chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Gait disturbance, Impaired driving ability, Skin burning sensation, Skin warm
Clinical narrative: This case was reported by a other health professional and described the occurrence of feeling bad in a 62-year-old female patient who received FLUARIX (batch number UI159AB, expiry date 30th June 2015). The patient's past medical history included breast cancer. Concurrent medical conditions included lymph node excision. On 26th September 2014, the patient received the 1st dose of FLUARIX (injection). On 26th September 2014, 4 hrs after receiving FLUARIX, the patient experienced feeling bad, shuffling gait, vomiting, skin burning sensation and hives in patches. On an unknown date, the outcome of the feeling bad, shuffling gait and vomiting were recovered/resolved and the outcome of the skin burning sensation was recovering/resolving and the outcome of the hives in patches was unknown. It was unkown if the reporter considered the feeling bad, shuffling gait, vomiting, skin burning sensation and hives in patches to be related to FLUARIX. Additional information: Nurse reporting at employee flu clinic, an employee (RPH) was administered vaccination in right arm. Within 4 hours, the pharmacist began feeling bad. At unknown time period, the pharmacist was displaying a shuffling gait, and said she couldn't drive. She refused to seek medical treatment. She also started vomiting. Pharmacist told nurse that she had a reaction in her left arm (which did not receive the vaccination). It began developing a red, burn like appearance, and felt really hot. Patient also developed hives in patches here and there. Patient continued to work and finished shift, and did not seek medical advice or go to ER. The nurse saw the patient today and noted that the patient said arm was improving despite still appearing red, with a burn like appearance and feeling warm.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria, Vomiting
Clinical narrative: This case was reported by a other health professional and described the occurrence of feeling bad in a 62-year-old female patient who received FLUARIX (batch number UI159AB, expiry date 30th June 2015). The patient's past medical history included breast cancer. Concurrent medical conditions included lymph node excision. On 26th September 2014, the patient received the 1st dose of FLUARIX (injection). On 26th September 2014, 4 hrs after receiving FLUARIX, the patient experienced feeling bad, shuffling gait, vomiting, skin burning sensation and hives in patches. On an unknown date, the outcome of the feeling bad, shuffling gait and vomiting were recovered/resolved and the outcome of the skin burning sensation was recovering/resolving and the outcome of the hives in patches was unknown. It was unkown if the reporter considered the feeling bad, shuffling gait, vomiting, skin burning sensation and hives in patches to be related to FLUARIX. Additional information: Nurse reporting at employee flu clinic, an employee (RPH) was administered vaccination in right arm. Within 4 hours, the pharmacist began feeling bad. At unknown time period, the pharmacist was displaying a shuffling gait, and said she couldn't drive. She refused to seek medical treatment. She also started vomiting. Pharmacist told nurse that she had a reaction in her left arm (which did not receive the vaccination). It began developing a red, burn like appearance, and felt really hot. Patient also developed hives in patches here and there. Patient continued to work and finished shift, and did not seek medical advice or go to ER. The nurse saw the patient today and noted that the patient said arm was improving despite still appearing red, with a burn like appearance and feeling warm.
Sex: F
Vaccine: FLU3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This case was reported by a other health professional and described the occurrence of expired vaccine used in a female patient who received FLUARIX (batch number XE294, expiry date unknown). On 30th September 2014, the patient received FLUARIX. On 30th September 2014, an unknown time after receiving FLUARIX, the patient experienced vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. It was unknown if the reporter considered the expired vaccine used to be related to FLUARIX. Additional information: Nurse reported she gave 4 female adult patients an expired dose of Flu vaccine on 30 September 2014, morning. No adverse event reported.
Age: 1.45
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 17-month-old female patient who received FLULAVAL (batch number 5AZ7H, expiry date 30th April 2015). On 29th September 2014, the patient received the 1st dose of FLULAVAL. on an unknown date, an unknown time after receiving FLULAVAL, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration and wrong vaccine administered to be related to FLULAVAL. Additional information received: Patient of 17 months of age who received inadvertently FLULAVAL QUADRIVALENT. Child too young for indicated age for vaccine.
