chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous medically confirmed report (initial receipt 26-Nov-2014) concerns a 57 year-old male patient. On 24-Nov-2014, the patient received intramuscular AFLURIA (batch number T51808) after it reached 32.5F for 6-7 hours on 22-Nov-2014. The vaccine did not freeze during the excursion. The pharmacist was not aware of any harm to the patient. There were no adverse events reported. The outcome was not reported. Reporter comments: The reporter assessed the events as non-serious. It was reported that it was ok for vaccine to be at 32 degrees F for up to 24 hours based on the bioCSL stability studies. Per company, it was okay for pharmacy to continue using it.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous medically confirmed report (initial receipt-26-Nov-2014) concerns a 61 year-old female patient. On 25-Nov-2014, the patient received intramuscular AFLURIA (batch number-T51808) after it reached 32.5F for 6-7 hours on 22-Nov-2014. The vaccine did not freeze during this excursion. The pharmacist was not aware of any harm to the patient. No adverse events were reported. The outcome was not reported. Reporter comments: The reporter assessed the events as non-serious. It was reported that it was ok for flu vaccine to be at 32 degree F for up to 24 hours based on the bioCSL stability studies. Per the company it was okay for the pharmacy to continue using the vaccine.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Injection site reaction
Clinical narrative: This non-serious spontaneous report (initial receipt 01-Dec-2014) concerns a 42 year-old patient who had received the flu vaccination before and did not have any problems. She had no history of shoulder injury and did not take chronic medications. Concomitant medication included an unspecified allergy medication taken on an as required basis. On 04-Nov-2014, the patient received AFLURIA (batch number not provided) 0.5mL in her right arm. On the same day, the patient also received PPD tuberculosis skin test. On 04-Nov-2014, the patient stated that the injection was very painful. Later that evening, the patient experienced a decreased range of motion in her right arm. She felt the arm pain, which was coming from "inside of her". Her arm felt heavy and numb that was hard to move. She thought it was muscle stiffness from the injection and had been using a heating pad, which helped. However, the symptoms bothered her for more than one week. She was unable to visit her primary care provider because of scheduling conflicts. Therefore, she visited a prompt care center where an x-ray was done and was diagnosed with bursitis in her right shoulder. She was referred to an ortho specialist for follow-up. She was not sure if she previously had AFLURIA, however, this was the first time she had problems following her annual flu vaccinations. Outcome was not yet recovered.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Musculoskeletal stiffness, Pain in extremity, Tuberculin test, X-ray limb abnormal
Clinical narrative: This non-serious spontaneous report (initial receipt 01-Dec-2014) concerns a 42 year-old patient who had received the flu vaccination before and did not have any problems. She had no history of shoulder injury and did not take chronic medications. Concomitant medication included an unspecified allergy medication taken on an as required basis. On 04-Nov-2014, the patient received AFLURIA (batch number not provided) 0.5mL in her right arm. On the same day, the patient also received PPD tuberculosis skin test. On 04-Nov-2014, the patient stated that the injection was very painful. Later that evening, the patient experienced a decreased range of motion in her right arm. She felt the arm pain, which was coming from "inside of her". Her arm felt heavy and numb that was hard to move. She thought it was muscle stiffness from the injection and had been using a heating pad, which helped. However, the symptoms bothered her for more than one week. She was unable to visit her primary care provider because of scheduling conflicts. Therefore, she visited a prompt care center where an x-ray was done and was diagnosed with bursitis in her right shoulder. She was referred to an ortho specialist for follow-up. She was not sure if she previously had AFLURIA, however, this was the first time she had problems following her annual flu vaccinations. Outcome was not yet recovered.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperaesthesia, Injection site discolouration, Injection site erythema, Injection site irritation, Injection site reaction
