chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: (L) forearm numbness continues 2 weeks after vaccine administration.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Paraesthesia, Paralysis
Clinical narrative: 17 yo girl with 4-extremity paralysis and tingling sensation on 10/9/15 the day after receiving above vaccines. 911 called from school. Given SOLU-MEDROL, BENADRYL en route to ER. By the time she arrived at ER after NS bolus, she started to move extremities again.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Pt felt the vaccine was given too high and she woke up around 3AM that night with intense sharp pain in her left arm that lasted throughout the day. Since then the pain has decreased but she has limited range of motion and has been taking ibuprofen to help the pain.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Pain in extremity
Clinical narrative: Injection site red, itchy, warm to touch. Has pain in arm. Informed to take BENADRYL, TYLENOL and cortisone cream to area.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Hypoaesthesia oral, VIIth nerve paralysis
Clinical narrative: Symptoms started with numb left side of tongue and progressed in to numbness and drooping of L side of face. Diagnosed with Bell's Palsy 10/30/15.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood urine present, Body temperature increased, Dizziness, Electrocardiogram normal, Glomerular filtration rate
Clinical narrative: Had flu and pneumonia vaccine at same injection. Temp 101, vomiting, red line circling halfway across upper left bicep where injection was made. Dizziness and near syncope. Nausea. Headache. Very sore left arm.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Influenza virus test negative, Injection site erythema, Nausea, Neutrophil count increased
Clinical narrative: Had flu and pneumonia vaccine at same injection. Temp 101, vomiting, red line circling halfway across upper left bicep where injection was made. Dizziness and near syncope. Nausea. Headache. Very sore left arm.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Presyncope, Protein urine present, Troponin normal, Vomiting
Clinical narrative: Had flu and pneumonia vaccine at same injection. Temp 101, vomiting, red line circling halfway across upper left bicep where injection was made. Dizziness and near syncope. Nausea. Headache. Very sore left arm.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Gait disturbance
Clinical narrative: Dizziness to the point that walking is difficult. I've gotten the flu shot every year for decades and this is the first time it's happened. There has been no change in my routine otherwise.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Body temperature increased, Chills, Condition aggravated, Cough
Clinical narrative: Pt stated that within in 30 min after the inject her arm became really sore and swollen. later that night she began to have chills and started coughing uncontrollably. The coughing brought on an asthma attack for which she used her nebulizer. In the middle of the night she became nauseated and vomited 4 times. Her temp was 101.6 but later in the morning came down to 99.4. Her arm also got better but pt reported she was not able to get out of bed until around 3:00pm when she began to feel better. She reports that although husband got same vaccine around the same time as she, he did not get sick.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Vomiting
Clinical narrative: Pt stated that within in 30 min after the inject her arm became really sore and swollen. later that night she began to have chills and started coughing uncontrollably. The coughing brought on an asthma attack for which she used her nebulizer. In the middle of the night she became nauseated and vomited 4 times. Her temp was 101.6 but later in the morning came down to 99.4. Her arm also got better but pt reported she was not able to get out of bed until around 3:00pm when she began to feel better. She reports that although husband got same vaccine around the same time as she, he did not get sick.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Fatigue, Frequent bowel movements, Hyperhidrosis
Clinical narrative: Fever, muscle pain, sweating, chills, bowel movements, vomiting, fatigue, loss of appetite.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia, Vomiting
Clinical narrative: Fever, muscle pain, sweating, chills, bowel movements, vomiting, fatigue, loss of appetite.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Dizziness, nausea (vertigo-like symptoms).
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Paraesthesia oral, Respiratory tract congestion
Clinical narrative: PATIENT CAME BACK WITH SWELLING, HEAT, AND REDNESS AROUND INJECTION SITE OF PNEUMOVAX. FLUVIRIN SITE WAS NORMAL SHE ALSO WAS COMPLAINING OF VOMITING UP PHLEGM AND TINGLING LIPS LIKE A COLD SORE COMING ON.  SHE SOUNDED VERY CONGESTED.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vomiting
Clinical narrative: PATIENT CAME BACK WITH SWELLING, HEAT, AND REDNESS AROUND INJECTION SITE OF PNEUMOVAX. FLUVIRIN SITE WAS NORMAL SHE ALSO WAS COMPLAINING OF VOMITING UP PHLEGM AND TINGLING LIPS LIKE A COLD SORE COMING ON.  SHE SOUNDED VERY CONGESTED.
