chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Pain, Pain in extremity, X-ray
Clinical narrative: The day after the vaccine he woke up and when he moves his arm he has a lot of pain in movement.  He also said his right eye was red but no pain.  He still has the pain in his right arm when he is moving.  He went to 4 different ER.    1) 10/29/2020  Urgent Care 2) 11/17/2020  Hospital 3) 11/20/2020  Emergency Dept. 4)  11/20/2020 Hospital ER 5) 12/03/2020  Dr.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pain, Pain in extremity
Clinical narrative: Low grade fever 99.9-100.4, body aches, muscle aches, sore right arm, tiredness, sleepiness, headache
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Somnolence
Clinical narrative: Low grade fever 99.9-100.4, body aches, muscle aches, sore right arm, tiredness, sleepiness, headache
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Mobility decreased
Clinical narrative: PATIENT UNABLE TO LIFT ARM ABOVE SHOULDER
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity
Clinical narrative: PATIENT UNABLE TO LIFT ARM ABOVE SHOULDER
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: I gave the child an ACTHIB vaccine with the incorrect diluent.  Spoke to sanofi, Sanofi nurse stated that the injection is now invalid, and the pt will have to come in and get a new one. sanofi also stated that it does not state anywhere that this injection is now harmful because everyone reacts differently to vaccines. Nurse also stated that there is no wait period before pt is able to get another HIB vaccine. Sanofi went over what other injections were given to pt at the time, the expiration date, the lot number, the reason for the wrong diluent being used.    Spoke to mother and explained to her what happened, how it happened, and what we need to do to fix this, mother was very nice and understanding, mother is now scheduled to bring patient in to give new injection of HIB vaccine.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Face injury, Loss of consciousness, Skin abrasion
Clinical narrative: Patient was fine in the office and then upon exiting the facility passed out while getting out the door to the car. Patient was helped by another nurse from another office and then brought back to our office via wheelchair where he was examined and placed on the table with feet up . Had many facial abrasions. was given juice and some cookies and crackers . Was given cold wash cloth for face. B/P was initially 70/60 . Continued to monitor until about 4:15 pm at which time he was up and sitting and then was able to walk to the door without dizziness or nausea. He was then place in wheelchair and brought out to the car . He walked into the car with minimal assist and said he felt fine.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient states she received incorrect vaccination administration. She has complaints of arm pain and inability to move her arm to a certain extent. She received vaccination over 2 months ago and seem to still have mild pain and issues with arm movement.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: Pentacel was ordered on the patient. MA drew up the Hib portion of the vaccine with a sterile dilutant instead of the DTap-IPV portion of the vaccine. The patient only received the Hib portion of the medication.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: patient complains her arm has been sore and weak for the past 2 weeks.
Age: 1.33
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Chest X-ray normal, Computerised tomogram head normal, Endotracheal intubation, Lumbar puncture, Seizure
Clinical narrative: Mother took child to the car post vaccinations and noted child having a seizure. Brought back into office and child continued to seize. Subsequently given Diastat rectally x's 2. Child continued to have seizure activity during the visit. Transported to ED by ambulance. Eventually intubated at ED.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Peripheral swelling, Rash macular, Swollen tongue
Clinical narrative: spots in mouth, swollen tongue, hands and feet. No rash, no fever, no site reaction
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fatigue 12/8/2020 fever 100.3 degrees 12 noon 12/8/2020 shivers 12 noon 12/8/ 2020 and body aches
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chest discomfort, Chills, Fatigue, Headache
Clinical narrative: fever, chills, headache, widespread body aches, stomach pain, nauseous feeling, tingling lips, breathing felt off, heavy chest, stuffiness in nose, tired
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasal congestion, Nausea, Pain, Paraesthesia oral, Pyrexia
Clinical narrative: fever, chills, headache, widespread body aches, stomach pain, nauseous feeling, tingling lips, breathing felt off, heavy chest, stuffiness in nose, tired
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Respiration abnormal
Clinical narrative: fever, chills, headache, widespread body aches, stomach pain, nauseous feeling, tingling lips, breathing felt off, heavy chest, stuffiness in nose, tired
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Discomfort, Feeling abnormal, Sensory loss
Clinical narrative: Patient states she felt sedated and half of the face was sedated and heavy and loss of sensation.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Feeling abnormal, Gait disturbance, Influenza like illness
Clinical narrative: Dizziness, whole body muscle aches (extreme like a bad flu), and nausea.  Dizziness noticed early a.m. when first woke up the day after the vaccine., but had difficulty sleeping due to muscle aches.  Dizziness /vertigo was bad enough to require me to lay down for the rest of the day Saturday. Needed some help walking early on, but that gradually improved  to where I could walk /stand up as long as I had something to hold onto (wall or counter, etc).  I was only able to eat toast and ramen .  Couldn't read or watch tv, too dizzy.  By the next morning (12/6/2020), muscle aches and nausea was gone but I still suffered dizziness if I moved too fast or bent over or turned my head. I could function, but was tired and "not quite right."  Still experienced very slight dizziness by Monday 12/7, continuing throughout that day, but manageable.   Today  12/8, I'm not quite feeling 100% but hopefully soon. Luckily I never need another dose of Shingrix!