Clinical narrative: This non-serious consumer report (initial receipt 05-Dec-2014) concerns a 62 year old female patient who had no relevant patient history. On the 28-Oct-2014, the patient received AFLURIA (batch number T50907) 0.5mL once via the intramuscular route. On the 30-Oct-2014, the patient noted the development of a two inch wide red to purplish ring around the injection site. The injection site was also puffy, sensitive and irritated. To date, there was still minor irritation and discolouration around the injection site, although the side effects have decreased since they initial presented. The puffiness had resolved two weeks from the initial presentation. Outcome was not recovered. Reporter comments: The reporter stated that the events were non-serious.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: This non-serious consumer report (initial receipt 05-Dec-2014) concerns a 62 year old female patient who had no relevant patient history. On the 28-Oct-2014, the patient received AFLURIA (batch number T50907) 0.5mL once via the intramuscular route. On the 30-Oct-2014, the patient noted the development of a two inch wide red to purplish ring around the injection site. The injection site was also puffy, sensitive and irritated. To date, there was still minor irritation and discolouration around the injection site, although the side effects have decreased since they initial presented. The puffiness had resolved two weeks from the initial presentation. Outcome was not recovered. Reporter comments: The reporter stated that the events were non-serious.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 05-Dec-2014) concerns an unknown demographics patient. On 12-Nov-2014, the patient received intramuscular AFLURIA (batch number T58406). The patient was administered less than 0.5mL dose of AFLURIA. It was reported that the needle was not fastened to the prefilled syringe which resulted in leakage of the dose. No adverse events were reported since administration. Outcome was unknown.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This medically confirmed spontaneous report (initial receipt-07-Nov-2014) concerns a 53 year old female patient. The patient did not receive any concomitant vaccine in the same or other arm. She had no known allergies or any significant medical history. On 18-Oct-2014, the patient received intramuscular AFLURIA (batch number: T51708) at 0.5 ml. On 18-Oct-2014, the patient developed soreness in the arm. The patient always received a flu shot annually but had never experienced a persisting local reaction. She was treated with ibuprofen and applied compresses to help with the soreness but these measures had only worked for maximum of 24 hours and then the soreness came back. Outcome was reported as not yet recovered. Reporter's comments: The reporter assessed the events as non-serious.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Rash macular
Clinical narrative: This non-serious consumer spontaneous report (initial receipt 05-Dec-2014) concerns a 69 year-old male patient who had no known drug allergies. He had received flu vaccines in the past (unknown brand). On 04-Dec-2014, the patient received intramuscular AFLURIA (batch number not provided) 0.5 mL. On 04-Dec-2014, following the vaccination, the patient developed a rash of red spots/blotches on his chest and back which they noticed on 05-Dec-2014 for the first time. The rash was not painful or itchy. The patient's physician was aware and instructed him to take diphenhydramine. At the time of the reporting, the patient had just started the diphenhydramine and did not know if it was helping with the rash. Outcome was not yet recovered. Reporter comments: the reporter assessed the events as 'related' to the AFLURIA vaccine.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: This medically confirmed spontaneous initial (initial receipt 13-Jan-2015) concerns a 77-year-old female patient with no relevant patient history. On 23-Dec-2014, the patient received intramuscular AFLURIA (batch number 09449221A) 0.5 mL once for the protection against seasonal influenza virus. Around the 26-Dec-2014, a few days after receiving the injection, the patient began to experience soreness in her arm where the vaccine was administered and her arm was sore after vaccination. The outcome was reported as not yet recovered.
Age: 1.0
Sex: U
Vaccine: FLUX, MMR
Symptoms: Injection site rash
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 06-Nov-2014) concerns an approximately 1 year old infant. On 08-Oct-2014, the infant patient received an unspecified influenza vaccine (manufacturer and batch number not provided) and VARIVAX (batch number not provided), both in the left leg. On the same day, the infant patient also receive MMR II injection (batch number not provided) in the right leg as a routine administration. On 08-Oct-2014, the infant patient developed a "pretty impressive rash" where the MMR II injection was given in the right leg. Outcome was unknown.