Age: 61.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: When I awoke the next day after receiving the shot. I noticed a swollen,reddish upper arm which has spread some around my bicep.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: About 20 minutes after vaccine about a dime to nickel sized bump/swelling at injection site, turned red and was itchy around the outside perimeter. When pt was in the pharmacy cold cloth was applied and pt stayed to be monitored for 30 minutes, no increase with swelling. Pt felt better, then notice the night of 10/31 that it was swelling again and was itchy. Pt took Benadryl that night. Morning of 11/1 pt said swelling was ~4-5 inches long, and 2-3 inches wide. Ice has reduced swelling and redness a little and has taken more Benadryl.
Age: 83.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Erythema, Pyrexia
Clinical narrative: Fever, red skin waist to Ankles red capillaries under the skin. Symptoms have not changed as of todays date. Going to primary Physcian tomorrow Nov. 2, If I can get appointment. Outcome unknown.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Migraine, Musculoskeletal stiffness, Neuralgia
Clinical narrative: Burning nerve pain (occipital nerve), migraine, stiff neck, stiff arm (spread all the way to halfway down forearm), stiff trapezius muscle. Symptoms started out relatively mild (0840 10/30/15) and then became intense (0700 10/31/15). Got even worse through 10/31/15 until received treatment. As of 11/01/15, symptoms present in a moderate state but managed with Methocarbamol, Tylenol with codeine, and Prednisone.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Rash
Clinical narrative: PATIENT DEVELOPED REDNESS, RASH, INFLAMMATION. TREATED WITH BENADRYL, STEROIDS, AND ANTIBIOTICS AT EMERGENCY ROOM.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, hot, bruising, getting worse each day. Now is 8 inches by 4 inches.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient developed redness and swelling and area is hot to touch on inside of the arm in which she received a pneumonia shot.  Area where shot was administered was not red or swollen.  I advised patient to ice the area, I drew a circle around the swollen area and told her to watch the area to make sure the swelling doesn't get larger.  I told her to take ibuprofen and a Benadryl tonight.  I will call her pcp tomorrow am and follow up with her after I speak to doctor.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redess, swelling, itching applied hydrocortisone cream and ice.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain in left shoulder that has progressivly worsened. Today is 11/01/2015. I no longer have complete function of my left arm. Cannot raise it up. Will make an appointment to see a neurologist on Monday or as soon as I can.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness, Musculoskeletal pain
Clinical narrative: LEFT SHOULDER BLADE PAIN, WEAKNESS IN THE LEGS SO PATIENT SOUGHT ER TX.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Vertigo, Vomiting
Clinical narrative: Light-headedness followed by vertigo, then nausea, then vomiting beginning around 11:00 p.m. Took Dramamine around 7:00 a.m. Slept until almost noon, by which time nausea had subsided substantially. Vertigo continues (3:30 p.m.).
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Red, slightly swollen, itchy area roughly 2 to 2.5 inches below the injection site. Roughly 2 inches in diameter.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Urinary incontinence
Clinical narrative: URINARY INCONTINENCE.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Computerised tomogram normal, Diarrhoea, Dysstasia, Gait disturbance
Clinical narrative: SUDDEN ONSET WATERY DIARRHEA WORSENED OVER TIME. CALLED 911 WHEN IT BECAME IMPOSSIBLE TO STAND OR WALK. HAD SHAKES, CHILLS, SEVERE SHIVERING OVER ENTIRE BODY. RECEIVED 3 IV BAGS, BLOOD DRAWN TWICE, CAT SCAN. NOTHING FOUND THAT WOULD HAVE CAUSE THIS EXCEPT WHITE BLOOD CELL COUNT INDICATING POSSIBLE VIRUS OR INFECTION. ER DOC INDICATED THAT THE FLU SHOT COULD HAVE BEEN THE CAUSE.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Tremor, White blood cell count increased
Clinical narrative: SUDDEN ONSET WATERY DIARRHEA WORSENED OVER TIME. CALLED 911 WHEN IT BECAME IMPOSSIBLE TO STAND OR WALK. HAD SHAKES, CHILLS, SEVERE SHIVERING OVER ENTIRE BODY. RECEIVED 3 IV BAGS, BLOOD DRAWN TWICE, CAT SCAN. NOTHING FOUND THAT WOULD HAVE CAUSE THIS EXCEPT WHITE BLOOD CELL COUNT INDICATING POSSIBLE VIRUS OR INFECTION. ER DOC INDICATED THAT THE FLU SHOT COULD HAVE BEEN THE CAUSE.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Pyrexia
Clinical narrative: Patient experienced inflammation around the injection site and it was very red and hot to touch. Area cover shoulder and patient complained of fever as well.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Arm is red and swollen where injection given. Started at injection site and spread around the arm.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Pyrexia, Urticaria
Clinical narrative: Urticarial rash around injection site over Rt. upper arm with itching and pain. Fever of 102 on 10/28/2015.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Itching.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: Severe dizziness.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Oropharyngeal pain, Tinnitus, Vision blurred
Clinical narrative: PT EXPERIENCED RINGING IN EARS, BLURRY EYES, SORE THROAT AND STOMACH ACHE FOR ABOUT 3-5 MINUTES AFTER FLU SHOT.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Injection site pruritus, Injection site swelling, Local reaction, Skin warm
Clinical narrative: Large localized reaction, HOT, baseball sized welt and rock hard swelling.  Within a few hours started vomiting. Mild vomiting for no more than a few hours.  Severe injection site swelling and itching continued for 5 days with itching continuing into day 6.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Urticaria, Vomiting
Clinical narrative: Large localized reaction, HOT, baseball sized welt and rock hard swelling.  Within a few hours started vomiting. Mild vomiting for no more than a few hours.  Severe injection site swelling and itching continued for 5 days with itching continuing into day 6.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Middle insomnia, Mobility decreased, Muscular weakness, Musculoskeletal pain
Clinical narrative: The day after the injection I started to experience shoulder pain and muscle weakness. Thee days after the injection I had joint and muscle pain all over my body that lasted for 48 hours. The pain woke me up at night the first 3 nights. Now, 12 days later I still have arm pain and have difficulty lifting my arm, deep pain inside the arm and joint pain.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: The day after the injection I started to experience shoulder pain and muscle weakness. Thee days after the injection I had joint and muscle pain all over my body that lasted for 48 hours. The pain woke me up at night the first 3 nights. Now, 12 days later I still have arm pain and have difficulty lifting my arm, deep pain inside the arm and joint pain.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: SWELLING AND REDNESS AT INJECTION SITE.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Fatigue, Headache, Influenza, Malaise
Clinical narrative: Flu symptoms, fever, aches, sore throat, headache, developed terrible cough, malaise, and tiredness.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Flu symptoms, fever, aches, sore throat, headache, developed terrible cough, malaise, and tiredness.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Gait disturbance, Hypoacusis, Myalgia, Nausea
Clinical narrative: 24 hours after vaccine pt became fatigued, febrile, nauseated, had vomiting and vertigo along with muscle aches. Was admitted to hospital on 10/30 and received IV fluids and empiric antibiotics of ceftriaxone IV 1g/50mL every 12 hours. On 10/30 pt started having ringing in right ear and congestion. 10/31 - hard of hearing bilateral ears. Started on FLONASE and CLARITIN. 11/1 pt just now able to tolerate sitting up on edge of bed and 1 short walk of about 25 ft.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Respiratory tract congestion, Tinnitus, Vertigo, Vomiting
Clinical narrative: 24 hours after vaccine pt became fatigued, febrile, nauseated, had vomiting and vertigo along with muscle aches. Was admitted to hospital on 10/30 and received IV fluids and empiric antibiotics of ceftriaxone IV 1g/50mL every 12 hours. On 10/30 pt started having ringing in right ear and congestion. 10/31 - hard of hearing bilateral ears. Started on FLONASE and CLARITIN. 11/1 pt just now able to tolerate sitting up on edge of bed and 1 short walk of about 25 ft.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site rash
Clinical narrative: Localized rash on arm below injection site; patient will take diphenhydramine and ice the affected area.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Asthenia, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Nausea approx. 24 hours. Swelling of upper arm with extreme pain for approx. 9 days. Extreme weakness.
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Left arm still sore after receiving flu vaccine 2 weeks later, sore in shoulder.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Hypoaesthesia, Injection site pain, Pain in extremity, X-ray
Clinical narrative: Extreme pain at injection site, pain radiating down arm, around shoulder and around back also numbness in fingers on same arm.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Nasopharyngitis, Pyrexia, Tremor
Clinical narrative: Faver, cold, shivering, shaking, tired. Symptoms started 2 hours after vaccine and dissipated 36 hours later.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Injection site erythema, Injection site rash, Nausea, Pyrexia
Clinical narrative: Patient reported nausea, fever, chills and developed a red rash from shoulder to the elbow 3 days after administration (right arm).
Age: 85.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Hyperhidrosis, Palpitations, Pyrexia
Clinical narrative: Heart racing, sweating, fever lasting > 2 days.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt received vaccine at pharmacy on 10/29/15 at 3:35 pm. Saturday 10/31/15 pt called to report that injection site was red, raised, sore, and hot to the touch. Pt was instructed to ice the area and take Acetaminophen -follow up on 11/1/15 pt reported symptoms lessened.
Age: 16.0
Sex: M
Vaccine: FLU3, MNQ, FLU3, MNQ
Symptoms: Injection site mass, Muscle twitching
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 22-AUG-2013) concerns a 16 year old male patient. On 12-APR-2014, the patient received AFLURIA (batch number P50608) via the intramuscular route in the right arm and MENVEO (batch number M11082) dose 1 via the intramuscular route in the left arm. On the 20-APR-2013, the patient developed a 2.5 inch lump on the left arm at the site of the meningitis vaccines. The patient reported muscle twitches for the two days prior to the lump developing. Outcome was reported as recovered. Reporter comments: The regular reported the case as non-serious.  Follow-up (11-MAY-2015): VAERS ID, formulation for FLUVAX, date of vaccination and formulation for MENVEO. Case correction (16-JUN-2015): PSUR comment added. AE # 2 term updated. AE #2 company causality updated.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Arm/shoulder pain few hours after vaccine.  Pain got worse.  Finally went to doctor after period of time.  Started PT.  Next went to orthopedist.  Have been in PT off and on since then.
Age: 80.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Paraesthesia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns an 80 year old male patient who had a medical history of chronic back pain, hypertension, hyperlipidemia, BPH (Benign Prostatic Hyperplasia) and warfarin therapy. The patient had no current illness. Medications at the time of vaccination included oxycodone-acetaminophen, warfarin, diltiazem, atorvastatin, metoprolol tartrate and tamsulosin. On the 06-Jan-2015, the patient received AFLURIA injection (batch number T56805) via the intramuscular route in the right arm. On the 07-Jan-2015, the patient developed sharp pain at the sight [sic] of the injection in his right arm and was currently having some pain. He stated that he had some numbness or tingling in his right hand and currently had limited mobility and not able to completely lift his right arm without assistance. The patient stated that this had been ongoing since the 07-Jan-2015 and had not resolved. No laboratory data was done at this time. Outcome was not recovered. Reporter comments: The regulator reported the case non-serious.
Age: 80.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Injection site pain, Mobility decreased, Paraesthesia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns an 80 year old male patient who had a medical history of chronic back pain, hypertension, hyperlipidemia, BPH (Benign Prostatic Hyperplasia) and warfarin therapy. The patient had no current illness. Medications at the time of vaccination included oxycodone-acetaminophen, warfarin, diltiazem, atorvastatin, metoprolol tartrate and tamsulosin. On the 06-Jan-2015, the patient received AFLURIA injection (batch number T56805) via the intramuscular route in the right arm. On the 07-Jan-2015, the patient developed sharp pain at the sight [sic] of the injection in his right arm and was currently having some pain. He stated that he had some numbness or tingling in his right hand and currently had limited mobility and not able to completely lift his right arm without assistance. The patient stated that this had been ongoing since the 07-Jan-2015 and had not resolved. No laboratory data was done at this time. Outcome was not recovered. Reporter comments: The regulator reported the case non-serious.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 33 year old female patient who as per the patient, had allergies to duloxetine, corticosteroids, pregabalin, nitrofurantoin, sulfa and penicillin. Medical conditions as per patient included Nash disease (nonalcoholic steatohepatitis), was a smoker and had slight asthma. Medications at the time of vaccination included estradiol, hydrochlorothiazide, diazepam, omeprazole, phentermine and hydrocodone/paracetamol. On the 19-Jan-2001, the patient received AFLURIA, (batch number T57505) via the intramuscular route. The patient also received PNEUMOVAX, (batch number K007262) via the intramuscular route. On the 20-Jan-2015, the patient called and stated that her arm was sore that morning but after her nap this afternoon, her arm was swollen, itchy and red. The patient was told she could take diphenhydramine if she thought it was an allergy. The patient called the doctor and went to see the doctor the next day on the 21-Jan-2015. The doctor prescribed cyproheptadine 4mg (1 twice daily for three days and then as needed). Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Acne, Rash erythematous
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 38 year old female patient who had no medical history and it was unknown whether the patient was on routine prescription medications. The patient had no current illness. On the 19-Sep-2014, the patient received AFLURIA (batch number T57906) in the left arm via the intramuscular route, dose 2. On the 22-Sep-2014, the patient developed a small pimple to the side of the injection site. It progress into a non-raised red rash on the arms, trunkk and left side of the face. The patient went to the PCP and was given a steroid injection x1 and PO medications. The patient immediately improved and the rash was gone before the patient had finished the seven days course of steroids PO. Outome was recovered.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Acne, Injection site reaction, Rash erythematous
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 38 year old female patient who had no medical history and it was unknown whether the patient was on routine prescription medications. The patient had no current illness. On the 19-Sep-2014, the patient received AFLURIA (batch number T57906) in the left arm via the intramuscular route, dose 2. On the 22-Sep-2014, the patient developed a small pimple to the side of the injection site. It progress into a non-raised red rash on the arms, trunkk and left side of the face. The patient went to the PCP and was given a steroid injection x1 and PO medications. The patient immediately improved and the rash was gone before the patient had finished the seven days course of steroids PO. Outome was recovered.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, X-ray normal