Age: 1.1
Sex: M
Vaccine: FLU3
Symptoms: Accidental overdose, Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 13-month-old male patient who received FLUARIX. Co-suspect products included FLUARIX. On 29th September 2014, the patient received the 1st dose of FLUARIX .5 ml and the 2nd dose of FLUARIX .5 ml. On an unknown date, an unknown time after receiving FLUARIX and FLUARIX, the patient experienced inappropriate age at vaccine administration, accidental overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration, accidental overdose and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration to be related to FLUARIX. It was unknown if the reporter considered the accidental overdose and inappropriate age at vaccine administration to be related to FLUARIX. Additional information received on 29 September 2014: 2 doses of FLUARIX was administered to a patient on the same day. Both doses were meant for his siblings. No other information was provided.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: SWOLLEN ARM PIT GLAND (AUXILLARY) IN SAME ARM AS SHOT, PAINFUL FOR 3 DAYS, SUBSIDED ON 4 TH DAY.  TODAY IS 6TH DAY, JUST SLIGHTLY TENDER. ALL NURSES AND DR'S DENIED IT WAS SIDE EFFECT.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Swelling of arm lasting 36 hours.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Large red rash around injection site (larger than an orange) hardness to touch and painful.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site joint pain
Clinical narrative: Left shoulder joint pain with certain motions, such as putting on coat. As of 11/19/14 he is still having pain in joint area.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Aldolase, Antinuclear antibody, Blood uric acid, Chills, Pain
Clinical narrative: Fever of 99.7, chills, body aches.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Rheumatoid factor
Clinical narrative: Fever of 99.7, chills, body aches.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Quarter size red raised reaction noted on Right arm.  Warm to touch.  Patient denies pain unless area is pressed.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Quarter size red raised reaction noted on Right arm.  Warm to touch.  Patient denies pain unless area is pressed.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Local swelling, Pain, Pain in extremity
Clinical narrative: Chills, body aches.  Approximately 28 hours after the vaccine was administered severe pain began in right wrist with swelling of top of the hand.  Pain and swelling began to subside after 24 hours when pain and swelling began behind right knee.  After another 24 hours the pain moved into right hip.  Pain in hip subsided about five days after the vaccine was given, when new pain and swelling returned to right wrist and hand.  As of today the right hand (wrist and fingers) remains painful and swollen.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Contusion, Pain, Pain in extremity, Rash
Clinical narrative: Rash, bruising, throbbing pain, unable to lay on side, unable to put clothes on without arm hurting, clindamycin 300mg 3x's day, steroid injection, Medrol pack, on second round of Medrol pack.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Palpitations
Clinical narrative: PATIENT REPORTS HEART PALPITATIONS WHICH BEGAN 3-4 HRS POST INOCULATION. THERE WAS AN APPARENT EXPERIENCE OF BREATHING DIFFICULTY ALSO.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Computerised tomogram, Gait disturbance, Mammogram, Mobility decreased, Nuclear magnetic resonance imaging
Clinical narrative: Progressive difficulty walking, lifting leg on steps until 12/29/11 admitted Hosp. pulmonary embolism of both lungs, and paralysis.  Discharged 1/2/12 to Rehab/NH disch. 4/12/12 to home recup. and therapy still unable to walk with no diagnosis & paralysis.  Later diff. moving, rotating R. arm Dec. 2012 vaccine.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Paralysis, Pulmonary embolism, X-ray
Clinical narrative: Progressive difficulty walking, lifting leg on steps until 12/29/11 admitted Hosp. pulmonary embolism of both lungs, and paralysis.  Discharged 1/2/12 to Rehab/NH disch. 4/12/12 to home recup. and therapy still unable to walk with no diagnosis & paralysis.  Later diff. moving, rotating R. arm Dec. 2012 vaccine.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Rash
Clinical narrative: Mother noticed that the child had a rash on 11/17/2014  the child received vaccines on 11/14/2014 and had grape flavored Tylenol, nothing else was new to the child.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Cough, Nasopharyngitis, Pyrexia, Upper respiratory tract infection
Clinical narrative: Mother reported at md office that child developed cold symptoms within 24 hours after receiving flu mist. URI sx started first then a cough a day or so later. Sx worsened 2 days before office visit which was 11/18. Fever onset the pm before office visit on 11/18. Inhalers were started as soon as cough started. There is no mention of wheezing or asthma attack on the md office documentation.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red, raised, itchy area at location of injection.  Perceived inflammation over large portion of right arm.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dysphagia, Injection site pain, Pharyngeal oedema, Pyrexia
Clinical narrative: Patient complained of stinging upon administration of vaccine, but did not complain of any other symptoms at that time. When I called to follow up with the patient on 11/19/2014, she stated that around 4:30 PM she began to get chills, a fever, and could not swallow due to swelling in her throat. She immediately went to the emergency room for treatment and was told her symptoms were likely due to a reaction to the vaccine.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Patient complained of stinging upon administration of vaccine, but did not complain of any other symptoms at that time. When I called to follow up with the patient on 11/19/2014, she stated that around 4:30 PM she began to get chills, a fever, and could not swallow due to swelling in her throat. She immediately went to the emergency room for treatment and was told her symptoms were likely due to a reaction to the vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN4, MMR, VARCEL
Symptoms: Epistaxis, Eye pain, Fatigue, Pain, Skin warm
Clinical narrative: Mother called to report her daughter has been feeling tired, achy and complaining her eyes hurt since receiving her shots on Friday, 11/14/14. Child received LAIV, Kinrix, MMR and VAR on 11/14/14. On Sunday, 11/15/14 had a bloody nose with approximate ¼ teaspoon of bloody drainage. Had another bloody nose on Tuesday, 11/18/14 with approximate ½ teaspoon of bloody drainage. Mother admits child picks her nose. Child felt warm to the touch the first 2 days after receiving her shots. Mother denies any other symptoms treated child with Tylenol.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose decreased, Blood test, Dizziness, Electrocardiogram, Gait disturbance
Clinical narrative: Tremors in hands & feet, numbness in all extremities, dizzy, blood sugar dropped to 42, blurry vision, unsteady gait, heart palpitations, nausea.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Nausea, Palpitations, Tremor, Vision blurred
Clinical narrative: Tremors in hands & feet, numbness in all extremities, dizzy, blood sugar dropped to 42, blurry vision, unsteady gait, heart palpitations, nausea.
Age: 37.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Red, swollen, painful.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count, Hypoaesthesia, Metabolic function test, Muscular weakness, Nuclear magnetic resonance imaging normal
Clinical narrative: I had a sudden onset of numbness to the left side of my face.  There was no facial drooping or slurred speech.  I did have some occasional left arm weakness during the event as well. I went to see my PCP the next day.  She prescribed a Medrol dose pack.  We didn't necessarily associate the symptoms with the flu vaccine at that time.  The symptoms improved slightly on the first 2 days of the Medrol dose pack and then returned.  I saw a Neurologist, and I had an MRI of my head and neck. The MRI's didn't show any findings that would be a causation for the facial numbness.  The symptoms finally resolved completely within approximately 3 months.  I didn't report the event, because I thought it was just a coincidence that I had my flu shot on the day my symptoms started.  However, I have recently learned that several others experienced similar symptoms after receiving their flu vaccine last year.  I did get a flu shot this year and didn't experience any adverse reactions.  I did notice that the vaccine and manufacturer were different on the vaccine that we received this year.  Last year the vaccine was Afluria, Lot #09249211A, Manufacturer was CSL Limited.  This years vaccine was Fluvirin, Lot #1411301, Manufacturer was Novartis.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Thyroid function test
Clinical narrative: I had a sudden onset of numbness to the left side of my face.  There was no facial drooping or slurred speech.  I did have some occasional left arm weakness during the event as well. I went to see my PCP the next day.  She prescribed a Medrol dose pack.  We didn't necessarily associate the symptoms with the flu vaccine at that time.  The symptoms improved slightly on the first 2 days of the Medrol dose pack and then returned.  I saw a Neurologist, and I had an MRI of my head and neck. The MRI's didn't show any findings that would be a causation for the facial numbness.  The symptoms finally resolved completely within approximately 3 months.  I didn't report the event, because I thought it was just a coincidence that I had my flu shot on the day my symptoms started.  However, I have recently learned that several others experienced similar symptoms after receiving their flu vaccine last year.  I did get a flu shot this year and didn't experience any adverse reactions.  I did notice that the vaccine and manufacturer were different on the vaccine that we received this year.  Last year the vaccine was Afluria, Lot #09249211A, Manufacturer was CSL Limited.  This years vaccine was Fluvirin, Lot #1411301, Manufacturer was Novartis.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Arthritis, Cardiac murmur, Fatigue, Laboratory test
Clinical narrative: Patient was in perfect health never got sick and was a college student who did ballet every day since she was three- years-old.  From the day she received the Gardasil vaccine she became tired and got aches and pains throughout her body.  The pain started with her hands then moved to her arms and spine.  Patient was diagnosed with three forms of arthritis and a heart murmur. Patient has been in pain every single day of her life and frequents the emergency room from the arthritis pain.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder, Muscular weakness, Myalgia, Pain, Pain in extremity
Clinical narrative: Patient was in perfect health never got sick and was a college student who did ballet every day since she was three- years-old.  From the day she received the Gardasil vaccine she became tired and got aches and pains throughout her body.  The pain started with her hands then moved to her arms and spine.  Patient was diagnosed with three forms of arthritis and a heart murmur. Patient has been in pain every single day of her life and frequents the emergency room from the arthritis pain.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Spinal pain
Clinical narrative: Patient was in perfect health never got sick and was a college student who did ballet every day since she was three- years-old.  From the day she received the Gardasil vaccine she became tired and got aches and pains throughout her body.  The pain started with her hands then moved to her arms and spine.  Patient was diagnosed with three forms of arthritis and a heart murmur. Patient has been in pain every single day of her life and frequents the emergency room from the arthritis pain.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Pain in shoulder joint esp. with abduction, limited shoulder ROM continuing 3 weeks after injection requiring physical therapy and prednisone taper.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain
Clinical narrative: Muscle soreness to upper arm.  Painful to raise arm above head.  Pain continued until now.  Arm is not getting bigger.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Pyrexia
Clinical narrative: REDNESS AT INJECION SITE (UPPER ARM AND EXTENDED DOWNWARD FROM INJECTION SITE), ITCHING AT INJECTION SITE, FEVER.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Myalgia, Nausea, Pain in extremity
Clinical narrative: Had flu shot for several years with no reaction. Woke up the next day with uncommonly sore arm, nausea, dizziness, and muscle soreness. Never sought treatment.
Age: 10.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test, Headache, Pyrexia
Clinical narrative: Severe constant headaches and low grade fever. Increasing worse with each day. Seen by the ER twice and regular physician and GI. No one can find any other reason for these symptoms.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain lower, Body temperature increased, Chest pain, Injection site vesicles, Local swelling
Clinical narrative: Blistering on injection site, nausea with dry heaves, 101 degree Fahrenheit temperature, swelling in groin area, swelling of arm vaccinated (left), chest ache, lower abdomen pain.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Peripheral swelling, Retching
Clinical narrative: Blistering on injection site, nausea with dry heaves, 101 degree Fahrenheit temperature, swelling in groin area, swelling of arm vaccinated (left), chest ache, lower abdomen pain.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Pain in extremity, Weight bearing difficulty
Clinical narrative: Sharp pain in left arm and hand. Difficulty moving arm or using arm/hand to support weight (i.e. carrying items, getting dressed, etc).
Age: 0.08
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Electroencephalogram abnormal, Exaggerated startle response, Gastrooesophageal reflux disease, Infantile spasms
Clinical narrative: Dfficulty staying asleep, startling and stiffening of body while sleeping, crying, reflux, difficulty keeping formula down.
Age: 0.08
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Infantile spitting up, Insomnia, Laboratory test, Metabolic function test, Musculoskeletal stiffness
Clinical narrative: Dfficulty staying asleep, startling and stiffening of body while sleeping, crying, reflux, difficulty keeping formula down.
Age: 0.08
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Vomiting
Clinical narrative: Dfficulty staying asleep, startling and stiffening of body while sleeping, crying, reflux, difficulty keeping formula down.
Age: 32.0
Sex: M
Vaccine: FLUR3
Symptoms: Chills, Diarrhoea, Fatigue, Impaired work ability, Middle insomnia
Clinical narrative: Diarrhea around 8 PM, felt ok besides a sore arm when I went to bed around 10 PM.  Woke up around 12:30 AM with severe chills, fever, and fatigue.  I put on more blankets, several layers of clothes and took Nyquil.  I woke up around 7 AM with a fever, chills and fatigue.  Had to call in sick to work for the first time in several years.  Slept until 3 PM.  It's now 8 PM and I still have diarrhea and fatigue.
