chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Urticaria
Clinical narrative: Pt had a red welt which was warm and hurt a little.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 70 year old male patient. Approximately in October 2013 (2 months ago), the patient was vaccinated with ZOSTAVAX (Lot number, expiry date, route and dose unknown) for vaccination. On unspecified dates within a week of administration of ZOSTAVAX, patient developed rash at his elbow and covered an unspecified area up his arms. It was reported that patient visited pharmacist and no treatment was given for rash. On an unspecified date, patient recovered from rash after a week adverse effect began. The outcome of rashes started at his elbow and covered an unspecified area up his arms was reported as recovered/resolved. No further information provided. This case # 1312USA011728 is linked to case # 1312USA010015 via same reporter link. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 70 year old female patient. Approximately in October 2013 (2 months ago), the patient was vaccinated with ZOSTAVAX (Lot number, expiry date, route and dose unknown) for vaccination. On unspecified dates within a week of administration of ZOSTAVAX, patient developed rash at her elbow and covered an unspecified area up her arms. It was reported that patient visited pharmacist and no treatment was given for rash. On an unspecified date, patient recovered from rash after a week adverse effect began. The outcome of rashes started at her elbow and covered an unspecified area up her arms was reported as recovered/resolved. No further information was provided. This case # 1312USA010015 is linked to case # 1312USA011728 via same reporter link. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 years old female patient. The patient had no pertinent medical history and drug reactions/allergies. On 18-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J007858, expiry date: 28-SEP-2014) (dose, location frequency and route unspecified). Concomitant therapies included with unspecified steroid cream. Pharmacist reported that the patient came back to the pharmacy today (on 19-DEC-2013) because there was a 1.5 inch warm, itchy, red, raised area around the injection site. Pharmacist reported that there was no rash presented. No treatment was given for the events. The patient had sought medical attention via pharmacy visit. At the time of report, the outcome of the events was not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a publics representative refers to a pharmacist colleague of unknown age and gender. The reporter stated that a pharmacist colleague administered ZOSTAVAX (Lot # unspecified) (dose, frequency, location and route unspecified) to a patient on an unspecified date and then this administering pharmacist colleague developed shingles a few days later. At the time of report, the outcome of the events was unknown. Additional information has been requested.
Age: 1.37
Sex: F
Vaccine: DTAP, MMR
Symptoms: Blood sodium decreased, Choking, Convulsion, Crying, Drooling
Clinical narrative: Seizure; patient had been drowsy with a runny nose all week. This morning she felt warm and took an early nap for about a half hour. When she woke up, she walked up to me (mother) and I picked her up. After a couple minutes she started to become stiff and making a gurgling noise. I told my husband something was wrong, he took her and said she was choking and held her over the garbage. I said she had nothing in her mouth. She was shaking and stiff and drooling. Her eyes got wide, then rolled upwards. I called 911 they said to take off her pjs, then my husband put water on her neck and she came out of the seizure and began to cry, then fell asleep. Paramedics arrived and checked her out and said it was probably a febrile seizure but to take her in anyway. Since her doctors office was closed we went to the ER. We spent 6 hours there and she was diagnosed with a febrile seizure.
Age: 1.37
Sex: F
Vaccine: DTAP, MMR
Symptoms: Febrile convulsion, Feeling hot, Gaze palsy, Musculoskeletal stiffness, Rhinorrhoea
Clinical narrative: Seizure; patient had been drowsy with a runny nose all week. This morning she felt warm and took an early nap for about a half hour. When she woke up, she walked up to me (mother) and I picked her up. After a couple minutes she started to become stiff and making a gurgling noise. I told my husband something was wrong, he took her and said she was choking and held her over the garbage. I said she had nothing in her mouth. She was shaking and stiff and drooling. Her eyes got wide, then rolled upwards. I called 911 they said to take off her pjs, then my husband put water on her neck and she came out of the seizure and began to cry, then fell asleep. Paramedics arrived and checked her out and said it was probably a febrile seizure but to take her in anyway. Since her doctors office was closed we went to the ER. We spent 6 hours there and she was diagnosed with a febrile seizure.
Age: 1.37
Sex: F
Vaccine: DTAP, MMR
Symptoms: Somnolence, Tremor
Clinical narrative: Seizure; patient had been drowsy with a runny nose all week. This morning she felt warm and took an early nap for about a half hour. When she woke up, she walked up to me (mother) and I picked her up. After a couple minutes she started to become stiff and making a gurgling noise. I told my husband something was wrong, he took her and said she was choking and held her over the garbage. I said she had nothing in her mouth. She was shaking and stiff and drooling. Her eyes got wide, then rolled upwards. I called 911 they said to take off her pjs, then my husband put water on her neck and she came out of the seizure and began to cry, then fell asleep. Paramedics arrived and checked her out and said it was probably a febrile seizure but to take her in anyway. Since her doctors office was closed we went to the ER. We spent 6 hours there and she was diagnosed with a febrile seizure.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Pain, Pyrexia, Stress urinary incontinence, Throat irritation
Clinical narrative: Began with a tickle in my throat that progressed to non stop coughing. After seeing the pulmonologist on 12/12/13 was given steroids, antibiotics and breathing treatments, fever of 101.3, body aches and continued coughing non stop. NOTHING relieved the cough except Benadryl. After steroids and antibiotics completed coughing continued and pulmonologist called in another round of both. After steroids completed cough continues and the only relief is Benadryl or Zyrtec. This is violent coughing causing severe loss of bladder control. Only minimal mucous produced in the beginning.
