chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Nausea, Nightmare, Tremor, Visual impairment
Clinical narrative: By about 10 p.m. day of vaccine began to feel very tired & arm tender but not red, no hives, swelling, etc. Went to bed 11:30 p.m.; had nightmares (unusual) & woke up at 2:30 a.m. Decided to go to bathroom. Could barely stand or walk; knees weak, legs felt like jello, and both arms shaking pretty violently from shoulders to fingertips on arms (this was the very frightening part). Made it to bathroom & back to bed by holding on to walls, door knobs, etc. Got up 10 minutes later to throw up - a lot. Other than 5 or 10 minutes at a time, never could get back to sleep. At some point needed to throw up again. Finally got out of bed about 5:30 a.m. Drank an half an Ensure Plus & threw it up soon after. Diarhea, total exhaustion and naps about every hour through rest of Sunday. Monday (17 June) totally exhausted, diarrhea continued though not as frequent, nausea improved, totally listless & sleepy. This continued until Saturday 22 June when I finally was able to leave the house (i.e. the bathroom) long enough to drive to pharmacy and ask if they had other complaints and might have gotten a bad batch of the vaccine.  Had a long talk with pharmacy manager who said she'd never heard of such a severe reaction & took info so she could submit a form to you. She suggested I take Imodium & Align (or similar) which helped by that evening. The next day had a lot of gas all day and a spell of diarrhea from 11 p.m. to 130 a.m. Still felt exhausted. Intermittent periods of diarrhea or very loose stool and being unusually tired (I may be "old", but have always remained active) have continued over 2 months BUT each time I think I need to find a new family physician (having discovered my current one has retired), I have a day or two with no problems. I am just now getting back to more of my normal activities.      I'm not only more than a little upset that I've lost 2 months out of my life, but that I paid $169.99 to do it. On top of that, I think I would have to be insane to risk taking shot #2, so I guess that means I'm not even protected from shingles. (I did have the "original" shingles vaccine about 12 years ago as soon after chemotherapy as my oncologist felt it was safe; no reaction from it.)
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: By about 10 p.m. day of vaccine began to feel very tired & arm tender but not red, no hives, swelling, etc. Went to bed 11:30 p.m.; had nightmares (unusual) & woke up at 2:30 a.m. Decided to go to bathroom. Could barely stand or walk; knees weak, legs felt like jello, and both arms shaking pretty violently from shoulders to fingertips on arms (this was the very frightening part). Made it to bathroom & back to bed by holding on to walls, door knobs, etc. Got up 10 minutes later to throw up - a lot. Other than 5 or 10 minutes at a time, never could get back to sleep. At some point needed to throw up again. Finally got out of bed about 5:30 a.m. Drank an half an Ensure Plus & threw it up soon after. Diarhea, total exhaustion and naps about every hour through rest of Sunday. Monday (17 June) totally exhausted, diarrhea continued though not as frequent, nausea improved, totally listless & sleepy. This continued until Saturday 22 June when I finally was able to leave the house (i.e. the bathroom) long enough to drive to pharmacy and ask if they had other complaints and might have gotten a bad batch of the vaccine.  Had a long talk with pharmacy manager who said she'd never heard of such a severe reaction & took info so she could submit a form to you. She suggested I take Imodium & Align (or similar) which helped by that evening. The next day had a lot of gas all day and a spell of diarrhea from 11 p.m. to 130 a.m. Still felt exhausted. Intermittent periods of diarrhea or very loose stool and being unusually tired (I may be "old", but have always remained active) have continued over 2 months BUT each time I think I need to find a new family physician (having discovered my current one has retired), I have a day or two with no problems. I am just now getting back to more of my normal activities.      I'm not only more than a little upset that I've lost 2 months out of my life, but that I paid $169.99 to do it. On top of that, I think I would have to be insane to risk taking shot #2, so I guess that means I'm not even protected from shingles. (I did have the "original" shingles vaccine about 12 years ago as soon after chemotherapy as my oncologist felt it was safe; no reaction from it.)