Age: 32.0
Sex: M
Vaccine: FLUR3
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Diarrhea around 8 PM, felt ok besides a sore arm when I went to bed around 10 PM.  Woke up around 12:30 AM with severe chills, fever, and fatigue.  I put on more blankets, several layers of clothes and took Nyquil.  I woke up around 7 AM with a fever, chills and fatigue.  Had to call in sick to work for the first time in several years.  Slept until 3 PM.  It's now 8 PM and I still have diarrhea and fatigue.
Age: 1.16
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Folliculitis, Injection site erythema, Injection site induration, Injection site nodule, Injection site pustule
Clinical narrative: Large red area around injection site, hard nodule underneath injection site, pus coming out of injection site. Multiple lesions that burst and heal over all over baby's buttocks, genital area and thighs. As of 7pm on 11/19/2014, baby has a fever of 100.9 degrees. Reported to the physician that the baby saw for the actual vaccine and was told that the baby's lesions were coincidental and was folliculitis and given the antibiotic cream Bactroban. I told the Dr. that I was skeptical of that diagnosis, as my daughter had not had any issues with folliculitis at all and had completely clear skin prior to the shot.
Age: 1.16
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Pyrexia, Skin lesion
Clinical narrative: Large red area around injection site, hard nodule underneath injection site, pus coming out of injection site. Multiple lesions that burst and heal over all over baby's buttocks, genital area and thighs. As of 7pm on 11/19/2014, baby has a fever of 100.9 degrees. Reported to the physician that the baby saw for the actual vaccine and was told that the baby's lesions were coincidental and was folliculitis and given the antibiotic cream Bactroban. I told the Dr. that I was skeptical of that diagnosis, as my daughter had not had any issues with folliculitis at all and had completely clear skin prior to the shot.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: Shingles.
Age: 0.62
Sex: F
Vaccine: DTAPHEPBIP, UNK
Symptoms: Muscle twitching
Clinical narrative: Random full body twitching lasting throughout the day, as she lays on her back.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker, concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of ROTATEQ lot # J004875, expiration date 17-OCT-2014, oral route. Healthcare worker reported an expired ROTATEQ was given to a patient. No adverse effects were noted. Co-suspected and concomitant therapies were not reported. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 13 years old adolescent and unknown gender. On 10-SEP-2014 the patient was vaccinated with an improperly stored GARDASIL (lot number J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 years old adolescent and unknown gender. On 03-SEP-2014 the patient was vaccinated with an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 years old adolescent and unknown gender. On 16-SEP-2014 the patient was vaccinated with an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 17-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect ws reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Activities of daily living impaired, Autoimmune disorder, Feeling abnormal, Hemiplegia
Clinical narrative: Case number PHEH2014US022803, is a combined initial and follow-up spontaneous report from a consumer (patient) and pharmacist received on 10 Nov 2014 and 11 Nov 2014. This report refers to a 57-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 145224) intramuscularly into left arm on 16 Oct 2014. Three days later she experienced partial paralysis which started at the injection site and spread down to left side of the body. The reaction started on 19 Oct 2014 and by 20 Oct 2014 it was horrible. On 20 Oct 2014, she went to the pharmacist as her arm was stiffening up with pain and could hardly move it. On the same day night, while on bed she screamed as her arm and shoulder felt like they were on fire; it was inflamed. She had a rash covering her arm and shoulder. On 21 Oct 2014, she went to medical center where it was stated that the vaccine triggered an autoimmune attack of her upper arm and was diagnosed with myositis. She was treated with ibuprofen every 4 hours, pain medications, immune suppressant and steroid as prescribed. On 22 Oct 2014, she was still in misery and attempted to work. By 23 Oct 2014, she could barely walk and paralysis was spreading. On 23 Oct 2014 and 24 Oct 2014, she was unable to leave the house or walk across the house. She was unable to open car doors, hold anything, difficulty to do her work and was unable to lift her arm up as it was frozen in there. She was unable to put on clothes or anything over her head; it's like having a stroke. She started physical therapy three times a week which helped her to regain mobility in her affected arm. As of 10 Nov 2014, paralysis was isolated to left arm and shoulder. Outcome of the events was reported as improving. Seriousness and causality of the events was not reported. Seriousness assessment of myositis and paralysis was upgraded based on the NVD key event list; stiffness, inflammation, burning sensation, difficulty in walking, pain in arm, injected limb mobility decreased based on the information in source document.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Injected limb mobility decreased, Monoplegia, Musculoskeletal stiffness, Myositis
Clinical narrative: Case number PHEH2014US022803, is a combined initial and follow-up spontaneous report from a consumer (patient) and pharmacist received on 10 Nov 2014 and 11 Nov 2014. This report refers to a 57-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 145224) intramuscularly into left arm on 16 Oct 2014. Three days later she experienced partial paralysis which started at the injection site and spread down to left side of the body. The reaction started on 19 Oct 2014 and by 20 Oct 2014 it was horrible. On 20 Oct 2014, she went to the pharmacist as her arm was stiffening up with pain and could hardly move it. On the same day night, while on bed she screamed as her arm and shoulder felt like they were on fire; it was inflamed. She had a rash covering her arm and shoulder. On 21 Oct 2014, she went to medical center where it was stated that the vaccine triggered an autoimmune attack of her upper arm and was diagnosed with myositis. She was treated with ibuprofen every 4 hours, pain medications, immune suppressant and steroid as prescribed. On 22 Oct 2014, she was still in misery and attempted to work. By 23 Oct 2014, she could barely walk and paralysis was spreading. On 23 Oct 2014 and 24 Oct 2014, she was unable to leave the house or walk across the house. She was unable to open car doors, hold anything, difficulty to do her work and was unable to lift her arm up as it was frozen in there. She was unable to put on clothes or anything over her head; it's like having a stroke. She started physical therapy three times a week which helped her to regain mobility in her affected arm. As of 10 Nov 2014, paralysis was isolated to left arm and shoulder. Outcome of the events was reported as improving. Seriousness and causality of the events was not reported. Seriousness assessment of myositis and paralysis was upgraded based on the NVD key event list; stiffness, inflammation, burning sensation, difficulty in walking, pain in arm, injected limb mobility decreased based on the information in source document.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Rash, Screaming, Skin burning sensation, Vaccination complication
Clinical narrative: Case number PHEH2014US022803, is a combined initial and follow-up spontaneous report from a consumer (patient) and pharmacist received on 10 Nov 2014 and 11 Nov 2014. This report refers to a 57-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 145224) intramuscularly into left arm on 16 Oct 2014. Three days later she experienced partial paralysis which started at the injection site and spread down to left side of the body. The reaction started on 19 Oct 2014 and by 20 Oct 2014 it was horrible. On 20 Oct 2014, she went to the pharmacist as her arm was stiffening up with pain and could hardly move it. On the same day night, while on bed she screamed as her arm and shoulder felt like they were on fire; it was inflamed. She had a rash covering her arm and shoulder. On 21 Oct 2014, she went to medical center where it was stated that the vaccine triggered an autoimmune attack of her upper arm and was diagnosed with myositis. She was treated with ibuprofen every 4 hours, pain medications, immune suppressant and steroid as prescribed. On 22 Oct 2014, she was still in misery and attempted to work. By 23 Oct 2014, she could barely walk and paralysis was spreading. On 23 Oct 2014 and 24 Oct 2014, she was unable to leave the house or walk across the house. She was unable to open car doors, hold anything, difficulty to do her work and was unable to lift her arm up as it was frozen in there. She was unable to put on clothes or anything over her head; it's like having a stroke. She started physical therapy three times a week which helped her to regain mobility in her affected arm. As of 10 Nov 2014, paralysis was isolated to left arm and shoulder. Outcome of the events was reported as improving. Seriousness and causality of the events was not reported. Seriousness assessment of myositis and paralysis was upgraded based on the NVD key event list; stiffness, inflammation, burning sensation, difficulty in walking, pain in arm, injected limb mobility decreased based on the information in source document.
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt reports red, raised itchy area at injection site where ZOSTAVAX given.