Age: 1.03
Sex: M
Vaccine: MMR
Symptoms: Blister, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Fever started 12/24/2013 followed by head to toe red rash bumps blisters appearing on 12/27/2013.
Age: 1.01
Sex: M
Vaccine: MM, PNC13, VARCEL
Symptoms: Abnormal behaviour, Hypotonia, Irritability, Nuclear magnetic resonance imaging, Retching
Clinical narrative: GAGGING, FOLLOWED BY 1 MINUTE OF FLOPPINESS AND UNRESPONSIVENESS , THEN CRANKINESS.  TAKEN TO E.R. WHERE NO INTERVENTION OR WORKUP DONE, EXCEPT GIVEN ZOFRAN.  NEXT DAY CONTINUED "NOT HIMSELF" FOR HALF A DAY, THEN WENT BACK TO NORMAL, ACTIVE SELF BY THE AFTERNOON.
Age: 1.01
Sex: M
Vaccine: MM, PNC13, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: GAGGING, FOLLOWED BY 1 MINUTE OF FLOPPINESS AND UNRESPONSIVENESS , THEN CRANKINESS.  TAKEN TO E.R. WHERE NO INTERVENTION OR WORKUP DONE, EXCEPT GIVEN ZOFRAN.  NEXT DAY CONTINUED "NOT HIMSELF" FOR HALF A DAY, THEN WENT BACK TO NORMAL, ACTIVE SELF BY THE AFTERNOON.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Borrelia test negative, Chest pain, Full blood count normal, Glycosylated haemoglobin normal
Clinical narrative: At first soreness at injection site on left arm--by the next day there was pain from injection site radiating to left shoulder, left side of back to shoulder blade, neck radiating to right neck and radiating to anterior of neck near throat and across chest. Numbness radiating down left arm with carpal tunnel like pain/numbness to left hand/fingers.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Metabolic function test normal, Musculoskeletal pain, Neck pain
Clinical narrative: At first soreness at injection site on left arm--by the next day there was pain from injection site radiating to left shoulder, left side of back to shoulder blade, neck radiating to right neck and radiating to anterior of neck near throat and across chest. Numbness radiating down left arm with carpal tunnel like pain/numbness to left hand/fingers.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Thyroid function test normal, Vitamin B12 normal, Vitamin B6 normal
Clinical narrative: At first soreness at injection site on left arm--by the next day there was pain from injection site radiating to left shoulder, left side of back to shoulder blade, neck radiating to right neck and radiating to anterior of neck near throat and across chest. Numbness radiating down left arm with carpal tunnel like pain/numbness to left hand/fingers.
Age: 1.49
Sex: M
Vaccine: DTAP, IPV
Symptoms: Asthma, Cough, Croup infectious, Pertussis
Clinical narrative: Received the DTaP vaccine and within 10 days awoke with most severe croup cough he ever had. Croup cough then turned into whooping type cough after 2 weeks then turned into chronic asthma cough as confirmed by allergy MD.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyskinesia, Fall, Gaze palsy, Head injury
Clinical narrative: Pt got dizzy, about 5-10 mins after vaccine, pt came got off the table to come talk to me the mother, she said mom I feel dizzy, as she was saying that she fell straight back on the back of her head and hit the floor had a few jerking movements and eyes rolled back into her head, we stayed at the doctors office until pt could get up and walk out of office nurse helped her out to the car, doctor checked her throughly before leaving pt has a current goose egg on back of head I was told that night to wake her often and watch for any nausea or severe headache that doesn't go away with Tynelol, I was informed that the vaccination wasn't the cause of her fainting but after reading the walk out sheet and reading the website I see that this is a known side affect. I wished I would of been more proactive and wished I would of known this could of happened I would of made her lay down for the entire 15 mins, but we were informed after 5 mins that we could leave.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Swelling, Syncope
Clinical narrative: Pt got dizzy, about 5-10 mins after vaccine, pt came got off the table to come talk to me the mother, she said mom I feel dizzy, as she was saying that she fell straight back on the back of her head and hit the floor had a few jerking movements and eyes rolled back into her head, we stayed at the doctors office until pt could get up and walk out of office nurse helped her out to the car, doctor checked her throughly before leaving pt has a current goose egg on back of head I was told that night to wake her often and watch for any nausea or severe headache that doesn't go away with Tynelol, I was informed that the vaccination wasn't the cause of her fainting but after reading the walk out sheet and reading the website I see that this is a known side affect. I wished I would of been more proactive and wished I would of known this could of happened I would of made her lay down for the entire 15 mins, but we were informed after 5 mins that we could leave.
