chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Mobility decreased
Clinical narrative: Severe Headache. Severe sharp stomach pains. Severe joint aches. Severe tissue pain from past breast surgery, which had not been present before. Other tissue pain. Dizziness, weakness, pain at site of shot. Was in bed for two weeks. Doctor said the symptoms would gradually diminish and end.    Eight months later they had barely diminished and I have lost a large percentage of my capabilities.  Trouble getting in car and getting up. Doctor is working on plan. Increased Bupropion. I'm taking vitamins and antiflametory meds. I did not have these symptoms before this vaccination. I actually felt as if I might die.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Cellulitis
Clinical narrative: Pt presented to urgent care for cellulitis left leg after vaccines on Friday at health department was given MMR/varicella together and DTaP and IPV 2 in each leg. Mother is not aware which leg got which vaccines he has had all 4 of these vaccines in the past without reaction. We did not give the vaccines so do not have lot numbers you will need to follow up with his primary's office that gave them.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Shivering chills resolved long enough to get to sleep.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis, Lethargy, Mobility decreased, Myalgia
Clinical narrative: After going home with my newborn baby I developed a high fever of 104.6, I was dizzy and unable to get up without support to nurse my baby. I was sweating Profusely and also experiencing muscle soreness and lethargy. I honestly thought I was going to die that night. Thankfully most symptoms subsided the following day but soreness and the excessive sweating stuck around for about 2 weeks after the injection. I will not ever get the flu vaccine again, or give it to any of my children.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: After going home with my newborn baby I developed a high fever of 104.6, I was dizzy and unable to get up without support to nurse my baby. I was sweating Profusely and also experiencing muscle soreness and lethargy. I honestly thought I was going to die that night. Thankfully most symptoms subsided the following day but soreness and the excessive sweating stuck around for about 2 weeks after the injection. I will not ever get the flu vaccine again, or give it to any of my children.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Fever, shivering, muscle pains, headache, upset stomach, weakness, tired.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever, shivering, muscle pains, headache, upset stomach, weakness, tired.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site pain
Clinical narrative: Pain during injection (more than I've had with any previous injection of any type); significant soreness and some pain, and intermittent burning sensation down arm, from shoulder, into the next day.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Mobility decreased, Myalgia
Clinical narrative: Received the Recombinant Zoster Vaccine injection shortly after 9:30 am at the Clinic on March 1st.  By about 1:00 am on Saturday, March 2nd, started feeling feverish, nauseated, cold shivers in spite of extra blankets and severe pain at site of injection. Muscle aches were so bad that had great difficulty arising from bed to use the bathroom. Symptoms continued the rest of Saturday with temperatures measured by a temple thermometer ranging from 99.8 to 100.4. Nausea and temperature finally subsided by Sunday late afternoon, but still experienced unusual fatigue. My wife also received the same type of vaccine within a few minutes of mine, had many of the same symptoms, but hers had mostly subsided by mid-Saturday morning.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Received the Recombinant Zoster Vaccine injection shortly after 9:30 am at the Clinic on March 1st.  By about 1:00 am on Saturday, March 2nd, started feeling feverish, nauseated, cold shivers in spite of extra blankets and severe pain at site of injection. Muscle aches were so bad that had great difficulty arising from bed to use the bathroom. Symptoms continued the rest of Saturday with temperatures measured by a temple thermometer ranging from 99.8 to 100.4. Nausea and temperature finally subsided by Sunday late afternoon, but still experienced unusual fatigue. My wife also received the same type of vaccine within a few minutes of mine, had many of the same symptoms, but hers had mostly subsided by mid-Saturday morning.
Age: 79.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Injected limb mobility decreased, Injection site nodule, Loss of personal independence in daily activities, Muscular weakness, Musculoskeletal disorder
Clinical narrative: Patient reports that he experienced prolonged weakness and pain in both arms. He states that the pain is persistent still today 7 months after received these vaccines. He says that his right arm is still more sore than the left arm and he cannot do much still with the right arm. He is not able to lift the arm and he states he couldn't drink his coffee initially or write checks or use his credit card. He required assistance with all of these tasks. He says lifting things and twisting make it worse. He says he still feels a knot in his right arm where the SHINGRIX vaccine was administered.
