chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Blood bicarbonate normal, Blood chloride normal, Blood creatinine increased, Blood glucose, Blood potassium normal
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 37 year old male patient. The patient had no allergy. His past medical history included DVT (deep vein thrombosis), eczema, hypertension, cardiomegaly and Crohn's. His concomitant medications included carvedilol, lisinopril and warfarin. On 27-Oct-2014, the patient received intramuscular AFLURIA (batch number T53309) in the left arm. On 28-Oct-2014, the patient developed acute fine sandpapery-vesicular-eruption on the left bicep about 9 inches from the intramuscular site where the patient received flu shot. The patient had no fever and was non-toxic. The laboratory tests showed white blood cell at 9.9, haemoglobin at 12.8, haematocrit at 37, platelets at 308, neutrophil percentage at 28, lymphocyte percentage at 53, eosinophil percentage at 6.5. Liver function tests showed sodium at 143, potassium at 3.7, chloride at 104, bicarbonates (HCO3) at 27, BUN at 19, creatinine at 1.9 and glucose at 80 (units not provided). The outcome was reported as unknown. Reporter comments: The health authority assessed the events as non-serious. The as reported terms were- blood bicarbonate normal, blood chloride normal, blood glucose normal, blood potassium normal, blood sodium normal, blood urea normal, injection site reaction, platelet count normal and white blood cell count normal.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Blood sodium normal, Blood urea, Eosinophil percentage increased, Haematocrit normal, Haemoglobin normal
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 37 year old male patient. The patient had no allergy. His past medical history included DVT (deep vein thrombosis), eczema, hypertension, cardiomegaly and Crohn's. His concomitant medications included carvedilol, lisinopril and warfarin. On 27-Oct-2014, the patient received intramuscular AFLURIA (batch number T53309) in the left arm. On 28-Oct-2014, the patient developed acute fine sandpapery-vesicular-eruption on the left bicep about 9 inches from the intramuscular site where the patient received flu shot. The patient had no fever and was non-toxic. The laboratory tests showed white blood cell at 9.9, haemoglobin at 12.8, haematocrit at 37, platelets at 308, neutrophil percentage at 28, lymphocyte percentage at 53, eosinophil percentage at 6.5. Liver function tests showed sodium at 143, potassium at 3.7, chloride at 104, bicarbonates (HCO3) at 27, BUN at 19, creatinine at 1.9 and glucose at 80 (units not provided). The outcome was reported as unknown. Reporter comments: The health authority assessed the events as non-serious. The as reported terms were- blood bicarbonate normal, blood chloride normal, blood glucose normal, blood potassium normal, blood sodium normal, blood urea normal, injection site reaction, platelet count normal and white blood cell count normal.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Lymphocyte percentage increased, Neutrophil percentage decreased, Platelet count normal, Rash vesicular, White blood cell count normal
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 37 year old male patient. The patient had no allergy. His past medical history included DVT (deep vein thrombosis), eczema, hypertension, cardiomegaly and Crohn's. His concomitant medications included carvedilol, lisinopril and warfarin. On 27-Oct-2014, the patient received intramuscular AFLURIA (batch number T53309) in the left arm. On 28-Oct-2014, the patient developed acute fine sandpapery-vesicular-eruption on the left bicep about 9 inches from the intramuscular site where the patient received flu shot. The patient had no fever and was non-toxic. The laboratory tests showed white blood cell at 9.9, haemoglobin at 12.8, haematocrit at 37, platelets at 308, neutrophil percentage at 28, lymphocyte percentage at 53, eosinophil percentage at 6.5. Liver function tests showed sodium at 143, potassium at 3.7, chloride at 104, bicarbonates (HCO3) at 27, BUN at 19, creatinine at 1.9 and glucose at 80 (units not provided). The outcome was reported as unknown. Reporter comments: The health authority assessed the events as non-serious. The as reported terms were- blood bicarbonate normal, blood chloride normal, blood glucose normal, blood potassium normal, blood sodium normal, blood urea normal, injection site reaction, platelet count normal and white blood cell count normal.