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 50 year old female patient who had a medical history of hypertension and back fusion surgery (a year ago). She had no current illness. Concomitant medications included clonazepam, oxycodone/APAP and lisinopril. On the 02-Oct-2014, the patient received the AFLURIA injection (batch number T50807) via an unknown route in the left arm. On the 02-Oct-2014, the patient's symptoms began at the time of immunization. The patient complained of pain in her left arm and not being able to lift her arm at all. The patient called the doctor four weeks after receiving the shot to ask if this was normal. The doctor stated that it could sometimes happen. Approximately five weeks after the immunisation, the patient said she could not lay on her side because it was very painful. The patient then told her pain management doctor who suggested she get a CAT (Computerised Axial Tomography) and an X-ray and suggested that maybe she had a disconnected shoulder. She saw her primary care doctor approximately five weeks ago who sent her to get an X-ray. The X-ray was normal. Her pain management doctor then suggested that it may be muscular and wrote her a prescription for a topical compound to apply to this area. If the compound did not work, she would get a nerve conduction study to see if the needle hit a nerve. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious and reported the term 'X-ray normal'.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity, X-ray normal
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 50 year old female patient who had a medical history of hypertension and back fusion surgery (a year ago). She had no current illness. Concomitant medications included clonazepam, oxycodone/APAP and lisinopril. On the 02-Oct-2014, the patient received the AFLURIA injection (batch number T50807) via an unknown route in the left arm. On the 02-Oct-2014, the patient's symptoms began at the time of immunization. The patient complained of pain in her left arm and not being able to lift her arm at all. The patient called the doctor four weeks after receiving the shot to ask if this was normal. The doctor stated that it could sometimes happen. Approximately five weeks after the immunisation, the patient said she could not lay on her side because it was very painful. The patient then told her pain management doctor who suggested she get a CAT (Computerised Axial Tomography) and an X-ray and suggested that maybe she had a disconnected shoulder. She saw her primary care doctor approximately five weeks ago who sent her to get an X-ray. The X-ray was normal. Her pain management doctor then suggested that it may be muscular and wrote her a prescription for a topical compound to apply to this area. If the compound did not work, she would get a nerve conduction study to see if the needle hit a nerve. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious and reported the term 'X-ray normal'.
Age: 56.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Limb discomfort
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 56 year old female patient who had a medical history of asthma. Concomitant medications included estradiol 2mg. The patient had no current illness. On the 09-Jan-2015, the patient received AFLURIA (batch number T51608) dose 1 via the intramuscular route in the left arm. On the 09-Jan-2015, the patient developed ongoing arm discomfort, in which he reported on the 20-Jan-2015. The patient had a referral for orthopedic evaluation. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious and reported that the patient attended the Emergency Room.
Age: 48.0
Sex: F
Vaccine: FLU3, FLUX, FLU3
Symptoms: Joint injury, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 48 year female patient. Medications at the time of vaccination included butalbital/acetaminophen/caffeine for migraines. On the 11-Nov-2014, the patient received AFLURIA (batch number "T52906") via the intramuscular route in the right arm, dose 3). On the 18-Nov-2014, the arm was sore for two days and then felt fine. The site was very painful and remained so, getting worse each day. The patient saw an orthopedic and had an MRI that revealed shoulder injury related to vaccine administration. Outcome was not reported.
Age: 48.0
Sex: F
Vaccine: FLU3, FLUX, FLU3
Symptoms: Bursitis, Inflammation, Injection site infection, Injection site pain, Injection site warmth
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 48 year female patient. Medications at the time of vaccination included butalbital/acetaminophen/caffeine for migraines. On the 11-Nov-2014, the patient received AFLURIA (batch number "T52906") via the intramuscular route in the right arm, dose 3). On the 18-Nov-2014, the arm was sore for two days and then felt fine. The site was very painful and remained so, getting worse each day. The patient saw an orthopedic and had an MRI that revealed shoulder injury related to vaccine administration. Outcome was not reported.
Age: 48.0
Sex: F
Vaccine: FLU3, FLUX, FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain in extremity, Pyrexia, Surgery, Tendonitis
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 48 year female patient. Medications at the time of vaccination included butalbital/acetaminophen/caffeine for migraines. On the 11-Nov-2014, the patient received AFLURIA (batch number "T52906") via the intramuscular route in the right arm, dose 3). On the 18-Nov-2014, the arm was sore for two days and then felt fine. The site was very painful and remained so, getting worse each day. The patient saw an orthopedic and had an MRI that revealed shoulder injury related to vaccine administration. Outcome was not reported.