Sex: F
Vaccine: FLU3
Symptoms: Drug administration error, Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 20-Oct-2014) concerns a female patient. On 20-Oct-2014, the patient received excrusioned AFLURIA (batch number: T51608) for prevention of influenza. It was reported that a total of 5 boxes AFLURIA pre-filled syringes were kept in the fridge. The temperature gauge was knocked over and red 47 degree Fahrenheit for 12 hours. Three excrusioned vaccines were administered. (refer to cases: 201404582 (another female patient) and 2014045856 (male patient)). Outcome was not reported.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 07-Jan-2015) concerns a 68 year-old male patient. On 17-Oct-2014, the patient received intramuscular AFLURIA (batch number T52008). The patient inadvertently received a second intramuscular AFLURIA (batch number T54009) on 07-Jan-2015, hence administered two doses during the flu season. The AFLURIA vaccine was given for the prevention of influenza. The patient has no reaction noted. The outcome was not reported.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Tendonitis
Clinical narrative: This non-serious medically confirmed report (initial receipt 17-OCT-2014) concerns a 43 year old female patient. The patient had received the flu shot before and had never had a problem up until now. The patient had no history of arm/shoulder injuries, no tobacco and was not pregnant. On the 23-SEP-2014, the patient received AFLURIA (batch number T57505) 0.5 ml annually via the intramuscular route. On the 23-SEP-2014, two hours after vaccination, the patient developed severe intense right deltoid and shoulder pain. The pain was constant, but worsened with movement. She had decreased range of motion. The pain appeared to be tendonitis -like. On the 06-OCT-2014, the patient returned to the doctor complaining of pain. The patient had no signs or symptoms of infection and no fever. There was no redness. The patient was prescribed oral prednisolone for six days. On the 15-OCT-2014, the patient returned to the office complaining of pain however stated that the prednisolone had helped. The patient was prescribed prednisolone again but for twelve days. The patient was instructed to call the doctor's office for an update and if was not better, would be referred to an "ortho" consult. Outcome was not yet recovered.
Sex: M
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: This medically confirmed health authority report (initial receipt 27-OCT-2013) concerns a male patient. Every year, the patient received the flu shot (manufacturer and batch number not reported) and always developed a very  mild reaction. Outcome was not reported. Linked to 2014046391.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Fatigue, Myalgia
Clinical narrative: This spontaneous consumer report (initial receipt 07-Nov-2014) concerns a female patient. The patient had a medical history of back pain but no known allergies. This was the first time that the patient received flu shot. In January 2013, the patient caught the flu. On an unspecified date, during the week 12-Oct-2014 to 18-Oct-2014, the patient received intramuscular AFLURIA (batch number not reported) at 0.5 ml. On an unspecified date, approximately 3 days after vaccination, the patient experienced extreme fatigue and severe muscle aches in shoulder, neck and middle and upper back. The patient was confined to the bed for couple of weeks. The patient had tried resting, massages and rubdowns to help control the aches but nothing helped. The muscle aches were similar to the aches she had when she caught the flu. Outcome was reported as not yet recovered. Reporter's comments: The patient insisted that the muscle aches are due to AFLURIA alone and could not be linked to her pre-existing back pain. The reporter assessed the case as non-serious and considered the events as related to AFLURIA (caused by vaccine).
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Adverse event
Clinical narrative: This medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 37 year old female patient. The patient's past drugs included acetylsalicylic acid, penicillin, ibuprofen, indomethacin and iodine. On an unspecified date in 2012, the patient received influenza vaccine (manufacturer and batch number not provided). On an unspecified date later, the patient had unspecified adverse events. The outcome was not reported. Linked case: 2014047529 (same patient).
Sex: M
Vaccine: FLUX
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This non-serious spontaneous consumer report (initial receipt 08-DEC-2014) concerns a male patient. On an unspecified date, the under-five year old patient received seasonal influenza vaccine (manufacturer and batch number not provided). The patient tolerated the vaccination. Outcome was unknown. Linked to 2014047135.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: This medically confirmed spontaneous report (initial receipt 19-DEC-2014) concerns a 66-year-old male patient. On 19-DEC-2014, the patient received intramuscular AFLURIA injection (batch number: 09249211A, expiry date: 30-JUN-2014) in the left a arm at 0.5 ml. The patient appeared fine after receiving the vaccine. The pharmacy did not realize that the vaccine was expired until the patient left. The outcome was not reported.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: This non-serious consumer report (initial receipt 16-DEC-2014) concerns a 57 year old female patient. In DEC-2014, the patient received a flue shot (manufacturer and batch number not reported). The patient was also taking Berniert. After receiving the flu shot, the patient experienced a severe sore throat, fever and aches throughout the body. Outcome was not reported. Linked to 2014047394 (Berinert case). Reporter comments: The reporter stated the events were not serious.
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Ear discomfort, Headache, Malaise, Stress
Clinical narrative: This non-serious consumer report (initial receipt 15-DEC-2014) concerns a female patient who had a medical history of tinnitus which was diagnosed several years ago. On the 13-DEC-2014, the patient received AFLURIA (batch number not reported) 0.5 ml via the intramuscular route. This was the patient's first flu vaccine. On the 13-DEC-2014, later that evening, she experienced tinnitus and headache. Her left ear felt clogged. She believed the stress from her headaches exacerbated her tinnitus. The headaches only appear in the evening are painful in which she felt sick. She did not seek medical treatment for them and did not take anything over-the-counter for the treatment. The events did not ablate after the suspect product was stopped.  Outcome was not yet reported.
