medication error (inappropriate age at vaccine administration).   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 06 MAY 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 7.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, Rash
Clinical narrative: Case number PHHY2014US070781, is an initial spontaneous report from a consumer (patient mother) via Vaccine adverse event reporting website (VAERS ID: 526069) received on 09 Jun 2014. This report refers to a 7 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUCELVAX, (batch number: 006031A) intramuscular into left arm on 30 Dec 2013. On 31 Dec 2013, patient had a rash reaction to the shot on chest and face and needed treatment (unspecified medication). He visited to the emergency room. Causality of the events was not reported. Outcome of the events was recovered. The event was reported as non-serious. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 09 Jun 2014: Added event "Inappropriate age at vaccine administration" and second indication as "Adult product administered to child".
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Feeling hot, Lymphadenopathy, Pain, Swelling
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 19-MAY-2014) concerns a 43 year old female patient who had a medical history of hypertension, hypoglycemia, iron deficiency anemia and fibroids.  On the 01-APR-2014, the patient received AFLURIA (batch number R53807) 1 dose via the intramuscular route in the left arm.  On the 02-APR-2014, the patient developed swollen lymph nodes in the armpit of the injection side. The patient developed swelling, heat, tenderness and pain radiating into the muscle over the breast. The patient could not put the arm down due to axillary pain.  Outcome was reported as not recovered.   Reporter comments: The regulator reported the case as non-serious. The regulator repoted the terms "feeling hot" and heat exhaustion".
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 19-MAY-2014) concerns a 43 year old female patient who had a medical history of hypertension, hypoglycemia, iron deficiency anemia and fibroids.  On the 01-APR-2014, the patient received AFLURIA (batch number R53807) 1 dose via the intramuscular route in the left arm.  On the 02-APR-2014, the patient developed swollen lymph nodes in the armpit of the injection side. The patient developed swelling, heat, tenderness and pain radiating into the muscle over the breast. The patient could not put the arm down due to axillary pain.  Outcome was reported as not recovered.   Reporter comments: The regulator reported the case as non-serious. The regulator repoted the terms "feeling hot" and heat exhaustion".
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Malaise, Tachycardia, Urticaria
Clinical narrative: This spontaneous health authority report (initial receipt 16-JUN-2014) concerns a 64-year-old female patient. On 01-OCT-2013, the patient received AFLURIA (batch number: 09049211A) in the right arm. On 01-OCT-2013, within 5 minutes of injection, the patient developed hives, tachycardia and pain at site. The patient took ALLEGRA 180 mg and the symptoms resolved in 20 minutes, except for the event of "generalized not feeling week" that resolved in 24 hours and the event of "soreness at site", which resolved in 2 weeks.  Outcome was reported as recovered.   Reporter's comments: The health authority assessed the case as non-serious.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Sensation of foreign body, Wheezing
Clinical narrative: This spontaneous health authority report (initial receipt 16-Jun-2014) concerns a 37-year-old female patient. The patient recovered birth control pills concomitantly. On 16-Sep-2013, at approximately 1.00 pm, the patient received intramuscular AFLURIA (batch number-R53607). On 16-Sep-2013, at 04.30 pm, the patient complained of chest tightness, feeling of lump in throat and wheezing. She took a decongestant and it resolved. Outcome was reported as recovered. Reporter's comment: The health authority assessed the case as non-serious. Company comments: Seriousness: Non-serious. Listedness: Unlisted. Causality: Possible.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal, Impaired driving ability, Pyrexia, Vomiting
Clinical narrative: This spontaneous health authority report (initial receipt- 16-Jun-2014) concerns a 64-year-old male patient. The patient received CIPRO, penicillin (PCN) and ZOSYN, atenolol and bupivacaine in the past. On 13-Sep-2013, the patient received intramuscular AFLURIA (batch number-R53607). On 13-Sep-2013, 10 minutes after the vaccination, the patient started becoming dizzy and unstable. Within 1 hour, he started vomiting and had fever (self-reported fever at 101.7 degree F). The patient was dizzy for days and could not drive for a week. Vomiting lasted several days. Outcome was reported as recovered. Reporter's comments: The reporter assessed the case as non-serious.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness
Clinical narrative: This non-serious spontaneous health authority report (initial receipt 16-Jun-2014) concerns a 47-year-old female patient. On 09-Dec-2013, the patient received intramuscular AFLURIA (batch number 'RS2807') in the left arm. On 09-Dec-2013, the patient experienced severe pain at the injection site and lingering muscle stiffness in shoulder and upper arm. She still had limited motion and stiffness in that upper arm. Reporter's comments: The health authority assessed the case as non-serious. However, the event led to patient's visit to the emergency room.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: This spontaneous health authority report (initial receipt 16-Jun-2014) concerns a 69-year-old female patient. The patient had a medical history of allergies to metronidazole, penicillin and TYLENOL, hypertension and atrioventricular block. On 18-Feb-2014, the patient received intramuscular AFLURIA (batch number: R51906) in the left arm. On 20-Feb-2014, the patient experienced an unevaluable event. Reporter's comments: The health authority assessed the case as non-serious. However, the event led to patient's visit to the emergency room.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Hypoaesthesia, Malaise, Pain in extremity
Clinical narrative: This spontaneous health authority report (initial receipt 16-JUN-2014) concerns a 65-year-old female patient. The patient had a medical history of diabetes, chronic  hepatitis C, hypertension,  hyperlipidemia, hypothyroid and cardiomegaly. Her concomitant medications included gabapentin, insulin, potassium chloride, levothyroxine, etodolac, fish oil and Lisinopril.  On 07-NOV-2013, the patient received  AFLURIA (batch number R53007) in the left arm.  On 07-NOV-2013, since the AFLURIA injection, the patient complained of pain in right arm and state been sick. The patient always got sick when he got the injection. The patient went to the emergency room and was given some medications and sent home. The patient also developed numb fingers with burning.   Outcome was reported as unknown.  Reporter's comments: The health authority assessed the case as non-serious.
Age: 64.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Rash, Rash pruritic
Clinical narrative: This spontaneous health authority report (initial receipt- 16-Jun-2014) concerns a 64-year-old male patient. The patient had a medical history of cough, diabetes, hypertension, morbid obesity, post-traumatic stress disorder (PTSD), depression, anxiety and hepatomegaly. His past medication included lisinopril. The patient's concomitant medication included acetylsalicylic acid, glipizide, hydrochlorothiazide, insulin, losartan and metformin hydrochloride. On 01-Nov-2013, the patient received AFLURIA (batch number R52907) in the left arm and the same day he also received HAVRIX (batch number: AHAVAB532AA) in the right arm. On 03-Nov-2013, about 2 days after vaccination, the patient experienced rash that started in the midline of chest wall. For 2 weeks, the patient complained of rash on anterior abdominal wall. The rash has spread and was very itchy. The patient received treatment with methylprednisolone (80 mg once) and diphenhydramine (PRN). Outcome was reported as recovered. Reporter's comments: The health authority assessed the case as non-serious. Case correction (14-Aug-2014): AE 2 re-coded.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Headache, Tachypnoea
Clinical narrative: This spontaneous health authority report (initial receipt- 16-Jun-2014) concerns a 63-year-old male patient. The patient had a medical history of prostate cancer, deep vein thrombosis and hypertension. His concomitant medications included acetylsalicylic acid, atorvastatin, fondaparinux, warfarin and gabapentin. On 07-Feb-2014, the patient received AFLURIA (batch number R55308) on the right arm. On 07-Feb-2014, the patient developed headache, tachypnea and felt unable to breath with shortness of breath. He was treated with acetaminophen. Outcome was reported as recovered. Reporter's comments: The health authority assessed the case as non-serious.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Bedridden, Fatigue, Headache, Incomplete course of vaccination, Nausea
Clinical narrative: This non-serious medically confirmed report (initial receipt 01-May-2014) was received via a sales representative and concerns a 16 year old female patient. The patient had no known drug allergies, however had a history of depression and dysautonomia. On 02-Nov-2012 at 16:00, the patient received the influenza virus vaccine (manufacturer and batch number not provided). The patient concomitantly received GARDASIL (batch number H010428) in the RD (right deltoid) via the intramuscular route 1 dose. On the 18-Dec-2012, the patient developed GI (gastrointestinal) effects such as nausea, vomiting and also syncope. The patient developed fatigue and headaches. She received her second dose of GARDASIL on 14-Feb-2013 at 15:50 (batch number H017698) in the RD (right deltoid) via the intramuscular route and had been bedridden since the second dose. The patient had decided not to receive the third GARDASIL dose. The patient required an emergency room/doctor's visit. Outcome was not recovered. Follow up (23-May-2014) Medical history, vaccination dates, AE onset date, additional events, outcome.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Syncope, Vomiting