Age: 79.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient reports that he experienced prolonged weakness and pain in both arms. He states that the pain is persistent still today 7 months after received these vaccines. He says that his right arm is still more sore than the left arm and he cannot do much still with the right arm. He is not able to lift the arm and he states he couldn't drink his coffee initially or write checks or use his credit card. He required assistance with all of these tasks. He says lifting things and twisting make it worse. He says he still feels a knot in his right arm where the SHINGRIX vaccine was administered.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Patient came in today (March 3rd) showing me her left arm. It was bruised near the elbow on the inside and it was read from the injection site down her forearm. Its very swollen and red.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Nausea
Clinical narrative: Severe pain at injection site, shivering, nauseous, and right arm where injected still very sore.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Pyrexia
Clinical narrative: Recieved shot on 2-27 at 647 pm Low grade fever after 5 hours. Soreness / upset stomach  all joints and then 102.5 fever from 2-28-2019 10am until 4pm on 2-28. All joints sore on 3-1 but no fever. 3-2 back to normal.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Pyrexia, Swelling
Clinical narrative: .On 2/27/2019 at 2 pm. At 8pm severe stomachache/cramping she was running a fever of 101 degrees and became nauseous with vomiting and diarrhea from 1030pm to midnight. Joint soreness all over and low fever continued all day 2-28-2019. On 3-1-2019 slight swelling near her collarbone and joint soreness and nausea. 3-2-2019 soreness and then 3-3-2019 back to normal.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: .On 2/27/2019 at 2 pm. At 8pm severe stomachache/cramping she was running a fever of 101 degrees and became nauseous with vomiting and diarrhea from 1030pm to midnight. Joint soreness all over and low fever continued all day 2-28-2019. On 3-1-2019 slight swelling near her collarbone and joint soreness and nausea. 3-2-2019 soreness and then 3-3-2019 back to normal.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Lymphadenopathy, Swelling
Clinical narrative: On Saturday morning, Jan. 26, 2019, I woke up and my neck was totally swollen - really big, smooth - from just under my chin to the bottom of my neck. It's possible that it started the night before, but I don't know. I had no trouble swallowing or eating or breathing. But the humongous swelling scared me. As I kept checking in the mirror periodically, the swelling was lessening. I searched the internet trying to find a cause, then remembered I had the SHINGRIX shot 2 days before, tho I couldn't imagine why an adverse effect or allergic reaction would come so long after the innoculation. Even tho the swelling kept lessening (I was in no pain), at around 3:30 p.m.,  I went to urgent care. A physician assistant or nurse practitioner, decided it was an allergic reaction to the SHINGRIX. She gave me a shot of cortisone in my rear end and prescribed the MEDROL PAK (Methylprednisolone 4 mg. dose pack) - a 6 day package to be started the day after. I followed up with my PCP a few days later, and at the time I was left with swollen lymph nodes.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Pain in extremity
Clinical narrative: Patient complained of sore and painful arm the day after injection, but injection became red and inflammed 2 days later.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: Chills and high fever. Rash on thigh. Taking Benadryl, Tylenol and ibuprofen.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Headache, nausea, muscle and joint pain, fatigue.
Age: 71.0
Sex: M
Vaccine: FLUA3
Symptoms: Acupuncture, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient says shot was painless and in the right location but 2-3 days starting having troubles with range of motion in right arm. Pain localized to injection site. has not got better. can left a shopping bag but opening a car door is difficult.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Same flu-like symptoms that patient had previously, lasted for a day, less severe this time around.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Red welt like covering the entire right deltoid, no report of pain or fever, seems like cosmetic only per patient. It is subsiding gradually.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills at about 11:00AM on 3/1/19, followed by fever and headache about 30 minutes later, lasting 36 hours (symptoms eased at 2:00PM on 3/3/19 ... one 200mg tablet of ibuprofen every 4-6 hours helped reduce but eradicate the symptoms.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Nausea
Clinical narrative: Nausea, fatigue, severe muscle pain.
Age: 0.08
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Bladder catheterisation, Lethargy, Lumbar puncture abnormal, Meningitis, Pyrexia
Clinical narrative: Patient developed at fever 1-2 hours after receiving her FIRST round of vaccinations HIB and Dtap on 1/24/14. Febrile for 2 days with increasing fever to 102.7 and then vomiting. She was brought to the emergency room where she received an IV with IV fluids, performed bloodwork, straight catheterized for urine. Pt was discharged from the hospital, but never improved and quickly declined in health. Continued vomiting, not tolerating fluids and becoming increasingly lethargic. Was seen by the pediatrician the next day and then directly admitted to the hospital. She received IV antibiotics, IV fluids. Spinal tap was done at the hospital and revealed that she had Meningitis. She remained in the Hospital for days to complete her daily IV antibiotic treatment and to received IV fluids. During the hospital stay, she had a cranial ultrasound performed and was seen by a Pediatric Neurologist from Hospital. Myself and my husband were treated prophylactically with Rifampin for meningitis exposure.  Total hospitalization days 10. Total days sick 13.
Age: 0.08
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Ultrasound skull, Vomiting, White blood cell count increased
Clinical narrative: Patient developed at fever 1-2 hours after receiving her FIRST round of vaccinations HIB and Dtap on 1/24/14. Febrile for 2 days with increasing fever to 102.7 and then vomiting. She was brought to the emergency room where she received an IV with IV fluids, performed bloodwork, straight catheterized for urine. Pt was discharged from the hospital, but never improved and quickly declined in health. Continued vomiting, not tolerating fluids and becoming increasingly lethargic. Was seen by the pediatrician the next day and then directly admitted to the hospital. She received IV antibiotics, IV fluids. Spinal tap was done at the hospital and revealed that she had Meningitis. She remained in the Hospital for days to complete her daily IV antibiotic treatment and to received IV fluids. During the hospital stay, she had a cranial ultrasound performed and was seen by a Pediatric Neurologist from Hospital. Myself and my husband were treated prophylactically with Rifampin for meningitis exposure.  Total hospitalization days 10. Total days sick 13.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PPV, VARCEL
Symptoms: Fatigue, Irritability, Vomiting
Clinical narrative: So he got his shot we came home he was just a little irritated. Then 24 hours later he's randomly throwing up and is still at random throwing up. When he throws up he's  just pukes and acts like nothing happened and continue playing. It's  very strange  he doesn't act like his stomach hurts and has No, no other sick symptoms. He's just tired, cranky and puking. He still has previous cough but has not gotten worse with this round of shots.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Eczema, Hypersomnia, Rash
Clinical narrative: Sleeping after shot, rash break out which was thought to be dermatitis which was an extreme abnormal but rash that was persistent for months after these shots but was then ruled to be eczema after a visit in Urgent Care.
Age: 74.0
Sex: M
Vaccine: FLUA3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Infusion, Lumbar puncture, Muscular weakness
Clinical narrative: This is a spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 20-Mar-2018 by Seqirus from VAERS (VAERS ID: 720792), concerning a 74-year-old, elderly male patient. It was reported that the patient had no relevant medical history and no current illness. The patient had no recent history of respiratory or gastrointestinal infection. However, it was also reported that, the patient's concomitant medications included Baclofen and Meloxicam. On 15-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, batch number: 178902, anatomical location: arm, expiry date: not reported) for an unknown indication. On 17-Sep-2017, 3 days after vaccination, the patient's leg was weak and had trouble while walking. On the same day, the patient was diagnosed with Guillain-Barre Syndrome. Hence, the patient was using cane and walker. On an unspecified date, the patient visited emergency room followed by hospitalization. Lumbar puncture was performed to draw spinal fluid. Additionally, myelogram was performed but the results were not reported. Subsequently, the patient started physical therapy. On 13-Oct-2017, the patient was on infusion for 5 days (unspecified medications) in the hospital. It was reported that, the patient was hospitalized for 8 days. At the time of the report, the outcome of the events was unknown. The reporter assessed the events (Guillain-Barre Syndrome) as serious (hospitalization). Follow-up received from other health professional on 19-Feb-2019: Literature information and reporters were added in the general tab. No changes were done in the narrative. Reporter's Comments: An elderly male patient initially presented with muscular weakness, gait disturbance, later diagnosed as Guillain-Barre syndrome (GBS) which meets level 4 of the Brighton Collaboration criteria, 2 days after receiving suspect vaccine FLUAD (TIV). Minimal information is provided regarding results of the investigations performed to rule out alternate cause of the GBS, concurrent clinical conditions and immune status of the subject. However, considering the plausible temporal relationship, typical clinical course/progression of GBS, the causal role of suspect vaccine cannot be ruled out. Hence, the causality was assessed as possibly related. The company assessed the event Guillain-Barre Syndrome as serious (medically significant).
