chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dysphagia, Fatigue, Flushing, Pruritus, Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 49 year-old female patient who had no known current illness and concomitant medications at the time of vaccination. Her medical history included lung disease, asthma, anaemia, blood disorder (Von Willebrand's), seizure disorder, splenectomy and cirrhosis of liver. On 05-Nov-2014, the patient received intramuscular AFLURIA (batch number T53709, dose 1) in the right arm. On the same day, the patient also received PNEUMOVAX (batch number K010016) in the left arm. On 06-Nov-2014, the patient began to experience flushed feeling (she thought she was having a fever, fatigue, itchy skin with no visible rash). She was suggested to take acetaminophen or ibuprofen (her choice to decide) and diphenhydramine if her skin continued to itch. The patient left the pharmacy area and continued with her shopping. After shopping, she returned to the pharmacy and reported that she was not feeling better. The pharmacy staff called the primary care physician who suggested the patient to do the same and that the reaction at this point with the exception to itch was a normal reaction to the flu shot. As there was no visible rash, it was thought that the itchiness was related to the flushing. It progressed to swelling under the chin area and she had some trouble swallowing. It was unsure when these progression symptoms started. She presented to the emergency room and was hospitalised. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious. The hospital also reported this event.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 49 year-old female patient who had no known current illness and concomitant medications at the time of vaccination. Her medical history included lung disease, asthma, anaemia, blood disorder (Von Willebrand's), seizure disorder, splenectomy and cirrhosis of liver. On 05-Nov-2014, the patient received intramuscular AFLURIA (batch number T53709, dose 1) in the right arm. On the same day, the patient also received PNEUMOVAX (batch number K010016) in the left arm. On 06-Nov-2014, the patient began to experience flushed feeling (she thought she was having a fever, fatigue, itchy skin with no visible rash). She was suggested to take acetaminophen or ibuprofen (her choice to decide) and diphenhydramine if her skin continued to itch. The patient left the pharmacy area and continued with her shopping. After shopping, she returned to the pharmacy and reported that she was not feeling better. The pharmacy staff called the primary care physician who suggested the patient to do the same and that the reaction at this point with the exception to itch was a normal reaction to the flu shot. As there was no visible rash, it was thought that the itchiness was related to the flushing. It progressed to swelling under the chin area and she had some trouble swallowing. It was unsure when these progression symptoms started. She presented to the emergency room and was hospitalised. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious. The hospital also reported this event.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Eye swelling, Eyelid oedema, Mouth swelling, Oedema mouth, Pharyngeal oedema
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 66 year-old male patient who had no known current illness at the time of vaccination. His medical history included a mild allergy to eggs which he belch/burp when he eats them. Concomitant medications included sildenafil, fish oil, crataegus laevigata, ergocalciferol, fiber dietary supplement, ubidecarenone, quercetin and ZYLFLAMEND (herbal preparation containing extracts of rosemary, turmeric, ginger, holy basil, green tea, hu zhang, Chinese goldthread, barberry, oregano and Baikal skullcap). On 13-Nov-2014, the patient received intramuscular AFLURIA (batch number T52108) in the right arm. On 13-Nov-2014, the patient began to experience swelling in throat, then had swollen/puffy eyes. It then followed by rash on chest, then more mouth swelling. She then went to the Emergency Room. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, and reported the symptoms of 'eyelid oedema' and 'oedema mouth'.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 66 year-old male patient who had no known current illness at the time of vaccination. His medical history included a mild allergy to eggs which he belch/burp when he eats them. Concomitant medications included sildenafil, fish oil, crataegus laevigata, ergocalciferol, fiber dietary supplement, ubidecarenone, quercetin and ZYLFLAMEND (herbal preparation containing extracts of rosemary, turmeric, ginger, holy basil, green tea, hu zhang, Chinese goldthread, barberry, oregano and Baikal skullcap). On 13-Nov-2014, the patient received intramuscular AFLURIA (batch number T52108) in the right arm. On 13-Nov-2014, the patient began to experience swelling in throat, then had swollen/puffy eyes. It then followed by rash on chest, then more mouth swelling. She then went to the Emergency Room. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, and reported the symptoms of 'eyelid oedema' and 'oedema mouth'.