Sex: M
Vaccine: FLU3
Symptoms: Cough, Lacrimation increased, Lip swelling, Nasal congestion, Retching
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a male patient. The patient had a medical history of penicillin allergy, hypertension and hyperlipidemia. The concomitant medications included Lisinopril and atorvastatin. On 27-Oct-2014, the patient received AFLURIA (batch number T51708) in the left arm. On 27-Oct-2014, about 3-4 hours after administration, the patient experienced tongue swelling and had gagging persistent cough. The patient also developed watery eyes, lips swelling and nasal congestion. He was treated with over the counter (OTC) diphenhydramine. The symptoms subsided over the next day or two. There was no swelling of throat. The outcome was reported as recovered. Reporter comments: The health authority assessed the events as non-serious.
Sex: M
Vaccine: FLU3
Symptoms: Swollen tongue
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a male patient. The patient had a medical history of penicillin allergy, hypertension and hyperlipidemia. The concomitant medications included Lisinopril and atorvastatin. On 27-Oct-2014, the patient received AFLURIA (batch number T51708) in the left arm. On 27-Oct-2014, about 3-4 hours after administration, the patient experienced tongue swelling and had gagging persistent cough. The patient also developed watery eyes, lips swelling and nasal congestion. He was treated with over the counter (OTC) diphenhydramine. The symptoms subsided over the next day or two. There was no swelling of throat. The outcome was reported as recovered. Reporter comments: The health authority assessed the events as non-serious.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Limb discomfort, Musculoskeletal pain, Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 42 year old female patient who had no current illness at the time of vaccination. On the 08-Oct-2014, the patient received AFLURIA (batch number T59807A) via the intramuscular route in the right arm. On the 08-Oct-2014, the patient developed an extremely heavy and achy right arm immediately after administration. Almost a month later, the patient developed acute shoulder pain with a loss of range of motion (could not move arm back or lift arm). The doctor prescribed prednisolone for three days which was not overly helpful. NSAIDS (non-steroidal anti-inflammatory drugs) also did not relieve the problem. No additional tests were done. The doctor suspected a tear in the tendon. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious and reported the term 'immediate post injection reaction'.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Tendon rupture
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 42 year old female patient who had no current illness at the time of vaccination. On the 08-Oct-2014, the patient received AFLURIA (batch number T59807A) via the intramuscular route in the right arm. On the 08-Oct-2014, the patient developed an extremely heavy and achy right arm immediately after administration. Almost a month later, the patient developed acute shoulder pain with a loss of range of motion (could not move arm back or lift arm). The doctor prescribed prednisolone for three days which was not overly helpful. NSAIDS (non-steroidal anti-inflammatory drugs) also did not relieve the problem. No additional tests were done. The doctor suspected a tear in the tendon. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious and reported the term 'immediate post injection reaction'.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Burning sensation, Herpes zoster, Hypoaesthesia, Paraesthesia
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 39 year old female patient who had a medical history of Multiple Sclerosis, Lupus and psoriatic arthritis. The patient had allergies to sulfa drugs, penicillin and amoxicillin. Concomitant medications included sertraline, methylphenidate and natalizumab. On the 23-Oct-2014, the patient received AFLURIA (batch number T59206) via the intramuscular route in the left arm. On the 27-Oct-2014, on Tuesday evening, the patient developed a burning sensation on the right midsection. On Wednesday at midday, the patient developed tingling and then a numb feeling on the right midsection. Before bed, the patient's right lower back was cramping with sharp, jabbing pain. On Thursday morning, the patient woke up in pain and with a rash on the right midsection on the abdomen and right lower back. The patient went to urgent care and was diagnosed with shingles. Treatment included acyclovir (800mg - 1 tablet five times per day for ten days). Outcome was recovered. Reporter comments: The regulator reported the case as non-serious. The regulator reported the term 'abdominal discomfort'.