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Diarrhoea, Dysstasia, Fatigue, Flatulence
Clinical narrative: couldn't hold a glass of water with her hands; nausea; diarrhea; throwing up; couldn't sleep; sore at the injection site; felt tired / exhausted; horrible nightmares; lights seemed yellow; barely walk; Both of her arms were shaking violently (she said it was much more than shivering or chills); This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax vaccine (the patient received Zostavax on an unknown date).   On 15th June 2019, the patient received the 1st dose of Shingrix. On 15th June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, fatigue, nightmare, visual impairment, walking difficulty, tremor limb, vomiting and sleeplessness. On 16th June 2019, the patient experienced nausea and diarrhea. On an unknown date, the patient experienced strength loss of. On an unknown date, the outcome of the injection site pain, fatigue, nightmare, visual impairment, walking difficulty, tremor limb and sleeplessness were recovered/resolved and the outcome of the strength loss of, vomiting and nausea were unknown and the outcome of the diarrhea was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fatigue, nightmare, visual impairment, walking difficulty, tremor limb, strength loss of, sleeplessness, nausea and diarrhea to be related to Shingrix. The reporter considered the vomiting to be related to Shingrix.  Additional details were reported as follows: The patient reported that the patient received her first dose of Shingrix and experienced sore arm at the injection site the first day. That same day she also felt tired and experienced horrible nightmares for the first 2 hours when she went to bed. When she woke up at night and put her legs on the floor, her lights seemed to be yellow and she could barely walk. Both of her arms were shaking violently, the patient said it was much more than shivering or chills, she couldn't hold a glass of water with her hands. The patient did not experience fever. She got back to bed, and then she started throwing up. Two hours after she woke up and was throwing up again. The patient couldn't sleep more than 5 to 10 minutes. The next morning she was having nausea, feeling exhausted and having diarrhea off and on until now, about 6 weeks.  The patient said that her nausea was now much better but diarrhea and exhausting were still going on off and on.  The reporter did not consent to follow-up.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Insomnia, Listless, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: couldn't hold a glass of water with her hands; nausea; diarrhea; throwing up; couldn't sleep; sore at the injection site; felt tired / exhausted; horrible nightmares; lights seemed yellow; barely walk; Both of her arms were shaking violently (she said it was much more than shivering or chills); This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax vaccine (the patient received Zostavax on an unknown date).   On 15th June 2019, the patient received the 1st dose of Shingrix. On 15th June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, fatigue, nightmare, visual impairment, walking difficulty, tremor limb, vomiting and sleeplessness. On 16th June 2019, the patient experienced nausea and diarrhea. On an unknown date, the patient experienced strength loss of. On an unknown date, the outcome of the injection site pain, fatigue, nightmare, visual impairment, walking difficulty, tremor limb and sleeplessness were recovered/resolved and the outcome of the strength loss of, vomiting and nausea were unknown and the outcome of the diarrhea was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fatigue, nightmare, visual impairment, walking difficulty, tremor limb, strength loss of, sleeplessness, nausea and diarrhea to be related to Shingrix. The reporter considered the vomiting to be related to Shingrix.  Additional details were reported as follows: The patient reported that the patient received her first dose of Shingrix and experienced sore arm at the injection site the first day. That same day she also felt tired and experienced horrible nightmares for the first 2 hours when she went to bed. When she woke up at night and put her legs on the floor, her lights seemed to be yellow and she could barely walk. Both of her arms were shaking violently, the patient said it was much more than shivering or chills, she couldn't hold a glass of water with her hands. The patient did not experience fever. She got back to bed, and then she started throwing up. Two hours after she woke up and was throwing up again. The patient couldn't sleep more than 5 to 10 minutes. The next morning she was having nausea, feeling exhausted and having diarrhea off and on until now, about 6 weeks.  The patient said that her nausea was now much better but diarrhea and exhausting were still going on off and on.  The reporter did not consent to follow-up.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Nightmare, Somnolence, Tenderness, Tremor
Clinical narrative: couldn't hold a glass of water with her hands; nausea; diarrhea; throwing up; couldn't sleep; sore at the injection site; felt tired / exhausted; horrible nightmares; lights seemed yellow; barely walk; Both of her arms were shaking violently (she said it was much more than shivering or chills); This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax vaccine (the patient received Zostavax on an unknown date).   On 15th June 2019, the patient received the 1st dose of Shingrix. On 15th June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, fatigue, nightmare, visual impairment, walking difficulty, tremor limb, vomiting and sleeplessness. On 16th June 2019, the patient experienced nausea and diarrhea. On an unknown date, the patient experienced strength loss of. On an unknown date, the outcome of the injection site pain, fatigue, nightmare, visual impairment, walking difficulty, tremor limb and sleeplessness were recovered/resolved and the outcome of the strength loss of, vomiting and nausea were unknown and the outcome of the diarrhea was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fatigue, nightmare, visual impairment, walking difficulty, tremor limb, strength loss of, sleeplessness, nausea and diarrhea to be related to Shingrix. The reporter considered the vomiting to be related to Shingrix.  