Age: 36.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Grip strength decreased, Joint range of motion decreased, Joint stiffness
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 36 year old male patient. On the 15-Nov-2014, the patient received AFLURIA (batch number T59507) via the intramuscular route in the right arm and VARIVAX (batch number K005427). On the 15-Nov-2014, the patient developed non-ROM (range of motion), could not grip with the right hand and could not bend at the elbow. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious, reported the patient presented at the Emergency Room, and reported the term 'injected limb mobility decreased'.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Cellulitis, Peripheral swelling, Rash, Skin warm
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 58 year old female patient. On the 21-Oct-2014, the patient received AFLURIA (batch number T59907) via the intramuscular route in the right arm. The patient also received PNEUMOVAX (batch number K007822) via the intramuscular route in the left arm and ZOSTAVAX (batch number K003602) via the subcutaneous route in the right arm. On the 24-Oct-2014, the patient developed a rash on her right side. It was hot to touch. It spread around her arm to the elbow. Her hand was swollen. She was treated for cellulitis. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious and presented at the 'Emergency Room'.
Age: 72.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Death, Discomfort, Dyspnoea, Leukaemia, Pain
Clinical narrative: This spontaneous medically confirmed report (initial receipt 21-Nov-2014) concerns a 72 year-old male patient. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not reported) and pneumococcal vaccine (manufacturer and batch number not reported) on the same day. On an unspecified date, the patient experienced pain and tightness similar to gall bladder symptoms. The patient was seen by a physician and was determined to have enlarged spleen. The patient was sent to an oncologist and was diagnosed with leukemia on an unspecified date. The patient's spleen was surgically removed as it was continuing to enlarge. The patient never fully recovered from the surgery and experienced breathing problems and died on 07-Nov-2014, before leaving the hospital. The outcome was reported as deceased.
Age: 72.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Splenectomy, Splenomegaly
Clinical narrative: This spontaneous medically confirmed report (initial receipt 21-Nov-2014) concerns a 72 year-old male patient. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not reported) and pneumococcal vaccine (manufacturer and batch number not reported) on the same day. On an unspecified date, the patient experienced pain and tightness similar to gall bladder symptoms. The patient was seen by a physician and was determined to have enlarged spleen. The patient was sent to an oncologist and was diagnosed with leukemia on an unspecified date. The patient's spleen was surgically removed as it was continuing to enlarge. The patient never fully recovered from the surgery and experienced breathing problems and died on 07-Nov-2014, before leaving the hospital. The outcome was reported as deceased.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Death, Hypopnoea, Unresponsive to stimuli
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 34 year-old male patient. Medications taken at the time of vaccination included alprazolam 2mg and hydrocodone/acetaminophen 7.5/325. On 06-Nov-2014, the patient received intramuscular AFLURIA (batch number T57806) in the left arm. On 07-Nov-2014, the patient was found unresponsive at his home by his mother. The patient's mother called 911 and reported very light breathing. She and the paramedics tried to perform CPR (Cardiopulmonary Resuscitation) but were unsuccessful and reported him dead at 2pm. Paramedics stated that it was similar to what they see in the heart attack victims. There were no visible illnesses or complaints. No injection site reactions were seen. No autopsy reports were received as of 18-Nov-2014. The outcome was death. Reporter's comments: The regulatory authority assessed the case as serious (resulted in death).
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Allergy test, Anaphylactic shock, Fatigue, Hypersensitivity, Muscle spasms
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 32 year old male patient who had no medical history and no current illness at the time of vaccination. The patient had no previous hospitalisations for anaphylaxis prior to 19-Sep-2009. On the 19-Sep-2009, the patient received AFLURIA (batch number 01649211A [thimerosal-containing]) as a routine mandatory influenza virus vaccine. On the 19-Sep-2009, the patient developed rapid throat and tongue swelling, spasms, fatigue/sleepiness, rash, itching and vertigo. The patient was treated for an allergic reaction with adrenaline and diphenhydramine. The patient was allergy tested. Immunotherapy proved some success. The patient was hospitalised numerous times since the initial incident on the 19-Sep-2009 for anaphylactic shock. Outcome was not recovered. Reporter comments: The regulator reported the case as serious (caused permanent disability, hospitalised)  and reported the terms 'allergy test'. Case correction (13-Feb-2015) Listedness for 'vertigo' and 'muscle spasm', re-rank events, overal case listedness.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Pruritus, Rash, Somnolence, Swollen tongue