Clinical narrative: This non-serious medically confirmed report (initial receipt 01-May-2014) was received via a sales representative and concerns a 16 year old female patient. The patient had no known drug allergies, however had a history of depression and dysautonomia. On 02-Nov-2012 at 16:00, the patient received the influenza virus vaccine (manufacturer and batch number not provided). The patient concomitantly received GARDASIL (batch number H010428) in the RD (right deltoid) via the intramuscular route 1 dose. On the 18-Dec-2012, the patient developed GI (gastrointestinal) effects such as nausea, vomiting and also syncope. The patient developed fatigue and headaches. She received her second dose of GARDASIL on 14-Feb-2013 at 15:50 (batch number H017698) in the RD (right deltoid) via the intramuscular route and had been bedridden since the second dose. The patient had decided not to receive the third GARDASIL dose. The patient required an emergency room/doctor's visit. Outcome was not recovered. Follow up (23-May-2014) Medical history, vaccination dates, AE onset date, additional events, outcome.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Injected limb mobility decreased, Injection site joint inflammation, Injection site pain
Clinical narrative: This medically confirmed health authority report (initial receipt- 16-Jun-2014) concerns a 44-year-old female patient. The patient's concurrent illness included conjunctivitis with red eyes and drainage crusted matted shut on waking. Her concomitant medication included escitalopram oxalate. On 01-Oct-2013, the patient received intramuscular AFLURIA (batch number: R56108) in the deltoid muscle. On 01-Oct-2013, the patient experienced pain during injection of the flu vaccine and extreme pain immediately at the injection site (upper 1/3 of deltoid muscle). The pain had never gone away. There was also decreased range of motion. The patient could not perform simple activities of daily living without help. The patient reported to the pharmacy regarding the pain from flu vaccine. On 08-Nov-2013, the patient visited the doctor due to pain. The patient was given pain medication which did not help. The patient repeated doctor's visits with no relief and the pain continued. On 24-Nov-2013, the patient went to the emergency department and was given pain medications and was diagnosed with rotator cuff tendonitis. The patient had applied heat and ice all this time since 01-Oct-2013. Since 2014, the patient underwent physical therapy with no relief. Magnetic resonance imaging was conducted and as per MD (medical doctor) shoulder surgery was needed due to extreme inflammation/tendonitis, torn rotator cuff and tons of adhesion. Outcome was reported as missing. Reporter's comments: The health authority assessed the events as non-serious. The authority reported event terms were 'immediate post-injection reaction' and 'nuclear magnetic resonance imaging abnormal'.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Joint adhesion, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: This medically confirmed health authority report (initial receipt- 16-Jun-2014) concerns a 44-year-old female patient. The patient's concurrent illness included conjunctivitis with red eyes and drainage crusted matted shut on waking. Her concomitant medication included escitalopram oxalate. On 01-Oct-2013, the patient received intramuscular AFLURIA (batch number: R56108) in the deltoid muscle. On 01-Oct-2013, the patient experienced pain during injection of the flu vaccine and extreme pain immediately at the injection site (upper 1/3 of deltoid muscle). The pain had never gone away. There was also decreased range of motion. The patient could not perform simple activities of daily living without help. The patient reported to the pharmacy regarding the pain from flu vaccine. On 08-Nov-2013, the patient visited the doctor due to pain. The patient was given pain medication which did not help. The patient repeated doctor's visits with no relief and the pain continued. On 24-Nov-2013, the patient went to the emergency department and was given pain medications and was diagnosed with rotator cuff tendonitis. The patient had applied heat and ice all this time since 01-Oct-2013. Since 2014, the patient underwent physical therapy with no relief. Magnetic resonance imaging was conducted and as per MD (medical doctor) shoulder surgery was needed due to extreme inflammation/tendonitis, torn rotator cuff and tons of adhesion. Outcome was reported as missing. Reporter's comments: The health authority assessed the events as non-serious. The authority reported event terms were 'immediate post-injection reaction' and 'nuclear magnetic resonance imaging abnormal'.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: Case number PHHY2014US097989 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 531175) website on 04 AUG 2014. This report refers to a 71 year old female patient. She had no known drug allergies or no health conditions. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309701) into left arm and Pneumovax (other manufacturer, pneumococcal vaccine, batch number: J004080) into right arm, both via intramuscular route on 24 OCT 2013. On the same day after vaccination, she experienced injection site pain and hardness (unspecified arm). She was taken to emergency room. Final outcome was reported as condition unchanged. The events were reported as non-serious. Causality was not reported.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus generalised
Clinical narrative: This medically confirmed health authority report (intial receipt 14-Jul-2014) concerns a 30-year-old female patient. The patient had a medical history of type 1 diabetes mellitus and allergis to PHENERGAN, latex and Compazaine. On 25-Oct-2014, the patient received AFLURIA (batch number not provided). On 25-Oct-2013, the patient experienced severe whole body pruritus and redness to left arm/chest. The patient did not complain of rash, urticaria, anaphylaxis, breathing difficulties or mouth/eye edema. The patient was treated with diphenhydramine and monitored. The patient recovered and was sent back to the vaccine adminitrator and PCP for follow-up. The outcome was reported as recovered. Reporter's comments: Seriousness: Non-serious. Listedness: Unlisted. Causality: Possible.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Local swelling
Clinical narrative: This medically confirmed health authority report (initial report 14-JUL-2014) concerns a 44-year-old male patient. The patient had a medical history of depression, back pain, cervicalgia, seborrheic dermatitis, insomnia, allergic rhinitis, irritable bowel syndrome, edema, hyperlipidemia, fatty liver, obesity, hiatal hernia and gastroesophageal reflux disease (GERD). The patient had intolerance to quinine (palpitations).   On 11-OCT-2013, the patient received AFLURIA (batch number R54207) in the left arm.  On 12-OCT-2013, within one day of vaccination, the patient experienced localized swelling and redness at the injection site. The events resolved in a couple of days. The outcome was reported as recovered.   Reporter's comments: The  health authority assessed the events as non-serious.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Middle insomnia, Oedema, Oedema peripheral, Panic attack, Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt 14-Jun-2014) concerns a 69-year-old male patient. On 06-Nov-2013, the patient received intramuscular AFLURIA (batch number: R56408) in the right arm and intramuscular PNEUMOVAX (batch number: J006242) in the left arm. On 06-Nov-2013, at night, the patient experienced fever, edema and felt hot in the left arm. Four days later, he woke in the middle of the night with a panic attack that he attributed to the vaccine. He called the doctor who recommended to take two tablets of hydroxyzine. His left arm recovered but the edema moved to the forearm. Then, all symptoms disappeared. The outcome was reported as recovered. Reporter's comments: The health authority assessed the events as non-serious. Company comments: Seriousness: Non-serious. Listedness: Unlisted. Causality: Possible. Case correction (24-Jul-2014): AE 3 split into 2 AEs (oedema and peripheral oedema).
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: This medically confirmed health authority report (initial receipt 14-Jun-2014) concerns a 69-year-old male patient. On 06-Nov-2013, the patient received intramuscular AFLURIA (batch number: R56408) in the right arm and intramuscular PNEUMOVAX (batch number: J006242) in the left arm. On 06-Nov-2013, at night, the patient experienced fever, edema and felt hot in the left arm. Four days later, he woke in the middle of the night with a panic attack that he attributed to the vaccine. He called the doctor who recommended to take two tablets of hydroxyzine. His left arm recovered but the edema moved to the forearm. Then, all symptoms disappeared. The outcome was reported as recovered. Reporter's comments: The health authority assessed the events as non-serious. Company comments: Seriousness: Non-serious. Listedness: Unlisted. Causality: Possible. Case correction (24-Jul-2014): AE 3 split into 2 AEs (oedema and peripheral oedema).
Age: 15.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, Off label use, Rash
Clinical narrative: Case number PHHY2014US100488, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 532725) website on 08 AUG 2014. This case refers to a 15-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated FLUCELVAX 2013/2014 (batch number: 010021A) intramuscularly into right arm on 03 JAN 2014. On an unknown date, after an unspecified period of vaccination, he experienced rash. The event was reported as non-serious. Outcome of the event was reported as condition unchanged. Causality of the event was not reported.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 08 AUG 2014: The BPI labeling of the event "Inappropriate age of vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: This medically confirmed health authority report (initial receipt 14-Jul-2014) concerns a 25-year-old female patient. On 14-Oct-2013, the patient received intramuscular AFLURIA (batch number '1253207') in the left arm. On 14-Oct-2013, the patient experienced tinnitus. The outcome was reported as recovered. Reporter's comments: The authority assessed the events as non-serious. Company comments: Seriousness: Non-serious. Listedness: Unlisted. Causality: Possible
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Groin pain, Muscle strain
Clinical narrative: This medically confirmed health authority report (initial report 14-JUL-2014) concerns a 20-year-old male patient.  On 30-MAY-2014, the patient received intramuscular AFLURIA (batch number R56508). On 31-MAY-2014, the patient experienced groin pain. On 02-JUN-2014, the patient saw a pediatrician. The patient had muscle strain. The outcome was reported as not recovered.   Reporter's comments: The health authority assessed the events as non-serious.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2014US115850, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 533976) website on 03 SEP 2014. This report refers to a 31-year-old male patient. He was vaccinated with FLUVIRIN 2013/2014 (batch number: 13413P) in the left deltoid on 28 OCT 2013. On the same date, after vaccination she experienced pain at injection site. The final outcome of the event was unknown. The event reported as non-serious event. The causality of the event was not reported.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Laboratory test normal, Neuralgia, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal
Clinical narrative: Case number PHHY2014US107270 is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 534030) website on 27 AUG 2014 with a follow up report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 534030) website on 16 SEP 2014 and with a follow up report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 534030) website on 10 OCT 2014. This report refers to a 49 years old female patient. Her medical history was not reported and concomitant medications included lisinopril and levothyroxine. She was vaccinated with FLUVIRIN 2013/2014 (manufacturer and batch number: not reported) intramuscularly in the right arm deltoid on 18 OCT 2013. On 25 OCT 2013, she had an achy pain in the life brachial arm. A week later she began to have numbness and tingling in the  left arm progressing to left leg and then to right arm and leg. She also had sharp shooting nerve pains. She went to emergency room and had brain and cervical spine nuclear magnetic resonance imaging (MRI) to rule out any other cause of symptoms and the laboratory and MRI reports were within the normal limits. It was reported that the everts progressively improved, but she still had buzzing around the feet and ankles and sporadic shooting pain in arms and legs. The final outcome of the event was reported as condition unchanged. The seriousness was not reported. The causality of the event was not reported.   Follow up report was received from the Vaccine Adverse Event Reporting System (VAERS reference number: 534030) website on 16 SEP 2014. Concomitant medications were updated.  Follow up report was received from the Vaccine Adverse Event Reporting System (VAERS reference number: 534030) website on 10 OCT 2014. The suspect vaccine was updated as FLUVIRIN 2013/2014.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Case number PHHY2014US107270 is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 534030) website on 27 AUG 2014 with a follow up report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 534030) website on 16 SEP 2014 and with a follow up report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 534030) website on 10 OCT 2014. This report refers to a 49 years old female patient. Her medical history was not reported and concomitant medications included lisinopril and levothyroxine. She was vaccinated with FLUVIRIN 2013/2014 (manufacturer and batch number: not reported) intramuscularly in the right arm deltoid on 18 OCT 2013. On 25 OCT 2013, she had an achy pain in the life brachial arm. A week later she began to have numbness and tingling in the  left arm progressing to left leg and then to right arm and leg. She also had sharp shooting nerve pains. She went to emergency room and had brain and cervical spine nuclear magnetic resonance imaging (MRI) to rule out any other cause of symptoms and the laboratory and MRI reports were within the normal limits. It was reported that the everts progressively improved, but she still had buzzing around the feet and ankles and sporadic shooting pain in arms and legs. The final outcome of the event was reported as condition unchanged. The seriousness was not reported. The causality of the event was not reported.   Follow up report was received from the Vaccine Adverse Event Reporting System (VAERS reference number: 534030) website on 16 SEP 2014. Concomitant medications were updated.  Follow up report was received from the Vaccine Adverse Event Reporting System (VAERS reference number: 534030) website on 10 OCT 2014. The suspect vaccine was updated as FLUVIRIN 2013/2014.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Coagulation test, Loss of consciousness, Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt 25-Aug-2014) concerns a 25 year old female patient. On the 16-Nov-2013, the patient was vaccinated with AFLURIA (batch number R55608) dose 1, via the intramuscular route. On the 17-Nov-2013, the patient had a slight fever overnight. The patient woke up the next morning within 45 minutes and went to the kitchen and passed out. She hit her head in the tile floor and regained consciousness. Her fiance called emergency services and she went to hospital. The patient had tests, in order to check for a blood clot. Outcome was recovered.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Injection site pruritus, Injection site rash, Myalgia, Pruritus
Clinical narrative: This initial health authority report (initial receipt 25-AUG-2014) concerns a 70-year-old male patient. The patient had a medical history of post-traumatic stress disorder, obstructive sleep apnea, depression, hypertension, arthritis, hyperlipidemia and benign prostatic  hyperplasia. On 02-OCT-2013, th4e patient received AFLURIA (batch number: R53507) that was injected in the left arm (dose 1).  On 25-OCT-2013, the patient developed itching on the left arm, neck and hip and had started on the left shoulder. A week later, the patient came to the emergency department. The patient also complained of worsening rash from the flu vaccine site to the arm, shoulder and neck for 4 days). The rash was itchy and red. There were no blisters. The patient tried hydrocortisone cream but it did not help. The patient also had a two or three day history of cough with no shortness of breath and generalized myalgia since yesterday, particularly in his neck. There was no swallowing difficulty. The patient was prescribed BENADRYL that did not help. The outcome was reported as recovered.   Reporter's comments: The health authority assessed the events as non-serious.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: This initial health authority report (initial receipt 25-AUG-2014) concerns a 70-year-old male patient. The patient had a medical history of post-traumatic stress disorder, obstructive sleep apnea, depression, hypertension, arthritis, hyperlipidemia and benign prostatic  hyperplasia. On 02-OCT-2013, th4e patient received AFLURIA (batch number: R53507) that was injected in the left arm (dose 1).  On 25-OCT-2013, the patient developed itching on the left arm, neck and hip and had started on the left shoulder. A week later, the patient came to the emergency department. The patient also complained of worsening rash from the flu vaccine site to the arm, shoulder and neck for 4 days). The rash was itchy and red. There were no blisters. The patient tried hydrocortisone cream but it did not help. The patient also had a two or three day history of cough with no shortness of breath and generalized myalgia since yesterday, particularly in his neck. There was no swallowing difficulty. The patient was prescribed BENADRYL that did not help. The outcome was reported as recovered.   Reporter's comments: The health authority assessed the events as non-serious.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: This non-serious medically confirmed health regulatory report (initial receipt 25-AUG-2014) concerns a 61-year-old female patient who had previously administered codeine and prednisone, and had tetracycline allergies. The patient had no current illness.   On 01-OCT 2013, the patient received AFLURIA (batch number R52206) in the left arm via "SYR" route.  On 01-OCT-2013, the patient experienced severe pain and stiffness in arm which were initially reported on 07-OCT-2013. The patient visited the emergency room.  On 25-JUN-2014, the patient reported that she had an magnetic resonance imaging (MRI) due to loss of range of motion, physical therapy and possible surgery in the future due to flu shot.  Outcome was reported as not recovered.    Reporter's comments: The regulatory reported the preferred term of "Nuclear magnetic resonance imaging".