Age: 48.0
Sex: F
Vaccine: FLU3, FLUX, FLU3
Symptoms: Ultrasound scan, X-ray
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 48 year female patient. Medications at the time of vaccination included butalbital/acetaminophen/caffeine for migraines. On the 11-Nov-2014, the patient received AFLURIA (batch number "T52906") via the intramuscular route in the right arm, dose 3). On the 18-Nov-2014, the arm was sore for two days and then felt fine. The site was very painful and remained so, getting worse each day. The patient saw an orthopedic and had an MRI that revealed shoulder injury related to vaccine administration. Outcome was not reported.
Age: 48.0
Sex: F
Vaccine: FLU3, FLUX, FLU3
Symptoms: Injection site pain, Joint injury, Nuclear magnetic resonance imaging abnormal, Vaccination complication
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 48 year female patient. Medications at the time of vaccination included butalbital/acetaminophen/caffeine for migraines. On the 11-Nov-2014, the patient received AFLURIA (batch number "T52906") via the intramuscular route in the right arm, dose 3). On the 18-Nov-2014, the arm was sore for two days and then felt fine. The site was very painful and remained so, getting worse each day. The patient saw an orthopedic and had an MRI that revealed shoulder injury related to vaccine administration. Outcome was not reported.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Eye pruritus, Gingival swelling, Lacrimation increased, Lip swelling, Nasal congestion
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 47 year old female patient. On the 24-Oct-2014, the patient received AFLURIA injection (batch number T51308) via the intramuscular route in the 'AR' (arm). On the 24-Oct-2014, the patient developed itchy and watery eyes, sneezing, severe sinus pressure, runny nose, swelling of the nose, lips and gums. The patient was treated with diphenhydramine for 24 hours. Outcome was recovered.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Paranasal sinus discomfort, Rhinorrhoea, Sneezing
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 47 year old female patient. On the 24-Oct-2014, the patient received AFLURIA injection (batch number T51308) via the intramuscular route in the 'AR' (arm). On the 24-Oct-2014, the patient developed itchy and watery eyes, sneezing, severe sinus pressure, runny nose, swelling of the nose, lips and gums. The patient was treated with diphenhydramine for 24 hours. Outcome was recovered.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Eye pruritus, Gingival swelling, Lacrimation increased, Lip swelling, Paranasal sinus discomfort
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 47 year old female patient. On the 24-Oct-2014, the patient received AFLURIA injection (batch number T51308) via the intramuscular route in the 'AR' (arm). On the 24-Oct-2014, the patient developed itchy and watery eyes, sneezing, severe sinus pressure, runny nose, swelling of the nose, lips and gums. The patient was treated with diphenhydramine for 24 hours. Outcome was recovered.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rhinorrhoea, Sneezing, Swelling
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 47 year old female patient. On the 24-Oct-2014, the patient received AFLURIA injection (batch number T51308) via the intramuscular route in the 'AR' (arm). On the 24-Oct-2014, the patient developed itchy and watery eyes, sneezing, severe sinus pressure, runny nose, swelling of the nose, lips and gums. The patient was treated with diphenhydramine for 24 hours. Outcome was recovered.
Age: 11.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns an 11 year old female patient. No medical history or current illness was reported. On 17-Oct-2014, the patient received intramuscular AFLURIA injection (batch number T50907) in the left arm. It was reported that ever since the patient got the flu shot, her left arm was painful and red while exercises (school gym class). The outcome was reported as unknown. Reporter's comments: The health authority assessed the events as non-serious.
Age: 15.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Dizziness, Gait disturbance, Muscle spasms, Muscle twitching, Nausea
Clinical narrative: Initial unsolicited report received from a physician on 16-Oct-2015. This case is linked to cases: 2015SA166544, 2015SA164326 and 2015SA164327 (same vaccine). This case involves a 15 years old patient (gender not provided), who was vaccinated with a dose of MENACTRA (manufacturer: Sanofi Pasteur, batch number: U4680AA, expiry date, route and site of administration were not provided) on 10-Feb-2015. Patient's medical history and concomitant medications were not provided. On 10-Feb-2015, within minutes of vaccination, patient complained of dizziness. The patient went to emergency department where seizure activity was noted (working diagnosis at that time was "allergic reaction" to vaccine). Patient also developed weakness in legs which was accompanied by twitching. After neurology consultation, assessment was pseudoseizure. Patient did not walk and was in wheelchair. OT/PT (Occupational Therapy and Physical Therapy) counselor thought "nothing was wrong". The patient was diagnosed with movement disorder and postural orthostatic tachycardia. Patient was still in a wheelchair. Laboratory investigations included EMG (Electromyography), MRI (Magnetic resonance imaging) and repeat EEG (electroencephalogram) which was normal/ unrevealing. Corrective treatment was not reported. It was reported that the patient went to emergency department. The outcome of the event of patient not walking, in wheelchair was not recovered. The outcome of the other events was not provided. The outcome of the event of patient not walking, in wheelchair was not recovered. The outcome of the other events of seizure, postural orthostatic tachycardia, pseudoseizure, weakness in legs accompanied by twitching, allergic reaction to vaccine and dizziness was not provided. Documents held by sender: none.
Age: 15.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Tremor
Clinical narrative: Initial unsolicited report received from a physician on 16-Oct-2015. This case is linked to cases: 2015SA166544, 2015SA164326 and 2015SA164327 (same vaccine). This case involves a 15 years old patient (gender not provided), who was vaccinated with a dose of MENACTRA (manufacturer: Sanofi Pasteur, batch number: U4680AA, expiry date, route and site of administration were not provided) on 10-Feb-2015. Patient's medical history and concomitant medications were not provided. On 10-Feb-2015, within minutes of vaccination, patient complained of dizziness. The patient went to emergency department where seizure activity was noted (working diagnosis at that time was "allergic reaction" to vaccine). Patient also developed weakness in legs which was accompanied by twitching. After neurology consultation, assessment was pseudoseizure. Patient did not walk and was in wheelchair. OT/PT (Occupational Therapy and Physical Therapy) counselor thought "nothing was wrong". The patient was diagnosed with movement disorder and postural orthostatic tachycardia. Patient was still in a wheelchair. Laboratory investigations included EMG (Electromyography), MRI (Magnetic resonance imaging) and repeat EEG (electroencephalogram) which was normal/ unrevealing. Corrective treatment was not reported. It was reported that the patient went to emergency department. The outcome of the event of patient not walking, in wheelchair was not recovered. The outcome of the other events was not provided. The outcome of the event of patient not walking, in wheelchair was not recovered. The outcome of the other events of seizure, postural orthostatic tachycardia, pseudoseizure, weakness in legs accompanied by twitching, allergic reaction to vaccine and dizziness was not provided. Documents held by sender: none.
Age: 15.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Abasia, Dizziness, Electroencephalogram normal, Electromyogram normal, Hypersensitivity
Clinical narrative: Initial unsolicited report received from a physician on 16-Oct-2015. This case is linked to cases: 2015SA166544, 2015SA164326 and 2015SA164327 (same vaccine). This case involves a 15 years old patient (gender not provided), who was vaccinated with a dose of MENACTRA (manufacturer: Sanofi Pasteur, batch number: U4680AA, expiry date, route and site of administration were not provided) on 10-Feb-2015. Patient's medical history and concomitant medications were not provided. On 10-Feb-2015, within minutes of vaccination, patient complained of dizziness. The patient went to emergency department where seizure activity was noted (working diagnosis at that time was "allergic reaction" to vaccine). Patient also developed weakness in legs which was accompanied by twitching. After neurology consultation, assessment was pseudoseizure. Patient did not walk and was in wheelchair. OT/PT (Occupational Therapy and Physical Therapy) counselor thought "nothing was wrong". The patient was diagnosed with movement disorder and postural orthostatic tachycardia. Patient was still in a wheelchair. Laboratory investigations included EMG (Electromyography), MRI (Magnetic resonance imaging) and repeat EEG (electroencephalogram) which was normal/ unrevealing. Corrective treatment was not reported. It was reported that the patient went to emergency department. The outcome of the event of patient not walking, in wheelchair was not recovered. The outcome of the other events was not provided. The outcome of the event of patient not walking, in wheelchair was not recovered. The outcome of the other events of seizure, postural orthostatic tachycardia, pseudoseizure, weakness in legs accompanied by twitching, allergic reaction to vaccine and dizziness was not provided. Documents held by sender: none.
Age: 15.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Movement disorder, Muscle twitching, Muscular weakness, Nuclear magnetic resonance imaging normal, Postural orthostatic tachycardia syndrome
Clinical narrative: Initial unsolicited report received from a physician on 16-Oct-2015. This case is linked to cases: 2015SA166544, 2015SA164326 and 2015SA164327 (same vaccine). This case involves a 15 years old patient (gender not provided), who was vaccinated with a dose of MENACTRA (manufacturer: Sanofi Pasteur, batch number: U4680AA, expiry date, route and site of administration were not provided) on 10-Feb-2015. Patient's medical history and concomitant medications were not provided. On 10-Feb-2015, within minutes of vaccination, patient complained of dizziness. The patient went to emergency department where seizure activity was noted (working diagnosis at that time was "allergic reaction" to vaccine). Patient also developed weakness in legs which was accompanied by twitching. After neurology consultation, assessment was pseudoseizure. Patient did not walk and was in wheelchair. OT/PT (Occupational Therapy and Physical Therapy) counselor thought "nothing was wrong". The patient was diagnosed with movement disorder and postural orthostatic tachycardia. Patient was still in a wheelchair. Laboratory investigations included EMG (Electromyography), MRI (Magnetic resonance imaging) and repeat EEG (electroencephalogram) which was normal/ unrevealing. Corrective treatment was not reported. It was reported that the patient went to emergency department. The outcome of the event of patient not walking, in wheelchair was not recovered. The outcome of the other events was not provided. The outcome of the event of patient not walking, in wheelchair was not recovered. The outcome of the other events of seizure, postural orthostatic tachycardia, pseudoseizure, weakness in legs accompanied by twitching, allergic reaction to vaccine and dizziness was not provided. Documents held by sender: none.