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 32 year old male patient who had no medical history and no current illness at the time of vaccination. The patient had no previous hospitalisations for anaphylaxis prior to 19-Sep-2009. On the 19-Sep-2009, the patient received AFLURIA (batch number 01649211A [thimerosal-containing]) as a routine mandatory influenza virus vaccine. On the 19-Sep-2009, the patient developed rapid throat and tongue swelling, spasms, fatigue/sleepiness, rash, itching and vertigo. The patient was treated for an allergic reaction with adrenaline and diphenhydramine. The patient was allergy tested. Immunotherapy proved some success. The patient was hospitalised numerous times since the initial incident on the 19-Sep-2009 for anaphylactic shock. Outcome was not recovered. Reporter comments: The regulator reported the case as serious (caused permanent disability, hospitalised)  and reported the terms 'allergy test'. Case correction (13-Feb-2015) Listedness for 'vertigo' and 'muscle spasm', re-rank events, overal case listedness.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 32 year old male patient who had no medical history and no current illness at the time of vaccination. The patient had no previous hospitalisations for anaphylaxis prior to 19-Sep-2009. On the 19-Sep-2009, the patient received AFLURIA (batch number 01649211A [thimerosal-containing]) as a routine mandatory influenza virus vaccine. On the 19-Sep-2009, the patient developed rapid throat and tongue swelling, spasms, fatigue/sleepiness, rash, itching and vertigo. The patient was treated for an allergic reaction with adrenaline and diphenhydramine. The patient was allergy tested. Immunotherapy proved some success. The patient was hospitalised numerous times since the initial incident on the 19-Sep-2009 for anaphylactic shock. Outcome was not recovered. Reporter comments: The regulator reported the case as serious (caused permanent disability, hospitalised)  and reported the terms 'allergy test'. Case correction (13-Feb-2015) Listedness for 'vertigo' and 'muscle spasm', re-rank events, overal case listedness.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns an 83 year old male patient with a past medical history of dementia. On the 01-Oct-2014, the patient received AFLURIA (batch number T50407) dose 1 in the left arm. On the 02-Oct-2014, the patient presented to the Emergency Department with a fever. The patient was hospitalised for six days. Treatment included acetaminophen 650mg once. Outcome was recovered. Reporter comments: The regulator reported the case as serious (hospitalisation).
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 54 year old male patient who had a HCTZ (hydrochlorothiazide) allergy, HTN (hypertension) and high cholesterol. The patient had shingles in the past. Concomitant medications included lisinopril, CoQA, niacin, 50+ MVI (multivitamins) and red yeast rice. The patient had no current illness at the time of vaccination. On the 12-Nov-2014, the patient received AFLURIA (batch number 'ndc33332-0014-0') dose 7, via the intramuscular route in the left arm. On the 15-Nov-2014, after having the AFLURIA injection, the patient developed a shingles outbreak on the rear left shoulder near where he had shingles in the past. The patient now had shingles four times and had the shingles vaccine a couple of years ago. Outcome was not reported. Reporter comments: The regulator reported the case as non-serious.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count, Hypoaesthesia, Metabolic function test, Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 49 year-old female patient who had an allergy to hydromorphone. Concomitant medications included hydroxyzine, amlodipine, salbutamol, salmeterol/fluticasone, acetylsalicylic acid, fish oil and multivitamins. On 07-Oct-2013, the patient received intramuscular AFLURIA (batch number 09249211A) in the right arm. On 07-Oct-2013, the patient experienced a sudden onset of numbness to her left side of her face and some occasional left arm weakness. There was no facial drooping or slurred speech. She went to see her primary care physician the next day who prescribed her a MEDROL dose pack. The symptoms improved slightly on the first two days of the MEDROL dose pack and then returned. On an unknown date she saw a neurologist and had an MRI (magnetic resonance imaging) of the head and neck. The MRI did not show any findings of the causation for the facial numbness. Other lab tests conducted included CBC (full blood count), CMP (comprehensive metabolic function test) and thyroid function test. The symptoms finally resolved completely within 3 months. She learnt that several others experienced similar symptoms after receiving their flu vaccine last year (refer to case TC-1560). She received FLUVIRIN (batch number 1411301) this year (2014) and did not experience any adverse reactions. The outcome was recovered. Reporter's comments: The reporter reported that she initially didn't associate the symptoms with the flu vaccine and didn't report this adverse event as she thought was a coincidence that she had the flu shot on the day of the symptoms started. The regulatory authority assessed the case as non-serious and presented at the 'Emergency Room'. The regulator reported the terms 'full blood count', 'metabolic function test', 'nuclear magnetic resonance imaging normal' and 'thyroid function test'.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Thyroid function test