Age: 27.0
Sex: F
Vaccine: FLUN4
Symptoms: Headache, Pruritus generalised, Rash macular
Clinical narrative: Pt. had FLUMIST nasal spray at 9 am. Pt. came back to clinic at 2:30 pm with c/o red splotches on chest, back and bilateral arms. Also c/o headache and itching on those areas. Pt stated itching started 30 mins prior to coming back to clinic. Pt stated she felt fine other than redness, headache and itching. Referred to Primary Care Physician for evaluation.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Paraesthesia, Rash
Clinical narrative: Patient developed a "rash" one week after flu vaccine - states rash on inner elbows and all of legs. Felt hot and tingling; also itched. Had same rash 3-4 years ago after the flu vaccine which lasted 3-4 months and was much worse. She has taken more antihistamines this time, which has helped.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUN4, IPV, MMRV
Symptoms: Urticaria
Clinical narrative: Hives on entire body 5 days s/p immunization. Treated with prednisone at urgent care, followed by 3 day course of prednisone 10 mg.
Age: 48.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Abdominal discomfort, Abdominal pain, Back pain, Cellulitis, Nausea
Clinical narrative: Fever, nausea, stomach discomfort, pain in back, arm, waist.
Age: 48.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever, nausea, stomach discomfort, pain in back, arm, waist.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Tremor
Clinical narrative: Patient stated that within 1-2 hours of vaccination she experienced uncontrollable shaking and was very cold for a 30 minute duration. She feels it was due to the vaccine.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: Patient reported her arm turned brick red and itchy. Area of redness and itchiness went from shoulder to 1 inch below elbow. Patient consulted physician and no treatment was advised.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site urticaria, Vision blurred
Clinical narrative: Red rash/hives down entire forearm and injection site and blurred vision.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Nerve injury, Syncope
Clinical narrative: Vaccine appeared to hit a nerve in arm. Patient fainted.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient developed hives.
Age: 0.7
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 8-month-old male patient who received FLUARIX (batch number LZ4S2. expiry date 22nd May 2015). On an unknown date, the patient received FLUARIX. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration and wrong vaccine administered to be related to FLUARIX.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray, Computerised tomogram head, Computerised tomogram thorax, Laboratory test, Lumbar puncture
Clinical narrative: Weakness legs 2 hours after vaccine acute sudden onset paralysis 2.5 days later; Diagnosis Transverse Myelitis 12 days acute hospital, currently IP Rehab.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Myelitis transverse, Nuclear magnetic resonance imaging spinal, Paralysis, Pathology test
Clinical narrative: Weakness legs 2 hours after vaccine acute sudden onset paralysis 2.5 days later; Diagnosis Transverse Myelitis 12 days acute hospital, currently IP Rehab.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Scan with contrast
Clinical narrative: Weakness legs 2 hours after vaccine acute sudden onset paralysis 2.5 days later; Diagnosis Transverse Myelitis 12 days acute hospital, currently IP Rehab.
Sex: F
Vaccine: FLU3
Symptoms: Expired drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a adult female patient who received FLUARIX (batch number unknown, expiry date June 2014). On 26th September 2014, the patient received the 1st dose of FLUARIX. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. It was unknown if the reporter considered the expired vaccine used to be related to FLUARIX. Additional information received on 26 September 2014. The nurse had no other information at time of reporting.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: Pt called on 11/14/14 stating that her arm still hurts from getting the flu vaccine over a month ago. She stated that it initially hurt, seemed like it was getting better and then started getting worse. She states it hurts to use it and lay on it. I recommended that she contact her doctor. She stated that it immediately hurt and caused a shooting sensation traveling down her arm at time of vaccination.