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 39 year old female patient who had a medical history of Multiple Sclerosis, Lupus and psoriatic arthritis. The patient had allergies to sulfa drugs, penicillin and amoxicillin. Concomitant medications included sertraline, methylphenidate and natalizumab. On the 23-Oct-2014, the patient received AFLURIA (batch number T59206) via the intramuscular route in the left arm. On the 27-Oct-2014, on Tuesday evening, the patient developed a burning sensation on the right midsection. On Wednesday at midday, the patient developed tingling and then a numb feeling on the right midsection. Before bed, the patient's right lower back was cramping with sharp, jabbing pain. On Thursday morning, the patient woke up in pain and with a rash on the right midsection on the abdomen and right lower back. The patient went to urgent care and was diagnosed with shingles. Treatment included acyclovir (800mg - 1 tablet five times per day for ten days). Outcome was recovered. Reporter comments: The regulator reported the case as non-serious. The regulator reported the term 'abdominal discomfort'.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 26 year old female patient who had no medical history, medications at time of vaccination or current illness at the time of vaccination. On the 16-Oct-2014, the patient received AFLURIA (batch number T58306) in the left arm. On the 17-Oct-2014, the patient developed hives and was treated with antihistamines on the 17-Oct-2014. On the 18-Oct-2014, the patient went to the Emergency Room due to a spreading rash and itchiness and was kept overnight for observation, was given prednisone, antihistamines and an IV (intravenous). On the 23-Oct-2014, the patient was re-evaluated and there was no rash and patient felt well. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Body temperature increased, Chest discomfort, Chills, Discomfort
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 35 year old female patient who had no current illness or medications at the time of vaccination. She had no history. On the 03-Nov-2014, the patient received AFLURIA (batch number T59006) dose 3, via the intramuscular route in the left arm. On the 04-Nov-2014, the patient developed extreme malaise upon waking in the morning. At 09:00, the patient felt very hot but was having chills. Following the chills, the patient began to feel nauseated and very thirsty, but only drank 16 ounces of water from the time she woke until 11:00am. At 10:00am, the patient began feeling pressure, pain and tightness in the chest as well as fluttering feeling in the chest cavity. The patient left work not feeling well at 11:10am and upon getting home, continued to have the same symptoms. The patient started urinating frequently, about once every 30 minutes although she had no other liquids to drink nor did she eat. At 19:00, she took her temperature and it was 100.1. It was almost 22:00 and most of her symptoms had subsided. Outcome was not reported. Reporter comments: The regulator reported the case as non-serious and reported the terms 'activities of daily living impaired' and 'body temperature increased'.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Feeling hot, Malaise, Nausea, Pollakiuria
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 35 year old female patient who had no current illness or medications at the time of vaccination. She had no history. On the 03-Nov-2014, the patient received AFLURIA (batch number T59006) dose 3, via the intramuscular route in the left arm. On the 04-Nov-2014, the patient developed extreme malaise upon waking in the morning. At 09:00, the patient felt very hot but was having chills. Following the chills, the patient began to feel nauseated and very thirsty, but only drank 16 ounces of water from the time she woke until 11:00am. At 10:00am, the patient began feeling pressure, pain and tightness in the chest as well as fluttering feeling in the chest cavity. The patient left work not feeling well at 11:10am and upon getting home, continued to have the same symptoms. The patient started urinating frequently, about once every 30 minutes although she had no other liquids to drink nor did she eat. At 19:00, she took her temperature and it was 100.1. It was almost 22:00 and most of her symptoms had subsided. Outcome was not reported. Reporter comments: The regulator reported the case as non-serious and reported the terms 'activities of daily living impaired' and 'body temperature increased'.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Thirst
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 35 year old female patient who had no current illness or medications at the time of vaccination. She had no history. On the 03-Nov-2014, the patient received AFLURIA (batch number T59006) dose 3, via the intramuscular route in the left arm. On the 04-Nov-2014, the patient developed extreme malaise upon waking in the morning. At 09:00, the patient felt very hot but was having chills. Following the chills, the patient began to feel nauseated and very thirsty, but only drank 16 ounces of water from the time she woke until 11:00am. At 10:00am, the patient began feeling pressure, pain and tightness in the chest as well as fluttering feeling in the chest cavity. The patient left work not feeling well at 11:10am and upon getting home, continued to have the same symptoms. The patient started urinating frequently, about once every 30 minutes although she had no other liquids to drink nor did she eat. At 19:00, she took her temperature and it was 100.1. It was almost 22:00 and most of her symptoms had subsided. Outcome was not reported. Reporter comments: The regulator reported the case as non-serious and reported the terms 'activities of daily living impaired' and 'body temperature increased'.