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 49 year-old female patient who had an allergy to hydromorphone. Concomitant medications included hydroxyzine, amlodipine, salbutamol, salmeterol/fluticasone, acetylsalicylic acid, fish oil and multivitamins. On 07-Oct-2013, the patient received intramuscular AFLURIA (batch number 09249211A) in the right arm. On 07-Oct-2013, the patient experienced a sudden onset of numbness to her left side of her face and some occasional left arm weakness. There was no facial drooping or slurred speech. She went to see her primary care physician the next day who prescribed her a MEDROL dose pack. The symptoms improved slightly on the first two days of the MEDROL dose pack and then returned. On an unknown date she saw a neurologist and had an MRI (magnetic resonance imaging) of the head and neck. The MRI did not show any findings of the causation for the facial numbness. Other lab tests conducted included CBC (full blood count), CMP (comprehensive metabolic function test) and thyroid function test. The symptoms finally resolved completely within 3 months. She learnt that several others experienced similar symptoms after receiving their flu vaccine last year (refer to case TC-1560). She received FLUVIRIN (batch number 1411301) this year (2014) and did not experience any adverse reactions. The outcome was recovered. Reporter's comments: The reporter reported that she initially didn't associate the symptoms with the flu vaccine and didn't report this adverse event as she thought was a coincidence that she had the flu shot on the day of the symptoms started. The regulatory authority assessed the case as non-serious and presented at the 'Emergency Room'. The regulator reported the terms 'full blood count', 'metabolic function test', 'nuclear magnetic resonance imaging normal' and 'thyroid function test'.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray, Computerised tomogram head, Computerised tomogram thorax, Laboratory test, Lumbar puncture
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 54 year old male patient who concomitantly suffered from hypertension. On the 17-Oct-2014, the patient received AFLURIA (batch number T58306) via the intramuscular route in the right arm. On the 17-Oct-2014, two hours after vaccination, the patient developed weakness in the legs. Two and a half days later, the patient developed acute sudden onset paralysis. Diagnosis was transverse myelitis. The patient spent twelve days in acute hospital and was ongoing IP (in-patient) rehabilitation. Laboratory data and scans included a chest X-ray, a CT (Computed tomogram) of the head and chest, a MRI (Magnetic Resonance Imaging) of the full spine with and without contrast, a lumbar puncture and multiple laboratory and pathology tests. Outcome was not recovered. Reporter comments: The regulator reported the case as serious and reported the terms 'chest X-ray', 'computerised tomogram head', 'computerised tomogram thorax', 'laboratory test', 'lumbar puncture', 'nuclear magnetic resonance imaging spinal', 'pathology test' and 'scan with contrast'.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Myelitis transverse, Nuclear magnetic resonance imaging spinal, Paralysis, Pathology test
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 54 year old male patient who concomitantly suffered from hypertension. On the 17-Oct-2014, the patient received AFLURIA (batch number T58306) via the intramuscular route in the right arm. On the 17-Oct-2014, two hours after vaccination, the patient developed weakness in the legs. Two and a half days later, the patient developed acute sudden onset paralysis. Diagnosis was transverse myelitis. The patient spent twelve days in acute hospital and was ongoing IP (in-patient) rehabilitation. Laboratory data and scans included a chest X-ray, a CT (Computed tomogram) of the head and chest, a MRI (Magnetic Resonance Imaging) of the full spine with and without contrast, a lumbar puncture and multiple laboratory and pathology tests. Outcome was not recovered. Reporter comments: The regulator reported the case as serious and reported the terms 'chest X-ray', 'computerised tomogram head', 'computerised tomogram thorax', 'laboratory test', 'lumbar puncture', 'nuclear magnetic resonance imaging spinal', 'pathology test' and 'scan with contrast'.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram head, Fall, Head injury, International normalised ratio increased, Laboratory test normal
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 54 year old male patient who had a medical history of hypertension, status post aortic valve replacement (tissue) on the 13-Oct-2014 and heparin-induced thrombocytopenia diagnosed on 17-Oct-2014. Concomitant medications included metoprolol tartrate, atorvastatin, aspirin, and warfarin. Warfarin was commenced on 22-Oct-2014 post hospital discharge and the last dose was taken on the 20-Nov-2014, the day before the adverse event. On the 21-Nov-2014, the patient received AFLURIA (batch number T51408) via the intramuscular route in the left arm. On the 21-Nov-2014, the patient had a seizure whilst in the store. The patient fell backwards and gashed his head on the shelving. The patient was transported by the ambulance to the medical centre since he was on warfarin for the positive HIT (heparin induced thrombocytopenia) diagnosis and was actively bleeding from his head wound. The patient was also non-responsive to questioning from the EMT (Emergency Medical Team) personnel. The patient had a red rash all over his face which went down towards the top of his shoulders but the doctor did not know what caused it (perhaps it was due to an allergy to bindings that they used to tie him down to the gurney in the ambulance, trying to protect his neck and keep his still as the patient was very combative in the ambulance). Outcome was recovered. Reporter comments: The regulator reported the case as non-serious and reported the terms 'computerised tomogram head normal' and 'laboratory test normal'.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Seizure, Unresponsive to stimuli, Wound haemorrhage
