chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Bone pain, Hepatitis A antibody, Liver function test
Clinical narrative: Bilateral collar bone pain, occurring afternoon the immunization was administered.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Diffuse redness in the armpit and around arm. Swelling and painful. Pt is following up w/local MD.
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Facial rash developed following receiving influenza vaccination. Rash on face developed 2 hours after receiving vaccination. No respiratory symptoms.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Redness and inflammation post vaccination. (R) thigh circumference-30.5 cm. (L) thigh circumference-34.5cm.
Sex: U
Vaccine: MMR, MMR
Symptoms: Inflammatory bowel disease
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concurrent condition and medical history were not reported. On an unknown date, the patient was vaccinated with an unspecified number of doses of M-M-R II (dose, lot#, expiration date and route were unknown). On an unknown date, the patient experienced an inflammatory bowel disease. The outcome of the event was unknown at the time of report. The relatedness between vaccination with M-M-R II and inflammatory bowel disease was not provided. Follow up information has been received on 07-OCT-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Upon internal review, inflammatory bowel disease was determined to be medically significant. Additional information has been requested. Event and Narrative was updated.
Age: 63.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain
Clinical narrative: Patient's husband reported severe arm pain in shoulder and upper arm, in the arm that intramuscular injection was given for Influenza vaccination. Injection was administered at pharmacy under protocol into left deltoid.
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Rash generalised, Urticaria
Clinical narrative: Full body rash.
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Rash generalised
Clinical narrative: Full body rash.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Crying, Emotional distress, Fear, Screaming
Clinical narrative: Crying episodes, increased anxiety and hypervigilance to sounds.  Unable to sleep for 4 nights.  NO fevers, rash, vomiting, diarrhea, change in appetite.  Behavioral problems come and go, but are different then prior to immunizations.  Parent took child to ED x2 due to behavioral concerns.  Exam (including vital signs) unremarkable at those times (05Oct and 10Oct).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Insomnia, Pyrexia, Screaming, Skin warm
Clinical narrative: Crying episodes, increased anxiety and hypervigilance to sounds.  Unable to sleep for 4 nights.  NO fevers, rash, vomiting, diarrhea, change in appetite.  Behavioral problems come and go, but are different then prior to immunizations.  Parent took child to ED x2 due to behavioral concerns.  Exam (including vital signs) unremarkable at those times (05Oct and 10Oct).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Anxiety, Crying, Hypervigilance, Insomnia
Clinical narrative: Crying episodes, increased anxiety and hypervigilance to sounds.  Unable to sleep for 4 nights.  NO fevers, rash, vomiting, diarrhea, change in appetite.  Behavioral problems come and go, but are different then prior to immunizations.  Parent took child to ED x2 due to behavioral concerns.  Exam (including vital signs) unremarkable at those times (05Oct and 10Oct).
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: Significant pain and mild swelling in vaccinated arm. 200 mg Naproxen at 6 PM did not reduce pain significantly, so 600 mg Ibuprofen was also given at 9:30 PM, reducing pain enough to sleep.  Fatigue throughout evening.  Pain continued at decreasing levels at least through date of reporting, with still noticeable swelling.
Age: 12.0
Sex: M
Vaccine: FLUX, HPVX, MNQ
Symptoms: Vaccination site cellulitis
Clinical narrative: Cellulitis at site of vaccination.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Dizziness, Headache, Impaired driving ability, Nausea
Clinical narrative: Upper body shakes, then about an hour later vomited 3 times, bad headache, light headed (almost fell twice). Was at my daughter's and was unable to drive home, therefore stayed overnight. Entire body felt very heavy throughout the night, as well as headache/nausea. In morning still felt the same and my sister drove me to my doctor's. Doctor prescribed Meclizine 25 MG Tablet, as well as Tylenol and Benadryl. Stayed in bed and slept. The night of Oct. 6th woke up middle of night damp pj's, as if fever had broken.  Felt better Oct. 7th.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Night sweats, Tremor, Vomiting
Clinical narrative: Upper body shakes, then about an hour later vomited 3 times, bad headache, light headed (almost fell twice). Was at my daughter's and was unable to drive home, therefore stayed overnight. Entire body felt very heavy throughout the night, as well as headache/nausea. In morning still felt the same and my sister drove me to my doctor's. Doctor prescribed Meclizine 25 MG Tablet, as well as Tylenol and Benadryl. Stayed in bed and slept. The night of Oct. 6th woke up middle of night damp pj's, as if fever had broken.  Felt better Oct. 7th.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site urticaria, Pruritus generalised, Urticaria
Clinical narrative: Redness and hives local to shot and spreading to chest, face, and back, itching all over.