Age: 71.0
Sex: U
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated, Dyspnoea, Ear congestion, Fatigue
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 71 year old patient who had a medical history of childhood asthma, which had not been present for over one year. On an unspecified date, the patient received AFLURIA (batch number T59807) via the intramuscular route in the left arm. On an unspecified date, the patient developed asthma, arm/body aches, a congested sinus and ear and runny nose. The patient found it hard to breathe for four days, arm and body pain lasted seven to ten days, congestion lasted over two weeks and terrible fatigue lasted two weeks. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 71.0
Sex: U
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Rhinorrhoea, Sinus congestion
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 71 year old patient who had a medical history of childhood asthma, which had not been present for over one year. On an unspecified date, the patient received AFLURIA (batch number T59807) via the intramuscular route in the left arm. On an unspecified date, the patient developed asthma, arm/body aches, a congested sinus and ear and runny nose. The patient found it hard to breathe for four days, arm and body pain lasted seven to ten days, congestion lasted over two weeks and terrible fatigue lasted two weeks. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Oedema peripheral, Skin warm
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 30 year old female patient who had no current illness at the time of vaccination. On the 29-Oct-2014, the patient received AFLURIA (batch number T57806) in the left arm. On the 30-Oct-2014, it was observed that the patient's left arm was red, oedematous and warm to touch. Cephalexin 500mg was prescribed as per diagnosis of cellulitis. The patient visited the Emergency Room. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site warmth, Oedema peripheral
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 33 year old female patient who had no current illness at the time of vaccination. On the 29-Oct-2014, the patient received AFLURIA (batch number T57806) in the left arm. On the 30-Oct-2014, it was observed that the patient's left arm was red, edematous and was warm to touch. The patient had cellulitis and was treated with methylprednisolone, amoxicillin/clavulanic acid and cetirizine. The patient attended the Emergency Room. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 18 year old male patient who had no current illness at the time of vaccination. On the 04-Nov-2014, the patient received AFLURIA (batch number T51808) via the intramuscular route in the right arm. On the 04-Nov-2014, about three minutes after receiving the flu shot, the patient passed out in a chair. The patient was moved to the floor and patient regained consciousness. He was moved to a sitting position after a few minutes and into a chair and then passed out again. 911 (emergency services) arrived seconds later and took the patient to the Emergency Room. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tendonitis, Tenosynovitis
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 62 year old female patient. Concomitant medications included pravastatin and dexlansoprazole. The patient had no current illness at the time of vaccination. On the 23-Sep-2014, the patient received AFLURIA (batch number not reported) dose 2 via the intramuscular route. On the 24-Sep-2014, the patient developed tendinitis and tenosynovitis (or inflammation of the tendon sheath lining the bicep muscle). The patient saw her primary doctor. Outcome was reported as not recovered. Reporter comments: the regulator reported the case as non-serious.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Mobility decreased, Nuclear magnetic resonance imaging
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 62 year old female patient. Concomitant medications included pravastatin and dexlansoprazole. The patient had no current illness at the time of vaccination. On the 23-Sep-2014, the patient received AFLURIA (batch number not reported) dose 2 via the intramuscular route. On the 24-Sep-2014, the patient developed tendinitis and tenosynovitis (or inflammation of the tendon sheath lining the bicep muscle). The patient saw her primary doctor. Outcome was reported as not recovered. Reporter comments: the regulator reported the case as non-serious.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Cellulitis, Erythema, Night sweats, Pain, Peripheral swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 54 year old female patient who had no history and no current illness at the time of vaccination. On the 14-Oct-2014, the patient received AFLURIA (batch number not reported) via the intramuscular route in the right arm, PNEUMOVAX (batch number K007826) via the intramuscular route in the right arm and BOOSTRIX (batch number P39A2) dose 1, via the intramuscular route in the left arm. On the 14-Oct-2014, two hours after receiving the vaccine, the patient experienced swelling and redness in the right arm. The swelling went to the elbow, was very sore and swollen. The patient took diphenhydramine that night and had extreme night sweats that night. The patient went to urgent care the next day and was told she had cellulitis and was given antibiotics. The patient went to her regular doctor that same day who instructed the patient not to take antibiotics unless the fever went to 100.5. The patient's fever reached 99.9 therefore the patient did not take antibiotics. On Friday, the patient still experienced slight redness towards the elbow, was sore, swelling had gone. The patient was still taking diphenhydramine and cetirizine. The patient felt better. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 54 year old female patient who had no history and no current illness at the time of vaccination. On the 14-Oct-2014, the patient received AFLURIA (batch number not reported) via the intramuscular route in the right arm, PNEUMOVAX (batch number K007826) via the intramuscular route in the right arm and BOOSTRIX (batch number P39A2) dose 1, via the intramuscular route in the left arm. On the 14-Oct-2014, two hours after receiving the vaccine, the patient experienced swelling and redness in the right arm. The swelling went to the elbow, was very sore and swollen. The patient took diphenhydramine that night and had extreme night sweats that night. The patient went to urgent care the next day and was told she had cellulitis and was given antibiotics. The patient went to her regular doctor that same day who instructed the patient not to take antibiotics unless the fever went to 100.5. The patient's fever reached 99.9 therefore the patient did not take antibiotics. On Friday, the patient still experienced slight redness towards the elbow, was sore, swelling had gone. The patient was still taking diphenhydramine and cetirizine. The patient felt better. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Hypoaesthesia, Mobility decreased, Musculoskeletal pain
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 40 year old male patient who had the AFLURIA in the past and developed pain in the left arm (see 2014047576) however it was also reported that the patient had never had a flu shot before. On the 29-Sep-2014, the patient received AFLURIA (batch number T57205) via the intramuscular route in the left arm. On the 30-Sep-2014, it started that night, the patient developed numbness in the fingers, sharp shocking pain in the shoulders, neck and elbow. It was so painful that the patient could barely move the arm. The patient missed work for two days. It seemed to go away but on Sunday 05-Nov-2014, the pain came back and the patient wasn't able to work for three straight days. The patient went back to the pharmacy who did not offer a solution but suggested to go to the physician. The patient had never had that type of pain in his arm whatsoever in his life. The patient was in a lot of pain. The patient went to see a doctor. At this point, the patient had missed a lot of days off work because everything from dressing to driving was a challenge. Treatment included two medications - meloxicam and methylprednisolone. After one day, the pain went away but came back two days after using all the medications prescribed. The patient missed more days off work and had felt like someone had hit him with a 2*4 on the arm, neck and shoulder. The patient was seeking further medical attention but due to the fact that he was a new hire at work with no insurance and only three paychecks (with a lot of missed time), the patient was unable to come up with an immediate solution. His workplace said he had missed too many days and fired him. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious. The reporter stated that he took the flu shot because it was a work requirement. The pharmacy staff did not believe that the flu shot could cause that kind of pain even though the patient had never had any type of pain in the arm in his life. The doctor continued saying there was no way the shot could cause that kind of pain.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 40 year old male patient who had the AFLURIA in the past and developed pain in the left arm (see 2014047576) however it was also reported that the patient had never had a flu shot before. On the 29-Sep-2014, the patient received AFLURIA (batch number T57205) via the intramuscular route in the left arm. On the 30-Sep-2014, it started that night, the patient developed numbness in the fingers, sharp shocking pain in the shoulders, neck and elbow. It was so painful that the patient could barely move the arm. The patient missed work for two days. It seemed to go away but on Sunday 05-Nov-2014, the pain came back and the patient wasn't able to work for three straight days. The patient went back to the pharmacy who did not offer a solution but suggested to go to the physician. The patient had never had that type of pain in his arm whatsoever in his life. The patient was in a lot of pain. The patient went to see a doctor. At this point, the patient had missed a lot of days off work because everything from dressing to driving was a challenge. Treatment included two medications - meloxicam and methylprednisolone. After one day, the pain went away but came back two days after using all the medications prescribed. The patient missed more days off work and had felt like someone had hit him with a 2*4 on the arm, neck and shoulder. The patient was seeking further medical attention but due to the fact that he was a new hire at work with no insurance and only three paychecks (with a lot of missed time), the patient was unable to come up with an immediate solution. His workplace said he had missed too many days and fired him. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious. The reporter stated that he took the flu shot because it was a work requirement. The pharmacy staff did not believe that the flu shot could cause that kind of pain even though the patient had never had any type of pain in the arm in his life. The doctor continued saying there was no way the shot could cause that kind of pain.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 44 year old female patient who had a medical history of asthma, ragweed and had shingles two weeks previously however it had cleared up. Concomitant medications included amoxicillin due to a tooth extraction on the 28-Oct-2014. Other concomitant medications included oxycodone-acetaminophen and acyclovir (shingles antiviral). On the 04-Nov-2014, the patient received AFLURIA (batch number not reported). On the 05-Nov-2014, the patient developed fever, aches and a headache. The shingles rash returned. Outcome was not reported. Reporter comments: The regulator reported the case as non-serious.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Neuralgia, Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 61 year old female patient. The patient had no history or current illness at the time of vaccination. On the 20-Oct-2014, the patient received AFLURIA (batch number T51406) dose 2 in the right arm. On the 21-Oct-2014, the patient complained of an abnormal soreness in the arm the day after the shot which continued for a week or two after. Nerve pain extended down the arm into the hand and a limited range of motion in the shoulder also presented. The patient went to the Emergency Room. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Neuralgia
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 63 year old female patient who had a medical history of neuralgia, chronic pain and high blood pressure. At the time of vaccination, the patient had diabetes and was recovering from surgery. Concomitant medications included lisinopril, morphine, oxycodone, metformin, ibuprofen, gabapentin, trazodone and glibenclamide. On the 08-Oct-2014, the patient received AFLURIA (batch number T59807A) in the left arm via the intramuscular route. On the 08-Oct-2014, the patient developed nerve pain with the immobility of the arm. Treatment included physical therapy. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia oral, Lip swelling, Paraesthesia oral, Throat tightness
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 51 year old female patient who had RLL (right lower lobe) pneumonia/CAP (Community Acquired Pneumonia) with failed outpatient levofloxacin therapy (six days of treatment) and with cyanosis of the fingernails and nose. The patient was negative for legionella antigen. The patient had a medical history of GERD (Gastroesophageal reflux disease), depression and was positive for EBV (Epstein Barr virus) antigen in 2011. Concomitant medications included sertraline, benzonatate, ceftriaxone, doxycycline, ipratropium/albuterol nebules. The patient had no other new meds. On the 06-Nov-2014, the patient received AFLURIA (batch number T53709) via the intramuscular route in the right arm. On the 06-Nov-2014, about 90 minutes later, the patient started to feel tingling in her tongue, her lips went completely numb and her throat felt very tight. The patient was given 25mg of PO diphenhydramine and after 20 minutes her throat felt better, tongue stopped tingling but her lips were still numb and a bit swollen. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 28.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Infection, Rash, Swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 28 year-old female patient who had no known current illness at the time of vaccination. On 03-Nov-2014, the patient received intramuscular AFLURIA (batch number T59807A) in the arm. On 04-Nov-2014, the patient experienced rash and swelling. Patient took antibiotics for infection. The outcome was  unknown. Reporter's comments: The regulatory authority assessed the case as non-serious and presented at the 'Emergency Room'. Case correction (30-Jan-2015): upgraded to serious.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Joint range of motion decreased, Pain
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 49 year old female patient. On the 09-Oct-2014, the patient received AFLURIA (batch number T57405) via the intramuscular route in the left arm. On an unspecified date, the patient experienced bursitis it [sic] shoulder, pain and loss of ROM (range of motion). The patient needed an MRI (magnetic resonance imaging) and 'PT'. The patient attended the Emergency Room. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious and reported the terms 'injected limb mobility decreased', 'injection site pain', 'injection site reaction' and 'nuclear magnetic resonance imaging'.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Flushing, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 58 year old female patient who had no current illness and an allergy to codeine, steroids and cortisone. On the 21-Oct-2014, the patient received AFLURIA (batch number 09749211A) via the intramuscular route in the left arm. On the 22-Oct-2014, the patient developed left upper arm redness, swelling, tenderness, facial flushing, pain in the neck and shoulder blades. The patient was diagnosed with cellulitis. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 58 year old female patient who had no current illness and an allergy to codeine, steroids and cortisone. On the 21-Oct-2014, the patient received AFLURIA (batch number 09749211A) via the intramuscular route in the left arm. On the 22-Oct-2014, the patient developed left upper arm redness, swelling, tenderness, facial flushing, pain in the neck and shoulder blades. The patient was diagnosed with cellulitis. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Blindness unilateral, Ear pain, Headache, Impaired work ability, Insomnia
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 36 year-old female patient who had no known current illness. On 23-Oct-2014, the patient received intramuscular AFLURIA (batch number T58606) in the left arm. On 01-Nov-2014, the patient experienced ear pain throughout the night after midnight and was not able to sleep. She went to the doctor with ear pain and pain in head behind her ear on Saturday 01-Nov-2014. On Sunday 02-Nov-2014, she went to the emergency room as her right side of face was paralysed. On Tuesday 04-Nov-2014 at around 6am, she went back to the emergency room as the symptoms were worse. She was not able to see out of right eye and had severe speech problems. She had been out of work since all of these symptoms started, and had been to the eye doctor, ENT (ear nose throat) and to the emergency room twice. She also had an MRI (magnetic resonance imaging) at the hospital which showed no tumours or anything. Treatment included steroids, acyclovir and eye lubrications. All the doctors felt that these symptoms came from the flu shot and called it Bell's palsy. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, and reported the symptoms of 'blindness' and 'nuclear magnetic resonance imaging normal'.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Speech disorder, VIIth nerve paralysis
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 36 year-old female patient who had no known current illness. On 23-Oct-2014, the patient received intramuscular AFLURIA (batch number T58606) in the left arm. On 01-Nov-2014, the patient experienced ear pain throughout the night after midnight and was not able to sleep. She went to the doctor with ear pain and pain in head behind her ear on Saturday 01-Nov-2014. On Sunday 02-Nov-2014, she went to the emergency room as her right side of face was paralysed. On Tuesday 04-Nov-2014 at around 6am, she went back to the emergency room as the symptoms were worse. She was not able to see out of right eye and had severe speech problems. She had been out of work since all of these symptoms started, and had been to the eye doctor, ENT (ear nose throat) and to the emergency room twice. She also had an MRI (magnetic resonance imaging) at the hospital which showed no tumours or anything. Treatment included steroids, acyclovir and eye lubrications. All the doctors felt that these symptoms came from the flu shot and called it Bell's palsy. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, and reported the symptoms of 'blindness' and 'nuclear magnetic resonance imaging normal'.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Pain in extremity, Paralysis, Radiculitis brachial
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 75 year-old male patient. His concomitant medications included Lisinopril, low dose acetylsalicylic acid, ranitidine and vitamin D3. On 13-Oct-2014, the patient received intramuscular AFLURIA injection (batch number not provided) in the arm (deltoid). On 23-Oct-2014, the patient developed post-vaccinal brachial neuritis with partial paralysis of the hand and severe pain. The patient also experienced moderately severe weakness of finger and wrist extensors, with milder weakness of triceps, unilateral, and some milder symptoms on the contralateral side. The outcome was unknown. Reporter's comments: The regulatory authority assessed the case as non-serious, and reported the symptom of 'pain in extremity'.
Age: 25.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Dizziness, Dyskinesia, Head injury, Immediate post-injection reaction, Laceration
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 25 year-old female patient who had no known current illness and no known medical history. Concomitant medication included levonorgestrel/ethinyl estradiol. On 07-Nov-2014, the patient received intramuscular AFLURIA (batch number T52508) in the left arm. On the same day, the patient also received intramuscular MENVEO (batch number A14068) in the right arm and intramuscular ADACEL (batch number U4955AA) in the left arm. On 07-Nov-2014, immediately following Tdap vaccination, the patient lost consciousness and experienced jerking / seizure-like movements. She hit her head on the vaccine refrigerator. Laceration was noted above her right eyebrow. Ammonia inhalant was used and she regained consciousness. She lost consciousness again while she was transferred from chair to the exam table. She was lowered to the floor, given ammonia inhalant and consciousness was regained. Her blood pressure was 76/48. Her head was elevated. She was given water and ginger ale which she tolerated. She had dizziness, and denied of nausea / vomiting and head pain. She was transferred to the emergency room for laceration. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, and reported the symptom of 'immediate post-injection reaction'.