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: This non-serious consumer report (initial receipt 15-DEC-2014) concerns a female patient who had a medical history of tinnitus which was diagnosed several years ago. On the 13-DEC-2014, the patient received AFLURIA (batch number not reported) 0.5 ml via the intramuscular route. This was the patient's first flu vaccine. On the 13-DEC-2014, later that evening, she experienced tinnitus and headache. Her left ear felt clogged. She believed the stress from her headaches exacerbated her tinnitus. The headaches only appear in the evening are painful in which she felt sick. She did not seek medical treatment for them and did not take anything over-the-counter for the treatment. The events did not ablate after the suspect product was stopped.  Outcome was not yet reported.
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: This medically confirmed health authority report (initial receipt 03-DEC-2014) concerns a female patient. The patient had medical history of hives from Penicillin. Her concomitant medication included levonorgestrel. On an unspecified date, the patient received influenza report (manufacturer and batch number not reported). On an unspecified date, the patient developed flu-like symptoms. The outcome was not reported. Linked case: 2014047332 (same patient).
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-DEC-2014) concerns an adult female patient. On an unspecified date, the patient received AFLURIA (batch number not reported). On an unspecified date, the patient developed such a pain in her arm that she had to have a physical therapy to lift her arm, after pain continued for six weeks. The patient also developed shoulder pain. Outcome was not reported. Case linked to: 201404074325 (same patient).
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Needle issue, Underdose, Wrong technique in drug usage process
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 05-Nov-2014) concerns a 57 year old female patient. On 04-Oct-2014, the patient received intramuscular AFLURIA (batch number T50307). AFLURIA was stored correctly. On 04-Oct-2014, during the vaccine administration, the needle became loose and the patient received less than the recommended dose of AFLURIA from a pharmacist (did not get the full dose). The outcome was unknown. Reporter comments: The reporter insisted that the reason the needle was not in place was due to a technique issue only and not due to the fault of the vaccine product. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This non-serious consumer report (initial receipt 17-Oct-2014) concerns a female patient. On an unspecified date, the patient received the flu shot (manufacturer and batch number not reported) and ZOSTAVAX injection (batch number not reported) one shot for vaccination. On the unspecified date in 2014 (earlier this week), the patient developed an injection site reaction that included swelling, redness and itchiness 48 hours after receiving the ZOSTAVAX. Within 24 hours of receiving the flu shot, the patient developed flu-like symptoms. Outcome was not reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nasopharyngitis, Neck pain, Pain, Poor quality sleep
Clinical narrative: This spontaneous consumer report (initial receipt 27-Oct-2014) concerns a 62 year-old female patient. Last year, the patient developed same reactions (as this year) after receiving flu vaccination, that lasted approximately 2 weeks. The reporter did not report the product she received last year (Refer to case: 2014046048). On 27-Oct-2014, at 2 pm, the patient received AFLURIA (batch number not reported) at 0.5 ml via intramuscular route for influenza vaccination. On 27-Oct-2014, in the evening, the patient started experiencing headaches and felt achy. She felt like she has a head cold. The symptoms began about 4 hours after receiving vaccine which included neck ache, tossing and turning and she could not sleep. Outcome was not reported.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This medically confirmed spontaneous report (initial receipt 23-Oct-2014) concerns a 62-year old male patient. The reporter was not aware of any past medical history of arm/shoulder injury. On 08-Oct-2014, the patient received AFLURIA (batch number T57606) in the left arm at 0.5 ml annually via intramuscular route for the prevention of influenza. This was the first time that the patient received AFLURIA or any flu vaccine. Two days after vaccination, the patient experienced pain and swelling in his right arm (opposite arm that received injection). The patient was constant and could be felt from his elbow to shoulder blade. The patient received tramadol 50 mg three times daily for pain, which did not help. The outcome was reported as not yet recovered.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Musculoskeletal stiffness, Nausea, Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a female patient. Her concomitant medication included NUVARING. The patient had medical history of allergy to diphenhydramine and azithromycin. On an unspecified date, the patient received influenza (seasonal) vaccine (manufacturer and batch number not reported) and pneumococcal vaccine (manufacturer and batch number not reported). On an unspecified date, the patient developed stiffness, fever, nausea and chills. The outcome was not reported. Linked case: 2014047580 (same patient).
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a male patient. On an unspecified date, the patient received the AFLURIA. On an unspecified date, the patient developed pain in the left arm. Outcome was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This medically confirmed spontaneous report (initial receipt 21-Oct-2014) concerns a female patient. On an unspecified date in Oct-2014, the patient received influenza vaccine injection (manufacturer and batch number not reported) via intradermal route (medication error). No adverse reactions were experienced since administration. Outcome was reported as recovered. Reporter causality: The reporter assessed the case as non-serious.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Malaise
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 14-Oct-2014) concerns a 56 year-old female patient who had allergies to lovastatin, methylprednisolone, ciprofloxacin, lisinopril, sumatriptan, acetaminophen/codeine, alprazolam, mitoxantrone, trimethoprim/sulfamethoxazole, acetaminophen/oxycodone, interferon beta-1b, interferon beta-1a, glatiramer acetate, Band Aids and TEGADERM dressings. Her concomitant medications included venlafaxine, eletriptan hydrobromide, dronabinol, butorphanol, MAALOX, gabapentin, tramadol, citalopram, esomaeprazole magnesium, morphine, chlorpromazine, macrogol, omeprazole/sodium bicarbonate, ranitidine, prasterone, lidocaine, paracetamol, diphenhydramine, heparin, normal saline/sodium chloride, EPIPEN, dexlansoprazole, glatiramer acetate, montelukast, pregabalin, carbamazepine, prochlorperazine, promethazine, cefuroxime axetil, ondansetron, salbutamol, memantine hydrochloride, nystatin, topiramate, zaleplon, frovatriptan succinate monohydrate, melatonin, guaifenesin, vaccinium macrocarpon, amitriptyline, lorazepam, azithromycin, diazepam, dronabinol, tizanidine, ibuprofen and cyanocobalamin. On an unspecified date, the patient received a Influenza virus vaccine (manufacturer and batch number not provided) three days after her PRIVIGEN infusion (batch numbers 4323300111 and 4364600037). On an unspecified date, the patient had been sick ever since the flu shot. She also reported being tired. The outcome was unknown. Reporter's comments: The reporter the case as non-serious and the causality of 'unassessable'.
Sex: M
Vaccine: FLUX
Symptoms: Dysphoria, Paraesthesia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 27-OCT-2014) concerns a 28-year-old male patient. The patient had medical history of allergies to penicillin, peanuts, tree-pollen and mold. The patient received influenza (seasonal) vaccine (no brand name) in the past and experienced dysphoria and paresthesias. On an unspecified date, the patient received influenza (seasonal) vaccine (manufacturer and batch number not reported). On an unspecified date, the patient developed dysphoria and paresthesias. Outcome was reported as unknown. Linked case: 2014046268 (same patient).
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This medically confirmed spontaneous report (initial receipt 07-NOV-2014) concerns a 16 year old female patient. On 15-OCT-2014, the patient inadvertently received intradermal AFLURIA (batch number: 09749211A), 0.1 ml, when the nurse thought that she was administering a TB skin test. On 22-OCT-2014, the patient received remaining 0.4 ml dose of AFLURIA intramuscularly. No adverse event was reported. Outcome was reported as recovered.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 20-Oct-2014) concerns a female patient. On 20-Oct-2014, the patient received excursioned AFLURIA (batch number: T51608) for prevention of influenza. It was reported that a total of 5 boxes AFLURIA pre-filled syringes were kept in the fridge. The temperature gauge was knocked over and red 47 degrees Fahrenheit for 12 hours. A total of three excursioned vaccines were administered (refer to case: 2014045855 (another female patient) and 2014045856 (male patient)). Outcome was not reported.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This non-serious medically confirmed report (initial receipt 10-Dec-2014) concerns a 60 year old female patient who had drug allergies to sulfa drugs, tetanus immunoglobulin, cyclosporine, ciprofloxacin, letrozole, exemestane and anastrozole. It was not known whether the patient had received AFLURIA in the past. The patient had received a flu vaccine before including GlaxoSmithKline's vaccine in 2009. The patient had no history of arm of shoulder injury. On the 11-Oct-2014, the patient received AFLURIA (batch number 10049221B) 0.5 mL annually via the intramuscular route in the left arm for the prevention of influenza. On the 12-Oct-2014, one day later, she noticed at the injection site that her arm was painful, red, swollen and warm to touch. On the 13-Oct-2014, she visited her physician who prescribed cephalexin, diphenhydramine and cortisone for her symptoms. As of the 10-Dec-2014, all the patient's symptoms had disappeared except for the pain which was affecting her range of motion. Outcome was not recovered.