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Sleep disorder, Vertigo
Clinical narrative: Dizziness, whole body muscle aches (extreme like a bad flu), and nausea.  Dizziness noticed early a.m. when first woke up the day after the vaccine., but had difficulty sleeping due to muscle aches.  Dizziness /vertigo was bad enough to require me to lay down for the rest of the day Saturday. Needed some help walking early on, but that gradually improved  to where I could walk /stand up as long as I had something to hold onto (wall or counter, etc).  I was only able to eat toast and ramen .  Couldn't read or watch tv, too dizzy.  By the next morning (12/6/2020), muscle aches and nausea was gone but I still suffered dizziness if I moved too fast or bent over or turned my head. I could function, but was tired and "not quite right."  Still experienced very slight dizziness by Monday 12/7, continuing throughout that day, but manageable.   Today  12/8, I'm not quite feeling 100% but hopefully soon. Luckily I never need another dose of Shingrix!
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Ear pain, Fatigue, Injection site pain
Clinical narrative: Muscle pain in the site, felt chills , tiredness and pain on left earlobe on 12/7/2020 and 12/8/2020.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Vomiting
Clinical narrative: Mother reported adverse reaction  on 11/16/2020  x telephone visit and Vaccine Concern.  Per: Mother Sx's began 10 days ago. Mother states she noticed vomiting after injection administration 11/06/2020. Mother states " we couldn't give him any food because he would throw up." Mother did not take patient to urgent care and patient is feeling better. Patient reported soreness in area of injection. Denies rash, site reaction, diarrhea, cough or cold sx's.  Provider will keep in observation. Patient has an appointment in 1 month.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Dyskinesia, Fatigue, Hypoaesthesia
Clinical narrative: The patient complained of fatigue, weakness, severe joint pain, and extremity numbness. Patient described feeling as is hands and feet were curling in and he had no control. Symptoms started on the evening after receiving the vaccination. About 2 weeks after vaccination, the patient continues to have increased fatigue.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Laboratory test, Urine analysis
Clinical narrative: The patient complained of fatigue, weakness, severe joint pain, and extremity numbness. Patient described feeling as is hands and feet were curling in and he had no control. Symptoms started on the evening after receiving the vaccination. About 2 weeks after vaccination, the patient continues to have increased fatigue.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Erythema, Swelling, Urticaria
Clinical narrative: Discomfort with area reddened and swollen, as well as hives.   Area effected from below elbow to shoulder.  No breathing problems noted.
Age: 81.0
Sex: F
Vaccine: FLUA4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Blindness, Dizziness, Nervousness, Rash, Syncope
Clinical narrative: Patient experienced a syncope episode with lightheadedness, feeling faint and vision closing in. She was very nervous before the vaccination. 15 minutes post vaccine she developed a rash on her inner crook of her elbows and forearms, face and legs. Patient states she experiences these rashes when under extreme stress or heat conditions such as final exams, long distance running track or hot tubs. She did not experience any tingling or swelling of the face lips or tongue. She was observed in pharmacy for 1 hour and rash dissipated. Patient states that most of the rash had gone away once she got home approximately 90 minutes after vaccination.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia
Clinical narrative: shoulder pain
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Loss of personal independence in daily activities, Pain, Pyrexia
Clinical narrative: 24 hour after injection, chills, body ache and fever up to  100.7 F. Gone after another 24 hour. Extreme fatigue for at least 48 hour. Unable to perform routine chores for 48 hours.