Age: 65.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Myalgia, Pruritus, Urticaria
Clinical narrative: This non-serious medically confirmed health regulatory report (initial receipt 25-AUG-2014) concerns a 65-year-old male patient who had previously administered nicotine polacrilex and varenicline.  On 18-SEP-2013, the patient received AFLURIA (batch number R52607, Dose 1) in right arm and PNEUMOVAX (batch J007059, Dose 1) in the left arm.  On 18-SEP-2013, the patient experienced myalgia, urticaria, pruritus and shortness of breath.  Outcome was reported ad recovered.  Reporter's comment: The health authority assessed the case as non-serious.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Swelling, Wound secretion
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 25-Aug-20124) concerns a 52 year old female patient. On the 02-Oct-2013, the patient received AFLURIA (batch number: R52206) via the intramuscular route in the right arm. On the 02-Oct-2013, the patient developed swelling and in Apr-2014, it oozed pus at the site. As of Jul-2014, the wound was still visible. Outcome was unknown.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, X-ray normal
Clinical narrative: Case number PHHY2014US122774 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 537645) website on 16 SEP 2014. This report refers to a 16 year old female patient. Her medical history included hypertension, migraine and allergy to penicillin. Her historical drug included sertraline and Vicodin both of which caused unspecified adverse event (no details given). On 16 OCT 2013, she was vaccinated with FLUVIRIN 2013/2014 (batch number: 13444P) in left arm. On the same day after vaccination, she experienced pain in left deltoid/shoulder. She was taken to emergency room for medical support. On 27 MAR 2014, an X-ray was performed which gave normal result. Final outcome was reported as condition unchanged. The HA reported the events as non-serious. Causality was not reported.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2014US136556, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 537912) website on 10 OCT 2014. This report refers to a 64-year-old female patient. Medical history was not reported. Past medications included penicillin and codeine. No concomitant medication was reported. She was vaccinated with FLUVIRIIN 2013/2014 (batch number: 1309701)  in to the left arm on 22 OCT 2013. On an unknown date after vaccination, her left arm was sore and cannot move arm outwards to the left. The final outcome of the events was not recovered. The events were reported as non-serious. Causality was not reported.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Case number PHHY2014US138009 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS ID: 539370) on 10 OCT 2014. This report refers to a 75 year old female patient. Her past medical history and concomitant medications were not reported. On 07 AUG 2014, she was vaccinated with FLUVIRIN 2014/2015 (batch number: 1410901) intramuscularly into her right arm. On the same day at 12:30 M, she developed numbness in her lips and on 08 AUG 2014, she developed numbness in her thumb and index finger of her right hand. The outcome of the events was unknown. The events were reported as non serious and the causality of the events was not reported.
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: Case number PHHY2014US137078, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 500430) web site on 10 Oct 2014. This report refers to a 64 year old male patient. He had history of nerve damage, hypertension and diabetes. Concomitant medications were not reported. He was not on any immunosuppressive drugs. He was vaccinated with FLUVIRIN (batch number: 145204) intramuscular into right arm on 13 Aug 2014. On the same day he also received ZOSTAVAX (batch number: J011828, other manufacturer) subcutaneous into left arm. On the same day he developed numbness on left side. Numbness on arm traveling down to the leg. Outcome of the event and causality assessment was not reported. The events were reported as non-serious.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Case number PHHY2014US136317, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number; 539958) website on 10 Oct 2014. This report refers to a 63-year-old polymedicated male patient. His medical history was not reported and had no current illness. He was vaccinated with FLUVIRIN, (batch number: 145005) intramuscularly into left arm along with PNEUMOVAX (batch number: J005071, other manufacturer) intramuscularly into right arm on 10 Aug 2014. On 12 Aug 2014, he experienced rash on abdomen. Outcome of the events was reported as unknown. These events were reported as non-serious. Causality of the events was not reported.