Sex: F
Vaccine: FLUX
Symptoms: Hyperaesthesia, Injection site pain, Pyrexia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a female patient. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date, following the flu vaccination, the patient experienced a sore injection site, felt feverish and sensitive skin. Outcome was not reported.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Pyrexia
Clinical narrative: This non-serious spontaneous consumer report (initial receipt 08-Dec-2014) concerns a 4 year-old male patient who previously received and tolerated seasonal influenza vaccine in the past 9se3e 2014047486) and was not taking any other medications, vitamins or herbal supplements. He did not receive any other immunisations in the last 3 months. On 17-Nov-2014, the patient inadvertently received intramuscular AFLURIA vaccine (batch number not provided pre-filled syringe) once, for the protection against seasonal influenza virus. On 21-Nov-2014, the patient experienced a fever of 102 Fahrenheit which lasted for one or two days. The reporter consulted a healthcare provider who informed that it was not likely due to receiving the vaccine. Antipyretic treatment was not administered. Outcome was reported as recovered.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Nasopharyngitis, Neck pain, Pain, Poor quality sleep
Clinical narrative: This spontaneous consumer report (initial receipt 27-OCT-2014) concerns a 62 year-old female patient. On an unspecified date in 2013, the patient received flu vaccination (manufacturer and batch number not reported). On an unspecified date in 2013, the patient started experiencing headaches and felt achy. She felt like she has a head cold. Other symptoms included neck ache, tossing and turning and she could not sleep. These symptoms lasted for approximately 2 weeks. Outcome was reported as recovered. Linked case: 2014046047 (same patient).
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report (initial receipt 24-Oct-2014) concerns a 58-year-old female patient. On 12-Oct-2014, the patient received AFLURIA (batch number not reported) via intramuscular route in the left arm at 0.5 ml once for protection against seasonal influenza virus. On 12-Oct-2014, the patient experienced extreme pain at the injection site that expanded to the rest of her arm. She had difficulty moving her arm due to soreness. She reported that the injection was administered higher up on the arm with other injections. Outcome was reported as not yet recovered.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: This non-serious medically confirmed report (initial receipt 23-Oct-2014) concerns a 57 year old female patient with no relevant patient history. On the 15-Oct-2014, the patient received the AFLURIA vaccine, (batch number not reported) 0.5 mL via the intramuscular route. A day or so later, the patient experienced pain in the injection site, arm and shoulder blade. Her arm had been very stiff and difficult to move and she stated that it felt like a burning toothache type of pain she lied down on it. The patient self-treated with acetaminophen, cold packs, muscle relaxers all of which had not been working to alleviate the adverse reaction. Outcome was not recovered. Reporter comments: The reporter stated the case to be non-serious.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: This medically confirmed spontaneous report (initial receipt 24-OCT-2014) concerns a 40-year-old female patient. The patient was average in height and weight. The patient received flu vaccine before, however this was the first time he had adverse events. On 21-OCT-2014, the patient received AFLURIA (batch number T52108) via intramuscular route at 0.5 ml. On 23-OCT-2014, the patient experienced severe vertigo with symptoms of nausea, dizziness and feeling faint. The patient had no history of vertigo and found it alarming. ON the afternoon of 23-OCT-2014, the patient felt a little better but the vertigo persisted. HE did not seek medical treatment and had done nothing to treat it. The outcome was reported as not yet recovered.
Age: 26.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain, Depressed level of consciousness, Nausea, Vomiting
Clinical narrative: This medically confirmed spontaneous report (initial receipt 24-OCT-2014) concerns a 26-year-old female patient. On 23-OCT-2014 at 12:00 PM, the patient received AFLURIA (batch number T51208) via intramuscular rout eat 0.5 ml once. On 24-OCT-2014, about 12 hours after the vaccination, the patient experienced intense nausea, vomiting, abdominal cramping and sensation that she was going to pass out. Outcome was reported as not yet recovered. Reporter's comments: The reporter assessed the events as non-serious.