Age: 74.0
Sex: M
Vaccine: FLUA3
Symptoms: Spinal myelogram, Walking aid user
Clinical narrative: This is a spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 20-Mar-2018 by Seqirus from VAERS (VAERS ID: 720792), concerning a 74-year-old, elderly male patient. It was reported that the patient had no relevant medical history and no current illness. The patient had no recent history of respiratory or gastrointestinal infection. However, it was also reported that, the patient's concomitant medications included Baclofen and Meloxicam. On 15-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, batch number: 178902, anatomical location: arm, expiry date: not reported) for an unknown indication. On 17-Sep-2017, 3 days after vaccination, the patient's leg was weak and had trouble while walking. On the same day, the patient was diagnosed with Guillain-Barre Syndrome. Hence, the patient was using cane and walker. On an unspecified date, the patient visited emergency room followed by hospitalization. Lumbar puncture was performed to draw spinal fluid. Additionally, myelogram was performed but the results were not reported. Subsequently, the patient started physical therapy. On 13-Oct-2017, the patient was on infusion for 5 days (unspecified medications) in the hospital. It was reported that, the patient was hospitalized for 8 days. At the time of the report, the outcome of the events was unknown. The reporter assessed the events (Guillain-Barre Syndrome) as serious (hospitalization). Follow-up received from other health professional on 19-Feb-2019: Literature information and reporters were added in the general tab. No changes were done in the narrative. Reporter's Comments: An elderly male patient initially presented with muscular weakness, gait disturbance, later diagnosed as Guillain-Barre syndrome (GBS) which meets level 4 of the Brighton Collaboration criteria, 2 days after receiving suspect vaccine FLUAD (TIV). Minimal information is provided regarding results of the investigations performed to rule out alternate cause of the GBS, concurrent clinical conditions and immune status of the subject. However, considering the plausible temporal relationship, typical clinical course/progression of GBS, the causal role of suspect vaccine cannot be ruled out. Hence, the causality was assessed as possibly related. The company assessed the event Guillain-Barre Syndrome as serious (medically significant).
Age: 73.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Guillain-Barre syndrome, Headache, Intensive care, Nerve conduction studies, Paraesthesia
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 726527), concerns a 73-year old elderly female patient. This is a review of safety profile of aIIV3 vaccine by analysing the reports of aIIV3 submitted from 01-Jul-2016 through 30-Jun-2018 to the Vaccine Adverse Event Reporting System (VAERS). The patient's current conditions included GERD (gastroesophageal reflux disease) and osteoporosis. It was reported that the patient did not have a recent history of a respiratory or gastrointestinal infection. The patient was allergic to ciprofloxacin, sulfa drugs and kiwi. The patient's concomitant medications included omeprazole, famotidine, azithromycin, multivitamin, and denosumab all for an unknown indication. On 26-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5ml (reported as 1), batch number: 179501, route of administration: intramuscular, anatomical location: arm) and PREVNAR 13 (dose: 1 as reported, batch number: S51635 as reported, route of administration: intramuscular, anatomical location: arm) for an unknown indication. On 03-Nov-2017, 8 days after vaccination, the patient presented in the ED (emergency department) with new onset of headache and paraesthesia consistent with Guillain-Barre syndrome. The patient was then transferred to the neurocritical intensive care unit with deteriorating respiratory status. On 07-Nov-2017, motor and sensory examination was performed (results were not provided). On 08-Nov-2017, motor conduction study was performed for which result not provided. The patient was admitted in the hospital for 9 days. At the time, the patient was on unspecified treatment. At the time of report, the patient had not yet recovered from the event Guillain-Barre syndrome. The reporter considered the event as serious due to hospitalization. Follow-up received from other health professional on 19-Feb-2019: Literature information and reporters were added in the general tab. It was reported that the patient did not have a recent history of a respiratory or gastrointestinal infection. Reference number (US-SEQIRUS-201801311) was added in the additional information tab. The narrative was amended accordingly. Reporter's Comments: An elderly female patient had onset of symptoms consistent with Guillain-Barre syndrome (Brighton collaboration level 4), 8 days after vaccination with FLUAD TIV and PREVNAR 13. The time to onset is plausible after vaccination. Hence, although minimal information is provided regarding investigations to rule out alternate etiologies and clinical status of the patient at the time of vaccination, the causal role of FLUAD TIV can be considered as possibly related and PREVNAR 13 was considered as co-suspect. This company assessed this case as serious (medically significant).