Age: 23.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Musculoskeletal pain, Neck pain
Clinical narrative: PAIN RADIATING UP THROUGH MY NECK AND DOWN PART OF MY BACK. PAIN HAS CONTINUED TO STAY IN MY THE UPPER PORTION OF MY BACK RIGHT BESIDE MY RIGHT SHOULDER BLADE. PAIN SEEMS TO BE WORSE IN MORNING WHEN I WAKE UP OR IF I AM NOT MOVING AROUND. ALL OF THIS WAS THE REGULAR FLU SHOT GIVEN BY OCCUPATIONAL HEALTH.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU4, PPV, FLU4, PPV
Symptoms: Pneumonia, Pyrexia
Clinical narrative: Pt received 2 shots on the same day in same arm (per pt request). Next day she had 104 fever, then continued for 3 days w/no relief from OTC products. Seeked medical assistance, at which she was admitted for PNA.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU4, PPV, FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Pt received 2 shots on the same day in same arm (per pt request). Next day she had 104 fever, then continued for 3 days w/no relief from OTC products. Seeked medical assistance, at which she was admitted for PNA.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: On 10/03/16, 84 yo F presented to clinic for scheduled appointment. During this visit, pt was ordered to receive pneumococcal conjugate vaccine 13-valent IM (PREVNAR 13) [IMM78] (Ord #217343176). Per immunization record, pt received 0.5 mL in left deltoid (NDC #0005-1971-01; Lot #n16561). Pt tolerated injection without incident and was discharged home. On 10/10, pt called clinic and reported that she had persistent redness at the injection site that started to spread towards her inner arm, was accompanied by pain and was not responding to treatment with ice and ibuprofen 400 mg every 4 hours. On exam, pt was found to be afebrile with Temp:  36.9 °C (98.5 °F). MD advised continued symptomatic care with ice and acetaminophen. Pt was advised to return to clinic in about 1 week if symptoms worsened or failed to improve.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pyrexia
Clinical narrative: Chills, fever(104.1F-Digital readout).
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary mass, Injection site inflammation
Clinical narrative: Case PHEH2016US025800 is an initial spontaneous report received from a pharmacist on 05 Oct 2016. This report refers to a 79 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1615401) at a dose of 0.5 ml intramuscularly on 03 Oct 2016. On 05 Oct 2016, it was reported that the patient received vaccine two days ago and now she had fist-sized inflammation under her armpit on the arm where the vaccine was administered. She had not sought out medical attention for bump since noticed. The outcome of events was unknown. The seriousness of events was reported as medically significant. The causality of the events was not reported.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pneumonia
Clinical narrative: This report was received from Pfizer and was assigned manufacturer report number 2016451998 for PREVNAR 23. Information has been received from a currently 77 year old female patient referring to herself. The patient's concurrent condition, medical history and concomitant medication were not reported. In 1994 or 1999 (not sure which year), the patient received her first pneumonia shot (manufacturer unknown) (lot #, expiration date, dose and route were not reported). It was reported there was no reaction except maybe a little bit of a sore arm. After receiving the shot in 1994 or 1999 (prior to 2005, date unspecified), the patient had pneumonia. She was unsure if she had arm tenderness at that time. The outcome of pneumonia and sore arm was unknown. The causality between the events and the pneumonia shot (manufacturer unknown) was not reported. Upon internal review, pneumonia was considered to be medically significant. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Given Flu vaccine on 10/6/16 - pain on scale of 8/10 started within a few hours. Seen in office on 10/7 for evaluation. No skin changes noted - pain noted with ROM -Limited ROM due to pain. Seen for eval today 10/10 -Refer to ortho for further eval for sore/tingling related to vaccine. Shot given in upper outer aspect of arm. Receiving narcotic pain med for pain relief.
Age: 69.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Amnesia, Confusional state
Clinical narrative: Pt reports confusion, memory loss lasting approximately 1 hour occurring after leaving physicians office. S/P receiving vaccination.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Product preparation error
Clinical narrative: Wrong diluent used. A sterile solution diluent was used in error to mix/reconstitue vaccine with.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Injection site pain, Neck pain, Swelling
Clinical narrative: 10/4/16 About the time patient went to bed, pain started in the site of vaccination and then into left side of neck. 10/5/16 Slept, next morning the left side of neck was very painful and then the right side of neck also became very painful. 10/6/16 By Thursday morning was lost control of shoulder muscles. Felt the area along his back between shoulders was swollen. Felt overall fatigue and not able to maintain normal activities. Tried to work but was unable to and went home. 10/7/16 Started to feel normal again and returned to work. Minor discomfort during the day. 10/11/2016.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Cardiac flutter, Dyspnoea, Rash, Urticaria
Clinical narrative: Pt had rash/hives around mouth and c/o SoB and heart "fluttering". Vitals were elevated. Provider rx'ed Epi x 2, Diphenhydramine 25mg x 2, Solumedrol 125mg x 1.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Blood in Stool, continue feeding and routine infant care and return in 1 week to recheck stool for blood.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient felt sore at injection site. Patient applied VASELINE/VICKS to injection site, but has no relief. She states that the pain is further up toward her shoulder blade and naproxen wasn't helpful.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Dizziness, Heart rate increased, Throat irritation
Clinical narrative: Assoc states felt heart beating fast, light headed, burning in throat to neck/chest area - lasted approx 8-10 min - radial pulse checked was 88-62 and regular - no hive, SOB, N/V.