Additional details were reported as follows: The patient reported that the patient received her first dose of Shingrix and experienced sore arm at the injection site the first day. That same day she also felt tired and experienced horrible nightmares for the first 2 hours when she went to bed. When she woke up at night and put her legs on the floor, her lights seemed to be yellow and she could barely walk. Both of her arms were shaking violently, the patient said it was much more than shivering or chills, she couldn't hold a glass of water with her hands. The patient did not experience fever. She got back to bed, and then she started throwing up. Two hours after she woke up and was throwing up again. The patient couldn't sleep more than 5 to 10 minutes. The next morning she was having nausea, feeling exhausted and having diarrhea off and on until now, about 6 weeks.  The patient said that her nausea was now much better but diarrhea and exhausting were still going on off and on.  The reporter did not consent to follow-up.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting, Walking aid user
Clinical narrative: couldn't hold a glass of water with her hands; nausea; diarrhea; throwing up; couldn't sleep; sore at the injection site; felt tired / exhausted; horrible nightmares; lights seemed yellow; barely walk; Both of her arms were shaking violently (she said it was much more than shivering or chills); This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax vaccine (the patient received Zostavax on an unknown date).   On 15th June 2019, the patient received the 1st dose of Shingrix. On 15th June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, fatigue, nightmare, visual impairment, walking difficulty, tremor limb, vomiting and sleeplessness. On 16th June 2019, the patient experienced nausea and diarrhea. On an unknown date, the patient experienced strength loss of. On an unknown date, the outcome of the injection site pain, fatigue, nightmare, visual impairment, walking difficulty, tremor limb and sleeplessness were recovered/resolved and the outcome of the strength loss of, vomiting and nausea were unknown and the outcome of the diarrhea was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fatigue, nightmare, visual impairment, walking difficulty, tremor limb, strength loss of, sleeplessness, nausea and diarrhea to be related to Shingrix. The reporter considered the vomiting to be related to Shingrix.  Additional details were reported as follows: The patient reported that the patient received her first dose of Shingrix and experienced sore arm at the injection site the first day. That same day she also felt tired and experienced horrible nightmares for the first 2 hours when she went to bed. When she woke up at night and put her legs on the floor, her lights seemed to be yellow and she could barely walk. Both of her arms were shaking violently, the patient said it was much more than shivering or chills, she couldn't hold a glass of water with her hands. The patient did not experience fever. She got back to bed, and then she started throwing up. Two hours after she woke up and was throwing up again. The patient couldn't sleep more than 5 to 10 minutes. The next morning she was having nausea, feeling exhausted and having diarrhea off and on until now, about 6 weeks.  The patient said that her nausea was now much better but diarrhea and exhausting were still going on off and on.  The reporter did not consent to follow-up.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Diarrhoea, Fatigue, Gait disturbance, Injection site pain
Clinical narrative: couldn't hold a glass of water with her hands; nausea; diarrhea; throwing up; couldn't sleep; sore at the injection site; felt tired / exhausted; horrible nightmares; lights seemed yellow; barely walk; Both of her arms were shaking violently (she said it was much more than shivering or chills); This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax vaccine (the patient received Zostavax on an unknown date).   On 15th June 2019, the patient received the 1st dose of Shingrix. On 15th June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, fatigue, nightmare, visual impairment, walking difficulty, tremor limb, vomiting and sleeplessness. On 16th June 2019, the patient experienced nausea and diarrhea. On an unknown date, the patient experienced strength loss of. On an unknown date, the outcome of the injection site pain, fatigue, nightmare, visual impairment, walking difficulty, tremor limb and sleeplessness were recovered/resolved and the outcome of the strength loss of, vomiting and nausea were unknown and the outcome of the diarrhea was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fatigue, nightmare, visual impairment, walking difficulty, tremor limb, strength loss of, sleeplessness, nausea and diarrhea to be related to Shingrix. The reporter considered the vomiting to be related to Shingrix.  Additional details were reported as follows: The patient reported that the patient received her first dose of Shingrix and experienced sore arm at the injection site the first day. That same day she also felt tired and experienced horrible nightmares for the first 2 hours when she went to bed. When she woke up at night and put her legs on the floor, her lights seemed to be yellow and she could barely walk. Both of her arms were shaking violently, the patient said it was much more than shivering or chills, she couldn't hold a glass of water with her hands. The patient did not experience fever. She got back to bed, and then she started throwing up. Two hours after she woke up and was throwing up again. The patient couldn't sleep more than 5 to 10 minutes. The next morning she was having nausea, feeling exhausted and having diarrhea off and on until now, about 6 weeks.  The patient said that her nausea was now much better but diarrhea and exhausting were still going on off and on.  The reporter did not consent to follow-up.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Nausea, Nightmare, Tremor, Visual impairment