Age: 73.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Respiratory disorder
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 726527), concerns a 73-year old elderly female patient. This is a review of safety profile of aIIV3 vaccine by analysing the reports of aIIV3 submitted from 01-Jul-2016 through 30-Jun-2018 to the Vaccine Adverse Event Reporting System (VAERS). The patient's current conditions included GERD (gastroesophageal reflux disease) and osteoporosis. It was reported that the patient did not have a recent history of a respiratory or gastrointestinal infection. The patient was allergic to ciprofloxacin, sulfa drugs and kiwi. The patient's concomitant medications included omeprazole, famotidine, azithromycin, multivitamin, and denosumab all for an unknown indication. On 26-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5ml (reported as 1), batch number: 179501, route of administration: intramuscular, anatomical location: arm) and PREVNAR 13 (dose: 1 as reported, batch number: S51635 as reported, route of administration: intramuscular, anatomical location: arm) for an unknown indication. On 03-Nov-2017, 8 days after vaccination, the patient presented in the ED (emergency department) with new onset of headache and paraesthesia consistent with Guillain-Barre syndrome. The patient was then transferred to the neurocritical intensive care unit with deteriorating respiratory status. On 07-Nov-2017, motor and sensory examination was performed (results were not provided). On 08-Nov-2017, motor conduction study was performed for which result not provided. The patient was admitted in the hospital for 9 days. At the time, the patient was on unspecified treatment. At the time of report, the patient had not yet recovered from the event Guillain-Barre syndrome. The reporter considered the event as serious due to hospitalization. Follow-up received from other health professional on 19-Feb-2019: Literature information and reporters were added in the general tab. It was reported that the patient did not have a recent history of a respiratory or gastrointestinal infection. Reference number (US-SEQIRUS-201801311) was added in the additional information tab. The narrative was amended accordingly. Reporter's Comments: An elderly female patient had onset of symptoms consistent with Guillain-Barre syndrome (Brighton collaboration level 4), 8 days after vaccination with FLUAD TIV and PREVNAR 13. The time to onset is plausible after vaccination. Hence, although minimal information is provided regarding investigations to rule out alternate etiologies and clinical status of the patient at the time of vaccination, the causal role of FLUAD TIV can be considered as possibly related and PREVNAR 13 was considered as co-suspect. This company assessed this case as serious (medically significant).
Age: 72.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Herpes zoster, Neuralgia, Pain in extremity
Clinical narrative: This spontaneous report was received from a 72 year old male patient reporting on himself. The patient's medical condition included: blood pressure measurement, atrial fibrillation, blood cholesterol, spinal column stenosis, Barrett's esophagus, singles (herpes zoster), horseshoe kidney, allergies to dust and cats and had a cardiac pacemarker insertion. Concomitant therapies included aspirin(ASPIRIN), benazepril hydrochloride (BENAZEPRIL HYDROCHLORIDE), diphenhydramine hydrochloride(BENADRYL), carvedilol(CARVEDILOL), fexofenadine hydrochloride(ALLEGRA), metronidazole(METRONIDAZOLE), montelukast sodium(SINGULAIR), omeprazole(PRILOSEC) and simvastatin(ZOCOR). In unspecified date of 2008 (reported as 9 years ago), the patient was vaccinated with ZOSTAVAX (dose, frequency, route of administration, indication, lot number and expiration date were not reported) for prophylaxis and then the patient had mild shingles again (herpes zoster). On 18-SEP-2012, the patient was vaccinated with PNEUMOVAX 23 in right arm (dose, frequency, route of administration, indication, lot number and expiration date were not reported). On 16- JAN-2015, the patient was vaccinated with PREVNAR 13 0.5 ml in right arm (batch# J67643, expiration date and route of administration were unknown) for prophylaxis. On 17-OCT-2017, the patient was vaccinated with PREVNAR 13 0.5 ml in right arm (batch# S43277, expiration date and route of administration were unknown) for prophylaxis again. In the same date, the patient was vaccinated with ZOSTAVAX subcutaneously in the other arm (left arm) (lot# M038350 and expiration date: 06-DEC-2017) (dose was not reported) for prophylaxis and did hurt a little (pain in extremity). In an unspecified date of 2017, the patient was experienced nerve pain caused by shingles (neuralgia) and according to the report, on 17-OCT-2017 (in the same date of the patient was vaccination with ZOSTAVAX) the patient started a treatment with gabapentin. The outcome of the events neuralgia, pain in extremity and herpes zoster were not reported. The causal relationship between the events and the therapy with ZOSTAVAX was not provided.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site joint pain, Injection site joint swelling, Injection site pain, Muscular weakness
Clinical narrative: Initial information received on 26-Feb-2019 regarding an unsolicited valid serious case received from a consumer. This case involves a 75-years-old female patient who experienced neuropathy with mobility decreased and pain in extremity, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given. On 06-Nov-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ043AB (Expiry date unknown) via unknown route in high up on the shoulder where the joint is (into the bursa). On 07-Nov-2018, the patient could not lift her arm related to the severe pain, unable to reach behind her back, unable to lift her arm, and has pain shoot down to her elbow and fingers one day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On 19-Nov-2019, Her HCP thought it was neuropathy (onset date and latency unknown) following administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. It was case also Medication error due to Vaccine administered at inappropriate site (It was reported that 1.5" needle was used, site: the nurse injected her high up on the shoulder where the joint, into the bursa). (Other relevant tests included no lab data). Final diagnosis was neuropathy, Pain in extremity and Mobility decreased. The patient was treated with GABAPENTIN and DICLOFENAC and ASPERCREME. The event outcome was reported as not recovered for all events at the time of report. Reporter causality: the reporter assessed the relationship with the vaccine as related. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none. Sender's Comments: Follow-up on 27-Feb-2019 doesn't change assessment. This case involves a 75 years old patient who experienced neuropathy, pain in extremity and mobility decreased while received vaccine FLUZONE HIGH DOSE. The time to onset is compatible with the role of vaccine. However, there is no information regarding patient's past history, medical condition at time of vaccination and lab tests ruling out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Initial information received on 26-Feb-2019 regarding an unsolicited valid serious case received from a consumer. This case involves a 75-years-old female patient who experienced neuropathy with mobility decreased and pain in extremity, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given. On 06-Nov-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ043AB (Expiry date unknown) via unknown route in high up on the shoulder where the joint is (into the bursa). On 07-Nov-2018, the patient could not lift her arm related to the severe pain, unable to reach behind her back, unable to lift her arm, and has pain shoot down to her elbow and fingers one day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On 19-Nov-2019, Her HCP thought it was neuropathy (onset date and latency unknown) following administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. It was case also Medication error due to Vaccine administered at inappropriate site (It was reported that 1.5" needle was used, site: the nurse injected her high up on the shoulder where the joint, into the bursa). (Other relevant tests included no lab data). Final diagnosis was neuropathy, Pain in extremity and Mobility decreased. The patient was treated with GABAPENTIN and DICLOFENAC and ASPERCREME. The event outcome was reported as not recovered for all events at the time of report. Reporter causality: the reporter assessed the relationship with the vaccine as related. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none. Sender's Comments: Follow-up on 27-Feb-2019 doesn't change assessment. This case involves a 75 years old patient who experienced neuropathy, pain in extremity and mobility decreased while received vaccine FLUZONE HIGH DOSE. The time to onset is compatible with the role of vaccine. However, there is no information regarding patient's past history, medical condition at time of vaccination and lab tests ruling out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Neuropathy peripheral, Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Initial information received on 26-Feb-2019 regarding an unsolicited valid serious case received from a consumer. This case involves a 75-years-old female patient who experienced neuropathy with mobility decreased and pain in extremity, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given. On 06-Nov-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ043AB (Expiry date unknown) via unknown route in high up on the shoulder where the joint is (into the bursa). On 07-Nov-2018, the patient could not lift her arm related to the severe pain, unable to reach behind her back, unable to lift her arm, and has pain shoot down to her elbow and fingers one day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On 19-Nov-2019, Her HCP thought it was neuropathy (onset date and latency unknown) following administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. It was case also Medication error due to Vaccine administered at inappropriate site (It was reported that 1.5" needle was used, site: the nurse injected her high up on the shoulder where the joint, into the bursa). (Other relevant tests included no lab data). Final diagnosis was neuropathy, Pain in extremity and Mobility decreased. The patient was treated with GABAPENTIN and DICLOFENAC and ASPERCREME. The event outcome was reported as not recovered for all events at the time of report. Reporter causality: the reporter assessed the relationship with the vaccine as related. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none. Sender's Comments: Follow-up on 27-Feb-2019 doesn't change assessment. This case involves a 75 years old patient who experienced neuropathy, pain in extremity and mobility decreased while received vaccine FLUZONE HIGH DOSE. The time to onset is compatible with the role of vaccine. However, there is no information regarding patient's past history, medical condition at time of vaccination and lab tests ruling out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Gait inability, Guillain-Barre syndrome, Immunoglobulin therapy, Paraesthesia
Clinical narrative: Principal Diagnosis (Reason for admission after study): Guillain-Barre Syndrome. Additional Diagnoses: Hypertension, hyperlipidemia, diabetes mellitus, osteoarthritis, and post traumatic stress disorder. History of Present Illness: 64 YO male with a Hypertension, hyperlipidemia, diabetes mellitus, osteoarthritis, and post traumatic stress disorder who presents to the emergency department complaining of worsening constipation, urinary retention and neuropathy. Patient reports that the symptoms started 2 weeks ago and were sudden in onset. He first started to feel tingling in his fingertips and toes. This gradually progressed to weakness of lower extremity with difficulty walking. He felt off balance and like he was falling to his left side. He only fell once on his knees and did not hit his head. Then he started to develop shooting pains down his legs and arms. He reports his skin was very sensitive to touch. He had some shoulder pain and weakness in his arms as well. Patient has also experienced constipation for the last 6 days (states that he usually has 2 BMs a day). He endorsed saddle anesthesia that was present several days ago and is now resolved. He also endorses difficulty initiating a urinary stream and emptying his bladder. Denies fecal or urinary incontinence. This has never happened to him before. He did not suffer any trauma prior to the onset of symptoms. He denies any recent illnesses, sick contacts, fevers, chills, night sweats, cough, or diarrhea. Patient visited the ED on Nov 1st with similar symptoms and had a normal work up which included CT head, x-ray of cervical, thoracic and lumbar spine. Was discharged with  diagnosis of possible Diabetic neuropathy and gabapentin was increased and steroid taper was added. Patient has also been given codeine/TYLENOL for the neuropathic pain about 4 days ago which also did not help. Hospital Course: Neurology was consulted and recommended an MRI of the cervical spine and a lumbar puncture. The MRI did not show any obvious lesions so an MRI of the thoracic and lumbar spine were ordered. Anesthesia was consulted to do a lumbar puncture. The MRI were relatively unremarkable however the lumbar puncture showed evidence of Guillain-Barre Syndrome. Neuro recommended IVIG over 5 days. There was slight improvement and no worsening of his weakness. His breathing has remained stable and unchanged his entire stay. He was having bouts of incontinence with the Guillain Barre and urology was consulted. They recommended renal ultrasound, bladder scan every shift--I and O cath for PVR greater than 200 ml PRN if 500 ml, place indwelling foley, might help his constipation if distended bladder, bowel regimen if pt still complains of constipation.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Anaesthesia, Balance disorder, CSF protein increased, Cardiac function test normal, Computerised tomogram head normal
Clinical narrative: Principal Diagnosis (Reason for admission after study): Guillain-Barre Syndrome. Additional Diagnoses: Hypertension, hyperlipidemia, diabetes mellitus, osteoarthritis, and post traumatic stress disorder. History of Present Illness: 64 YO male with a Hypertension, hyperlipidemia, diabetes mellitus, osteoarthritis, and post traumatic stress disorder who presents to the emergency department complaining of worsening constipation, urinary retention and neuropathy. Patient reports that the symptoms started 2 weeks ago and were sudden in onset. He first started to feel tingling in his fingertips and toes. This gradually progressed to weakness of lower extremity with difficulty walking. He felt off balance and like he was falling to his left side. He only fell once on his knees and did not hit his head. Then he started to develop shooting pains down his legs and arms. He reports his skin was very sensitive to touch. He had some shoulder pain and weakness in his arms as well. Patient has also experienced constipation for the last 6 days (states that he usually has 2 BMs a day). He endorsed saddle anesthesia that was present several days ago and is now resolved. He also endorses difficulty initiating a urinary stream and emptying his bladder. Denies fecal or urinary incontinence. This has never happened to him before. He did not suffer any trauma prior to the onset of symptoms. He denies any recent illnesses, sick contacts, fevers, chills, night sweats, cough, or diarrhea. Patient visited the ED on Nov 1st with similar symptoms and had a normal work up which included CT head, x-ray of cervical, thoracic and lumbar spine. Was discharged with  diagnosis of possible Diabetic neuropathy and gabapentin was increased and steroid taper was added. Patient has also been given codeine/TYLENOL for the neuropathic pain about 4 days ago which also did not help. Hospital Course: Neurology was consulted and recommended an MRI of the cervical spine and a lumbar puncture. The MRI did not show any obvious lesions so an MRI of the thoracic and lumbar spine were ordered. Anesthesia was consulted to do a lumbar puncture. The MRI were relatively unremarkable however the lumbar puncture showed evidence of Guillain-Barre Syndrome. Neuro recommended IVIG over 5 days. There was slight improvement and no worsening of his weakness. His breathing has remained stable and unchanged his entire stay. He was having bouts of incontinence with the Guillain Barre and urology was consulted. They recommended renal ultrasound, bladder scan every shift--I and O cath for PVR greater than 200 ml PRN if 500 ml, place indwelling foley, might help his constipation if distended bladder, bowel regimen if pt still complains of constipation.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Constipation, Dysstasia, Fall, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Principal Diagnosis (Reason for admission after study): Guillain-Barre Syndrome. Additional Diagnoses: Hypertension, hyperlipidemia, diabetes mellitus, osteoarthritis, and post traumatic stress disorder. History of Present Illness: 64 YO male with a Hypertension, hyperlipidemia, diabetes mellitus, osteoarthritis, and post traumatic stress disorder who presents to the emergency department complaining of worsening constipation, urinary retention and neuropathy. Patient reports that the symptoms started 2 weeks ago and were sudden in onset. He first started to feel tingling in his fingertips and toes. This gradually progressed to weakness of lower extremity with difficulty walking. He felt off balance and like he was falling to his left side. He only fell once on his knees and did not hit his head. Then he started to develop shooting pains down his legs and arms. He reports his skin was very sensitive to touch. He had some shoulder pain and weakness in his arms as well. Patient has also experienced constipation for the last 6 days (states that he usually has 2 BMs a day). He endorsed saddle anesthesia that was present several days ago and is now resolved. He also endorses difficulty initiating a urinary stream and emptying his bladder. Denies fecal or urinary incontinence. This has never happened to him before. He did not suffer any trauma prior to the onset of symptoms. He denies any recent illnesses, sick contacts, fevers, chills, night sweats, cough, or diarrhea. Patient visited the ED on Nov 1st with similar symptoms and had a normal work up which included CT head, x-ray of cervical, thoracic and lumbar spine. Was discharged with  diagnosis of possible Diabetic neuropathy and gabapentin was increased and steroid taper was added. Patient has also been given codeine/TYLENOL for the neuropathic pain about 4 days ago which also did not help. Hospital Course: Neurology was consulted and recommended an MRI of the cervical spine and a lumbar puncture. The MRI did not show any obvious lesions so an MRI of the thoracic and lumbar spine were ordered. Anesthesia was consulted to do a lumbar puncture. The MRI were relatively unremarkable however the lumbar puncture showed evidence of Guillain-Barre Syndrome. Neuro recommended IVIG over 5 days. There was slight improvement and no worsening of his weakness. His breathing has remained stable and unchanged his entire stay. He was having bouts of incontinence with the Guillain Barre and urology was consulted. They recommended renal ultrasound, bladder scan every shift--I and O cath for PVR greater than 200 ml PRN if 500 ml, place indwelling foley, might help his constipation if distended bladder, bowel regimen if pt still complains of constipation.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hyperaesthesia, Immunoglobulin therapy, Incontinence, Lumbar puncture abnormal, Muscular weakness
Clinical narrative: Principal Diagnosis (Reason for admission after study): Guillain-Barre Syndrome. Additional Diagnoses: Hypertension, hyperlipidemia, diabetes mellitus, osteoarthritis, and post traumatic stress disorder. History of Present Illness: 64 YO male with a Hypertension, hyperlipidemia, diabetes mellitus, osteoarthritis, and post traumatic stress disorder who presents to the emergency department complaining of worsening constipation, urinary retention and neuropathy. Patient reports that the symptoms started 2 weeks ago and were sudden in onset. He first started to feel tingling in his fingertips and toes. This gradually progressed to weakness of lower extremity with difficulty walking. He felt off balance and like he was falling to his left side. He only fell once on his knees and did not hit his head. Then he started to develop shooting pains down his legs and arms. He reports his skin was very sensitive to touch. He had some shoulder pain and weakness in his arms as well. Patient has also experienced constipation for the last 6 days (states that he usually has 2 BMs a day). He endorsed saddle anesthesia that was present several days ago and is now resolved. He also endorses difficulty initiating a urinary stream and emptying his bladder. Denies fecal or urinary incontinence. This has never happened to him before. He did not suffer any trauma prior to the onset of symptoms. He denies any recent illnesses, sick contacts, fevers, chills, night sweats, cough, or diarrhea. Patient visited the ED on Nov 1st with similar symptoms and had a normal work up which included CT head, x-ray of cervical, thoracic and lumbar spine. Was discharged with  diagnosis of possible Diabetic neuropathy and gabapentin was increased and steroid taper was added. Patient has also been given codeine/TYLENOL for the neuropathic pain about 4 days ago which also did not help. Hospital Course: Neurology was consulted and recommended an MRI of the cervical spine and a lumbar puncture. The MRI did not show any obvious lesions so an MRI of the thoracic and lumbar spine were ordered. Anesthesia was consulted to do a lumbar puncture. The MRI were relatively unremarkable however the lumbar puncture showed evidence of Guillain-Barre Syndrome. Neuro recommended IVIG over 5 days. There was slight improvement and no worsening of his weakness. His breathing has remained stable and unchanged his entire stay. He was having bouts of incontinence with the Guillain Barre and urology was consulted. They recommended renal ultrasound, bladder scan every shift--I and O cath for PVR greater than 200 ml PRN if 500 ml, place indwelling foley, might help his constipation if distended bladder, bowel regimen if pt still complains of constipation.