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 54 year old male patient who had a medical history of hypertension, status post aortic valve replacement (tissue) on the 13-Oct-2014 and heparin-induced thrombocytopenia diagnosed on 17-Oct-2014. Concomitant medications included metoprolol tartrate, atorvastatin, aspirin, and warfarin. Warfarin was commenced on 22-Oct-2014 post hospital discharge and the last dose was taken on the 20-Nov-2014, the day before the adverse event. On the 21-Nov-2014, the patient received AFLURIA (batch number T51408) via the intramuscular route in the left arm. On the 21-Nov-2014, the patient had a seizure whilst in the store. The patient fell backwards and gashed his head on the shelving. The patient was transported by the ambulance to the medical centre since he was on warfarin for the positive HIT (heparin induced thrombocytopenia) diagnosis and was actively bleeding from his head wound. The patient was also non-responsive to questioning from the EMT (Emergency Medical Team) personnel. The patient had a red rash all over his face which went down towards the top of his shoulders but the doctor did not know what caused it (perhaps it was due to an allergy to bindings that they used to tie him down to the gurney in the ambulance, trying to protect his neck and keep his still as the patient was very combative in the ambulance). Outcome was recovered. Reporter comments: The regulator reported the case as non-serious and reported the terms 'computerised tomogram head normal' and 'laboratory test normal'.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fibromyalgia, Myalgia, Neuralgia, Osteoarthritis
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 46 year old female patient. On 10-Nov-2014, the patient received AFLURIA (batch number: T50307) in the left arm. On 10-Nov-2014, the patient experienced high fever, chills, upper neuralgia and nerve/muscle pain that lasted for a few days. The patient also developed fibromyalgia and osteoarthritis and 'ME'. The pain started in the arm and radiated throughout the body. On 14-Nov-2014, the patient was back to normal. The outcome was reported as recovered. Reporter comments: The health authority assessed the events as non-serious.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 46 year old female patient. On 10-Nov-2014, the patient received AFLURIA (batch number: T50307) in the left arm. On 10-Nov-2014, the patient experienced high fever, chills, upper neuralgia and nerve/muscle pain that lasted for a few days. The patient also developed fibromyalgia and osteoarthritis and 'ME'. The pain started in the arm and radiated throughout the body. On 14-Nov-2014, the patient was back to normal. The outcome was reported as recovered. Reporter comments: The health authority assessed the events as non-serious.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Atrial fibrillation
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 66 year old male patient who had no medical history and no current illness at the time of vaccination. On the 25-Sep-2014, the patient received AFLURIA (batch number '51208') in the right arm. On the 29-Sep-2014, the patient developed new onset of A-fib (atrial fibrillation). Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypotension, Shock, Tunnel vision
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 41 year old female patient who had no medical history and no current illness at the time of vaccination. Medications included cetirizine and a multivitamin. On the 14-Nov-2014, the patient received AFLURIA (batch number T58206) via the intramuscular route and left arm. On the 14-Nov-2014, the patient felt like she was going to pass out faint and her blood pressure was really low. Her vision was tunnel. Her friends who were nurses could not get a reading for 15 minutes. She felt like she was in shock. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious and reported the term 'depressed level of consciousness'.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV, FLU3
Symptoms: Abscess, Blood test, Cellulitis, Injection site reaction, Mobility decreased
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 46 year old female patient who had no current illness at the time of vaccination but had an allergy to shellfish and sulphur. On the 21-Oct-2014, the patient received AFLURIA (batch number T58906) in an unknown route and site. The patient also received PNEUMOVAX (batch number K006681) in an unknown route and site. On the 22-Oct-2014, by the next morning after vaccination, the patient could not hardly move the arm. It started with blotches in the area of the injection. The patient then developed fever. On the second day, the patient visited the doctor and received a shot of antibiotic and had blood work. That night in the Emergency Room, the swelling was spreading. The patient was admitted to hospital for IV (intravenous) antibiotics for two days. Laboratory data showed cellulitis and an abscess. Outcome was recovered. Reporter comments: The regulator reported the case as serious and reported the terms 'blood test', 'injection site reaction', 'rash macular'.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV, FLU3
Symptoms: Pyrexia, Rash macular
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 46 year old female patient who had no current illness at the time of vaccination but had an allergy to shellfish and sulphur. On the 21-Oct-2014, the patient received AFLURIA (batch number T58906) in an unknown route and site. The patient also received PNEUMOVAX (batch number K006681) in an unknown route and site. On the 22-Oct-2014, by the next morning after vaccination, the patient could not hardly move the arm. It started with blotches in the area of the injection. The patient then developed fever. On the second day, the patient visited the doctor and received a shot of antibiotic and had blood work. That night in the Emergency Room, the swelling was spreading. The patient was admitted to hospital for IV (intravenous) antibiotics for two days. Laboratory data showed cellulitis and an abscess. Outcome was recovered. Reporter comments: The regulator reported the case as serious and reported the terms 'blood test', 'injection site reaction', 'rash macular'.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV, FLU3