Age: 52.0
Sex: F
Vaccine: DTAP, UNK
Symptoms: Erythema, Headache, Local swelling, Pain in extremity, Pyrexia
Clinical narrative: Fever, sore arm, head ache 8:00 pm. - by 8:00 am 12/28/2013 arm very sore no fever.  5:00 pm 12/28/2013 fever of 101 arm swollen with redness took ibuprofen and flu medication. By 8:00 am 12/29/2013 fever 101.1 called nurse and let fever run the rest of the day with no medication.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, hot and extremely sore left upper arm and shoulder.
Age: 27.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Dyspnoea, Throat irritation, Throat tightness, Wheezing
Clinical narrative: Pt reported to nurse at 6:30pm same day of vaccines (4 hrs after receiving) that she thought she was having reaction. Described as "tickle and tightness in throat", "difficulty breathing" & occasional expiratory wheezes. Pt later stated that she started feeling this 20 minutes after receiving vaccines but did not report it. Pt appeared in no apparent distress at any time. Dr. was notified and Benadryl 25mg by mouth was administered at 7:51pm and albuterol nebulizer treatment. At 9:56PM. pt reports feeling 100% better and is no longer complaining of any of reported symptoms.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Extreme pain in upper arm/shoulder when I move it certain ways.  Very difficult to lift arm, difficult to sleep on my left side (side of injection).  Pain started the day I received flu shot and I am still experiencing the pain now almost 4 weeks later.  Pain lessened some after a couple weeks then slightly alleviated more so for a few days after massage.  But now pain has returned to original pain level.  Ibuprofen at anti-inflammatory dose of 800mg provides some temporary relief.  Shot was given by a nurse leaning to give flu injections.  Injection site felt too high up on arm, about a finger width down from shoulder bone (at junction of shoulder and upper arm).  I tried to keep arm actively moving and continued to massage injection site for first few days.  Planning a visit to my doctor.
Age: 16.0
Sex: F
Vaccine: HPV4, MEN, VARCEL
Symptoms: Abasia, Abdominal pain upper, Angina pectoris, Arthralgia, Back pain
Clinical narrative: Patient got the first Gardasil shot 7-25-12, the second 9/26/12, and the third shot 1/28/13.  Im not sure the exact onset date except to say she got the second and third shot during her junior year in high school and she was continually telling me how fatigued, tired, dizzy, light headed and tired she was.  She also had continued to complain about her heart racing, short of breath, heart pains, sleeping difficulty, chest pain, rib pain under her breast, brain fog, headaches, back aches, stomach pain, limb heaviness, neck pain random pains everywhere, seeing different shapes and colors in her vision, severe hip pain, electrical shock pain, and numerous other pains.  In Aug 2013 (the beginning of her Senior  year in high school) she was walking slowly like she had rode a horse to long, Sept 2013 she needed a walker because she was starting to trip and had trouble standing, Oct 2013 she had to use a wheelchair and unable to walk by herself.   We have had MRI, bone scans, CT scans, xrays and numerous bloodwork.
Age: 16.0
Sex: F
Vaccine: HPV4, MEN, VARCEL
Symptoms: Blood test, Bone scan, Chest pain, Computerised tomogram, Dizziness
Clinical narrative: Patient got the first Gardasil shot 7-25-12, the second 9/26/12, and the third shot 1/28/13.  Im not sure the exact onset date except to say she got the second and third shot during her junior year in high school and she was continually telling me how fatigued, tired, dizzy, light headed and tired she was.  She also had continued to complain about her heart racing, short of breath, heart pains, sleeping difficulty, chest pain, rib pain under her breast, brain fog, headaches, back aches, stomach pain, limb heaviness, neck pain random pains everywhere, seeing different shapes and colors in her vision, severe hip pain, electrical shock pain, and numerous other pains.  In Aug 2013 (the beginning of her Senior  year in high school) she was walking slowly like she had rode a horse to long, Sept 2013 she needed a walker because she was starting to trip and had trouble standing, Oct 2013 she had to use a wheelchair and unable to walk by herself.   We have had MRI, bone scans, CT scans, xrays and numerous bloodwork.