Age: 25.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Loss of consciousness, Seizure like phenomena
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 25 year-old female patient who had no known current illness and no known medical history. Concomitant medication included levonorgestrel/ethinyl estradiol. On 07-Nov-2014, the patient received intramuscular AFLURIA (batch number T52508) in the left arm. On the same day, the patient also received intramuscular MENVEO (batch number A14068) in the right arm and intramuscular ADACEL (batch number U4955AA) in the left arm. On 07-Nov-2014, immediately following Tdap vaccination, the patient lost consciousness and experienced jerking / seizure-like movements. She hit her head on the vaccine refrigerator. Laceration was noted above her right eyebrow. Ammonia inhalant was used and she regained consciousness. She lost consciousness again while she was transferred from chair to the exam table. She was lowered to the floor, given ammonia inhalant and consciousness was regained. Her blood pressure was 76/48. Her head was elevated. She was given water and ginger ale which she tolerated. She had dizziness, and denied of nausea / vomiting and head pain. She was transferred to the emergency room for laceration. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, and reported the symptom of 'immediate post-injection reaction'.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Campylobacter infection, Campylobacter test positive, Diarrhoea, Hyperhidrosis
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 25 year-old male patient who had no known current illness. On 27-Sep-2014, the patient received intramuscular AFLURIA (batch number T59907) in the right arm. On 30-Sep-2014, the patient developed a fever (101.3), nausea without vomiting, diarrhoea, diaphoresis and abdominal cramping. On 02-Oct-2014, Thursday, his temperature increased to 102.8. On 03-Oct-2014, he was admitted to the hospital until 06-Oct-2014. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as serious (caused hospitalisation) and presented at the 'Emergency Room'. The regulatory reported the symptoms of 'campylobacter test positive' and 'lymphadenitis'. It was thought that it was related to the flu vaccine due to the egg connection.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Lymphadenitis, Nausea, Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 25 year-old male patient who had no known current illness. On 27-Sep-2014, the patient received intramuscular AFLURIA (batch number T59907) in the right arm. On 30-Sep-2014, the patient developed a fever (101.3), nausea without vomiting, diarrhoea, diaphoresis and abdominal cramping. On 02-Oct-2014, Thursday, his temperature increased to 102.8. On 03-Oct-2014, he was admitted to the hospital until 06-Oct-2014. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as serious (caused hospitalisation) and presented at the 'Emergency Room'. The regulatory reported the symptoms of 'campylobacter test positive' and 'lymphadenitis'. It was thought that it was related to the flu vaccine due to the egg connection.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Inadequate aseptic technique in use of product, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 62 year-old male patient who had no known current illness and no relevant history. Concomitant medications included amitriptyline, oxybutynin, diazepam, levothyroxine, oxycodone-APAP, tamsulosin and gabapentin. On 02-Nov-2014, the patient received intramuscular AFLURIA (batch number T59306) in the left arm. The vaccinating pharmacist failed to swab/clean the injection site on the patient's arm prior to the administration of flu vaccine. On 04-Nov-2014, the patient experienced redness and swelling at the injection site one and a half days after the vaccination. She tested positive for cellulitis at the injection site and required treatment with antibiotic (levofloxacin 500mg daily for 7 days). On 07-Nov-2014 at 7:30pm, she was recovering. The outcome was recovered on an unknown date. Reporter's comments: The regulatory authority assessed the case as non-serious, the patient presented at the 'Emergency Room'.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 30 year-old female patient who had no known current illness and no known medical history. Concomitant medication included spironolactone. On 07-Oct-2014, the patient received intramuscular AFLURIA (batch number T57505) in the left arm. On 19-Oct-2014, she had pins and needles in both feet. On 20-Oct-2014, there was a progression of paraesthesia. On 21-Oct-2014, the paraesthesia progression went upwards involving legs, thighs, abdomen, arms and hands. On 23-Oct-2014, she had perioral and facial numbness. On 18-Nov-2014, the patient experienced a warm sensation to the right foot. She went to the emergency room and was hospitalised for 7 days. The outcome was unknown. Reporter's comments: The regulatory authority assessed the case as serious (led to hospitalisation).
Age: 64.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pruritus
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 64 year-old male patient who had no known current illness. He had no known medical history except for shingles in 1984-1985. Concomitant medications included rosuvastatin and lisinopril. On 08-Nov-2014, the patient received AFLURIA (batch number '33332-0014-01', non-CSL batch) in the right arm and ZOSTAVAX (batch 00006-4963) in the left arm. Both vaccines were given via route 'SYR'. On 09-Nov-2014, the patient developed itchiness and shingles rash on the right side of stomach at the site of the previous case of shingles that occurred in 1984-1985. The doctor confirmed on 10-Nov-2014 at 09:30AM. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Hypogeusia, Mouth haemorrhage
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 48 year-old female patient. On 23-Oct-2014, the patient received intramuscular AFLURIA (batch number 09949211A) in the left arm. On 24-Oct-2014, the patient developed a metallic taste in the mouth, a decreased sense of taste, and petechiae all over oral mucosa and palate. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious.