chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Loss of consciousness, Muscle spasms, Psychomotor hyperactivity
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hypoglycemia in a 52-year-old female patient who received FLUVIRAL (batch number G44A3, expiry date 30th April 2015). This case was associated with a product complaint. Previously administered products included influenza vaccine without adverse event. (The subject reported herself as extremely healthy with no medical history that prevents her from getting flu vaccines. She has been getting flu vaccines for years and had never had adverse events before). On 26th September 2014, the patient received FLUVIRAL. On 26th September 2014, 15 min after receiving FLUVIRAL, the patient experienced hypoglycemia (serious criteria hospitalization and clinically significant/intervention required), injection site sting, funny taste in mouth, confusion, irritable, angry, disoriented, lightheaded, seeing black spots, lower voice, sweaty, flashing lights, loss of consciousness (serious criteria GSK medically significant), leg cramps and hungry. On an unknown date, the patient experienced product complaint. The patient was treated with EPIPEN and Dextrose. On 26th September 2014, the outcome of the hypoglycemia, injection site sting, funny taste in mouth, confusion, irritable, angry, disoriented, lightheaded, seeing black spots, lower voice, sweaty, flashing lights and loss of consciousness were recovered/resolved. On an unknown date, the outcome of the leg cramps and hungry were recovered/resolved and the outcome of the product complaint was not reported. The reporter considered the hypoglycemia, injection site sting, funny taste in mouth, confusion, irritable, angry, disoriented, lightheaded, seeing black spots, lower voice, sweaty, flashing lights, loss of consciousness, leg cramps and hungry to be probably related to FLUVIRAL. Additional details received: The patient had lunch at 12:40 and was vaccinated at 4:15 pm. The reporter mentioned that the nurse who administered the vaccine also had HUMALOG in the refrigerator. However, it was reported that the vial for HUMALOG was significantly bigger than that for FLULAVAL, and was located in a different location in the refrigerator. The administrating nurse also was almost positive that she did not administer HUMALOG. A total of 6 patients were vaccinated at the same school and all 6 experienced hypoglycemia symptoms. All of them were vaccinated with the same lot of FLULAVAL (2 different vials). At the time of reporting, investigations were pending. Follow up information received from an electronic newspaper on 06October 2014: a lawsuit has been filed by two of the concerned patients against the school district alleging that they were given shots of insulin instead of the GSK flu vaccine shots they believed they were receiving. Investigations were still ongoing.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Anger, Blood glucose decreased, Blood potassium decreased, Confusional state, Disorientation
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hypoglycemia in a 52-year-old female patient who received FLUVIRAL (batch number G44A3, expiry date 30th April 2015). This case was associated with a product complaint. Previously administered products included influenza vaccine without adverse event. (The subject reported herself as extremely healthy with no medical history that prevents her from getting flu vaccines. She has been getting flu vaccines for years and had never had adverse events before). On 26th September 2014, the patient received FLUVIRAL. On 26th September 2014, 15 min after receiving FLUVIRAL, the patient experienced hypoglycemia (serious criteria hospitalization and clinically significant/intervention required), injection site sting, funny taste in mouth, confusion, irritable, angry, disoriented, lightheaded, seeing black spots, lower voice, sweaty, flashing lights, loss of consciousness (serious criteria GSK medically significant), leg cramps and hungry. On an unknown date, the patient experienced product complaint. The patient was treated with EPIPEN and Dextrose. On 26th September 2014, the outcome of the hypoglycemia, injection site sting, funny taste in mouth, confusion, irritable, angry, disoriented, lightheaded, seeing black spots, lower voice, sweaty, flashing lights and loss of consciousness were recovered/resolved. On an unknown date, the outcome of the leg cramps and hungry were recovered/resolved and the outcome of the product complaint was not reported. The reporter considered the hypoglycemia, injection site sting, funny taste in mouth, confusion, irritable, angry, disoriented, lightheaded, seeing black spots, lower voice, sweaty, flashing lights, loss of consciousness, leg cramps and hungry to be probably related to FLUVIRAL. Additional details received: The patient had lunch at 12:40 and was vaccinated at 4:15 pm. The reporter mentioned that the nurse who administered the vaccine also had HUMALOG in the refrigerator. However, it was reported that the vial for HUMALOG was significantly bigger than that for FLULAVAL, and was located in a different location in the refrigerator. The administrating nurse also was almost positive that she did not administer HUMALOG. A total of 6 patients were vaccinated at the same school and all 6 experienced hypoglycemia symptoms. All of them were vaccinated with the same lot of FLULAVAL (2 different vials). At the time of reporting, investigations were pending. Follow up information received from an electronic newspaper on 06October 2014: a lawsuit has been filed by two of the concerned patients against the school district alleging that they were given shots of insulin instead of the GSK flu vaccine shots they believed they were receiving. Investigations were still ongoing.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dizziness, Dysgeusia, Dysphonia, Hunger, Hyperhidrosis
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hypoglycemia in a 52-year-old female patient who received FLUVIRAL (batch number G44A3, expiry date 30th April 2015). This case was associated with a product complaint. Previously administered products included influenza vaccine without adverse event. (The subject reported herself as extremely healthy with no medical history that prevents her from getting flu vaccines. She has been getting flu vaccines for years and had never had adverse events before). On 26th September 2014, the patient received FLUVIRAL. On 26th September 2014, 15 min after receiving FLUVIRAL, the patient experienced hypoglycemia (serious criteria hospitalization and clinically significant/intervention required), injection site sting, funny taste in mouth, confusion, irritable, angry, disoriented, lightheaded, seeing black spots, lower voice, sweaty, flashing lights, loss of consciousness (serious criteria GSK medically significant), leg cramps and hungry. On an unknown date, the patient experienced product complaint. The patient was treated with EPIPEN and Dextrose. On 26th September 2014, the outcome of the hypoglycemia, injection site sting, funny taste in mouth, confusion, irritable, angry, disoriented, lightheaded, seeing black spots, lower voice, sweaty, flashing lights and loss of consciousness were recovered/resolved. On an unknown date, the outcome of the leg cramps and hungry were recovered/resolved and the outcome of the product complaint was not reported. The reporter considered the hypoglycemia, injection site sting, funny taste in mouth, confusion, irritable, angry, disoriented, lightheaded, seeing black spots, lower voice, sweaty, flashing lights, loss of consciousness, leg cramps and hungry to be probably related to FLUVIRAL. Additional details received: The patient had lunch at 12:40 and was vaccinated at 4:15 pm. The reporter mentioned that the nurse who administered the vaccine also had HUMALOG in the refrigerator. However, it was reported that the vial for HUMALOG was significantly bigger than that for FLULAVAL, and was located in a different location in the refrigerator. The administrating nurse also was almost positive that she did not administer HUMALOG. A total of 6 patients were vaccinated at the same school and all 6 experienced hypoglycemia symptoms. All of them were vaccinated with the same lot of FLULAVAL (2 different vials). At the time of reporting, investigations were pending. Follow up information received from an electronic newspaper on 06October 2014: a lawsuit has been filed by two of the concerned patients against the school district alleging that they were given shots of insulin instead of the GSK flu vaccine shots they believed they were receiving. Investigations were still ongoing.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Hypoglycaemia, Injection site pain, Irritability, Loss of consciousness, Muscle spasms
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hypoglycemia in a 52-year-old female patient who received FLUVIRAL (batch number G44A3, expiry date 30th April 2015). This case was associated with a product complaint. Previously administered products included influenza vaccine without adverse event. (The subject reported herself as extremely healthy with no medical history that prevents her from getting flu vaccines. She has been getting flu vaccines for years and had never had adverse events before). On 26th September 2014, the patient received FLUVIRAL. On 26th September 2014, 15 min after receiving FLUVIRAL, the patient experienced hypoglycemia (serious criteria hospitalization and clinically significant/intervention required), injection site sting, funny taste in mouth, confusion, irritable, angry, disoriented, lightheaded, seeing black spots, lower voice, sweaty, flashing lights, loss of consciousness (serious criteria GSK medically significant), leg cramps and hungry. On an unknown date, the patient experienced product complaint. The patient was treated with EPIPEN and Dextrose. On 26th September 2014, the outcome of the hypoglycemia, injection site sting, funny taste in mouth, confusion, irritable, angry, disoriented, lightheaded, seeing black spots, lower voice, sweaty, flashing lights and loss of consciousness were recovered/resolved. On an unknown date, the outcome of the leg cramps and hungry were recovered/resolved and the outcome of the product complaint was not reported. The reporter considered the hypoglycemia, injection site sting, funny taste in mouth, confusion, irritable, angry, disoriented, lightheaded, seeing black spots, lower voice, sweaty, flashing lights, loss of consciousness, leg cramps and hungry to be probably related to FLUVIRAL. Additional details received: The patient had lunch at 12:40 and was vaccinated at 4:15 pm. The reporter mentioned that the nurse who administered the vaccine also had HUMALOG in the refrigerator. However, it was reported that the vial for HUMALOG was significantly bigger than that for FLULAVAL, and was located in a different location in the refrigerator. The administrating nurse also was almost positive that she did not administer HUMALOG. A total of 6 patients were vaccinated at the same school and all 6 experienced hypoglycemia symptoms. All of them were vaccinated with the same lot of FLULAVAL (2 different vials). At the time of reporting, investigations were pending. Follow up information received from an electronic newspaper on 06October 2014: a lawsuit has been filed by two of the concerned patients against the school district alleging that they were given shots of insulin instead of the GSK flu vaccine shots they believed they were receiving. Investigations were still ongoing.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Photopsia, Product quality issue, Visual impairment, Wrong drug administered
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hypoglycemia in a 52-year-old female patient who received FLUVIRAL (batch number G44A3, expiry date 30th April 2015). This case was associated with a product complaint. Previously administered products included influenza vaccine without adverse event. (The subject reported herself as extremely healthy with no medical history that prevents her from getting flu vaccines. She has been getting flu vaccines for years and had never had adverse events before). On 26th September 2014, the patient received FLUVIRAL. On 26th September 2014, 15 min after receiving FLUVIRAL, the patient experienced hypoglycemia (serious criteria hospitalization and clinically significant/intervention required), injection site sting, funny taste in mouth, confusion, irritable, angry, disoriented, lightheaded, seeing black spots, lower voice, sweaty, flashing lights, loss of consciousness (serious criteria GSK medically significant), leg cramps and hungry. On an unknown date, the patient experienced product complaint. The patient was treated with EPIPEN and Dextrose. On 26th September 2014, the outcome of the hypoglycemia, injection site sting, funny taste in mouth, confusion, irritable, angry, disoriented, lightheaded, seeing black spots, lower voice, sweaty, flashing lights and loss of consciousness were recovered/resolved. On an unknown date, the outcome of the leg cramps and hungry were recovered/resolved and the outcome of the product complaint was not reported. The reporter considered the hypoglycemia, injection site sting, funny taste in mouth, confusion, irritable, angry, disoriented, lightheaded, seeing black spots, lower voice, sweaty, flashing lights, loss of consciousness, leg cramps and hungry to be probably related to FLUVIRAL. Additional details received: The patient had lunch at 12:40 and was vaccinated at 4:15 pm. The reporter mentioned that the nurse who administered the vaccine also had HUMALOG in the refrigerator. However, it was reported that the vial for HUMALOG was significantly bigger than that for FLULAVAL, and was located in a different location in the refrigerator. The administrating nurse also was almost positive that she did not administer HUMALOG. A total of 6 patients were vaccinated at the same school and all 6 experienced hypoglycemia symptoms. All of them were vaccinated with the same lot of FLULAVAL (2 different vials). At the time of reporting, investigations were pending. Follow up information received from an electronic newspaper on 06October 2014: a lawsuit has been filed by two of the concerned patients against the school district alleging that they were given shots of insulin instead of the GSK flu vaccine shots they believed they were receiving. Investigations were still ongoing.
Age: 71.0
Sex: F
Vaccine: FLU3, FLUC3, FLU3
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: I did not speak to patient, but the message below was sent to the business owner 10/02/2014 at 9:03 AM. "I started having severe shoulder pain and a doctor said it was bursitis, the shot was given too high up on my shoulder."
Age: 71.0
Sex: F
Vaccine: FLU3, FLUC3, FLU3
Symptoms: Bursitis, Drug administered at inappropriate site, Musculoskeletal pain
Clinical narrative: I did not speak to patient, but the message below was sent to the business owner 10/02/2014 at 9:03 AM. "I started having severe shoulder pain and a doctor said it was bursitis, the shot was given too high up on my shoulder."
Age: 71.0
Sex: F
Vaccine: FLU3, FLUC3, FLU3
Symptoms: Bursitis, Drug administered at inappropriate site, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: I did not speak to patient, but the message below was sent to the business owner 10/02/2014 at 9:03 AM. "I started having severe shoulder pain and a doctor said it was bursitis, the shot was given too high up on my shoulder."
Age: 41.0
Sex: F
Vaccine: FLU3, FLUC3, FLU3
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: Received a flu shot and 36 hrs later had severe shoulder pain. Dr confirmed it is bursitis. The flu shot was given very high up on my shoulder, injected into the bursa instead of deltoid muscle. It has been nearly 2 weeks and the pain is increasing and I have limited range of motion. The pain is constant. Shot given on 9/23/14. General Practitioner confirmed bursitis on 9/26/14. The flu shot was administered by a nurse (given at my place of employment).
Age: 41.0
Sex: F
Vaccine: FLU3, FLUC3, FLU3
Symptoms: Bursitis, Drug administered at inappropriate site, Musculoskeletal pain
Clinical narrative: Received a flu shot and 36 hrs later had severe shoulder pain. Dr confirmed it is bursitis. The flu shot was given very high up on my shoulder, injected into the bursa instead of deltoid muscle. It has been nearly 2 weeks and the pain is increasing and I have limited range of motion. The pain is constant. Shot given on 9/23/14. General Practitioner confirmed bursitis on 9/26/14. The flu shot was administered by a nurse (given at my place of employment).
Age: 41.0
Sex: F
Vaccine: FLU3, FLUC3, FLU3
Symptoms: Bursitis, Drug administered at inappropriate site, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Received a flu shot and 36 hrs later had severe shoulder pain. Dr confirmed it is bursitis. The flu shot was given very high up on my shoulder, injected into the bursa instead of deltoid muscle. It has been nearly 2 weeks and the pain is increasing and I have limited range of motion. The pain is constant. Shot given on 9/23/14. General Practitioner confirmed bursitis on 9/26/14. The flu shot was administered by a nurse (given at my place of employment).
Age: 66.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Pt reports itching and rash around injections site.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Dizziness, Headache, Lip swelling, Nausea
Clinical narrative: Dizziness, nausea, severe itching, headache, pain from neck to base of spine, swollen lips.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pruritus
Clinical narrative: Dizziness, nausea, severe itching, headache, pain from neck to base of spine, swollen lips.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia, Injection site pruritus, Local swelling, Musculoskeletal stiffness
Clinical narrative: Intense itching at site and total arm numbness with hand swelling/stiffness.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Pain, Pyrexia, Skin warm
Clinical narrative: Hot, swollen upper arm from shoulder to elbow, mild fever, general body aches.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Swelling face
Clinical narrative: Face swollen; weakness.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: Pain started in shoulder upon injection. I felt he did it too high on shoulder and was about to tell him that when he injected. It still hurts almost a year later and now am having issues with certain motions.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Swelling face
Clinical narrative: Facial swelling and itching.
Age: 28.0
Sex: M
Vaccine: FLUX
Symptoms: Burning sensation, Herpes zoster, Rash vesicular
Clinical narrative: Post Flu Vaccine. Superficial burning to outer left arm after 5 days developed into blistery rash on the top of the arm. Diagnosed as Shingles, currently taking Valtrex.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pruritus, Rash, Skin warm, Swelling
Clinical narrative: Patient developed a rash in the inside part of his arm, with slight itching, some redness and swelling, slight warmth to the touch, no fever.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Erythema, Local swelling, Pain in extremity, Pyrexia, Throat irritation
Clinical narrative: Reaction: patient developed erythema, swelling and pain in left arm after injection of influenza and pneumococcal-23 vaccines. Other symptoms include patient reported fever of 102F, and scratchy throat. Management: the patient took diphenhydramine at home with no relief and acetaminophen for fever. The day following vaccination, patient reported to clinic for evaluation. Plan per clinic note to use ice, elevation, and diphenhydramine to treat local reaction. Patient instructed to present to emergency room if symptoms worsen.
Age: 18.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Headache, Myalgia, Night sweats, Pyrexia
Clinical narrative: Chills, night sweats, muscle soreness, 102.9 fever, headache.
Age: 43.0
Sex: M
Vaccine: TYP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Noted swelling to right tricep where Varicella was administered. Also erythema, tenderness to touch and warmness to area.
Age: 62.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: Reaction: patient developed flu-like symptoms (nausea, chills, diarrhea, headache, fatigue, dizziness, and body aches), injection site warmth and swelling approximately 6 hours after receiving the pneumococcal-23 and influenza vaccines in the same arm. Management: Patient refused appointment and therefore received care at home to manage symptoms. Instructed to seek urgent care if symptoms worsened.
Age: 62.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Influenza like illness, Injection site swelling, Injection site warmth, Nausea, Pain
Clinical narrative: Reaction: patient developed flu-like symptoms (nausea, chills, diarrhea, headache, fatigue, dizziness, and body aches), injection site warmth and swelling approximately 6 hours after receiving the pneumococcal-23 and influenza vaccines in the same arm. Management: Patient refused appointment and therefore received care at home to manage symptoms. Instructed to seek urgent care if symptoms worsened.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Laboratory test, Lymphadenopathy, Sepsis
Clinical narrative: Septicemic, headaches, lymph nodes enlarged, in hospital 2 days with no medicines given.
Age: 87.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Paraesthesia, Pharyngeal oedema, Rash, Throat irritation
Clinical narrative: PATIENT STATES THAT SHORTLY AFTER RECEIVING INFLUENZA AND SHINGLES VACCINES, SHE STARTED HAVING TINGLING SENSATIONS ON FINGERS AND TOES AND BROKE OUT IN RASH BY THE TIME SHE ARRIVED AT HOSPITAL. SHE ALSO HAD ITCHING AND SWELLING IN THE THROAT.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Needle issue, Pain, Poor quality sleep, X-ray limb
Clinical narrative: Person giving vaccine "stuck" twice, claimed needle on first injection malfunctioned.  Vaccination was given very high on my left arm over my nearly-non-existent deltoid muscle. I pointed out it wasn't a good site.  But second injection in same spot. My shoulder soon began to hurt, got worse each day, now extreme pain during normal daily activities when I raise my elbow or entire arm. Think the needle stuck my rotator cuff tendon or a bursa or acromion or other unintended location.  Initial eval by orthopedist 10/7/14, x-rays were normal but he could not diagnose injury and referred me to shoulder specialist for further diagnosis on 10/14/14. Pain wakes me at night, shoulder aches when I steer my car.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Altered state of consciousness, Chills, Dysphonia, Feeling abnormal
Clinical narrative: Pt noticed arm hurt to raise 2:00 PM. Head ache to frontal lobe along with neck and shoulder pain 5:00 PM. Nausea, hard chill 10:00 PM. Treated with Ultram pain pill 10:30 PM. Felt bad all night. 10/7/2014 5:30 AM up to shower Nausea, felt like going to pass out, ache all over.  Missed work, in and out of sleep all day.  10/8/2014 felt better, neck and shoulders still ache, voice hoarse. 10/9/2014 arm still hurst to raise.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Musculoskeletal pain, Nausea, Neck pain, Pain
Clinical narrative: Pt noticed arm hurt to raise 2:00 PM. Head ache to frontal lobe along with neck and shoulder pain 5:00 PM. Nausea, hard chill 10:00 PM. Treated with Ultram pain pill 10:30 PM. Felt bad all night. 10/7/2014 5:30 AM up to shower Nausea, felt like going to pass out, ache all over.  Missed work, in and out of sleep all day.  10/8/2014 felt better, neck and shoulders still ache, voice hoarse. 10/9/2014 arm still hurst to raise.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Pt noticed arm hurt to raise 2:00 PM. Head ache to frontal lobe along with neck and shoulder pain 5:00 PM. Nausea, hard chill 10:00 PM. Treated with Ultram pain pill 10:30 PM. Felt bad all night. 10/7/2014 5:30 AM up to shower Nausea, felt like going to pass out, ache all over.  Missed work, in and out of sleep all day.  10/8/2014 felt better, neck and shoulders still ache, voice hoarse. 10/9/2014 arm still hurst to raise.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Activities of daily living impaired, Asthenia, Blood creatinine normal, Blood culture negative, Diarrhoea
Clinical narrative: Received both FLUZONE influenza vaccine and PNEUMOVAC 23 injections on the same day, same arm (left) on 10/1/14. By 10/2/14 she developed swelling and pain in the left arm with limited mobility of that arm. She also developed fever, diarrhea and overall weakness- unable to get out of bed. Was admitted to the hospital for possible left arm cellulitis. PNEUMOVAC 23 lot = K009107, FLUZONE lot= U5041DA.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Haematocrit decreased, Haemoglobin decreased, Injected limb mobility decreased, Local swelling, Mobility decreased
Clinical narrative: Received both FLUZONE influenza vaccine and PNEUMOVAC 23 injections on the same day, same arm (left) on 10/1/14. By 10/2/14 she developed swelling and pain in the left arm with limited mobility of that arm. She also developed fever, diarrhea and overall weakness- unable to get out of bed. Was admitted to the hospital for possible left arm cellulitis. PNEUMOVAC 23 lot = K009107, FLUZONE lot= U5041DA.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Neutrophil count normal, Pain in extremity, Platelet count decreased, Pyrexia, White blood cell count increased
Clinical narrative: Received both FLUZONE influenza vaccine and PNEUMOVAC 23 injections on the same day, same arm (left) on 10/1/14. By 10/2/14 she developed swelling and pain in the left arm with limited mobility of that arm. She also developed fever, diarrhea and overall weakness- unable to get out of bed. Was admitted to the hospital for possible left arm cellulitis. PNEUMOVAC 23 lot = K009107, FLUZONE lot= U5041DA.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Pyrexia
Clinical narrative: Received both FLUZONE influenza vaccine and PNEUMOVAC 23 injections on the same day, same arm (left) on 10/1/14. By 10/2/14 she developed swelling and pain in the left arm with limited mobility of that arm. She also developed fever, diarrhea and overall weakness- unable to get out of bed. Was admitted to the hospital for possible left arm cellulitis. PNEUMOVAC 23 lot = K009107, FLUZONE lot= U5041DA.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Gaze palsy, Laboratory test, Nuclear magnetic resonance imaging normal, Paralysis
Clinical narrative: On 7-12-14, child awoke from nap mom noticed (L) eye turned in. Didn't think much about it. But she woke up next AM (L) eye worse. Took child to ER. Was admitted 7-13-14. MRI - 7-14-14. Normal per mom. Dx with 5th nerve palsy. Uses cyclopentolate 1% eye drops qd to strength muscle. Cause unknown Dr. told her possible SE vaccine, or virus. Had f/u with office 10-2-14. Remains in follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient reported that the sight of injection was red and itching. Redness had a diameter of about 4 inches from site of injection.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Swollen tongue
Clinical narrative: The base of my tongue started swelling about 10 min after receiving the shot and within 20 minutes my throat began to swell and I was rushed to the emergency room. I received and epi injection and then an oral dose of a combination of Benadryl and steroids.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: 101 degree fever, aches, pains, exhaustion, pain at injection site.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on arms, back, and chest.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an about 5-10 patients of unknown age and gender. Medical history was not reported. The pharmacist informed that in August 2014 the patients were vaccinated with ZOSTAVAX vial, subcutaneous (lot number, expiration date and dosage were not reported) which was improperly exposed to defrost cycling up to 7 F for <1 hour per cycle for 1 cycle per day each day. The date that this ZOSTAVAX was placed into this freezer was unspecified. No known adverse effects were reported. Follow up information has been received from a pharmacist refers to a 65 years old male patient with blood pressure and cholesterol. On 21-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, in the left arm. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Sensory disturbance
Clinical narrative: Felt odd sensation in arm and into 4th & 5th fingers lasting over night.  10/09/2014 AM continues with "odd" numbness in R) 5th finger.
Age: 54.0
Sex: M
Vaccine: FLUX, FLU4
Symptoms: Oedema peripheral, Pain, Swelling
Clinical narrative: Swollen right arm pit area including chest and back with mild pain. Went to urgent care and was prescribed and antibiotic.
Age: 54.0
Sex: M
Vaccine: FLUX, FLU4
Symptoms: Axillary pain, Nipple swelling, Swelling
Clinical narrative: Swollen right arm pit area including chest and back with mild pain. Went to urgent care and was prescribed and antibiotic.
Age: 83.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Pain in right leg and hip day after the vaccinations.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dyspnoea, Eye inflammation, Eyelid function disorder, Injection site pain, Pruritus
Clinical narrative: Mother states that patient's face became swollen and itchy, and eyes became inflammed and she was upable to open them at 1900 last night. She took 1 Benadryl with no symptom relief. Began having labored breathing and mother took her to ED at 2100. Per mother's report, Vistaril 25 mg was given in ED, and a presciption was given but not yet filled. Patient has not taken any medication since that time. Today 0900 her face and eyes are once again inflammed and she is having pain at the injection site. Mother reported that she is not having any breathing problems today. Advised mother to take her back to the ED right away if breathing problems start again. Called NP. She suggested that patient take Benadryl q 4-6 hours x 1 week. Instructed mother to fill presciption right away. Public health nurse will follow up with mother today.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Swelling face
Clinical narrative: Mother states that patient's face became swollen and itchy, and eyes became inflammed and she was upable to open them at 1900 last night. She took 1 Benadryl with no symptom relief. Began having labored breathing and mother took her to ED at 2100. Per mother's report, Vistaril 25 mg was given in ED, and a presciption was given but not yet filled. Patient has not taken any medication since that time. Today 0900 her face and eyes are once again inflammed and she is having pain at the injection site. Mother reported that she is not having any breathing problems today. Advised mother to take her back to the ED right away if breathing problems start again. Called NP. She suggested that patient take Benadryl q 4-6 hours x 1 week. Instructed mother to fill presciption right away. Public health nurse will follow up with mother today.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, RV1
Symptoms: Barium double contrast, Chest X-ray, Haematochezia, Intussusception, Irritability
Clinical narrative: Hospitalized for bloody stool, emesis and irritability on 8/4/14. Trans to a second hospital on 8/5/14. IV fluids. Intussusception noted. Resolution with air contrast enema. Discharged on 8/6/14 feeding well and no further bloody stools.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, RV1
Symptoms: Laboratory test, Ultrasound abdomen, Urinary system X-ray, Vomiting
Clinical narrative: Hospitalized for bloody stool, emesis and irritability on 8/4/14. Trans to a second hospital on 8/5/14. IV fluids. Intussusception noted. Resolution with air contrast enema. Discharged on 8/6/14 feeding well and no further bloody stools.
Age: 63.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Persistant soreness, swelling, and redness at injection site.
Age: 22.0
Sex: F
Vaccine: FLU4, HPV4, PPV
Symptoms: Injection site erythema, Injection site swelling, Myalgia, Pain, Pyrexia
Clinical narrative: 10/5/2014 @ 4:34pm pt. called c/o fever & muscle aches onset 18 hours after receiving vaccines. Educated on vaccine reactions. 10/6/2014 @ 8:21am pt. called MD office c/o redness & swelling to injection site of pneumococcal vaccine approx. 5-6 inches in diameter and fever of 102.9 with body aches. Pt going to Urgent Care. At 2:43pm pt calls informing MD in ER and being admitted to hospital.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site urticaria, Rash erythematous, Rash pruritic, Vaccination complication
Clinical narrative: Large welt (over 2 inches in diameter) formed at flu vaccination site within 24 hours, welt began declining and red itchy rash began to spread, mostly across upper arms, chest, abdomen. Patient self treated with oral Benadryl and OTC antihistamines. Four days post vaccination, rash persisted and spread to lower arms & upper thighs- patient was prescribed prednisone & topical ointment.  Two weeks post vaccine rash has persisted and worsened despite completion of oral prednisone regimen, patient consulted with allergist and is beginning Allegra am, Pepcid + Zyrtec pm daily to treat itch/rash that is believed to be a viral reaction to the vaccine.
Age: 19.0
Sex: M
Vaccine: FLUX, MEN
Symptoms: Cough, Myalgia, Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: Low fever, cough, severe sore throat, severe nasal congestion (no airflow through nose), body/muscle aches. Onset shortly after receiving vaccination, lasting one week thus far, no recovery as of yet. DayQuil, Advil, and Tylenol Extra Strength taken for treatment, DayQuil most effective.
Age: 19.0
Sex: M
Vaccine: FLUX, MEN
Symptoms: Pyrexia
Clinical narrative: Low fever, cough, severe sore throat, severe nasal congestion (no airflow through nose), body/muscle aches. Onset shortly after receiving vaccination, lasting one week thus far, no recovery as of yet. DayQuil, Advil, and Tylenol Extra Strength taken for treatment, DayQuil most effective.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Hyperhidrosis, Hypoglycaemia
Clinical narrative: This case was reported by a physician and described the occurrence of about to pass out in a 43-year-old female patient who received FLUVIRAL (batch number G44A3, expiry date 30th April 2015). This case was associated with a product complaint. On 23rd September 2014, the patient received FLUVIRAL. On 23rd September 2014, less than an hour after receiving FLUVIRAL, the patient experienced about to pass out (serious criteria GSK medically significant and clinically significant/intervention required), feeling nauseous abdominal cramp, lightheaded, diarrhea, sweating and increased need for sleep. On an unknown date, the patient experienced product complaint. On 24th September 2014, the outcome of the about to pass out, feeling nauseous, abdominal cramp, lightheaded, diarrhea, sweating and increased need for sleep were recovered/resolved. On an unknown date, the outcome of the product complaint was unknown. The reporter considered the about to pass out, feeling nauseous, abdominal cramp, lightheaded, diarrhea, sweating and increased need for sleep to be probably related to FLUVIRAL. Additional details received: The reporter mentioned that the nurse who administered the vaccine also had HUMALOG in the refrigerator. However, it was reported that the vial for HUMALOG was significantly bigger than that for FLULAVAL, and was located in a different location in the refrigerator. The administrating nurse also was almost positive that she did not administer HUMALOG. A total of 6 patients were vaccinated at the same school and all 6 experienced hypoglycemia  symptoms. All of them were vaccinated with the same lot of FLULAVAL (2 different vials). These cases have been linked in the GSK database (see case US2014GSK000221). At the time of reporting, investigations were pending. Follow up information received from an electronic newspaper on 06October 2014: a lawsuit has been filed by two of concerned patients against the school district alleging that they were given shots of insulin instead of the GSK flu vaccine shots they believed they were receiving. Investigations were still ongoing.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Product quality issue, Somnolence, Wrong drug administered
Clinical narrative: This case was reported by a physician and described the occurrence of about to pass out in a 43-year-old female patient who received FLUVIRAL (batch number G44A3, expiry date 30th April 2015). This case was associated with a product complaint. On 23rd September 2014, the patient received FLUVIRAL. On 23rd September 2014, less than an hour after receiving FLUVIRAL, the patient experienced about to pass out (serious criteria GSK medically significant and clinically significant/intervention required), feeling nauseous abdominal cramp, lightheaded, diarrhea, sweating and increased need for sleep. On an unknown date, the patient experienced product complaint. On 24th September 2014, the outcome of the about to pass out, feeling nauseous, abdominal cramp, lightheaded, diarrhea, sweating and increased need for sleep were recovered/resolved. On an unknown date, the outcome of the product complaint was unknown. The reporter considered the about to pass out, feeling nauseous, abdominal cramp, lightheaded, diarrhea, sweating and increased need for sleep to be probably related to FLUVIRAL. Additional details received: The reporter mentioned that the nurse who administered the vaccine also had HUMALOG in the refrigerator. However, it was reported that the vial for HUMALOG was significantly bigger than that for FLULAVAL, and was located in a different location in the refrigerator. The administrating nurse also was almost positive that she did not administer HUMALOG. A total of 6 patients were vaccinated at the same school and all 6 experienced hypoglycemia  symptoms. All of them were vaccinated with the same lot of FLULAVAL (2 different vials). These cases have been linked in the GSK database (see case US2014GSK000221). At the time of reporting, investigations were pending. Follow up information received from an electronic newspaper on 06October 2014: a lawsuit has been filed by two of concerned patients against the school district alleging that they were given shots of insulin instead of the GSK flu vaccine shots they believed they were receiving. Investigations were still ongoing.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Presyncope
Clinical narrative: Near syncopal episodes twice in less than 24 hours from administration of vaccine.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Myalgia
Clinical narrative: Muscle and joint pain lasting for greater than 8 days.  Treated with Advil and aspirin and improving after 8 days.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthma, Chills, Condition aggravated, Injection site erythema, Injection site induration
Clinical narrative: Muscle aches, fever, chills, increased asthma symptoms lasted 6 days, and large local reaction at site of Pneumovax (right arm) injection with redness, warmth, pain and induration for >1.5wks.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site warmth, Local reaction, Myalgia, Pyrexia
Clinical narrative: Muscle aches, fever, chills, increased asthma symptoms lasted 6 days, and large local reaction at site of Pneumovax (right arm) injection with redness, warmth, pain and induration for >1.5wks.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Echocardiogram normal, Electrocardiogram normal, Heart rate increased, Muscle spasms
Clinical narrative: Given HPV#3 on 10/1/14 at clinic on base. Seen in ER that night for reaction to vaccine. Fever 103 with elevated HR.  Severe back pain with spasms. Admitted overnight for observation. No rash or hives.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Troponin increased, Vaccination complication
Clinical narrative: Given HPV#3 on 10/1/14 at clinic on base. Seen in ER that night for reaction to vaccine. Fever 103 with elevated HR.  Severe back pain with spasms. Admitted overnight for observation. No rash or hives.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Mobility decreased, Myalgia, Neck pain, Paraesthesia
Clinical narrative: Extreme deltoid muscle pain front and rear deltoid muscle of injected left arm after painful injection.  Unknown if permanent injury at this time.  Limited arm mobility, pain at deltoid, to trapezius, front & back of neck, and tingling of arm to fingers identified to date.  Constant pain; interrupted sleep.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder
Clinical narrative: Extreme deltoid muscle pain front and rear deltoid muscle of injected left arm after painful injection.  Unknown if permanent injury at this time.  Limited arm mobility, pain at deltoid, to trapezius, front & back of neck, and tingling of arm to fingers identified to date.  Constant pain; interrupted sleep.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain, Skin warm, Tenderness
Clinical narrative: PATIENT EXPERIENCED REDNESS AND SWELLING FROM SHOULDER TO ELBOW, AREA WAS VERY SORE/TENDER AND PATIENT COMPLAINED THAT IT FELT WARM.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient fainted approximately 5 minutes post flu immunization.
Age: 39.0
Sex: F
Vaccine: FLUC3
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Approximately 2 hours after receiving the vaccination patient noted raised red rash which covered upper back with no breaks in the rash.  It was very itchy and covered an area approximately 10 inches across and 7 inches down.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Dizziness postural, Serology test
Clinical narrative: Onset of dizziness upon rising from bed, continued entire day, worsened on 09/20/2014. Went to Urgent Care, testing (blood work/CAT Scan) was negative. Continues episodically to date.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Lip swelling, Pruritus, Urticaria
Clinical narrative: Approx 7:00 PM I broke out with hives and had major itching all night long and on 10/08/2014 all day, included the majority of my body buttocks, inside thighs, feet, hands, arms. Approximately 8:00 AM my lower lip severely swelled about 3-4X's larger than normal. I put a call into the Dr. office, but they never called back ended up going to the Emergency Room the evening of 10/08/2014. The Dr. diagnosis was "Acute Allergic Reaction" to the flu shot. I was administered famotidine, fexofenadine, and methylprednisolone intravenously and was given prescriptions for Medrol (pak) 4MG #21 tablets, Pepcid 20MG #10 tablets and Allegra 180MG #30 Package.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Unresponsive to stimuli
Clinical narrative: Pt was "unresponsive." Patient's husband described patient sitting at table with eyes open but did not respond to vocal cues or to touch; he stated it lasted about 30 seconds; he said he almost called 911, but patient eventually responded.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Vertigo
Clinical narrative: Vertigo, feeling that I may fall down. Lasted approximately an hour.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Local swelling
Clinical narrative: Patient experience swelling in arms, bruising.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Dyspnoea, Fatigue
Clinical narrative: Chills, shortness of breath, temp of 101.5 Called and spoke to Dr office on 10/09/2014 to let them know the reaction and was told that if the same symptoms appear on 10/09/14 to go to the ER. At this time patients feels tired.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Irritability, Pyrexia
Clinical narrative: Rec'd immunization in AM, and brought to the ER in the evening due to high fever and fussiness (103.4 rectally per mom).  Infant was 37.7 rectally in ER.  No tylenol was given prior to ER visit.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Patient didn't have an adverse event. Clinical Coordinator wants the pharmacist to fill out a VAERS because Fluvirin 2014-2015 with preservative was administered to a pregnant woman.
Age: 27.0
Sex: F
Vaccine: FLUN4
Symptoms: Oropharyngeal pain, Pruritus
Clinical narrative: Woke up with itchy nose, sore throat.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Feeling of body temperature change, Hyperhidrosis, Pain
Clinical narrative: Hot, cold, sweats, dizzy, full body aches.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Eye swelling, Malaise, Musculoskeletal stiffness, Ocular hyperaemia
Clinical narrative: Pt stated she developed swollen/red eyes, stiff neck at 8 PM on Wed 10/1/14, then developed body aches, soreness in upper chest the following day.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Pt stated she developed swollen/red eyes, stiff neck at 8 PM on Wed 10/1/14, then developed body aches, soreness in upper chest the following day.
Age: 22.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: L deltoid site red, hot, arm hurts, may have chills.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient developed a rash all over arms and chest the morning after receiving the shot.  He took 2 doses of Benadryl and the rash subsided.
Age: 23.0
Sex: F
Vaccine: FLUN4
Symptoms: Hypersensitivity, Pruritus, Wheezing
Clinical narrative: Pt stated itching over her neck, and then started to have minor wheezing. At 0900 vitals where taken and wheezing progressed. Then Benadryl was given 50 mg PO. At 0918 Pt was moved to Treatment Room. At 0935 an IV was administered and Solu Medrol 125 MG was given IV. At 0955 Pt was put on NRB oxygen at 15 lpm. No other treatments where administered and Pt was released at 1400. Pt was diagnosed with having an allergic reaction to Flu Mist.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Rash, Rash pruritic
Clinical narrative: Light rash on trunk, breasts and back developed that was itchy and stinging.  The rash resoved by the next day.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Erythema, Hypersensitivity, Local swelling, Pregnancy test urine negative
Clinical narrative: Employee was treated in the ED. Symptoms: skin rash to  Lt arm that was red, raised, macular, with hives, swelling, Lt arm erythema, itching and cough. Medication Prescribed: Medrol dose pak, Pepcid 20 mg, Benadryl.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Rash erythematous, Rash macular, Urticaria
Clinical narrative: Employee was treated in the ED. Symptoms: skin rash to  Lt arm that was red, raised, macular, with hives, swelling, Lt arm erythema, itching and cough. Medication Prescribed: Medrol dose pak, Pepcid 20 mg, Benadryl.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient experienced a rash at the site of her Zostavax vaccination. At a 2 week follow up the rash has subsided.