Age: 26.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain, Depressed level of consciousness, Dizziness, Nausea, Vomiting
Clinical narrative: This medically confirmed spontaneous report (initial receipt 24-OCT-2014) concerns a 26-year-old female patient. On 23-OCT-2014 at 12:00 PM, the patient received AFLURIA (batch number T51208) via intramuscular rout eat 0.5 ml once. On 24-OCT-2014, about 12 hours after the vaccination, the patient experienced intense nausea, vomiting, abdominal cramping and sensation that she was going to pass out. Outcome was reported as not yet recovered. Reporter's comments: The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLU3
Symptoms: Cough, Lymphadenopathy, Malaise, Nausea, Pain
Clinical narrative: This medically confirmed spontaneous report (initial receipt- 21-Oct-2014) concerns a female patient. It was not known if AFLURIA was administered in the past. In the past, after flu vaccine administration, the patient became ill and experienced fever for up to two weeks post injection, enlarged lymph nodes, aching, cough and nausea. This happened consistently every year. The reporter could not provide previous flu vaccine brands and manufacturers. On an unspecified date, the patient received AFLURIA (batch number not reported). On an unspecified date, the patient became ill after receiving flu vaccine. She also developed fever (which lasted up to two weeks), enlarged lymph nodes, aching, cough and nausea. Outcome was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: This medically confirmed spontaneous report (initial receipt- 21-Oct-2014) concerns a female patient. It was not known if AFLURIA was administered in the past. In the past, after flu vaccine administration, the patient became ill and experienced fever for up to two weeks post injection, enlarged lymph nodes, aching, cough and nausea. This happened consistently every year. The reporter could not provide previous flu vaccine brands and manufacturers. On an unspecified date, the patient received AFLURIA (batch number not reported). On an unspecified date, the patient became ill after receiving flu vaccine. She also developed fever (which lasted up to two weeks), enlarged lymph nodes, aching, cough and nausea. Outcome was not reported.
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Muscle tightness
Clinical narrative: This medically confirmed spontaneous report (initial receipt 21-OCT-2014) concerns a male patient. On 14-OCT-2014, the patient received AFLURIA (batch  number T52808) at 0.5 ml via intramuscular route in the right deltoid. On 14-OCT-2014, the patient experienced muscle tightness at the injection site. On 21-OCT-2014, the patient returned to the clinic due to muscle tightness. The reporter did not know what made the tightness better or worse. Outcome was reported as not yet recovered.
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 20-OCT-2014) concerns a male patient. On 20-OCT-2014, the patient received excursion AFLURIA (batch number T51608). It was reported that a total of 5 boxes of AFLURIA pre-filled syringes were kept in the fridge and the temperature gauge was knocked over and red 47 degree Fahrenheit for 12 hours. Three excursion vaccines were administered. (Refer to cases 2014045852 and 2014045856). Outcome was not reported. Reporter's comments: The reporter believed that the patient was fine.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 34 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml.  Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 48 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. on 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 53 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time.  On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This non-serious medically confirmed report (initial receipt 29-OCT-2014) concerns a 53 year old female patient who had no known allergies and no relevant medical history. On the 29-OCT-2014, the patient received AFLURIA (batch number T58506) 0.5 ml via the intramuscular route. AFLURIA had been stored incorrectly and reached a maximum temperature of 50.5 F for an estimated duration of seven hours. The patient received the AFLURIA at the clinic without any complaints.  Outcome was unknown.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a patient who was a child. On 27-OCT-2014, the patient received intramuscular AFLURIA batch number not reported) at 0.5 ml. The AFLURIA pre-filled syringe that was administered to the patient underwent temperature excursion of 68 degree F for 48 hours. No adverse events were reported. Outcome was not reported. Reporter's comments: The reporter assessed the events as non-serious. Linked case: 2014046068 (same reporter).
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014)  concerns a 52 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature  excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns an adult patient. On 27-OCT-2014, the patient received intramuscular AFLURIA (batch number not reported) at 0.5 ml. The AFLURIA pre-filled syringe that was administered to the patient underwent temperature excursion at 68 degree F for 48 hours. No adverse events were reported. Outcome was not reported. Reporter's comments: The reporter assessed the events as non-serious.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 28 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically  confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 30 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 57 year old female patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received te4mperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 33 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014,  AFLURIA again had temperature  excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. No adverse reactions have been reported since administration. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 32 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular at 0.5 ml.. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 32 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular at 0.5 ml.. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 49 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular at 0.5 ml.. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 39 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular at 0.5 ml.. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 52 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular at 0.5 ml.. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 34 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 55 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.