Age: 1.39
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 16-month-old female patient who received FLULAVAL 2014-2015 season (batch number 5AZ7H, expiry date 30th April 2015. On 26 September 2014, the patient received the 1st dose of FLULAVAL 2014-2014 season, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration and wrong vaccine administered to be related to FLULAVAL 2014-2015 season. Additional information received: 16 months patient who received inadvertently FLULAVAL Quadrivalent.  Child too young for indicated vaccine.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram thorax, Cough, Dyspnoea, Fatigue, Rash
Clinical narrative: 10/3 very tired and had rash, 10/4 - increasing SOB - cough worked only 3 hrs had to go home - saw PCP - placed on antibiotics - no better so returned saw Dr placed on steroids and another antibiotic - felt a little better. After steroid finished started with SOB again - went to ER - Dr - IV meds, CT scan chest, nebulizer tx. Back to PCP for follow up sent to pulmonologist - O2 and oral steroids follow up.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Mass, Pain, Skin warm, Swelling
Clinical narrative: 1-2 hrs after ID FLUZONE 3" diameter baseball like lump - red warm to touch - called her 11/4 - no return call - spoke with her 11/15 - Redness and swelling gone - still a lump with soreness.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Mobility decreased, Muscle twitching, Pain, Paraesthesia
Clinical narrative: Received vaccination 10/16/14. Still have pain 11/19/14. Can't raise arm or do certain motions. Numbness and tingling. Feels like muscle twisting.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Headache, Heart rate increased, Nausea, Pain in extremity
Clinical narrative: Debilitating pain on the arm, headache, nausea, fast heartbeat, fever.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Debilitating pain on the arm, headache, nausea, fast heartbeat, fever.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 14 years old adolescent and unknown gender. On 03-SEP-2014 the patient was vaccinated with an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 15 years old adolescent patient and unknown gender. On 11-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Nausea, Syncope
Clinical narrative: Moderate nausea with lightheadedness and syncopal episode this AM.
Age: 21.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: This case was reported by a other health professional and described the occurrence of underdose in a 21-year-old male patient who received HAVRIX pediatric (batch number N3431?, expiry date 19th February 2016). On an unknown date, the patient received HAVRIX pediatric .5 ml. On an unknown date, an unknown time after receiving HAVRIX pediatric, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown. It was unknown if the reporter considered the underdose to be related to HAVRIX pediatric. Additional information: This 21 years old was inadvertently given a pediatric dose of HAVRIX (720 EL.U).
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site erythema, Injection site mass, Injection site pain, Malaise
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 49 year old female patient with no drug reactions/allergies. No medical history was reported. On 06-NOV-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 dose not reported, subcutaneously (lot # K007825, expiration date: 13-JAN-2016). It was also reported that patient was vaccinated with an unspecified influenza vaccine in the same arm a few weeks prior to the PNEUMOVAX 23 (unknown date in 2014), but experienced no reaction from it. On unspecified date in November 2014, after administration of PNEUMOVAX 23, the patient developed "a fever of 102" (units not provided), felt very ill, nauseous and dizzy. The patient sought medical attention, she called pharmacy and unspecified physician. Pharmacist also reported that patient developed huge, red and tender lump at the injection site (unknown date in November 2014). The patient was treated with an unspecified anti-nausea medication, TYLENOL and was advised to rest. No laboratory diagnostic was performed. The outcome of the events was reported as recovering/resolving. Relatedness between the events and PNEUMOVAX 23 was not provided. This is one of several reports from the same source. The pharmacist requested lot check for the PNEUMOVAX 23. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 49 year old female patient with no drug reactions/allergies. No medical history was reported. On 06-NOV-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 dose not reported, subcutaneously (lot # K007825, expiration date: 13-JAN-2016). It was also reported that patient was vaccinated with an unspecified influenza vaccine in the same arm a few weeks prior to the PNEUMOVAX 23 (unknown date in 2014), but experienced no reaction from it. On unspecified date in November 2014, after administration of PNEUMOVAX 23, the patient developed "a fever of 102" (units not provided), felt very ill, nauseous and dizzy. The patient sought medical attention, she called pharmacy and unspecified physician. Pharmacist also reported that patient developed huge, red and tender lump at the injection site (unknown date in November 2014). The patient was treated with an unspecified anti-nausea medication, TYLENOL and was advised to rest. No laboratory diagnostic was performed. The outcome of the events was reported as recovering/resolving. Relatedness between the events and PNEUMOVAX 23 was not provided. This is one of several reports from the same source. The pharmacist requested lot check for the PNEUMOVAX 23. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. In July 2014 the patients were vaccinated with an improperly stored GARDASIL (dose, route, lot number and expiration date were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Follow up information has been received from the Licensed Practical Nurse. The Licensed Practical Nurse stated that she did not have the information (patient identifiers, lot numbers, expiration dates, and dates of vaccine administration) available at this time. No further information was available at this time of report. Follow up information has been received from the Licensed Practical Nurse on 28-OCT-2014. The patient identifiers were reported and the patient was 15 years old Adolescent. The patient was vaccinated with GARDASIL on 26-SEP-2014. Lot was reported as J015378, expiration date 09-APR-2016 for the vaccine GARDASIL. Additional information has been requested.