Age: 67.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia, Vomiting
Clinical narrative: Flu-like symptoms at first. Fever, soreness. Then vomiting.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Eye irritation, Lymphadenopathy, Migraine, Palpitations
Clinical narrative: as per patient, first flu shot. does not remember if she received in the past as a child. as per patient, received Afluria 20-21 preservative free flu shot on 11/18/2020 around 6:30pm. 2 hours later, patient experienced swelling of glands, jaw, tongue, wheezing, eyes burning (could not open or close), racing heart, chills. had difficulty sleeping at night. woke up in morning 11/19/2020 with migraine. by 11/19/2020 around noon, all symptoms resolved or went away. patient confirmed not allergic to eggs.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Sleep disorder, Swelling face, Swollen tongue, Wheezing
Clinical narrative: as per patient, first flu shot. does not remember if she received in the past as a child. as per patient, received Afluria 20-21 preservative free flu shot on 11/18/2020 around 6:30pm. 2 hours later, patient experienced swelling of glands, jaw, tongue, wheezing, eyes burning (could not open or close), racing heart, chills. had difficulty sleeping at night. woke up in morning 11/19/2020 with migraine. by 11/19/2020 around noon, all symptoms resolved or went away. patient confirmed not allergic to eggs.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Injection site pain, Joint range of motion decreased, Mobility decreased, Pain in extremity
Clinical narrative: Patient woke up day after vaccine administration with pain/soreness at injection site but resolved after a couple of days. However, patient stated that on Friday morning after vaccine administration, he woke up with strong pain in his left arm/shoulder. He stated he could barely lift his arm and had very limited range of motion. Patient did not report adverse event to pharmacy immediately, we were made aware of adverse event a week after vaccine administration. Patient states that as of today, he can lift his arm about 135 degrees from resting position and the pain is decreasing.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient states that she developed a large, red welt on her arm the day after she had received the vaccine. She states that it took 5 to 7 days to resolve and states it was painful.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Haematochezia, Intussusception
Clinical narrative: 2-3 days after oral vaccine, patient developed bloody stools and was found to have intussusception.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose normal, Cold sweat, Dizziness, Hypotension, Immediate post-injection reaction
Clinical narrative: Patient started having a minor seizure immediately after the flu shot was injected. He was shaking, dizzy, and his skin began to feel clammy and cold. The shaking would stop and start again. He was breathing and upright the whole time. The ambulance was called right after the reaction began. When paramedics arrived they tested the patients blood glucose, which was normal. His blood pressure was very low, but I don't know the exact numbers. They monitored blood pressure for several minutes and said they weren't leaving until his blood pressure came up. The patient said he was not on any medications and had not had anything to eat since breakfast. He admitted that he was not very well hydrated. He said he had a similar reaction to one of his Gardasil shots, but has never had a reaction to any other vaccine including the flu shot. The patient eventually left the pharmacy area on his own will after about a half an hour, the paramedics said that they needed his brother to take him to urgent care right away since he did not want to go in the ambulance. That is all the information I have at this time.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Seizure, Tremor
Clinical narrative: Patient started having a minor seizure immediately after the flu shot was injected. He was shaking, dizzy, and his skin began to feel clammy and cold. The shaking would stop and start again. He was breathing and upright the whole time. The ambulance was called right after the reaction began. When paramedics arrived they tested the patients blood glucose, which was normal. His blood pressure was very low, but I don't know the exact numbers. They monitored blood pressure for several minutes and said they weren't leaving until his blood pressure came up. The patient said he was not on any medications and had not had anything to eat since breakfast. He admitted that he was not very well hydrated. He said he had a similar reaction to one of his Gardasil shots, but has never had a reaction to any other vaccine including the flu shot. The patient eventually left the pharmacy area on his own will after about a half an hour, the paramedics said that they needed his brother to take him to urgent care right away since he did not want to go in the ambulance. That is all the information I have at this time.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Pt received duplicate Fluzone HD vaccines on 09/21/20 (UJ460AB) and on 10/26/20 (UJ546AB).  Pt didn't recall receiving first dose and offered no reason for coming in for second dose.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever of 101, swelling at injection site, pain at injection site