Age: 67.0
Sex: U
Vaccine: FLU3
Symptoms: Local swelling, Tenderness
Clinical narrative: Patient was given flu shot in left upper arm. Returned on 10-7-16 with 4x4 swollen, tender area.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Influenza like illness, Nausea, Vertigo
Clinical narrative: 24 hrs after vaccination. Flu like symptoms, vertigo, dizziness, nausea. Recovered after 72 hrs.
Age: 61.0
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Red, swollen, stabbing pain. I received the Influenza Virus Vaccine (AFLURIA preservative free intramuscular suspension prefilled syringe 0.5 ML). I have this large red spot or rash on my arm (picture took). It has been swollen and hurting with a stabbing pain where the needle went in. I have always taken the flu shot this is the first time I have ever had any problems. Have been sleeping most of the day. Thinking things may get better. Since, I have never had any problems before in the past. If, the problem don't get any better I will be going to the hospital to seek help.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Nodule, Swelling
Clinical narrative: He was given AFLURIA and PREVNAR 13 in the same arm. The area where he got the AFLURIA developed a large swollen nodule and arm became bruised 36 hours after the shot and is still swollen and bruised a week later. Received PREVNAR 13 the same day in the same arm about 1 inch apart but that area doesn't seem to be involved.
Age: 38.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Erythema, Injection site swelling, Skin warm, Swelling
Clinical narrative: Pt. reports to this clinic observe increased swelling at the injection site, noted approx. nickel size redness/swelling warm to touch. Instructed pt. to take ibuprofen or another anti-inflammatory, also can apply cool pack she had only did this, 20 minutes at a time. Also explain can use hydrocortisone cream or topical BENADRYL topically.
Age: 50.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received vaccine at 1031 10/10/16. Developed warmth, swelling, slight pink color, under at left deltoid injection site approx. 1900 10/10/16. Was advised on home treatment but told nurse he did not try any suggested advice.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: CSF test, Electromyogram, Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Progressive LE ascending weakness/paresthesias with clinical evidence of Guillain Barre syndrome requiring hospitalization/IVIg plus plasma exchange.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Nerve conduction studies, Paraesthesia, Plasmapheresis
Clinical narrative: Progressive LE ascending weakness/paresthesias with clinical evidence of Guillain Barre syndrome requiring hospitalization/IVIg plus plasma exchange.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Vaccine administered at 10:55 am, at 11:02 am client had broke out with hives around the neck. EPIPEN Jr. auto injector used at 11:03 am and Ambulance called. Ambulance arrived at 11:08 am, breathing ok at that time. Ambulance departed with client to ER at 11:20 am.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Patient called the office stating that the area where the injection was given was "fine" for 3 days and on the 3rd day she developed a raised, spotted, red rash. Patient was seen and DX: with cellulitis and given an antibiotic.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Chills, Headache, Mobility decreased, Pain
Clinical narrative: Chills, Severe headache and body aches, heart palpitations, chest soreness.  Unable to get out of bed.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Palpitations
Clinical narrative: Chills, Severe headache and body aches, heart palpitations, chest soreness.  Unable to get out of bed.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site mass, Rash erythematous, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Lump on vaccine site, red rash with heat spreading down my upper arm.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash generalised, Swelling face
Clinical narrative: Patient received 2nd set of shots (Dtap-IPV-Hib-PCV13-MMR-Var) on 10/3/16. Mother called on 10/6/16 & stated that patient ran a fever on 10/4 and 10/5 but on 10/6, woke up and "face was swollen and small red bumps all over his body". Advised to go see PMD. On 10/11/16, I called to check on patient and Mother informed that he remained the same today.  Stated she did could not get in to see the Doctor on 10/6.  Advised her today that she should take him in to see Doctor. Verbalized understanding.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Bone pain, Hallucination, Pyrexia, Vomiting
Clinical narrative: Approx. 8 hrs after getting vaccine pt said she felt severe bone/joint pain coupled with a fever of 103F, vomiting, and hallucinations. Resolved after 24 hours.
Age: 52.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Headache, Injection site erythema, Injection site rash, Injection site swelling, Neck pain
Clinical narrative: Influenza Vaccine given in Right Deltoid. Approximately 30 minutes post vaccine administration, redness, swelling and fine rash to upper arm and vaccine site developed. Severe headache, neck and jaw pain also developed. All symptoms lasted approximately 12 hours. Pt reported she took ibuprofen and BENADRYL for symptoms.