Clinical narrative: couldn't hold a glass of water with her hands; nausea; diarrhea; throwing up; couldn't sleep; sore at the injection site; felt tired / exhausted; horrible nightmares; lights seemed yellow; barely walk; Both of her arms were shaking violently (she said it was much more than shivering or chills); This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax vaccine (the patient received Zostavax on an unknown date).   On 15th June 2019, the patient received the 1st dose of Shingrix. On 15th June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, fatigue, nightmare, visual impairment, walking difficulty, tremor limb, vomiting and sleeplessness. On 16th June 2019, the patient experienced nausea and diarrhea. On an unknown date, the patient experienced strength loss of. On an unknown date, the outcome of the injection site pain, fatigue, nightmare, visual impairment, walking difficulty, tremor limb and sleeplessness were recovered/resolved and the outcome of the strength loss of, vomiting and nausea were unknown and the outcome of the diarrhea was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fatigue, nightmare, visual impairment, walking difficulty, tremor limb, strength loss of, sleeplessness, nausea and diarrhea to be related to Shingrix. The reporter considered the vomiting to be related to Shingrix.  Additional details were reported as follows: The patient reported that the patient received her first dose of Shingrix and experienced sore arm at the injection site the first day. That same day she also felt tired and experienced horrible nightmares for the first 2 hours when she went to bed. When she woke up at night and put her legs on the floor, her lights seemed to be yellow and she could barely walk. Both of her arms were shaking violently, the patient said it was much more than shivering or chills, she couldn't hold a glass of water with her hands. The patient did not experience fever. She got back to bed, and then she started throwing up. Two hours after she woke up and was throwing up again. The patient couldn't sleep more than 5 to 10 minutes. The next morning she was having nausea, feeling exhausted and having diarrhea off and on until now, about 6 weeks.  The patient said that her nausea was now much better but diarrhea and exhausting were still going on off and on.  The reporter did not consent to follow-up.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: couldn't hold a glass of water with her hands; nausea; diarrhea; throwing up; couldn't sleep; sore at the injection site; felt tired / exhausted; horrible nightmares; lights seemed yellow; barely walk; Both of her arms were shaking violently (she said it was much more than shivering or chills); This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax vaccine (the patient received Zostavax on an unknown date).   On 15th June 2019, the patient received the 1st dose of Shingrix. On 15th June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, fatigue, nightmare, visual impairment, walking difficulty, tremor limb, vomiting and sleeplessness. On 16th June 2019, the patient experienced nausea and diarrhea. On an unknown date, the patient experienced strength loss of. On an unknown date, the outcome of the injection site pain, fatigue, nightmare, visual impairment, walking difficulty, tremor limb and sleeplessness were recovered/resolved and the outcome of the strength loss of, vomiting and nausea were unknown and the outcome of the diarrhea was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fatigue, nightmare, visual impairment, walking difficulty, tremor limb, strength loss of, sleeplessness, nausea and diarrhea to be related to Shingrix. The reporter considered the vomiting to be related to Shingrix.  Additional details were reported as follows: The patient reported that the patient received her first dose of Shingrix and experienced sore arm at the injection site the first day. That same day she also felt tired and experienced horrible nightmares for the first 2 hours when she went to bed. When she woke up at night and put her legs on the floor, her lights seemed to be yellow and she could barely walk. Both of her arms were shaking violently, the patient said it was much more than shivering or chills, she couldn't hold a glass of water with her hands. The patient did not experience fever. She got back to bed, and then she started throwing up. Two hours after she woke up and was throwing up again. The patient couldn't sleep more than 5 to 10 minutes. The next morning she was having nausea, feeling exhausted and having diarrhea off and on until now, about 6 weeks.  The patient said that her nausea was now much better but diarrhea and exhausting were still going on off and on.  The reporter did not consent to follow-up.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Blister, Rash
Clinical narrative: I wAs clear At TiME oF shot. BROKE out iN RASh and BlisteRs. Went BAck to store ANd showed Myself To The Pharmacy Dr Lady. She and Another Pharmacy LAdy sAid They hAd NeveR seen Anything Like it. I had 2 precription to have filled, So I Stoped At Pharmacy, Had my scripts filled and got my flue shot while I was there. It was apx 3:30 pm in evening. Felt Fine. Woke up at 6 AM got up and noticed I was Broke out all over my face and neck with Blisters and a rash. So I got ready for church and when I got home, I went straight back to pharmacy. The LAdy pharmacy Looks at me and said I've never seen anyone look this bad. She took me down the Isles and got me Diphenhydramine HCI 25 mg and 1% HydRoCoRtsone ANtipRURitic CREAM. 6 DAy LAtter my FAce, Neck, BrEAST is Finally clearing up. I'm not Al the WAy CleAR yet But Alot clearer This is 8 DAy LAteR. Thank You for You're Concern.
Age: 83.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Asthenia, Chills, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: DAY 1 - 8/23 - Left arm hurts, very nauseated with chills and very weak all day.  DAY 2 - 8/24 - Arm is very painful & very fatigued. DAY 3 - 8/25 - Arm still sore, red & swollen at injection sight DAY 4 - 8/26 - Arm still sore, red & swollen DAY 5 - 8/27 Arm not quite as sore, turning pink but itchy. DAY 6 - 8/28 Same as above DAY 7 - 8/29 Finally felt better.
Age: 83.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Nausea, Pain in extremity, Vaccination complication
Clinical narrative: DAY 1 - 8/23 - Left arm hurts, very nauseated with chills and very weak all day.  DAY 2 - 8/24 - Arm is very painful & very fatigued. DAY 3 - 8/25 - Arm still sore, red & swollen at injection sight DAY 4 - 8/26 - Arm still sore, red & swollen DAY 5 - 8/27 Arm not quite as sore, turning pink but itchy. DAY 6 - 8/28 Same as above DAY 7 - 8/29 Finally felt better.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Breath odour, Dental caries, Dry mouth, Pain, Tooth discolouration
Clinical narrative: Dry mouth, yellowing of teeth, Loss of teeth, Pain, decayed breath,
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Tooth loss
Clinical narrative: Dry mouth, yellowing of teeth, Loss of teeth, Pain, decayed breath,
Age: 29.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Abdominal discomfort, Body temperature increased, Chills, Diarrhoea, Exposure during pregnancy
Clinical narrative: A few hours after receiving the Tdap booster I started to have negative health side effects starting with nausea, upset stomach, aches, diarrhea, and chills. These effects continued for approximately 36 hours, and starting around 18 hours also included elevated temperature (no fever, highest recorded 99.5F), and elevated heart rate (100-110bpm). The vaccine was administered during pregnancy as recommended by my OBGYN for immunity for the baby. I had recently had the Tdap booster in 2015, and had no reaction that I can recall. All symptoms appear to have substantially decreased.
Age: 29.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Heart rate increased, Nausea, Pain
Clinical narrative: A few hours after receiving the Tdap booster I started to have negative health side effects starting with nausea, upset stomach, aches, diarrhea, and chills. These effects continued for approximately 36 hours, and starting around 18 hours also included elevated temperature (no fever, highest recorded 99.5F), and elevated heart rate (100-110bpm). The vaccine was administered during pregnancy as recommended by my OBGYN for immunity for the baby. I had recently had the Tdap booster in 2015, and had no reaction that I can recall. All symptoms appear to have substantially decreased.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hypersensitivity, Myalgia
Clinical narrative: sensitivity, headache, fever, sore arm, muscle aches, tired, shivering, nausea
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: sensitivity, headache, fever, sore arm, muscle aches, tired, shivering, nausea
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Loss of personal independence in daily activities, Pain
Clinical narrative: Exactly 24 hours from receiving the vaccine I experienced profound fatigue and aches.  I was actually paddle boarding and was unable to paddle back to the dock.  Went directly to bed and for 30 hours had all body aches (even in my groin!) and extreme fatigue.  I kept myself hydrated and took some ibuprofen which eased the aches.  I contacted my PCP @ 1 PM on 26th and she suggested I maintain what I've been doing and rest.  By noon on 28th I was fine!
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site inflammation, Pruritus
Clinical narrative: Patient  reports redness and itchiness lasting 4 days. there is also slight inflammation at the site of injection. when asked, the patient said its resolving slowly but was worried about outcomes.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Muscle pain, fever, chills throughout the night, weakness, flu-like symptoms
Sex: U
Vaccine: MMRV
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: No adverse effects were reported; a patient moved their arm and only received a partial dose of PROQUAD as a result; This spontaneous report was received from a physician and refers to a patient of unspecified age and gender. No details regarding the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were provided.   On 26-AUG-2019, the patient moved their arm and only received a partial dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rha)(PROQUAD), lot # R011214, expiration date 15-OCT-2019 (exact dose, dose number, route and site of administration were not provided) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events were reported in the patient; the patient received a dose of PEDVAX HIB at age 1 month 26 days; This spontaneous report was received from a medical assistant and refers to a 1 month and 26 day old patient of unspecified gender. No details regarding the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were provided.  On 26-JUL-2019, the patient received a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), lot # R036177, expiration date 08-OCT-2021 (exact dose, dose number, route and site of administration were not provided) for prophylaxis. No adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: NO adverse effect reported; a patient was administered a dose of improperly stored VARIV AX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 20-AUG-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), lot # S004554, expiration date 14-FEB-2021 (strength, route of administration and exact dose were not reported), for prophylaxis. No adverse effect was reported. Administered dose of vaccine experienced the temperature excursion of -14 Celsius degrees to -10 Celsius degress (also reported as -14.4 Celsius degrees) for 18 minutes. The digital data logger was involved in recording the temperature excursion details. There were no previous temperature excursions reported.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Herpes zoster, Hyperhidrosis
Clinical narrative: severe and debilitating nerve, muscle and joint pain over her entire body including, but not limited to, her spine, flank, extremities and otherareas of her body; chills; sweats; shingles; severe and debilitating nerve, muscle and joint pain over her entire body including, but not limited to, her spine, flank, extremities and otherareas of her body; severe and debilitating nerve, muscle and joint pain over her entire body including, but not limited to, her spine, flank, extremities and otherareas of her body; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On 13-JUL-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), in September 2016, patient suffered debilitating injuries including internal shingles, severe and debilitating nerve, muscle and joint pain over her entire body including, but not limited to, her spine, flank, extremities and other areas of her body, as well as chills and sweats. These symptoms greatly diminished her quality of life and ability to function. These symptoms lasted for months and resulted in several hospitalizations including the administration of many tests and medications including valacyclovir hydrochloride (VALTREX). The cause of these injuries was never determined by her healthcare providers. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX) and caused by the zoster vaccine live (ZOSTAVAX). As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and debilitating personal injuries and suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Internal shingles, severe and debilitating nerve, muscle and joint pain over her entire body including, but not limited to, her spine, flank, extremities and other areas of her body, chills and sweats were considered to be disabling.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Neuralgia, Quality of life decreased
Clinical narrative: severe and debilitating nerve, muscle and joint pain over her entire body including, but not limited to, her spine, flank, extremities and otherareas of her body; chills; sweats; shingles; severe and debilitating nerve, muscle and joint pain over her entire body including, but not limited to, her spine, flank, extremities and otherareas of her body; severe and debilitating nerve, muscle and joint pain over her entire body including, but not limited to, her spine, flank, extremities and otherareas of her body; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On 13-JUL-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), in September 2016, patient suffered debilitating injuries including internal shingles, severe and debilitating nerve, muscle and joint pain over her entire body including, but not limited to, her spine, flank, extremities and other areas of her body, as well as chills and sweats. These symptoms greatly diminished her quality of life and ability to function. These symptoms lasted for months and resulted in several hospitalizations including the administration of many tests and medications including valacyclovir hydrochloride (VALTREX). The cause of these injuries was never determined by her healthcare providers. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX) and caused by the zoster vaccine live (ZOSTAVAX). As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and debilitating personal injuries and suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Internal shingles, severe and debilitating nerve, muscle and joint pain over her entire body including, but not limited to, her spine, flank, extremities and other areas of her body, chills and sweats were considered to be disabling.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  In 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) vaccination, patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of herpes zoster was unknown.      Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Polyneuropathy