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: flat pin point rash on chest appeared after 2 hours and lasted 3 days
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Blood cholesterol, Blood cortisol, Blood test, Chest X-ray
Clinical narrative: Emergency room, many tests to rule things out and told to take supplements Vitamin D3 MK7, Vitamin C, Opti-Zinc.  Also did the AIP diet protocol for about 3 weeks and now starting to add foods back in.  It's been 8 weeks and I'm just now starting to feel a little more like myself with a little more energy.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Electrocardiogram, Epstein-Barr virus antibody, Feeling abnormal, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Emergency room, many tests to rule things out and told to take supplements Vitamin D3 MK7, Vitamin C, Opti-Zinc.  Also did the AIP diet protocol for about 3 weeks and now starting to add foods back in.  It's been 8 weeks and I'm just now starting to feel a little more like myself with a little more energy.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Scan adrenal gland, Thyroid function test, Troponin, Ultrasound thyroid, Vitamin D decreased
Clinical narrative: Emergency room, many tests to rule things out and told to take supplements Vitamin D3 MK7, Vitamin C, Opti-Zinc.  Also did the AIP diet protocol for about 3 weeks and now starting to add foods back in.  It's been 8 weeks and I'm just now starting to feel a little more like myself with a little more energy.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Pruritus
Clinical narrative: Day of vaccination, in the evening felt like i had been hit and my arm was almost immobile.  If I moved my arm, pain localized in the socket was intense.  I went to bed early because of the pain.  For the next 2 days the pain continued, my arm had to stay close to my body, with little movement.  On the 3rd day could feel the pain lessening.  The fourth day I could move it freely and finally returned to normal.  i didn?t report my problem with the vaccine but today had boil like itchy skin above the shoulder joint.  I took a picture of the skin.   With the eruption of my skin, I thought I should report it.  I?ve never had a vaccine shot that brought pain like this, and then later reaction of a boil-like itch.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Asthenia, Coordination abnormal, Decreased appetite, Dizziness
Clinical narrative: Had a restless night as arm became very sore with soreness spreading to neck and spine areas. Woke with a headache and sensation of stuffy head. Muscles, especially in back, were very sore and achy. Over the course of the day started feeling like I had the flu. Headaches, muscles aches, nausea, dizzyness, light-headed, lack of appetite, mild fever (100.2), and general feeling of unwellness and lack of energy. Lasted 4 days. OTC ibuprofen and cold meds aleviated but did not fully clear symptoms. Thought I had a cold. Had the second shot in the series (7th Dec, early afternoon, same location) and woke up this morning with identical symptoms to last time.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Head discomfort, Headache, Influenza like illness, Malaise, Myalgia
Clinical narrative: Had a restless night as arm became very sore with soreness spreading to neck and spine areas. Woke with a headache and sensation of stuffy head. Muscles, especially in back, were very sore and achy. Over the course of the day started feeling like I had the flu. Headaches, muscles aches, nausea, dizzyness, light-headed, lack of appetite, mild fever (100.2), and general feeling of unwellness and lack of energy. Lasted 4 days. OTC ibuprofen and cold meds aleviated but did not fully clear symptoms. Thought I had a cold. Had the second shot in the series (7th Dec, early afternoon, same location) and woke up this morning with identical symptoms to last time.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Neck pain, Pyrexia, Restlessness, Sleep disorder
Clinical narrative: Had a restless night as arm became very sore with soreness spreading to neck and spine areas. Woke with a headache and sensation of stuffy head. Muscles, especially in back, were very sore and achy. Over the course of the day started feeling like I had the flu. Headaches, muscles aches, nausea, dizzyness, light-headed, lack of appetite, mild fever (100.2), and general feeling of unwellness and lack of energy. Lasted 4 days. OTC ibuprofen and cold meds aleviated but did not fully clear symptoms. Thought I had a cold. Had the second shot in the series (7th Dec, early afternoon, same location) and woke up this morning with identical symptoms to last time.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Spinal pain, Vaccine positive rechallenge
Clinical narrative: Had a restless night as arm became very sore with soreness spreading to neck and spine areas. Woke with a headache and sensation of stuffy head. Muscles, especially in back, were very sore and achy. Over the course of the day started feeling like I had the flu. Headaches, muscles aches, nausea, dizzyness, light-headed, lack of appetite, mild fever (100.2), and general feeling of unwellness and lack of energy. Lasted 4 days. OTC ibuprofen and cold meds aleviated but did not fully clear symptoms. Thought I had a cold. Had the second shot in the series (7th Dec, early afternoon, same location) and woke up this morning with identical symptoms to last time.