Age: 52.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain in jaw
Clinical narrative: Influenza Vaccine given in Right Deltoid. Approximately 30 minutes post vaccine administration, redness, swelling and fine rash to upper arm and vaccine site developed. Severe headache, neck and jaw pain also developed. All symptoms lasted approximately 12 hours. Pt reported she took ibuprofen and BENADRYL for symptoms.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Discomfort, Pruritus, Swelling
Clinical narrative: ITCHY, SWOLLEN AND UNCOMFORTABLE.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Flank pain, Injection site pain, Lymphadenopathy, Musculoskeletal pain
Clinical narrative: Parent reports child c/o pain all over left side of her body - arm, shoulder, flank, buttocks and thigh upper abd pain and "swollen glands under her chin". Parent gave Ibuprofen says helped only small amount. Parent did not seek any medical attention until telling IZ clinic of symptoms today. Was referred to seek medical attention today/ options reviewed with parent for medical care facilities.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Parent reports child c/o pain all over left side of her body - arm, shoulder, flank, buttocks and thigh upper abd pain and "swollen glands under her chin". Parent gave Ibuprofen says helped only small amount. Parent did not seek any medical attention until telling IZ clinic of symptoms today. Was referred to seek medical attention today/ options reviewed with parent for medical care facilities.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Head injury, Intensive care, Syncope
Clinical narrative: Syncope 10 minutes after Tdap had head injury with this - admitted to ICU.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # M007762 with expiration date 07-DEC-2018 and lot # M014927 with expiration date 18-FEB-2019 (dose and route of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 11.8 degrees Celsius for 1 hour 3 minutes. Data logger was involved. There was previous excursion of 10.2 Celsius for 1 hour 3 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Urticaria
Clinical narrative: Rapid heartbeat, feeling faint, mild hives, feeling out of breath.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Asthenia, Balance disorder, CSF protein increased, Diabetic neuropathy
Clinical narrative: Feet started hurting and tingling about November 2nd. Got progressively worse throughout the week. Decided to go to doctor. Was told it was diabetic nerve pain. Went another week with feet still hurting more and more and my balance and leg strength reducing. Started getting tingling in fingers. Went to doctor again and Doctor sent me to a neurologist the following week. Kept appointment with neurologist and neurologist told me it was diabetic nerve pain. Numbness in feet and hands, pain in feet, and balance getting worse. Getting difficult to put on socks and shoes and open jars with hands. Got a cane because people thought I was drunk when I entered a room. Unable to carry a cup of coffee.  Went to a podiatrist to have feet checked out. Podiatrist called General Practitioner to say that they needed to take a look at me as something was going on. GP's office called and set me up to come in the following week. In the meantime I was talking with someone and he said that his relative had the same problem. CIDP. When I looked it up it sounded just like what I had. I brought this info to my GP and GP agreed that it very well could be GBS and wrote a note to the neurologist with whom I had an appointment that same day. Neurologist also agreed with this and told me to go to the emergency room right away and I would be tested and admitted for treatment.  This was in early December 2015.  Did a Nerve conduction test and a Spinal Tap. Spinal Tap found protein for GBS.  I received 5 days if IVIG in hospital and then sent to rehab for 2 weeks. I did walk into rehab very erratically with cane. Last time I walked by myself from that point to January 30th.  Unable to identify objects in my hands without looking. On January 1, 2016 I went to emergency and was admitted and treated with 5 courses of plasmapheresis over a 5 day span.  I was then discharged from the hospital and insisted on going home instead of rehab.  I did not feel that rehab had done anything for me the previous time I was there.  I was home for two weeks and I started to feel worse again.  Went to hospital again and was admitted again and again treated with 5 courses of plasmapheresis over a 5 day span.  Upon completion of the plasmapheresis, I was placed on 60 mg of prednisone per day.  I was taken home in a wheelchair and after a couple of days, I went to a walker.  After a couple more days, I felt stronger and started experimenting with releasing the walker and taking steps on my own.  On the 4th day after release from the hospital, I was walking on my own.  I did very well for the next 8 months and then on October 29, 2016, I started feeling pains in my feet again and progressed to tingling and starting to lose my balance for no reason.  Because of a hurricane on the east coast, I was unable to contact my doctor until October 10, 2016.  The doctor placed me on prednisone and that is where I'm at right now.  If I don't progress toward the recovery side in 3 or 4 days, I'll head for the emergency room.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Grip strength decreased, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture abnormal