Age: 15.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Psychogenic seizure, Seizure, Wheelchair user
Clinical narrative: Initial unsolicited report received from a physician on 16-Oct-2015. This case is linked to cases: 2015SA166544, 2015SA164326 and 2015SA164327 (same vaccine). This case involves a 15 years old patient (gender not provided), who was vaccinated with a dose of MENACTRA (manufacturer: Sanofi Pasteur, batch number: U4680AA, expiry date, route and site of administration were not provided) on 10-Feb-2015. Patient's medical history and concomitant medications were not provided. On 10-Feb-2015, within minutes of vaccination, patient complained of dizziness. The patient went to emergency department where seizure activity was noted (working diagnosis at that time was "allergic reaction" to vaccine). Patient also developed weakness in legs which was accompanied by twitching. After neurology consultation, assessment was pseudoseizure. Patient did not walk and was in wheelchair. OT/PT (Occupational Therapy and Physical Therapy) counselor thought "nothing was wrong". The patient was diagnosed with movement disorder and postural orthostatic tachycardia. Patient was still in a wheelchair. Laboratory investigations included EMG (Electromyography), MRI (Magnetic resonance imaging) and repeat EEG (electroencephalogram) which was normal/ unrevealing. Corrective treatment was not reported. It was reported that the patient went to emergency department. The outcome of the event of patient not walking, in wheelchair was not recovered. The outcome of the other events was not provided. The outcome of the event of patient not walking, in wheelchair was not recovered. The outcome of the other events of seizure, postural orthostatic tachycardia, pseudoseizure, weakness in legs accompanied by twitching, allergic reaction to vaccine and dizziness was not provided. Documents held by sender: none.
Age: 53.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Laboratory test, VIIth nerve paralysis
Clinical narrative: This medically confirmed health authority report (initial receipt 11-May-2015) concerns a 53 year old male patient. No current illness was reported. On 29-Oct-2014, the patient received AFLURIA injection (batch number T52308) in the right arm. On 06-Nov-2014, the patient experienced Bell's Palsy. The patient was seen at the emergency room thinking of having stroke. Stroke protocol tests were performed. The patient was still receiving weekly PT. The outcome was reported as not recovered. Reporter's comments: The regulator assessed the events as non-serious, reported that the patient presented at the Emergency Room, and reported the term 'Laboratory test'.
Age: 64.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Arthralgia, Fatigue, Joint stiffness, Pain, Paraesthesia
Clinical narrative: Case number PHEH2015US021398 is an initial spontaneous report received from a consumer (patient's husband) on 19 Oct 2015. This report refers to a 64 year old female patient. Past medical history and concomitant medications were not reported. There was a bat in patient's house and hence the doctor recommended vaccination for protection in the event the patient was bitten. Her vaccination history included three dose of post exposure RABAVERT (batch number: 556011A (for first and second dose), 559011A (for third dose) on unknown dates following which she experienced fatigue, tiredness and needles poking on her skin (see related case numbers: PHEH2015US022072, PHEH2015US022073 and PHEH2015US022074). She received fourth dose of RABAVERT (batch number: 559011A) on an unspecified date. On an unknown date after vaccination, she experienced fatigue and was really tired after the injection. She felt like she had needles poking on her skin throughout the day. She also experienced right ankle and hand swelling which were very painful, right foot spasms at night, body stiffness, soreness of shoulder that woke her up at night and body soreness due to which she could not turn over in bed. She stated that it was so painful that she could not sleep. She had tight and burning muscles in her body. She also had swelling (unspecified). She had an emergency room visit in Aug 2015 in which she was told that she had an allergic reaction to the vaccine and she was asked to take ADVIL for pain. Her symptoms did not improve and hence she went to health care professional's (HCP) office in Aug 2015 where she was diagnosed with rheumatoid arthritis based on her inflammatory test. She was informed by the nurse in the office that RABAVERT can create false positive rheumatoid arthritis results. The final outcome of the events was not reported. The events were reported as disabling. The causality of the events was not reported.