Symptoms: Influenza, Influenza A virus test positive, Polymerase chain reaction positive
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 46 year old female patient who had no current illness at the time of vaccination but had an allergy to shellfish and sulphur. On the 21-Oct-2014, the patient received AFLURIA (batch number T58906) in an unknown route and site. The patient also received PNEUMOVAX (batch number K006681) in an unknown route and site. On the 22-Oct-2014, by the next morning after vaccination, the patient could not hardly move the arm. It started with blotches in the area of the injection. The patient then developed fever. On the second day, the patient visited the doctor and received a shot of antibiotic and had blood work. That night in the Emergency Room, the swelling was spreading. The patient was admitted to hospital for IV (intravenous) antibiotics for two days. Laboratory data showed cellulitis and an abscess. Outcome was recovered. Reporter comments: The regulator reported the case as serious and reported the terms 'blood test', 'injection site reaction', 'rash macular'.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dry mouth, Ear pain, Feeling cold, Headache
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 20 year-old male patient who had no known current illness at the time of vaccination. His medical history included grade 5 arteriovenous malformation (right frontal lobe) which was diagnosed in 2007 and simple partial seizures. Concomitant medications included oxcarbazepine, topiramate and lamotrigine to control the seizures. On 10-Nov-2014, the patient received AFLURIA injection (batch number T50207) in the right arm. On 11-Nov-2014, within 12 hours of the vaccination, the patient experienced a very serious adverse reaction to the flu shot. He was awaken from sleep with a massive headache, sharp shooting pain "like a knife" in both ears and both earlobes, sharp shooting pain in lower back of neck, a "pins and needles" sensation in his torso (chest and back), arm pain and dry mouth. His body temperatures were normal, but he felt cold, was shivering and teeth chattering, and needed to wrap himself up in a blanket. Although he did not experience a seizure, these symptoms mimicked the symptoms of the onset of seizures that he had. He was not well enough to go to work, and lost a full day of pay. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, and reported the symptoms of 'convulsion' and 'condition aggravated'. The reporter stated that these symptoms and adverse events were reported to both the patient's neurologist and the pharmacy.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity, Paraesthesia, Seizure like phenomena, Vaccination complication
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 20 year-old male patient who had no known current illness at the time of vaccination. His medical history included grade 5 arteriovenous malformation (right frontal lobe) which was diagnosed in 2007 and simple partial seizures. Concomitant medications included oxcarbazepine, topiramate and lamotrigine to control the seizures. On 10-Nov-2014, the patient received AFLURIA injection (batch number T50207) in the right arm. On 11-Nov-2014, within 12 hours of the vaccination, the patient experienced a very serious adverse reaction to the flu shot. He was awaken from sleep with a massive headache, sharp shooting pain "like a knife" in both ears and both earlobes, sharp shooting pain in lower back of neck, a "pins and needles" sensation in his torso (chest and back), arm pain and dry mouth. His body temperatures were normal, but he felt cold, was shivering and teeth chattering, and needed to wrap himself up in a blanket. Although he did not experience a seizure, these symptoms mimicked the symptoms of the onset of seizures that he had. He was not well enough to go to work, and lost a full day of pay. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, and reported the symptoms of 'convulsion' and 'condition aggravated'. The reporter stated that these symptoms and adverse events were reported to both the patient's neurologist and the pharmacy.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Angioedema, Pruritus, Urticaria
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns an 81 year old male patient who had not reported any current illness. Concomitant medications included simvastatin, terazosin, naproxen, metoprolol, losartan, clopidogrel, aspirin and salbutamol. On the 14-Nov-2014, the patient received AFLURIA (batch number T52808) dose 1, via the intramuscular route in the right arm. On the 15-Nov-2014 at 06:30, the patient developed itching and a wheal. At 08:00, the patient developed angioedema of the lips but no shortness of breath or dysphagia. The patient took his medications and ate breakfast in the morning. The wheal and itching propagated across the skin. The patient went to the emergency room. At 11:30, a diphenhydramine 50mg intravenous push was given, oral ranitidine 300mg given and intramuscular epinephrine 250mcg was given in left deltoid. At 11:30, dexamethasone 12mg intravenous push was also given. Outcome was reported as recovered. Reporter comments: the regulator reported the case as non-serious.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Swelling face