Age: 16.0
Sex: F
Vaccine: HPV4, MEN, VARCEL
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Fibromyalgia, Gait disturbance
Clinical narrative: Patient got the first Gardasil shot 7-25-12, the second 9/26/12, and the third shot 1/28/13.  Im not sure the exact onset date except to say she got the second and third shot during her junior year in high school and she was continually telling me how fatigued, tired, dizzy, light headed and tired she was.  She also had continued to complain about her heart racing, short of breath, heart pains, sleeping difficulty, chest pain, rib pain under her breast, brain fog, headaches, back aches, stomach pain, limb heaviness, neck pain random pains everywhere, seeing different shapes and colors in her vision, severe hip pain, electrical shock pain, and numerous other pains.  In Aug 2013 (the beginning of her Senior  year in high school) she was walking slowly like she had rode a horse to long, Sept 2013 she needed a walker because she was starting to trip and had trouble standing, Oct 2013 she had to use a wheelchair and unable to walk by herself.   We have had MRI, bone scans, CT scans, xrays and numerous bloodwork.
Age: 16.0
Sex: F
Vaccine: HPV4, MEN, VARCEL
Symptoms: Headache, Insomnia, Musculoskeletal chest pain, Neck pain, Nuclear magnetic resonance imaging
Clinical narrative: Patient got the first Gardasil shot 7-25-12, the second 9/26/12, and the third shot 1/28/13.  Im not sure the exact onset date except to say she got the second and third shot during her junior year in high school and she was continually telling me how fatigued, tired, dizzy, light headed and tired she was.  She also had continued to complain about her heart racing, short of breath, heart pains, sleeping difficulty, chest pain, rib pain under her breast, brain fog, headaches, back aches, stomach pain, limb heaviness, neck pain random pains everywhere, seeing different shapes and colors in her vision, severe hip pain, electrical shock pain, and numerous other pains.  In Aug 2013 (the beginning of her Senior  year in high school) she was walking slowly like she had rode a horse to long, Sept 2013 she needed a walker because she was starting to trip and had trouble standing, Oct 2013 she had to use a wheelchair and unable to walk by herself.   We have had MRI, bone scans, CT scans, xrays and numerous bloodwork.
Age: 16.0
Sex: F
Vaccine: HPV4, MEN, VARCEL
Symptoms: Pain, Palpitations, Paraesthesia, Sensation of heaviness, Visual impairment
Clinical narrative: Patient got the first Gardasil shot 7-25-12, the second 9/26/12, and the third shot 1/28/13.  Im not sure the exact onset date except to say she got the second and third shot during her junior year in high school and she was continually telling me how fatigued, tired, dizzy, light headed and tired she was.  She also had continued to complain about her heart racing, short of breath, heart pains, sleeping difficulty, chest pain, rib pain under her breast, brain fog, headaches, back aches, stomach pain, limb heaviness, neck pain random pains everywhere, seeing different shapes and colors in her vision, severe hip pain, electrical shock pain, and numerous other pains.  In Aug 2013 (the beginning of her Senior  year in high school) she was walking slowly like she had rode a horse to long, Sept 2013 she needed a walker because she was starting to trip and had trouble standing, Oct 2013 she had to use a wheelchair and unable to walk by herself.   We have had MRI, bone scans, CT scans, xrays and numerous bloodwork.
Age: 16.0
Sex: F
Vaccine: HPV4, MEN, VARCEL
Symptoms: Walking aid user, Wheelchair user, X-ray
Clinical narrative: Patient got the first Gardasil shot 7-25-12, the second 9/26/12, and the third shot 1/28/13.  Im not sure the exact onset date except to say she got the second and third shot during her junior year in high school and she was continually telling me how fatigued, tired, dizzy, light headed and tired she was.  She also had continued to complain about her heart racing, short of breath, heart pains, sleeping difficulty, chest pain, rib pain under her breast, brain fog, headaches, back aches, stomach pain, limb heaviness, neck pain random pains everywhere, seeing different shapes and colors in her vision, severe hip pain, electrical shock pain, and numerous other pains.  In Aug 2013 (the beginning of her Senior  year in high school) she was walking slowly like she had rode a horse to long, Sept 2013 she needed a walker because she was starting to trip and had trouble standing, Oct 2013 she had to use a wheelchair and unable to walk by herself.   We have had MRI, bone scans, CT scans, xrays and numerous bloodwork.
Age: 19.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Erythema, Local reaction, Rash pruritic
Clinical narrative: On 12/29/13 - pt called of local reaction - redness, itchy rash in the area of Hep B administration.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 4" red, warm, itchy, tender raised area on left deltoid.
Sex: U
Vaccine: VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a consumer, who is a patient of a physician, refers to another patient of unknown age and gender. On an unknown date the separate patient was vaccinated with ZOSTAVAX (dose, route, lot # unknown). On an unknown date, the patient experienced bells palsy after receiving ZOSTAVAX. The outcome of the event was unknown. Additional information is not expected.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13
Symptoms: Convulsion, Electroencephalogram, Nuclear magnetic resonance imaging normal
Clinical narrative: 10/17/13 - afternoon day of shot twitching, eyes rolled back, limp, lethargic admitted to hospital - work up neg per neurology, treated by neuro referral.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13
Symptoms: Blood culture, CSF culture, Culture urine, Electroencephalogram, Gaze palsy
Clinical narrative: 10/17/13 - afternoon day of shot twitching, eyes rolled back, limp, lethargic admitted to hospital - work up neg per neurology, treated by neuro referral.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13
Symptoms: Hypotonia, Lethargy, Muscle twitching, Neurological examination normal, Nuclear magnetic resonance imaging
Clinical narrative: 10/17/13 - afternoon day of shot twitching, eyes rolled back, limp, lethargic admitted to hospital - work up neg per neurology, treated by neuro referral.
Age: 45.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Bacterial test negative, Borrelia test negative, HIV test negative, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient works at hospital - flu shot is mandatory. Received shot on 10/30/13. On 11/10/13 feet were numb. 11/11/13 condition worse. 11/12/13 Dr. 11/13/13 Emergency Room Hos. admitted (paralyzed neck down). 11/14/13 transferred to another hospital ICU started IGG treatment for Guillain Barre. 11/15/13 condition worse (cannot move) MRI. 11/16/13 respirator/feeding tube (critical). 11/17/13 IGG not working. 11/18/13 start new treatment (plasmapheresis). 11/20 left lung collapsed. 11/21 temp/heart rate up. Suction lungs. 11/27 removed respirator. 12/4 moved to P.T. unit. Continuing to improve slowly. (No feeling in legs/feet).
Age: 45.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Body temperature increased, Gastrointestinal tube insertion, Guillain-Barre syndrome, Heart rate increased, Hypoaesthesia
Clinical narrative: Patient works at hospital - flu shot is mandatory. Received shot on 10/30/13. On 11/10/13 feet were numb. 11/11/13 condition worse. 11/12/13 Dr. 11/13/13 Emergency Room Hos. admitted (paralyzed neck down). 11/14/13 transferred to another hospital ICU started IGG treatment for Guillain Barre. 11/15/13 condition worse (cannot move) MRI. 11/16/13 respirator/feeding tube (critical). 11/17/13 IGG not working. 11/18/13 start new treatment (plasmapheresis). 11/20 left lung collapsed. 11/21 temp/heart rate up. Suction lungs. 11/27 removed respirator. 12/4 moved to P.T. unit. Continuing to improve slowly. (No feeling in legs/feet).
Age: 45.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypokinesia, Immunoglobulin therapy, Intensive care, Mechanical ventilation, Nuclear magnetic resonance imaging
Clinical narrative: Patient works at hospital - flu shot is mandatory. Received shot on 10/30/13. On 11/10/13 feet were numb. 11/11/13 condition worse. 11/12/13 Dr. 11/13/13 Emergency Room Hos. admitted (paralyzed neck down). 11/14/13 transferred to another hospital ICU started IGG treatment for Guillain Barre. 11/15/13 condition worse (cannot move) MRI. 11/16/13 respirator/feeding tube (critical). 11/17/13 IGG not working. 11/18/13 start new treatment (plasmapheresis). 11/20 left lung collapsed. 11/21 temp/heart rate up. Suction lungs. 11/27 removed respirator. 12/4 moved to P.T. unit. Continuing to improve slowly. (No feeling in legs/feet).
Age: 45.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Paralysis, Plasmapheresis, Pneumothorax
Clinical narrative: Patient works at hospital - flu shot is mandatory. Received shot on 10/30/13. On 11/10/13 feet were numb. 11/11/13 condition worse. 11/12/13 Dr. 11/13/13 Emergency Room Hos. admitted (paralyzed neck down). 11/14/13 transferred to another hospital ICU started IGG treatment for Guillain Barre. 11/15/13 condition worse (cannot move) MRI. 11/16/13 respirator/feeding tube (critical). 11/17/13 IGG not working. 11/18/13 start new treatment (plasmapheresis). 11/20 left lung collapsed. 11/21 temp/heart rate up. Suction lungs. 11/27 removed respirator. 12/4 moved to P.T. unit. Continuing to improve slowly. (No feeling in legs/feet).
Age: 78.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Aldolase normal, Areflexia, Asthenia, Blood creatine phosphokinase normal, Blood electrolytes normal
Clinical narrative: This case was reported in a literature article and described the occurrence of relapse of chronic inflammatory demyelinating polyneuropathy in a 78-year-old male subject who was vaccinated with Influenza vaccine (season and manufacturer unspecified). The subject's medical history included a previous similar episode with respiratory issue requiring tracheostomy after an upper respiratory infection when he was 10-year-old. This episode was presumably an episode of Guillain-Barre syndrome which developed into Chronic Inflammatory Demyelinating Polyneuropathy. On an unspecified date the subject received an unspecified dose of Influenza vaccine (unknown route and injection site). Within days of vaccination with Influenza vaccine (unspecified), the subject experienced generalized weakness. He also experienced difficulty in getting up from a chair and difficulty while lifting his arm. This case was assessed as medically serious by GSK. Physical examination showed significant proximal as well as distal muscle weakness in bilateral upper and lower extremities. Sensations were preserved and reflexes were absent. His laboratory work up including electrolytes, Thyroid Stimulating Hormone, Creatinine phosphatase and aldolase levels were normal. Nuclear Magnetic Resonance Imaging of head was unremarkable. An electromyogram with nerve conduction study showed evidence of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). The subject was treated with corticosteroids. The subject showed gradual improvement in weakness and was advised to avoid influenza vaccines. The authors reported that the activation of CIDP was probably triggered by the vaccination with Influenza vaccine.