Clinical narrative: Feet started hurting and tingling about November 2nd. Got progressively worse throughout the week. Decided to go to doctor. Was told it was diabetic nerve pain. Went another week with feet still hurting more and more and my balance and leg strength reducing. Started getting tingling in fingers. Went to doctor again and Doctor sent me to a neurologist the following week. Kept appointment with neurologist and neurologist told me it was diabetic nerve pain. Numbness in feet and hands, pain in feet, and balance getting worse. Getting difficult to put on socks and shoes and open jars with hands. Got a cane because people thought I was drunk when I entered a room. Unable to carry a cup of coffee.  Went to a podiatrist to have feet checked out. Podiatrist called General Practitioner to say that they needed to take a look at me as something was going on. GP's office called and set me up to come in the following week. In the meantime I was talking with someone and he said that his relative had the same problem. CIDP. When I looked it up it sounded just like what I had. I brought this info to my GP and GP agreed that it very well could be GBS and wrote a note to the neurologist with whom I had an appointment that same day. Neurologist also agreed with this and told me to go to the emergency room right away and I would be tested and admitted for treatment.  This was in early December 2015.  Did a Nerve conduction test and a Spinal Tap. Spinal Tap found protein for GBS.  I received 5 days if IVIG in hospital and then sent to rehab for 2 weeks. I did walk into rehab very erratically with cane. Last time I walked by myself from that point to January 30th.  Unable to identify objects in my hands without looking. On January 1, 2016 I went to emergency and was admitted and treated with 5 courses of plasmapheresis over a 5 day span.  I was then discharged from the hospital and insisted on going home instead of rehab.  I did not feel that rehab had done anything for me the previous time I was there.  I was home for two weeks and I started to feel worse again.  Went to hospital again and was admitted again and again treated with 5 courses of plasmapheresis over a 5 day span.  Upon completion of the plasmapheresis, I was placed on 60 mg of prednisone per day.  I was taken home in a wheelchair and after a couple of days, I went to a walker.  After a couple more days, I felt stronger and started experimenting with releasing the walker and taking steps on my own.  On the 4th day after release from the hospital, I was walking on my own.  I did very well for the next 8 months and then on October 29, 2016, I started feeling pains in my feet again and progressed to tingling and starting to lose my balance for no reason.  Because of a hurricane on the east coast, I was unable to contact my doctor until October 10, 2016.  The doctor placed me on prednisone and that is where I'm at right now.  If I don't progress toward the recovery side in 3 or 4 days, I'll head for the emergency room.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Muscular weakness, Nerve conduction studies, Neuralgia, Pain in extremity, Paraesthesia
Clinical narrative: Feet started hurting and tingling about November 2nd. Got progressively worse throughout the week. Decided to go to doctor. Was told it was diabetic nerve pain. Went another week with feet still hurting more and more and my balance and leg strength reducing. Started getting tingling in fingers. Went to doctor again and Doctor sent me to a neurologist the following week. Kept appointment with neurologist and neurologist told me it was diabetic nerve pain. Numbness in feet and hands, pain in feet, and balance getting worse. Getting difficult to put on socks and shoes and open jars with hands. Got a cane because people thought I was drunk when I entered a room. Unable to carry a cup of coffee.  Went to a podiatrist to have feet checked out. Podiatrist called General Practitioner to say that they needed to take a look at me as something was going on. GP's office called and set me up to come in the following week. In the meantime I was talking with someone and he said that his relative had the same problem. CIDP. When I looked it up it sounded just like what I had. I brought this info to my GP and GP agreed that it very well could be GBS and wrote a note to the neurologist with whom I had an appointment that same day. Neurologist also agreed with this and told me to go to the emergency room right away and I would be tested and admitted for treatment.  This was in early December 2015.  Did a Nerve conduction test and a Spinal Tap. Spinal Tap found protein for GBS.  I received 5 days if IVIG in hospital and then sent to rehab for 2 weeks. I did walk into rehab very erratically with cane. Last time I walked by myself from that point to January 30th.  Unable to identify objects in my hands without looking. On January 1, 2016 I went to emergency and was admitted and treated with 5 courses of plasmapheresis over a 5 day span.  I was then discharged from the hospital and insisted on going home instead of rehab.  I did not feel that rehab had done anything for me the previous time I was there.  I was home for two weeks and I started to feel worse again.  Went to hospital again and was admitted again and again treated with 5 courses of plasmapheresis over a 5 day span.  Upon completion of the plasmapheresis, I was placed on 60 mg of prednisone per day.  I was taken home in a wheelchair and after a couple of days, I went to a walker.  After a couple more days, I felt stronger and started experimenting with releasing the walker and taking steps on my own.  On the 4th day after release from the hospital, I was walking on my own.  I did very well for the next 8 months and then on October 29, 2016, I started feeling pains in my feet again and progressed to tingling and starting to lose my balance for no reason.  Because of a hurricane on the east coast, I was unable to contact my doctor until October 10, 2016.  The doctor placed me on prednisone and that is where I'm at right now.  If I don't progress toward the recovery side in 3 or 4 days, I'll head for the emergency room.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Plasmapheresis, Scan brain, Walking aid user, Wheelchair user
Clinical narrative: Feet started hurting and tingling about November 2nd. Got progressively worse throughout the week. Decided to go to doctor. Was told it was diabetic nerve pain. Went another week with feet still hurting more and more and my balance and leg strength reducing. Started getting tingling in fingers. Went to doctor again and Doctor sent me to a neurologist the following week. Kept appointment with neurologist and neurologist told me it was diabetic nerve pain. Numbness in feet and hands, pain in feet, and balance getting worse. Getting difficult to put on socks and shoes and open jars with hands. Got a cane because people thought I was drunk when I entered a room. Unable to carry a cup of coffee.  Went to a podiatrist to have feet checked out. Podiatrist called General Practitioner to say that they needed to take a look at me as something was going on. GP's office called and set me up to come in the following week. In the meantime I was talking with someone and he said that his relative had the same problem. CIDP. When I looked it up it sounded just like what I had. I brought this info to my GP and GP agreed that it very well could be GBS and wrote a note to the neurologist with whom I had an appointment that same day. Neurologist also agreed with this and told me to go to the emergency room right away and I would be tested and admitted for treatment.  This was in early December 2015.  Did a Nerve conduction test and a Spinal Tap. Spinal Tap found protein for GBS.  I received 5 days if IVIG in hospital and then sent to rehab for 2 weeks. I did walk into rehab very erratically with cane. Last time I walked by myself from that point to January 30th.  Unable to identify objects in my hands without looking. On January 1, 2016 I went to emergency and was admitted and treated with 5 courses of plasmapheresis over a 5 day span.  I was then discharged from the hospital and insisted on going home instead of rehab.  I did not feel that rehab had done anything for me the previous time I was there.  I was home for two weeks and I started to feel worse again.  Went to hospital again and was admitted again and again treated with 5 courses of plasmapheresis over a 5 day span.  Upon completion of the plasmapheresis, I was placed on 60 mg of prednisone per day.  I was taken home in a wheelchair and after a couple of days, I went to a walker.  After a couple more days, I felt stronger and started experimenting with releasing the walker and taking steps on my own.  On the 4th day after release from the hospital, I was walking on my own.  I did very well for the next 8 months and then on October 29, 2016, I started feeling pains in my feet again and progressed to tingling and starting to lose my balance for no reason.  Because of a hurricane on the east coast, I was unable to contact my doctor until October 10, 2016.  The doctor placed me on prednisone and that is where I'm at right now.  If I don't progress toward the recovery side in 3 or 4 days, I'll head for the emergency room.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain upper, Nausea, Pyrexia, Rash, Rash erythematous
Clinical narrative: Per mom, on 9/8 after receiving the BEXSERO vaccine, on the way home, developed stomach pain. By dinner time, started vomiting. Mom then gave Benadryl. THen developed red, itchy rash on legs. By the morning, the rash was generalized. Vomited for 1 day total and nauseated for 3 days total. Rash lasted X 1 week. Had low-grade fever.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Rash generalised, Rash pruritic, Vomiting
Clinical narrative: Per mom, on 9/8 after receiving the BEXSERO vaccine, on the way home, developed stomach pain. By dinner time, started vomiting. Mom then gave Benadryl. THen developed red, itchy rash on legs. By the morning, the rash was generalized. Vomited for 1 day total and nauseated for 3 days total. Rash lasted X 1 week. Had low-grade fever.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Face injury, Fall, Syncope
Clinical narrative: Patient received Gardasil 9, Menactra, and Adacel in clinic. Shortly after patient fainted and fell on the floor. Hit his face, was assessed by Dr. and no signs of injury or neurological changes present. Patient left clinic appearing well.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability, Lethargy, Pyrexia, Somnolence, Staring
Clinical narrative: LETHARGY, FEVER, EXCESSIVE SLEEPINESS, DIFFICULT TO WAKE TO FEED SYMPTOMS LASTED FOR 4 DAYS. FUSSINESS, OFF AND ON BLANK STARE LASTED FOR 8 DAYS.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site induration, Injection site mass
Clinical narrative: Mother reported firm area on right thigh where Pediarix vaccine was administered. He came back to clinic a week later to get it checked. At the time of that visit on 8/29/2016 he had a firm sized discrete mass about size of nickel on same spot. He was well otherwise.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Back pain, Body temperature increased, Urine analysis normal
Clinical narrative: Increasing low back pain which became severe by 10/3. Started having temp up to 101 on 10/4 with extreme weakness; could not get out of bed. Saw doctor on 10/4 and got urine test which was neg. Temp and severe low back pain and extreme weakness continued. Saw doctor on 10/7 and started on 5 days of 10 mg Prednisone, 6-5-4-3-2-1. Temp back to normal by 10/9 but severe back pain and weakness continues to be a problem as of the date of this submission, 10/11. If it does not improve in a few days will return to doctor.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Injection site bruising, Injection site erythema, Injection site haemorrhage, Injection site induration, Injection site pain
Clinical narrative: Redness and swelling of injection site. 5 cm x 1 cm rectangular area of purple brusing on left thigh, felt slightly firm under bruising site. Minimally tender. About 10 scattered pinpoint petechiae on left thigh leg and ankle.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Injection site swelling, Petechiae
Clinical narrative: Redness and swelling of injection site. 5 cm x 1 cm rectangular area of purple brusing on left thigh, felt slightly firm under bruising site. Minimally tender. About 10 scattered pinpoint petechiae on left thigh leg and ankle.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea
Clinical narrative: STARTED TO EXPERIENCE CONSTANT DIARRHEA WHICH LASTED UNTIL 10/10/2016.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Large erythematous rash just below injection site, approximately 5cmX5cm, area was raised and warm to the touch, treated with ice and ibuprofen.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Fever of 101.3, chills, body aches, headache, vomiting.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Patient experienced itching on the arm of the injection site 10/9/16 and then developed a rash on 10/10/16 about 3 inches by 2.5 inches below the injection site.
Age: 62.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Headache, Immediate post-injection reaction, Urticaria
Clinical narrative: Patient said that he had a mild headache immediately post vaccination, and about 5 minutes later, a red wheal of approximately 10x10cm noted on left anterior chest wall close to the vaccination site. Patient denied itching to the wheal, shortness of breath or any other symptom. BENADRYL offered to patient but he declined and said that he was okay. Patient was kept in the clinic for 30 minutes and monitored. Vital signs were 137/83, pulse 87, temp 97.1. 30 minutes after patient was given the vaccine, site of wheal was inspected, and the redness had reduced as well as the wheal. Patient denied any shortness of breath, wheezing, itching weakness. Patient said that he needed to go, and left the clinic. Patient informed that VAERS will be notified and that he should go to the emergency room if his reaction gets worse. Patient verbalized understanding.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Patient woke up with fever, body ache and fatigue.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Patient experienced high fever over night after vaccine. Also felt extreme fatigue, aches, chills, and low grade fever 3 days later.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # L015282 with expiration date 30-APR-2017, lot# M002419 with expiration date 12-JAN-2018 and lot # L039613 with expiration date 08-OCT-2017 (dose and route of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 11.8 degrees Celsius for 1 hour 3 minutes. Data logger was involved. There was previous excursion of 10.2 Celsius for 1 hour 3 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 year old male patient (also reported as 57 years old). No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 08-OCT-2016, the patient was vaccinated with ZOSTAVAX (which had a lot # of M020071 with an expiration date of 18-JUL-2017), subcutaneously, (the dose and dosage number were unknown). No concomitant therapies were reported. Subsequently, on 10-OCT-2016, the patient experienced swelling, redness, warmth, and tenderness at the injection site. No treatment was provided for the events and no product quality complaint was involved. At the time of reporting, it was believed that the events remained unsolved. The reporter failed to provide any explicit causal relationship between the events and the vaccination with ZOSTAVAX. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient states that the afternoon after receiving vaccines her right arm began to hurt as she was counseled would occur and has continued to hurt ever since and that it is still hurting and she has limited movement in her right arm.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Fatigue, Influenza like illness, Lethargy, Myalgia
Clinical narrative: Muscle aches and extreme fatigue; tired and lethargic; lasted about 5-7 days.  Just not herself; felt "fluish".
Age: 32.0
Sex: M
Vaccine: FLUX
Symptoms: Malaise, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Vomit, Nausea, Fever, body Aches, Malaise.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Arthralgia, Balance disorder, Chills, Dizziness
Clinical narrative: (times are approx.) 9/9/15 5:15 pm  Received shot in left arm at pharmacy. 5:25 pm - Felt flush and slightly dizzy while driving home, quickly got worse, broke out into sweat, pulled over into a neighborhood.  Started to pass out. Everything in a haze.  Thought about calling 911, but wasn't getting worse.  Slowly started feeling better.  After about 5 minutes drove the short distance to home. 5:35 pm - Arrived home and was soaking wet.  Somone commented that I was gray.  Still dizzy and light headed. 6:00 pm - Still dizzy, took pulse = 56 and BP = 125/69.  Felt cold even though house was 74 degrees.  Put on warm clothes, but still felt cold.  Wrapped up in blanket in chair and rested.  Felt like when have fever with chills. 8:00 pm  Suddenly got very warm.  Felt like had fever.  Took temp = exactly 98.6. As evening went on began to notice scratchy throat and hoarseness when talking.  Had to keep clearing throat to talk. Later on noticed if close eyes it feels like head is swimming and felt unbalanced.  Don't notice much dizziness or swimming when eyes open.  When went to bed head was swimming. 9/10/16 In morning woke early with slight headache and very warm.  Head still slightly swimming.  Ate breakfast.  Felt in a haze and just didn't feel good.  Didn't want to move around very fast. Noticed left elbow joint painful  down deep in joint. As morning went on head still slightly swimming, but noticeably less. Late afternoon stopped noticing head swimming, even with eyes closed. At night, no noticeable symptoms and elbow no longer painful. 9/11/16 Woke up after sleeping solid for 9 hours.  Don't usually sleep that long. Left arm near injection site sore and red, which had not been before now.  During day redness spread some. 9/12/16 Injection site now painful to light touch. 9/13/16 New occasional aching down deep in upper arm and twinges of pain when move arm. 9/14/16  9/16/16 Aching in arm slowly diminished and no other symptoms.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysphonia, Feeling abnormal, Feeling cold, Feeling hot, Flushing
Clinical narrative: (times are approx.) 9/9/15 5:15 pm  Received shot in left arm at pharmacy. 5:25 pm - Felt flush and slightly dizzy while driving home, quickly got worse, broke out into sweat, pulled over into a neighborhood.  Started to pass out. Everything in a haze.  Thought about calling 911, but wasn't getting worse.  Slowly started feeling better.  After about 5 minutes drove the short distance to home. 5:35 pm - Arrived home and was soaking wet.  Somone commented that I was gray.  Still dizzy and light headed. 6:00 pm - Still dizzy, took pulse = 56 and BP = 125/69.  Felt cold even though house was 74 degrees.  Put on warm clothes, but still felt cold.  Wrapped up in blanket in chair and rested.  Felt like when have fever with chills. 8:00 pm  Suddenly got very warm.  Felt like had fever.  Took temp = exactly 98.6. As evening went on began to notice scratchy throat and hoarseness when talking.  Had to keep clearing throat to talk. Later on noticed if close eyes it feels like head is swimming and felt unbalanced.  Don't notice much dizziness or swimming when eyes open.  When went to bed head was swimming. 9/10/16 In morning woke early with slight headache and very warm.  Head still slightly swimming.  Ate breakfast.  Felt in a haze and just didn't feel good.  Didn't want to move around very fast. Noticed left elbow joint painful  down deep in joint. As morning went on head still slightly swimming, but noticeably less. Late afternoon stopped noticing head swimming, even with eyes closed. At night, no noticeable symptoms and elbow no longer painful. 9/11/16 Woke up after sleeping solid for 9 hours.  Don't usually sleep that long. Left arm near injection site sore and red, which had not been before now.  During day redness spread some. 9/12/16 Injection site now painful to light touch. 9/13/16 New occasional aching down deep in upper arm and twinges of pain when move arm. 9/14/16  9/16/16 Aching in arm slowly diminished and no other symptoms.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Injection site erythema, Injection site pain, Pain
Clinical narrative: (times are approx.) 9/9/15 5:15 pm  Received shot in left arm at pharmacy. 5:25 pm - Felt flush and slightly dizzy while driving home, quickly got worse, broke out into sweat, pulled over into a neighborhood.  Started to pass out. Everything in a haze.  Thought about calling 911, but wasn't getting worse.  Slowly started feeling better.  After about 5 minutes drove the short distance to home. 5:35 pm - Arrived home and was soaking wet.  Somone commented that I was gray.  Still dizzy and light headed. 6:00 pm - Still dizzy, took pulse = 56 and BP = 125/69.  Felt cold even though house was 74 degrees.  Put on warm clothes, but still felt cold.  Wrapped up in blanket in chair and rested.  Felt like when have fever with chills. 8:00 pm  Suddenly got very warm.  Felt like had fever.  Took temp = exactly 98.6. As evening went on began to notice scratchy throat and hoarseness when talking.  Had to keep clearing throat to talk. Later on noticed if close eyes it feels like head is swimming and felt unbalanced.  Don't notice much dizziness or swimming when eyes open.  When went to bed head was swimming. 9/10/16 In morning woke early with slight headache and very warm.  Head still slightly swimming.  Ate breakfast.  Felt in a haze and just didn't feel good.  Didn't want to move around very fast. Noticed left elbow joint painful  down deep in joint. As morning went on head still slightly swimming, but noticeably less. Late afternoon stopped noticing head swimming, even with eyes closed. At night, no noticeable symptoms and elbow no longer painful. 9/11/16 Woke up after sleeping solid for 9 hours.  Don't usually sleep that long. Left arm near injection site sore and red, which had not been before now.  During day redness spread some. 9/12/16 Injection site now painful to light touch. 9/13/16 New occasional aching down deep in upper arm and twinges of pain when move arm. 9/14/16  9/16/16 Aching in arm slowly diminished and no other symptoms.