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 60 year old female patient who had no known medical history and current illness at the time of vaccination. On 23-Oct-2014, the patient received intramuscular AFLURIA (batch number T53209) in the right arm. On 23-Oct-2014, within 30 minutes of administration, the patient experienced itchy eyes. She was advised by the flu shot clinic held at her place of employment to try diphenhydramine and follow-up if the symptoms worsened. Four to five days after the vaccination, the patient went to urgent care for swelling in face (angioedema). The patient was treated with a steroid pak. As there was no improvement after completing the treatment, the patient went to primary care doctor. The patient was prescribed a longer dose of steroid as well as ranitidine and loratadine. She was referred to an allergist for further testing. The outcome was reported as not recovered. The patient was not 100% better and was dealing with the aftermath. Reporter comments: The health authority assessed the case as non-serious and presented at the Emergency Room.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Contusion, Dizziness, Injection site pain, Mobility decreased
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 21 year old female patient who had a medical history of panic disorder but no current illness at the time of vaccination. On the 06-Nov-2014, the patient received AFLURIA (batch number T53609A) via the intramuscular route in the left arm. The vaccination seemed higher that she was used to, in the area a little below the acromion on the lateral shoulder. Starting on the 06-Nov-2014, after receiving the influenza vaccine, the patient developed left shoulder pain for nearly one month. The patient normally looks away during a vaccination, but recalled thinking that she did not feel the typical upper arm muscle squeeze before the injection (which demonstrated bunching up of the deltoid). Afterwards she noticed that the shot was more painful and she felt a little lightheaded. Over 48 hours after the injection, the left shoulder pain increased significantly. She could not raise her arm to wash her hair. She had trouble getting dressed and undressed. Her whole lateral side of her shoulder hurt at rest and with movement, also some of anterior upper arm. She also developed a bruise of her shoulder. The patient went winter coat shopping with her mother and was not able to try on coats without assistance. Motions with forward elevation, internal rotation and lateral elevation were painful and the patient was trying to avoid these motions. It appeared to be a painful rotator cuff complete with strain/tendonitis immediately following an influenza vaccination. The patient was given a handout on rotator cuff injury and was referred to PT (Physio or physical therapy) for improvement in function and symptoms. Treatment included naproxen, which she had used consistently but the symptoms if anything had worsened over the Thanksgiving break and was not sure whether naproxen was working. The patient also used heat pads with some relief. The patient attended the Emergency Room. Outcome was not recovered. Reporter comments: The patient did not think the joint itself was involved given the painless passive ROM (range of movement). The regulator reported the case as non-serious and reported the terms 'immediate post-injection reaction' and 'mobility decreased'.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle strain, Tendonitis
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 21 year old female patient who had a medical history of panic disorder but no current illness at the time of vaccination. On the 06-Nov-2014, the patient received AFLURIA (batch number T53609A) via the intramuscular route in the left arm. The vaccination seemed higher that she was used to, in the area a little below the acromion on the lateral shoulder. Starting on the 06-Nov-2014, after receiving the influenza vaccine, the patient developed left shoulder pain for nearly one month. The patient normally looks away during a vaccination, but recalled thinking that she did not feel the typical upper arm muscle squeeze before the injection (which demonstrated bunching up of the deltoid). Afterwards she noticed that the shot was more painful and she felt a little lightheaded. Over 48 hours after the injection, the left shoulder pain increased significantly. She could not raise her arm to wash her hair. She had trouble getting dressed and undressed. Her whole lateral side of her shoulder hurt at rest and with movement, also some of anterior upper arm. She also developed a bruise of her shoulder. The patient went winter coat shopping with her mother and was not able to try on coats without assistance. Motions with forward elevation, internal rotation and lateral elevation were painful and the patient was trying to avoid these motions. It appeared to be a painful rotator cuff complete with strain/tendonitis immediately following an influenza vaccination. The patient was given a handout on rotator cuff injury and was referred to PT (Physio or physical therapy) for improvement in function and symptoms. Treatment included naproxen, which she had used consistently but the symptoms if anything had worsened over the Thanksgiving break and was not sure whether naproxen was working. The patient also used heat pads with some relief. The patient attended the Emergency Room. Outcome was not recovered. Reporter comments: The patient did not think the joint itself was involved given the painless passive ROM (range of movement). The regulator reported the case as non-serious and reported the terms 'immediate post-injection reaction' and 'mobility decreased'.