Age: 78.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Blood thyroid stimulating hormone normal, Chronic inflammatory demyelinating polyradiculoneuropathy, Condition aggravated, Dysstasia, Electromyogram abnormal
Clinical narrative: This case was reported in a literature article and described the occurrence of relapse of chronic inflammatory demyelinating polyneuropathy in a 78-year-old male subject who was vaccinated with Influenza vaccine (season and manufacturer unspecified). The subject's medical history included a previous similar episode with respiratory issue requiring tracheostomy after an upper respiratory infection when he was 10-year-old. This episode was presumably an episode of Guillain-Barre syndrome which developed into Chronic Inflammatory Demyelinating Polyneuropathy. On an unspecified date the subject received an unspecified dose of Influenza vaccine (unknown route and injection site). Within days of vaccination with Influenza vaccine (unspecified), the subject experienced generalized weakness. He also experienced difficulty in getting up from a chair and difficulty while lifting his arm. This case was assessed as medically serious by GSK. Physical examination showed significant proximal as well as distal muscle weakness in bilateral upper and lower extremities. Sensations were preserved and reflexes were absent. His laboratory work up including electrolytes, Thyroid Stimulating Hormone, Creatinine phosphatase and aldolase levels were normal. Nuclear Magnetic Resonance Imaging of head was unremarkable. An electromyogram with nerve conduction study showed evidence of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). The subject was treated with corticosteroids. The subject showed gradual improvement in weakness and was advised to avoid influenza vaccines. The authors reported that the activation of CIDP was probably triggered by the vaccination with Influenza vaccine.
Age: 78.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Mobility decreased, Muscular weakness, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: This case was reported in a literature article and described the occurrence of relapse of chronic inflammatory demyelinating polyneuropathy in a 78-year-old male subject who was vaccinated with Influenza vaccine (season and manufacturer unspecified). The subject's medical history included a previous similar episode with respiratory issue requiring tracheostomy after an upper respiratory infection when he was 10-year-old. This episode was presumably an episode of Guillain-Barre syndrome which developed into Chronic Inflammatory Demyelinating Polyneuropathy. On an unspecified date the subject received an unspecified dose of Influenza vaccine (unknown route and injection site). Within days of vaccination with Influenza vaccine (unspecified), the subject experienced generalized weakness. He also experienced difficulty in getting up from a chair and difficulty while lifting his arm. This case was assessed as medically serious by GSK. Physical examination showed significant proximal as well as distal muscle weakness in bilateral upper and lower extremities. Sensations were preserved and reflexes were absent. His laboratory work up including electrolytes, Thyroid Stimulating Hormone, Creatinine phosphatase and aldolase levels were normal. Nuclear Magnetic Resonance Imaging of head was unremarkable. An electromyogram with nerve conduction study showed evidence of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). The subject was treated with corticosteroids. The subject showed gradual improvement in weakness and was advised to avoid influenza vaccines. The authors reported that the activation of CIDP was probably triggered by the vaccination with Influenza vaccine.
Age: 78.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Blood thyroid stimulating hormone normal, Chronic inflammatory demyelinating polyradiculoneuropathy, Dysstasia, Electromyogram abnormal, Mobility decreased
Clinical narrative: This case was reported in a literature article and described the occurrence of relapse of chronic inflammatory demyelinating polyneuropathy in a 78-year-old male subject who was vaccinated with Influenza vaccine (season and manufacturer unspecified). The subject's medical history included a previous similar episode with respiratory issue requiring tracheostomy after an upper respiratory infection when he was 10-year-old. This episode was presumably an episode of Guillain-Barre syndrome which developed into Chronic Inflammatory Demyelinating Polyneuropathy. On an unspecified date the subject received an unspecified dose of Influenza vaccine (unknown route and injection site). Within days of vaccination with Influenza vaccine (unspecified), the subject experienced generalized weakness. He also experienced difficulty in getting up from a chair and difficulty while lifting his arm. This case was assessed as medically serious by GSK. Physical examination showed significant proximal as well as distal muscle weakness in bilateral upper and lower extremities. Sensations were preserved and reflexes were absent. His laboratory work up including electrolytes, Thyroid Stimulating Hormone, Creatinine phosphatase and aldolase levels were normal. Nuclear Magnetic Resonance Imaging of head was unremarkable. An electromyogram with nerve conduction study showed evidence of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). The subject was treated with corticosteroids. The subject showed gradual improvement in weakness and was advised to avoid influenza vaccines. The authors reported that the activation of CIDP was probably triggered by the vaccination with Influenza vaccine.
Age: 78.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Muscular weakness, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: This case was reported in a literature article and described the occurrence of relapse of chronic inflammatory demyelinating polyneuropathy in a 78-year-old male subject who was vaccinated with Influenza vaccine (season and manufacturer unspecified). The subject's medical history included a previous similar episode with respiratory issue requiring tracheostomy after an upper respiratory infection when he was 10-year-old. This episode was presumably an episode of Guillain-Barre syndrome which developed into Chronic Inflammatory Demyelinating Polyneuropathy. On an unspecified date the subject received an unspecified dose of Influenza vaccine (unknown route and injection site). Within days of vaccination with Influenza vaccine (unspecified), the subject experienced generalized weakness. He also experienced difficulty in getting up from a chair and difficulty while lifting his arm. This case was assessed as medically serious by GSK. Physical examination showed significant proximal as well as distal muscle weakness in bilateral upper and lower extremities. Sensations were preserved and reflexes were absent. His laboratory work up including electrolytes, Thyroid Stimulating Hormone, Creatinine phosphatase and aldolase levels were normal. Nuclear Magnetic Resonance Imaging of head was unremarkable. An electromyogram with nerve conduction study showed evidence of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). The subject was treated with corticosteroids. The subject showed gradual improvement in weakness and was advised to avoid influenza vaccines. The authors reported that the activation of CIDP was probably triggered by the vaccination with Influenza vaccine.
Age: 16.0
Sex: F
Vaccine: FLUN4
Symptoms: Vasculitis
Clinical narrative: A report from a pharmacist concerns a 16 year old female. No relevant history, concomitant disease, or concomitant medications were reported. On 31-Oct-2013, the patient received FLUMIST QUADRIVALENT (intranasal). The reporting pharmacist, who was the patient's neighbor, reported that the patient had FLUMIST QUADRIVALENT on 31-Oct-2013 and on 06-Dec-2013 was admitted to the hospital with vasculitis. The outcome of the vasculitis was unknown. The reporter assessed the vasculitis to be serious by the criterion of hospitalization.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender (reported as over 12 years). On an unknown date the patient was vaccinated with PROQUAD for an unspecified indication (anatomical locations, route, dose number, lot number and expiration date unknown). Concomitant medications were not reported. The pharmacist stated that on an unknown date an unspecified patient, over 12 years of age received PROQUAD, and no adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a female patient of unknown age regarding herself. On an unknown date the patient was vaccinated with ZOSTAVAX. On an unknown date, the patient experienced unspecified adverse experiences since receiving ZOSTAVAX (date and location unspecified). The reporter declined to participate in any reporting and only wanted medical advice. The outcome of adverse experiences unspecified was unknown. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 4 year old patient of unknown gender. On 11-DEC-2013 the patient was vaccinated with an expired dose of PROQUAD injections (lot # H015791, expiration date 12-NOV-2013) in the right arm (dose unspecified). No adverse effect had been observed or reported. Additional information has been requested.
Age: 1.27
Sex: M
Vaccine: MMR
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: This spontaneous report as received from a nurse refers to an approximately 15 month old male patient. On 03-MAR-2011, the patient was vaccinated with the first dose of MMR II, lot # 669200/1346Z, therapy type rHA (expiration date, dose, frequency and route not reported). On an unknown date in March 2011, the patient experienced redness, swelling, and injection-site pain after receipt of a dose of MMR II. No treatment was given for adverse event. The patient recovered on an unspecified date, and he was in the practice today ("10-DEC_2013") for his second dose of MMR II. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: Large red itching whelp at injection site within 24 hrs. Continued to get larger and covered upper arm hot, red, profuse itching. MD visit - order for 7 days BENADRYL 50 mg q 6 hours, ZANTAC 150 Bid x 7, and topical oint.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Photopsia
Clinical narrative: This spontaneous report as received from a 61 year old male patient. The patient's medical history included ocular migraine. Past drug included unspecified drug for the treatment of ocular migraine, a year ago. On 18-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX in the upper left arm for preventative vaccine for "shingles" (dose and route not provided0. The patient stated that six hours after receiving the vaccine he began experiencing "light flashes" in his left eye, which have continued intermittently since (exact timeframe not given). The patient had reached out to the pharmacist that administered the vaccine who has referred him to speak with his primary physician and to the manufacturer. The primary physician has referred him to an optometrist. The patient has not scheduled an appointment yet. No treatment was given. No lab test was performed. The outcome of adverse event was not recovered. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 38 year old female patient without any pertinent medical history or drug reactions/allergies. On 11-DEC-2013 the patient was vaccinated with PNEUMOVAX23 injection (dose and route not reported, lot # J009827, expired date: 10-AUG-2014). There was no concomitant medication. On 13-DEC-2013 the patient experienced swelling in the administration arm that "went all the way down to her elbow". It was reported that the patient called her unspecified physician on an unspecified date and he prescribed prednisone to treat the swelling. The pharmacist reported that with the administration of prednisone the swelling went away on an unspecified date in December 2013. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unknown age. On an unknown date, adult patient was vaccinated with RECOMBIVAX HB of strength 5 Microgram/0.5Milliliter pediatric vaccine (dose, route and frequency were not provided). No concomitant medications were reported. No adverse effect reported. Outcome was unknown and causality was assessed as not related. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients. Demographic information was not provided. On 23-DEC-2013 the patients were vaccinated with a dose of GARDASIL which had been exposed to -5 degrees Celsius for 20 minutes which was not supported. Route, strength, dose and lot number were not reported. No adverse effects were reported. This is 1 of 3 reports received from the same source (other case IDs 1312USA010886 and 1312USA012121). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients. Demographic information was not provided. On 23-DEC-2013 the patients were vaccinated with a dose of VAQTA 25/0.5 U/ml which had been exposed to -5 degrees Celsius for 20 minutes which was not supported. Route, dose and lot number were not reported. No adverse effects were reported. This is 1 of 3 reports received from the same source (other case IDs 1312USA010886 and 1312USA012120). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients. Demographic information was not provided. On 23-DEC-2013 the patients were vaccinated with a dose of RECOMBIVAX HB 10mcg/ml which had been exposed to -5 degrees Celsius for 20 minutes which was not supported. Route, dose and lot number not reported. No adverse effects were reported. This is 1 of 3 reports received from the same source (other case IDs 1312USA012120 and 1312USA012121. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Myalgia
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. The patients medical history included unspecified musculoskeletal disorder similar to fibromyalgia. On an unknown date the patient was vaccinated with unspecified hepatitis B vaccine (manufacturer unknown). On an unknown date, after the first dose the patient experienced muscle aches and pain. The same adverse symptoms occurred after she received second dose of the unspecified hepatitis B vaccine. Patient sought medical attention by informing her physician. Outcome and causality was unknown. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on torso and all extremities appeared within 24 hours of flu vaccination. Seen by her own physician.
Sex: U
Vaccine: RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a patient of unknown age and gender. On 27-DEC-2013 the patient was vaccinated with ROTATEQ dose 4, 2 ml, oral. Nurse reported that on 17-JUL-2013, patient was vaccinated with ROTATEQ vial dose number 1, 2 ml, (lot number and expiry date unknown) oral. On 30-SEP-2013 and 18-DEC-2013, patient received second and third doses as recommended in the prescribing information and also on 27-DEC-2013 patient received fourth dose. No adverse effects were reported. No further information was provided. The outcome of the event was unknown. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dizziness, Throat tightness, Vomiting, Wheezing
Clinical narrative: About 1 hr after receiving flu shot, patient started to wheeze, have tightness in throat and cough. She used Albuterol and also took a BENADRYL. She also threw up and felt faint. Lasted for about 4-5 hours.
Sex: M
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: This spontaneous report as received from a consumer refers to her son a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (route and lot number not provided) dose 1. On an unknown date the patient got sick. Action taken, outcome and relatedness were not provided. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out, but gained consciousness immediately.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: Pt developed mild Shingles rash lower back that developed into blisters over the following week - she was on a cruise.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Ultrasound antenatal screen
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a 16 year old female patient. Pertinent medical history and drug allergies were reported as none. On 06-NOV-2013, the patient was vaccinated with GARDASIL (lot # H017698, expiration date 02-JUL-2015, dose 1, 0.5 ml, intramuscular). No concomitant therapy was reported. In 2013 a few weeks later, the patient was confirmed to be pregnant with last menstrual period of 01-OCT-2013 and estimated date of conception of 08-JUL-2014. The patient sought medical attention (office visit). The patient had an ultrasound done at her Obstetrics Gynecology office which confirmed that she was 12 weeks pregnant. The patient did not receive any treatment. The pregnancy outcome was unknown. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient report: 3 in x 5 in area of redness, swelling, soreness at site fatigue.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Hypoaesthesia, Swelling face
Clinical narrative: Swelling of inside of cheek on left side - numb feeling - difficulty swallowing when taking pills. Duration from 10/9/13 to present.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Flu shot given 12-18-13 (L) deltoid. Patient reports on 19th midday she noticed site was sore and a circle area swollen and slightly red. No treatment. 12-20 injection site - 40 mm circle - slightly raised and red, warm to touch. Advised by NP to take ZYRTEC and apply ice. 12-23-13 site fully normal - Patient said it was gone by next day.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Large, warm, red rash.