Age: 27.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Syncope
Clinical narrative: SYNCOPE, LEGS ELEVATED ABOVE HEAD AND PATIENT REGAINED CONSCIENCE WITH 1 MINUTE
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Amylase normal, Blood immunoglobulin E, C-reactive protein decreased, Decreased appetite, Dizziness
Clinical narrative: On 11/4/2020, she received Menveo #2 and Bexsero #1. The next day had arm pain on left arm, which lasted a whole week. On the 6th, had numbness on anterior right lateral calf, which lasted about a day. Overnight and into the next day, she developed nausea and globus sensation.  On Sunday the 8th, went to restaurant and after eating, she was feeling increasingly nauseous but didn't throw up. Felt like she couldn't breathe. No one else was sick. Once at home, she kept gagging. Dizzy. ED: ibuprofen and nausea meds ODT (has used a few, but they didn't help at all). Had had blood work drawn the same day Broke out in a rash around the same time- seen here and Dx Urticaria. Never took the cetirizine because rash self-resolved after about 1 week of intermittent coming and going. No rash for past 2 weeks.  Seen here on 11/12. Urgent Care visit on either the 17th/18th who recommended PMD follow-up. Last Thursday 11/19 called, but never got a call back. So Mom came by yesterday to get this appointment.  At this time, she continues to have spitting up - clear - no blood, occasionally feels like a luggie is stuck in throat and can't cough it up. Denies abdominal or chest pain. Diarrhea started around same time as spitting and ongoing with TID BMs that are liquid - no blood.  Dizziness happening at random and worse when standing up. Drinking water (about 2 cups/day) and juice (about 1 cup/day). Also not eating well initially because of globus sensation, which has resolved, so now feels like she can eat again. In middle of drinking, she'll get hit with sensation to spit up.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Full blood count normal, Hypoaesthesia, Lipase normal, Liver function test normal, Metabolic function test
Clinical narrative: On 11/4/2020, she received Menveo #2 and Bexsero #1. The next day had arm pain on left arm, which lasted a whole week. On the 6th, had numbness on anterior right lateral calf, which lasted about a day. Overnight and into the next day, she developed nausea and globus sensation.  On Sunday the 8th, went to restaurant and after eating, she was feeling increasingly nauseous but didn't throw up. Felt like she couldn't breathe. No one else was sick. Once at home, she kept gagging. Dizzy. ED: ibuprofen and nausea meds ODT (has used a few, but they didn't help at all). Had had blood work drawn the same day Broke out in a rash around the same time- seen here and Dx Urticaria. Never took the cetirizine because rash self-resolved after about 1 week of intermittent coming and going. No rash for past 2 weeks.  Seen here on 11/12. Urgent Care visit on either the 17th/18th who recommended PMD follow-up. Last Thursday 11/19 called, but never got a call back. So Mom came by yesterday to get this appointment.  At this time, she continues to have spitting up - clear - no blood, occasionally feels like a luggie is stuck in throat and can't cough it up. Denies abdominal or chest pain. Diarrhea started around same time as spitting and ongoing with TID BMs that are liquid - no blood.  Dizziness happening at random and worse when standing up. Drinking water (about 2 cups/day) and juice (about 1 cup/day). Also not eating well initially because of globus sensation, which has resolved, so now feels like she can eat again. In middle of drinking, she'll get hit with sensation to spit up.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Nausea, Rash, Red blood cell sedimentation rate increased, Retching, Sensation of foreign body