Age: 48.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 48 year old male patient who had a medical history of depression, CHF (Congestive heart failure), GERD (Gastroesophageal Reflux Disease), anxiety and IBS (Irritable Bowel Syndrome). The patient had no current illness at the time of vaccination, but had a primary care visit. On the 24-Nov-2014, the patient received AFLURIA (batch number '45978') dose 1 in the left arm. The patient also received PNEUMOVAX (batch number K008409) dose 1 in the left arm. On the 25-Nov-2014, the patient developed myalgia, fever, chills and pain and swelling around the injection sites. Treatment included ibuprofen 600mg once. The patient spent two days in hospital. Outcome was recovered. Reporter comments: The regulator reported the case as serious (hospitalisation).
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature decreased, Feeling cold, Muscle spasms, Peripheral coldness, Respiratory arrest
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 61 year-old female patient who had no known current illness at the time of vaccination. Her medical history included 'sulfa'. Concomitant medications included valsartan and hydrochlorothiazide. On 02-Dec-2014, the patient received intramuscular AFLURIA (batch number T59206) in the left arm. On 05-Dec-2014, the patient got cold and then had a cramp at right ankle. Her body temperature dropped and her skin got very cold. She then stopped breathing and fainted. She was given CPR (cardiopulmonary resuscitation) by her husband. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as serious (life threatening). The health authority reported terms are 'resuscitation' and 'dyspnea'.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Resuscitation, Syncope
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 61 year-old female patient who had no known current illness at the time of vaccination. Her medical history included 'sulfa'. Concomitant medications included valsartan and hydrochlorothiazide. On 02-Dec-2014, the patient received intramuscular AFLURIA (batch number T59206) in the left arm. On 05-Dec-2014, the patient got cold and then had a cramp at right ankle. Her body temperature dropped and her skin got very cold. She then stopped breathing and fainted. She was given CPR (cardiopulmonary resuscitation) by her husband. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as serious (life threatening). The health authority reported terms are 'resuscitation' and 'dyspnea'.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Immobile, Joint range of motion decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging, Periarthritis
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 38 year old female patient who had no known current illness and medical history. On 23-Sep-2014, the patient received intramuscular AFLURIA (batch number '1064922A') in the left arm. On 23-Sep-2014, the patient experienced shoulder pain and immobility. She underwent MRI and X-ray. The patient was diagnosed with frozen shoulder and small tear in rotator cuff. The outcome was reported as unknown. Reporter comments: The health authority assessed the events as non-serious. The as reported symptoms were-'Joint range of motion decreased', 'Nuclear magnetic resonance imaging' and 'X-ray'.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Rotator cuff syndrome, X-ray
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 38 year old female patient who had no known current illness and medical history. On 23-Sep-2014, the patient received intramuscular AFLURIA (batch number '1064922A') in the left arm. On 23-Sep-2014, the patient experienced shoulder pain and immobility. She underwent MRI and X-ray. The patient was diagnosed with frozen shoulder and small tear in rotator cuff. The outcome was reported as unknown. Reporter comments: The health authority assessed the events as non-serious. The as reported symptoms were-'Joint range of motion decreased', 'Nuclear magnetic resonance imaging' and 'X-ray'.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Joint stiffness
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 51 year-old male patient who had no known current illness at the time of vaccination. His medical history included arthritis and high blood pressure. Concomitant medications included tramadol, testosterone gel, armodafinil, pantoprazole and hydralazine. On 08-Dec-2014, the patient received intramuscular AFLURIA (batch number T53108) in the left arm. On 08-Dec-2014, the patient began feeling soreness at the injection site, which progressed to joint soreness, fever and convulsions (from around 6 pm to 1 AM on 09-Dec-2014). He continued to have headache, joint stiffness, fatigue and fever. Had the patient been able to drive at that point, he would have gone to the emergency room. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Seizure
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 51 year-old male patient who had no known current illness at the time of vaccination. His medical history included arthritis and high blood pressure. Concomitant medications included tramadol, testosterone gel, armodafinil, pantoprazole and hydralazine. On 08-Dec-2014, the patient received intramuscular AFLURIA (batch number T53108) in the left arm. On 08-Dec-2014, the patient began feeling soreness at the injection site, which progressed to joint soreness, fever and convulsions (from around 6 pm to 1 AM on 09-Dec-2014). He continued to have headache, joint stiffness, fatigue and fever. Had the patient been able to drive at that point, he would have gone to the emergency room. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious.