chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Nausea, Pain
Clinical narrative: This spontaneous report was received from a physician's assistant and refers to a 30 year old female patient with asthma. The patient's drug reactions or allergies included morphine and codeine with unknown reaction. On 21-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23, lot number L027732, expiration date 23-FEB-2017, on an unspecified deltoid, (dose and route were not reported). There was no concomitant medication reported. The patient called the office on 23-NOV-2015 to reported that on 22-NOV-2015, she experienced fever of 101.8F (pyrexia), she was achy (pain), had chills and nausea, and the injection site on the unspecified deltoid was red (injection site erythema) and swollen (injection site swelling) "bigger than a quarter, smaller than her palm." The reported stated that over the phone she prescribed unspecified antihistamines and ice for the site and also requested for lot check for PNEUMOVAX 23. At the time of the report, the outcome of the she experienced fever of 101.8F, was achy, had chills and nausea, and the injection site on the unspecified deltoid was red and swollen was reported as recovered on an unspecified date in November 2015. The relatedness between the events and therapy with for PNEUMOVAX 23 was not reported. This is one of two reports from the same reporter (case # 1512USA000632). Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a physician's assistant and refers to a 30 year old female patient with asthma. The patient's drug reactions or allergies included morphine and codeine with unknown reaction. On 21-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23, lot number L027732, expiration date 23-FEB-2017, on an unspecified deltoid, (dose and route were not reported). There was no concomitant medication reported. The patient called the office on 23-NOV-2015 to reported that on 22-NOV-2015, she experienced fever of 101.8F (pyrexia), she was achy (pain), had chills and nausea, and the injection site on the unspecified deltoid was red (injection site erythema) and swollen (injection site swelling) "bigger than a quarter, smaller than her palm." The reported stated that over the phone she prescribed unspecified antihistamines and ice for the site and also requested for lot check for PNEUMOVAX 23. At the time of the report, the outcome of the she experienced fever of 101.8F, was achy, had chills and nausea, and the injection site on the unspecified deltoid was red and swollen was reported as recovered on an unspecified date in November 2015. The relatedness between the events and therapy with for PNEUMOVAX 23 was not reported. This is one of two reports from the same reporter (case # 1512USA000632). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse also reported as from a medical assistant) referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on unknown dates, the patients were administered improperly stored doses of ROTATEQ oral solution (lot # L008996 with expiration date 01-DEC-2016, lot# L010126 with expiration date 22-JAN-2017, Lot# K019370 with expiration date 16-JUL-2017; dose was not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse (also reported as from a medical assistant) referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on unknown dates, the patients were administered improperly stored doses of GARDASIL 9 injection (lot # L007560 with expiration date 15-JUN-2017, lot # L013429 with expiration date 1-JUL-2017, lot# L017407 with expiration date 15-AUG-2017 and lot# reported as L030869 with expiration date 18-JUN-2018; dose and route were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. Since 30-NOV-2015, the unspecified number of patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot# L003227; expiry date: 13-OCT-2016, lot# K007826; expiry date: 03-FEB-2016). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, via a company representative, referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On an unknown dates, the patient received 3 doses of an unspecified form of GARDASIL (Lot# and expiration date were not reported). The second dose and the third dose were separated by "7 weeks". No adverse effect reported. It was unspecified if the patient received GARDASIL or GARDASIL 9, therefore the adverse event was filed for GARDASIL. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The medical history and drug reactions/allergies of the patients were not reported. On unspecified dates since 11-SEP-2015, the unspecified patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # K002924, expiration date 25-FEB-2017 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects had been reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On 18-NOV-2015, the patient was vaccinated with an expired dose of ZOSTAVAX 0.65 ml (route of administration and frequency were unspecified) (lot # K010969, expiration date: 10-NOV-2015). Concomitant therapies were not reported. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same source. Additional information is not expected since the reporter wished not to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. Since 30-NOV-2015, the unspecified number of patients were vaccinated with improperly stored doses of ROTATEQ (lot# K011952; expiry date: 17-JUN-2016, lot# K013868; expiry date: 27-APR-2016, lot# L008059; expiry date: 18-DEC-2016, lot# K004795; expiry date: 11-FEB-2016). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On 10-NOV-2015, the patient was vaccinated with an expired dose of ZOSTAVAX 0.65 ml (route of administration and frequency were unspecified) (lot # K010969, expiration date: 10-NOV-2015). Concomitant therapies were not reported. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same source. Additional information is not expected since the reporter wished not to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. Since 30-NOV-2015, the unspecified number of patients were vaccinated with improperly stored doses of GARDASIL 9 (lot# L016428 and expiry date: 30-JUL-2017). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On 19-NOV-2015, the patient was vaccinated with an expired dose of ZOSTAVAX 0.65 ml (route of administration and frequency were unspecified) (lot # K010969, expiration date: 10-NOV-2015). Concomitant therapies were not reported. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same source. Additional information is not expected since the reporter wished not to be contacted.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored doses of PEDVAXHIB (K021152 Expiration date: 02-JAN-2016). No adverse effect reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored doses of M-M-R II (L006545 Expiration date: 16-NOV-2017 and L012838 Expiration date: 10-MAR-2018). No adverse effect reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13
Symptoms: Autism, Crying, Insomnia, Middle insomnia, Speech disorder
Clinical narrative: Patient would stay up until 4 am in the morning go to sleep then wake up at 6 AM. This routine happened daily. Patient was speaking (words) then he regressed. He started babbling and crying.
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13
Symptoms: Speech disorder developmental
Clinical narrative: Patient would stay up until 4 am in the morning go to sleep then wake up at 6 AM. This routine happened daily. Patient was speaking (words) then he regressed. He started babbling and crying.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on unspecified dates, the patients were administered an unspecified number of improperly stored doses of RECOMBIVAX HB injection (lot # K026666 with expiration date 22-OCT-2016, lot# L004754 with expiration date 10-NOV-2016 and lot# L016427 with expiration date 13-APR-2017; dose and route were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on unspecified dates, the patients were administered an unspecified number of improperly stored doses of M-M-R II injection (lot# reported as L000459 with expiration date 06-JAN-2017 and lot# L008684 with expiration date 13-MAR-2017; albumin status, dose and route were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored doses of GARDASIL 9 (Lot # L007560 Expiration date: 15-JUN-2017). No adverse effect reported. No Product Quality Complaint (PQC) was involved. This is one of several repots received from the same source. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Rash.  She was evaluated in the ED.  Diagnosis was hives.  She was given Pepcid, Prednisone and Benadryl.
Age: 1.56
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Extra dose administered
Clinical narrative: 15 month immunizations were administered again at 18 months when patient came in for 18 month immunizations.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Anxiety, Conversion disorder, Hypoacusis, Obsessive-compulsive disorder, Panic reaction
Clinical narrative: From time of waking severe hysteria, panic, anxiety attack and Obsessive Compulsive behavior. Trouble understanding directions and hearing. Lasting for hours at a time a few times a day for the following three months.  After three months, attacks reduced to once daily. Continues to this day.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Impaired driving ability, Vision blurred, Visual impairment
Clinical narrative: Visual disturbances. Blurry vision, foggy could not read normal things I could previous day. Address labels, cell-phone, even did not drive a car.  I was seeing a blurry film in my vision.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Allergy to vaccine, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient developed an itchy red rash on torso, back, arms legs and top of feet, while at home. Patient took 75mg of Benadryl that evening  went to bed. Upon awaken in the morning (12/03/15) much improved   with slight raised red bumps. Patient denied respiratory symptoms or  distress, no nausea or vomiting. Patient came to urgent care on 12/03/15 for evaluation of his  symptoms. Patient give Rx for Epipen  and Tdap was added to his allergies list on his records.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Balance disorder, Dizziness, Dysarthria
Clinical narrative: DIZZINESS, SLURRED SPEECH, WEAKNESS TO THE POINT OF NEEDING ASSISTANCE. UNBALANCED, HOSPITALIZATION, TESTS ALL NEGATIVE.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test normal
Clinical narrative: DIZZINESS, SLURRED SPEECH, WEAKNESS TO THE POINT OF NEEDING ASSISTANCE. UNBALANCED, HOSPITALIZATION, TESTS ALL NEGATIVE.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: Noticed right hand swelling up and middle and ring finger slightly tingling.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Lip swelling, Oral discomfort, Pyrexia
Clinical narrative: Fever of 99.4, roof of mouth burning, headache, lips slightly swollen, and it comes and goes. Patient states he doesn't feel like he has a fever right now.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Bursal fluid accumulation, Hypoaesthesia, Injection site cyst, Lymphadenopathy, Nuclear magnetic resonance imaging abnormal
Clinical narrative: On Saturday I awoke with a fever and severely swollen arm and lymph nodes. I was icing the arm and was very worried. By Sunday my arm was going numb and I was waiting for the symptons to subside. I continued with acetaminophen and icing the arm. By Monday morning I called my doctor and was rushed in to see him.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: On Saturday I awoke with a fever and severely swollen arm and lymph nodes. I was icing the arm and was very worried. By Sunday my arm was going numb and I was waiting for the symptons to subside. I continued with acetaminophen and icing the arm. By Monday morning I called my doctor and was rushed in to see him.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Musculoskeletal stiffness, Nuclear magnetic resonance imaging
Clinical narrative: Pain, stiffness in shoulder. Limited ROM (range of movement).
Age: 55.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dry throat, Pain
Clinical narrative: Pt c/o dry throat and generalized aches. Symptoms lasted less than 24 hours.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Insomnia, Mobility decreased, Pain
Clinical narrative: Pain, cannot lift arm over shoulder, weakness, and insomnia. Patient tried Advil which did not help.  Symptoms began within 2 hours after administration.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Flushing, Injection site erythema, Swelling
Clinical narrative: Flushed face, swollen eyes and nose, injection erythema.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RVX
Symptoms: Vomiting
Clinical narrative: Vomiting.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Feeding tube user, Intensive care, Laboratory test, Tracheostomy, Unresponsive to stimuli
Clinical narrative: He entered one hospital first. Was out for 4 days. Then was taken to second Hospital where he still is mostly unresponsive. They had him in CCU for 18 days. He is now on the Medical floor. Has a trach and a feeding tube. He is at 37 days and counting in the second facility.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Activities of daily living impaired, Chills, Nausea
Clinical narrative: 14 hours post Gardasil 9 vaccination. Developed Chills without fever and Nausea. Brought home from school.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Pain in shoulder.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Rash, Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: Itchy red maculopapular rash over entire body (trunk, abdomen, back, arms, legs, genital area).
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site pruritus, Injection site swelling
Clinical narrative: Itchy & swollen beyond injection site via observation.
Age: 52.0
Sex: F
Vaccine: FLU3, HEPA, TDAP
Symptoms: Injection site rash, Rash
Clinical narrative: RASHES ON CHEST, BACK, AND SHOULDER.
Age: 91.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient's daughter came in stating that her mom's arm was itching, red & thick looking.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation, Injection site rash
Clinical narrative: A SLIGHT RASH AND INFLAMMATION BY INJECTION SITE.
Age: 1.03
Sex: F
Vaccine: DTAP
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Large (3 inch diameter), red, very bruised area extremely tender to touch on the upper right thigh where vaccine was administered.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Abdominal discomfort, Abdominal pain upper, Chills, Diarrhoea, Pain
Clinical narrative: Patient stated that 24 hours after she recieved her Fluzone Hd and Prevnar 13 vaccine she started feeling sick to her stomach with cramps, diarrhea, patient said she also had chills over the weekend and aches. She said the chills and aches have went away but still has the stomach upset.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Decreased appetite, Fatigue, Pyrexia, Rash vesicular, Vomiting
Clinical narrative: Symptoms continue from last 36 hours: fever, vomiting, chicken pox like rash, fatigue, loss of appetite. Administered infant Advil, lots of fluids and resting.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Autoimmune disorder, Autoimmune thyroiditis, Fatigue, Fibromyalgia
Clinical narrative: Symptoms of multiple auto immune diseases (Fibromyalgia, Hashimoto's Thyroiditis, IBS, Polyarthalgia, Fatigue, Headaches, Psoriasis).  This is also known as GULF WAR SYNDROME!
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Gulf war syndrome, Headache, Irritable bowel syndrome, Psoriasis
Clinical narrative: Symptoms of multiple auto immune diseases (Fibromyalgia, Hashimoto's Thyroiditis, IBS, Polyarthalgia, Fatigue, Headaches, Psoriasis).  This is also known as GULF WAR SYNDROME!
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Feeling hot, Neck pain, Vision blurred
Clinical narrative: Felt warm, neck aching, shortness of breath, blurred vision. Called family Dr and ordered an Allegra 24 hr. Took BP 137/91 And BS 84. Remained in pharmacy for one hour for observation. I walked her to car and felt good. She reported back to me at 6pm and 8pm no more symptoms.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out after being given PREVNAR and FLUZONE HD. Only out for 30 seconds. Gave cold cloth and water and she was fine and left in about 20 minutes.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Pt. reported headache, nausea and vomiting, fever of 101.8 degrees F.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness
Clinical narrative: Had a Dtap in (L) deltoid and reports continuing "weakness" in shoulder muscle.
Age: 69.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Myalgia, Nodule
Clinical narrative: Sustained deep soreness in muscles x 10 d post - FLUZONE HD and PREVNAR; No redness or swelling; Knot like sensations recommended ibuprofen, see MD if not relieved.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route were not reported). On an unknown date, 12 hours after the vaccination, the patient developed a rash in an unspecified location which looked a lot like shingles. The patient had sought medical attention via unspecified method. At the time of this report, the event outcome was reported as not recovered. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Muscular weakness, Neurological examination abnormal, Pain in extremity, Sensory loss
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of autoimmune disorder in a 61-year-old female patient who received FLUARIX QUADRIVALENT (batch number 3L9LD, expiry date 30th June 2016). On 13th October 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 15th October 2015, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced autoimmune disorder (serious criteria GSK medically significant), injection site pain and Parsonage-Turner syndrome. On an unknown date, the outcome of the autoimmune disorder, injection site pain and Parsonage-Turner syndrome were unknown. The reporter considered the autoimmune disorder, injection site pain and Parsonage-Turner syndrome to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: On 13th October 2015, at 14:00, the patient received the FLUARIX QUADRIVALENT vaccination from the prefilled, preservative-free syringe in the left deltoid. On 15th October 2015, she began to experience increased soreness in the area of the injection, pain radiating down her left arm and pain that moved up from the site of injection into her shoulder. Her physician had diagnosed her with Brachial Plexitis/Parsonage-Turner Syndrome. He indicated that this was an autoimmune reaction almost certainly caused by the flu shot.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Autoimmune disorder, Injection site pain, Neuralgic amyotrophy, Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of autoimmune disorder in a 61-year-old female patient who received FLUARIX QUADRIVALENT (batch number 3L9LD, expiry date 30th June 2016). On 13th October 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 15th October 2015, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced autoimmune disorder (serious criteria GSK medically significant), injection site pain and Parsonage-Turner syndrome. On an unknown date, the outcome of the autoimmune disorder, injection site pain and Parsonage-Turner syndrome were unknown. The reporter considered the autoimmune disorder, injection site pain and Parsonage-Turner syndrome to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: On 13th October 2015, at 14:00, the patient received the FLUARIX QUADRIVALENT vaccination from the prefilled, preservative-free syringe in the left deltoid. On 15th October 2015, she began to experience increased soreness in the area of the injection, pain radiating down her left arm and pain that moved up from the site of injection into her shoulder. Her physician had diagnosed her with Brachial Plexitis/Parsonage-Turner Syndrome. He indicated that this was an autoimmune reaction almost certainly caused by the flu shot.
Age: 1.08
Sex: F
Vaccine: VARCEL, HEPA, MMR, VARCEL
Symptoms: Laboratory test, Malaise, Skin lesion
Clinical narrative: Case admitted to hospital 11/1/15 after 4 days of fever, congestion, cough, and wheezing which continued to worsen. Hospitalized 11/1/15-11/24/15, in PICU from 11/5/15 until discharged home. Diagnoses included RSV bronchiolitis, acute resp distress syndrome, pneumomediastinum, bilateral pneumothorax; ventilated from 11/5/15 to 11/17/15 and treated with IV steroids in varying dosages 11/8/15-11/17/15. Medical record states lesions noted on external genitalia 11/22/15 were thought to be pustular. On 11/23/15 lesions noted in additional areas, and varicella suspected; dermatology was consulted, specimen sent for varicella culture, and acyclovir started. Mother reported child had 200-240 lesions, most were papular. No known exposure. Clinical specimen sent to CDC for genotyping.
Age: 1.08
Sex: F
Vaccine: VARCEL, HEPA, MMR, VARCEL
Symptoms: Acute respiratory distress syndrome, Cough, Genital lesion, Intensive care, Mechanical ventilation
Clinical narrative: Case admitted to hospital 11/1/15 after 4 days of fever, congestion, cough, and wheezing which continued to worsen. Hospitalized 11/1/15-11/24/15, in PICU from 11/5/15 until discharged home. Diagnoses included RSV bronchiolitis, acute resp distress syndrome, pneumomediastinum, bilateral pneumothorax; ventilated from 11/5/15 to 11/17/15 and treated with IV steroids in varying dosages 11/8/15-11/17/15. Medical record states lesions noted on external genitalia 11/22/15 were thought to be pustular. On 11/23/15 lesions noted in additional areas, and varicella suspected; dermatology was consulted, specimen sent for varicella culture, and acyclovir started. Mother reported child had 200-240 lesions, most were papular. No known exposure. Clinical specimen sent to CDC for genotyping.
Age: 1.08
Sex: F
Vaccine: VARCEL, HEPA, MMR, VARCEL
Symptoms: Pneumomediastinum, Pneumothorax, Polymerase chain reaction positive, Pyrexia, Rash papular
Clinical narrative: Case admitted to hospital 11/1/15 after 4 days of fever, congestion, cough, and wheezing which continued to worsen. Hospitalized 11/1/15-11/24/15, in PICU from 11/5/15 until discharged home. Diagnoses included RSV bronchiolitis, acute resp distress syndrome, pneumomediastinum, bilateral pneumothorax; ventilated from 11/5/15 to 11/17/15 and treated with IV steroids in varying dosages 11/8/15-11/17/15. Medical record states lesions noted on external genitalia 11/22/15 were thought to be pustular. On 11/23/15 lesions noted in additional areas, and varicella suspected; dermatology was consulted, specimen sent for varicella culture, and acyclovir started. Mother reported child had 200-240 lesions, most were papular. No known exposure. Clinical specimen sent to CDC for genotyping.
Age: 1.08
Sex: F
Vaccine: VARCEL, HEPA, MMR, VARCEL
Symptoms: Respiratory syncytial virus bronchiolitis, Respiratory tract congestion, Skin lesion, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Case admitted to hospital 11/1/15 after 4 days of fever, congestion, cough, and wheezing which continued to worsen. Hospitalized 11/1/15-11/24/15, in PICU from 11/5/15 until discharged home. Diagnoses included RSV bronchiolitis, acute resp distress syndrome, pneumomediastinum, bilateral pneumothorax; ventilated from 11/5/15 to 11/17/15 and treated with IV steroids in varying dosages 11/8/15-11/17/15. Medical record states lesions noted on external genitalia 11/22/15 were thought to be pustular. On 11/23/15 lesions noted in additional areas, and varicella suspected; dermatology was consulted, specimen sent for varicella culture, and acyclovir started. Mother reported child had 200-240 lesions, most were papular. No known exposure. Clinical specimen sent to CDC for genotyping.
Age: 1.08
Sex: F
Vaccine: VARCEL, HEPA, MMR, VARCEL
Symptoms: Wheezing
Clinical narrative: Case admitted to hospital 11/1/15 after 4 days of fever, congestion, cough, and wheezing which continued to worsen. Hospitalized 11/1/15-11/24/15, in PICU from 11/5/15 until discharged home. Diagnoses included RSV bronchiolitis, acute resp distress syndrome, pneumomediastinum, bilateral pneumothorax; ventilated from 11/5/15 to 11/17/15 and treated with IV steroids in varying dosages 11/8/15-11/17/15. Medical record states lesions noted on external genitalia 11/22/15 were thought to be pustular. On 11/23/15 lesions noted in additional areas, and varicella suspected; dermatology was consulted, specimen sent for varicella culture, and acyclovir started. Mother reported child had 200-240 lesions, most were papular. No known exposure. Clinical specimen sent to CDC for genotyping.
Age: 77.0
Sex: F
Vaccine: PNC13, TDAP, FLU3, TDAP
Symptoms: Pain in extremity
Clinical narrative: Prolonged muscle soreness going on for more than 2 months. Still has hard time lifting or using her left arm. MD prescribed steroid shot still no relief.
Age: 77.0
Sex: F
Vaccine: PNC13, TDAP, FLU3, TDAP
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: Prolonged muscle soreness going on for more than 2 months. Still has hard time lifting or using her left arm. MD prescribed steroid shot still no relief.
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis to R deltoid (site of injection).
Age: 23.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Disorientation, Dizziness
Clinical narrative: Patient experienced extreme dizziness and mild disorientation. He never lost consciousness. He was fine after 15 minutes of lying down with legs elevated.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pericarditis
Clinical narrative: Patient went to hospital with pericarditis.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Blood test normal, Computerised tomogram normal, Electrocardiogram normal, Electroencephalogram normal, Fracture treatment
Clinical narrative: Major Tonic-Clonic (Grand Mal) Seizure while sleeping (lasted about 10 min total from onset until full consciousness regained). During tonic part of seizure, both shoulders dislocated and bilateral (left and right) proximal humeral fractures resulted. Patient was in bed during entire episode and did not fall... fractures and dislocations resulted only due to muscle contractions (spouse awoke to hearing the bones dislocating and fracturing). Patient was in great health and had no prior history with seizures. Patient was admitted to Hospital on 11/18/2015 for neurological testing and treatment of bilateral proximal humeral fractures with dislocation. Due to extent of humeral fractures, patient was transferred to another hospital on 11/18/2015 where neurological testing was finished and a closed reduction of the shoulders was performed. All neurological testing was clear and no cause could be found from the tests primary possible trigger was flu shot received 12 hours prior to seizure. Humeral fractures were subsequently repaired by Dr. during 8 hour surgery on 11/23/2015. Recovery path will be lengthy with potential future surgeries on both arms to stabilize shoulders due to damage caused by seizure. Patient is now on seizure medication as a precautionary measure to avoid any possibility of additional episodes while arms are healing.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Generalised tonic-clonic seizure, Humerus fracture, Joint dislocation, Muscle contractions involuntary, Neurological examination normal
Clinical narrative: Major Tonic-Clonic (Grand Mal) Seizure while sleeping (lasted about 10 min total from onset until full consciousness regained). During tonic part of seizure, both shoulders dislocated and bilateral (left and right) proximal humeral fractures resulted. Patient was in bed during entire episode and did not fall... fractures and dislocations resulted only due to muscle contractions (spouse awoke to hearing the bones dislocating and fracturing). Patient was in great health and had no prior history with seizures. Patient was admitted to Hospital on 11/18/2015 for neurological testing and treatment of bilateral proximal humeral fractures with dislocation. Due to extent of humeral fractures, patient was transferred to another hospital on 11/18/2015 where neurological testing was finished and a closed reduction of the shoulders was performed. All neurological testing was clear and no cause could be found from the tests primary possible trigger was flu shot received 12 hours prior to seizure. Humeral fractures were subsequently repaired by Dr. during 8 hour surgery on 11/23/2015. Recovery path will be lengthy with potential future surgeries on both arms to stabilize shoulders due to damage caused by seizure. Patient is now on seizure medication as a precautionary measure to avoid any possibility of additional episodes while arms are healing.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Nuclear magnetic resonance imaging normal, Shoulder operation
Clinical narrative: Major Tonic-Clonic (Grand Mal) Seizure while sleeping (lasted about 10 min total from onset until full consciousness regained). During tonic part of seizure, both shoulders dislocated and bilateral (left and right) proximal humeral fractures resulted. Patient was in bed during entire episode and did not fall... fractures and dislocations resulted only due to muscle contractions (spouse awoke to hearing the bones dislocating and fracturing). Patient was in great health and had no prior history with seizures. Patient was admitted to Hospital on 11/18/2015 for neurological testing and treatment of bilateral proximal humeral fractures with dislocation. Due to extent of humeral fractures, patient was transferred to another hospital on 11/18/2015 where neurological testing was finished and a closed reduction of the shoulders was performed. All neurological testing was clear and no cause could be found from the tests primary possible trigger was flu shot received 12 hours prior to seizure. Humeral fractures were subsequently repaired by Dr. during 8 hour surgery on 11/23/2015. Recovery path will be lengthy with potential future surgeries on both arms to stabilize shoulders due to damage caused by seizure. Patient is now on seizure medication as a precautionary measure to avoid any possibility of additional episodes while arms are healing.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Humerus fracture, Joint dislocation, Seizure, Surgery, Upper limb fracture
Clinical narrative: Major Tonic-Clonic (Grand Mal) Seizure while sleeping (lasted about 10 min total from onset until full consciousness regained). During tonic part of seizure, both shoulders dislocated and bilateral (left and right) proximal humeral fractures resulted. Patient was in bed during entire episode and did not fall... fractures and dislocations resulted only due to muscle contractions (spouse awoke to hearing the bones dislocating and fracturing). Patient was in great health and had no prior history with seizures. Patient was admitted to Hospital on 11/18/2015 for neurological testing and treatment of bilateral proximal humeral fractures with dislocation. Due to extent of humeral fractures, patient was transferred to another hospital on 11/18/2015 where neurological testing was finished and a closed reduction of the shoulders was performed. All neurological testing was clear and no cause could be found from the tests primary possible trigger was flu shot received 12 hours prior to seizure. Humeral fractures were subsequently repaired by Dr. during 8 hour surgery on 11/23/2015. Recovery path will be lengthy with potential future surgeries on both arms to stabilize shoulders due to damage caused by seizure. Patient is now on seizure medication as a precautionary measure to avoid any possibility of additional episodes while arms are healing.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to unspecified number of patients of unknown age and gender. Since 11-NOV-2015 unspecified number of patients were vaccinated with PNEUMOVAX 23 [Lot# L002310, Expiry date: 08-JUN-2016] which were exposed to temperatures outside of the recommended range. No adverse event were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Injection site pain, Injection site swelling, Irritability
Clinical narrative: Fussy and crying after imms. Inj site tender to touch and "puffy".
Age: 1.26
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Urticaria
Clinical narrative: Per verbal report by guardian - pt developed hives approx 45 -60 min after vaccination of influ and dtap. Pt was given BENADRYL and hives began to disappear within 20 minutes of administration. Guardian advised to monitor for further reaction.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to unspecified number of patients of unknown age and gender. Since 11-NOV-2015 unspecified number of patients were vaccinated with GARDASIL (Lot# L007560, Expiry date: 15-JUN-2017, Lot# L013429, Expiry date: 21-JUL-2017 and Expiry date: 21-JUN-2017, Lot# L017407, Expiry date: 15-AUG-2017) which were exposed to temperatures outside of the recommended range (incorrect product storage). No adverse event were reported. This case is one of the several reports from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Antinuclear antibody negative, Borrelia test negative, Dysaesthesia, Full blood count normal, Injection site dysaesthesia
Clinical narrative: Generalized dysesthesias, mostly on anterior trunk and upper arms. Pain while dressing and movement; no focal findings. Attributed to vaccination with Prevnar-13. Relief with ibuprofen, not aspirin. Persisting for over 2 weeks.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Pain, Red blood cell sedimentation rate normal
Clinical narrative: Generalized dysesthesias, mostly on anterior trunk and upper arms. Pain while dressing and movement; no focal findings. Attributed to vaccination with Prevnar-13. Relief with ibuprofen, not aspirin. Persisting for over 2 weeks.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on an unspecified dates, the patients were administered an unspecified number of improperly stored doses of ROTATEQ oral liquid (lot # K020181 with expiration date 24-JUN-2016 and lot# K024700 with expiration date 30-JUL-2016; dose was not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional referring to a patient of unknown age and gender. The patient concurrent condition and medical history were unknown. On 25-NOV-2015, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (Lot # reported as 1014427, expiration date 09-MAR-2018) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported. The registered nurse reported that since 25-NOV-2015, the patients have been vaccinated with unspecified doses of PROQUAD (Merck) which were exposed to temperatures outside of the recommended range (Lot #L031601, expiration date 18-FEB-2017; Lot# L033696, expiration date 28-FEB-2017) (strength and route were not provided). Concomitant medication was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to unspecified number of patients of unknown age and gender. Since 11-NOV-2015 unspecified number of patients were vaccinated with M-M-R II [Lot# L019488, Expiry date: 11-FEB-2018, Lot# K014833, Expiry date: 14-SEP-2016, Lot# L001336, Expiry date: 13-JAN-2017, Lot# L012479, Expiry Date: 10-APR-2017 and Lot# L007217 Expiry Date: 03-MAR-2017] which were exposed to temperatures outside of the recommended range. No adverse event were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported. The registered nurse reported that since 25-NOV-2015, the patients have been vaccinated with unspecified doses of VARIVAX (Merck) which were exposed to temperatures outside of the recommended range (lot # L008272, expiration date 11-MAR-2017) (Strength and route were not provided). Concomitant medication was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Between 09-NOV-2015 and 12-NOV-2015, the patients were vaccinated with improperly stored doses of GARDASIL lot # L013429 exp 01-JUL-2017, (route and dose were not provided). No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history or drug allergies/drug reactions were not reported. On 03-DEC-2015, the patient was vaccinated with GARDASIL (lot # J003727, expiration date 07-NOV-2015), (dose, route of administration and anatomical location were not reported). There was no concomitant medication reported and no adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to unspecified number of patients of unknown age and gender. Since 11-NOV-2015 unspecified number of patients were vaccinated with GARDASIL [Lot# K010215, Expiry date: 05-MAY-2017, Lot# L010596, Expiry date: 06-APR-2017] which were exposed to temperatures outside of the recommended range (incorrect product storage). No adverse event were reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL, lot# K006117, expiry date 14-OCT-2017 and lot# K007264, expiry date 02-MAR-2017. No adverse effects reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of four reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL 9, lot# K026246, expiry date 28-JAN-2017. No adverse effects reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of four reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB, lot# L002866, expiry date 10-NOV-2017 00:00 and lot# L030865, expiry date 07-JUN-2018. No adverse effects reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of four report received from the same reporter. Additional information has been requested.