Clinical narrative: On 11/4/2020, she received Menveo #2 and Bexsero #1. The next day had arm pain on left arm, which lasted a whole week. On the 6th, had numbness on anterior right lateral calf, which lasted about a day. Overnight and into the next day, she developed nausea and globus sensation.  On Sunday the 8th, went to restaurant and after eating, she was feeling increasingly nauseous but didn't throw up. Felt like she couldn't breathe. No one else was sick. Once at home, she kept gagging. Dizzy. ED: ibuprofen and nausea meds ODT (has used a few, but they didn't help at all). Had had blood work drawn the same day Broke out in a rash around the same time- seen here and Dx Urticaria. Never took the cetirizine because rash self-resolved after about 1 week of intermittent coming and going. No rash for past 2 weeks.  Seen here on 11/12. Urgent Care visit on either the 17th/18th who recommended PMD follow-up. Last Thursday 11/19 called, but never got a call back. So Mom came by yesterday to get this appointment.  At this time, she continues to have spitting up - clear - no blood, occasionally feels like a luggie is stuck in throat and can't cough it up. Denies abdominal or chest pain. Diarrhea started around same time as spitting and ongoing with TID BMs that are liquid - no blood.  Dizziness happening at random and worse when standing up. Drinking water (about 2 cups/day) and juice (about 1 cup/day). Also not eating well initially because of globus sensation, which has resolved, so now feels like she can eat again. In middle of drinking, she'll get hit with sensation to spit up.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Urticaria
Clinical narrative: On 11/4/2020, she received Menveo #2 and Bexsero #1. The next day had arm pain on left arm, which lasted a whole week. On the 6th, had numbness on anterior right lateral calf, which lasted about a day. Overnight and into the next day, she developed nausea and globus sensation.  On Sunday the 8th, went to restaurant and after eating, she was feeling increasingly nauseous but didn't throw up. Felt like she couldn't breathe. No one else was sick. Once at home, she kept gagging. Dizzy. ED: ibuprofen and nausea meds ODT (has used a few, but they didn't help at all). Had had blood work drawn the same day Broke out in a rash around the same time- seen here and Dx Urticaria. Never took the cetirizine because rash self-resolved after about 1 week of intermittent coming and going. No rash for past 2 weeks.  Seen here on 11/12. Urgent Care visit on either the 17th/18th who recommended PMD follow-up. Last Thursday 11/19 called, but never got a call back. So Mom came by yesterday to get this appointment.  At this time, she continues to have spitting up - clear - no blood, occasionally feels like a luggie is stuck in throat and can't cough it up. Denies abdominal or chest pain. Diarrhea started around same time as spitting and ongoing with TID BMs that are liquid - no blood.  Dizziness happening at random and worse when standing up. Drinking water (about 2 cups/day) and juice (about 1 cup/day). Also not eating well initially because of globus sensation, which has resolved, so now feels like she can eat again. In middle of drinking, she'll get hit with sensation to spit up.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Gait inability, Musculoskeletal stiffness
Clinical narrative: Never had a problem before.  This time, my arm was stiff, not uncommon...however 2 days later, I IMMEDIATELY woke up and was unable to walk.  My hips felt like I had run a 20 mile marathon.  I was so stiff that, I had to use my hands to lift my legs.  Went to chiropractor for a few sessions, felt alittle relief...but it is STILL not good.  Feel like I have MS or something.  Went to my family doctor last week, he ordered tests and blood work.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Rash, Rash pruritic, Vaccine positive rechallenge
Clinical narrative: 2 days after the injection I had the redness at the site (to be expected) and a rash all over my upper torso.  The next day or so I had a severe headache.  Day 4 the rash intensified and started itching terribly.  I still have a rash on 12/8/2020 although it is much less itchy and red than before.