Clinical narrative: herpes zoster polyneuropathy; herpes zoster polyneuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  In 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by physician for herpes zoster polyneuropathy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of herpes zoster polyneuropathy was unknown.     Upon internal review, polyneuropathy was considered to be medically significant.  Additional information has been requested.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Asthenia, Dizziness, Extra dose administered, Gait disturbance, Pain
Clinical narrative: Extra dose administered; Was weak; Barely could walk; She felt like she was going to pass out; Had aches; Was shaky; This case was reported by a nurse via sales rep and described the occurrence of weakness in a adolescent female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (received 1st dose in 2015) and Menveo (received booster dose in July 2019).   In August 2019, the patient received Bexsero and the 3rd dose of Menveo. In August 2019, less than a month after receiving Bexsero and Menveo, the patient experienced weakness, walking difficulty, felt faint, pain and tremor. On an unknown date, the patient experienced extra dose administered. On an unknown date, the outcome of the weakness, walking difficulty, felt faint, pain, tremor and extra dose administered were unknown.   It was unknown if the reporter considered the weakness, walking difficulty, felt faint, pain and tremor to be related to Bexsero and Menveo.  Additional case details were reported as follows: The age at vaccination was not reported. The patient accidentally received a 3rd dose in August 2019 (co-administration with Bexsero).  The patients was so weak and barely could walk a couple days after administration. The patient went to emergency room.  She felt like she was going to pass out and had aches, and was shaky. The reporter denied permission to follow up.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Tremor
Clinical narrative: Extra dose administered; Was weak; Barely could walk; She felt like she was going to pass out; Had aches; Was shaky; This case was reported by a nurse via sales rep and described the occurrence of weakness in a adolescent female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (received 1st dose in 2015) and Menveo (received booster dose in July 2019).   In August 2019, the patient received Bexsero and the 3rd dose of Menveo. In August 2019, less than a month after receiving Bexsero and Menveo, the patient experienced weakness, walking difficulty, felt faint, pain and tremor. On an unknown date, the patient experienced extra dose administered. On an unknown date, the outcome of the weakness, walking difficulty, felt faint, pain, tremor and extra dose administered were unknown.   It was unknown if the reporter considered the weakness, walking difficulty, felt faint, pain and tremor to be related to Bexsero and Menveo.  Additional case details were reported as follows: The age at vaccination was not reported. The patient accidentally received a 3rd dose in August 2019 (co-administration with Bexsero).  The patients was so weak and barely could walk a couple days after administration. The patient went to emergency room.  She felt like she was going to pass out and had aches, and was shaky. The reporter denied permission to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Suspected vaccination failure; Experienced Flu A; This case was reported by a consumer and described the occurrence of vaccination failure in a 62-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza a virus infection. On an unknown date, the outcome of the vaccination failure and influenza a virus infection were unknown.   It was unknown if the reporter considered the vaccination failure and influenza a virus infection to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Flu A vaccine and experienced flu. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. This case has been linked with US2019AMR154734, reported for same patient for Shingrix vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number KC9C4, expiry date 30th March 2020) for prophylaxis.   On 20th May 2019, the patient received the 1st dose of Shingrix. On 20th May 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The patient experienced influenza like symptoms, after vaccination with dose of Shingrix. This case was 1 of the 2 linked cases.
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Irritability, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: increased fussiness; Inappropriate age at vaccine administration; wrong vaccine administered; This case was reported by a nurse via call center representative and described the occurrence of irritability in a 11-month-old male patient who received DTPa-IPV (Kinrix) (batch number 2439H, expiry date 25th April 2020) for prophylaxis.  On an unknown date, the patient received Kinrix. On an unknown date, unknown after receiving Kinrix, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.  Additional details were provided as follows: The nurse called to report that Kinrix was inadvertantly administered to children less than 4 years of age, rather than Pediarix, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up. There may be more patient, they are researching it at the time of reporting. This case linked with US2019133766, reported by same reporter.   Follow up information received from Nurse on 26th August 2019: The patient's demographic details were updated. On 19th December 2018, the patient received the 2nd dose of Kinrix 0.5 ml intramuscularly. The patient's mother reported increased fuzziness. She was out of town and her husband was taking care of patient so she is not exactly sure of specific symptoms. It was unknown if the reporter considered the irritability to be related to Kinrix. The VAERS details were updated.