Age: 64.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Abdominal discomfort, Chills, Dizziness, Dry throat, Headache
Clinical narrative: Nausea, upset stomach, queasiness, headache, body ache, very dry throat, lightheadedness -- second night got very bad chills, but no fever.
Age: 64.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Nausea, upset stomach, queasiness, headache, body ache, very dry throat, lightheadedness -- second night got very bad chills, but no fever.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Severe pain in the immunization arm on exertion. Per the patient, pain is a 9.5/10 when he lifts things with the immunization arm
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Pharyngeal swelling, Swollen tongue
Clinical narrative: The patient answered "yes" on the immunization screening consent form for the question: Have you ever had a serious reaction or fainted after receiving a vaccination? She reported that she had fainted after a flu shot a long time ago, but was willing to proceed with the flu shot when she asked. She was counseled to remain in the vaccination room for a few minutes after the immunization was administered. She was moved to the lobby to continue waiting the remaining 15 to 20 minutes. Shortly after she returned to the counter to report that her tongue and throat were swelling. She reported at this time that she had experienced an anaphylactic reaction to some allergy shots when she was younger, and this "feels the same." We immediately called for emergency assistance and brought her into our vaccination room. As per protocol, she was given 1 dose 0.3 mg of epinephrine by IM administration and her blood pressure and heart rate were checked. She confirmed the absence of any hives or itching so we did not administer diphenhydramine.  Emergency assistance arrived and after speaking with the patient and listening to our report,  she was transported to the emergency room for further evaluation and continued monitoring.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: chills, &  low fever... (sore arm muscle)
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthralgia, Incorrect route of product administration
Clinical narrative: Pt was given a vaccine on 10/29. On 10/30 she experienced severe pain in her shoulder. After a few days she was seen by her doctor who indicated that vaccine was given in the bursa from her description of the pain. She was treated with oral steroids which did not help to alleviate the pain.  She reports that over time the pain is subsiding, but she is still experiencing pain with ADL. She is consulting with a kinesiologist to aid in movement therapy.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site swelling, Myalgia, Sleep disorder
Clinical narrative: soreness and swelling at injection site, muscle aches, loss of sleep, shivering
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Decreased appetite, Diarrhoea, Headache, Herpes zoster
Clinical narrative: Vaccinated on 11-6-2020, Rash to R posterior Back on 11-21-20 with back pain, numbness, headaches. Diagnosed with Shingles at CMG + walkin clinic on 11-25-2020. Felt OK except back pain. Was sick in bed 12-1-2020 for 4 days with low grade Fever, severe malaise, nasuea, diahrrea anorexia and back pain although the rash was rapidly improving was put on Acyclovir 500mg QD on 11-25-2020.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Malaise, Nausea, Pyrexia, Rash
Clinical narrative: Vaccinated on 11-6-2020, Rash to R posterior Back on 11-21-20 with back pain, numbness, headaches. Diagnosed with Shingles at CMG + walkin clinic on 11-25-2020. Felt OK except back pain. Was sick in bed 12-1-2020 for 4 days with low grade Fever, severe malaise, nasuea, diahrrea anorexia and back pain although the rash was rapidly improving was put on Acyclovir 500mg QD on 11-25-2020.
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered
Clinical narrative: a dose of VAQTA that was administered and expired; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 01-DEC-2020, the patient was vaccinated with a dose of expired hepatitis a vaccine, inactivated (VAQTA) (lot # S024396, expiration date 12-OCT-2020, route was not reported) for prophylaxis (expired product administered). The vaccine did not experience any temperature excursions. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: S024396; expirationdate: 12-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Pain, Scar
Clinical narrative: permanent scarring; a severe and painful shingles outbreak; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On or around 07-AUG-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not reported) for the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a severe and painful shingles outbreak. As a result of zoster vaccine live (ZOSTAVAX), she suffered additional, recurring shingles outbreaks, consisting of blistering, redness, and burning pain. These continuous shingles outbreaks have resulted in permanent scarring on her back and were caused by zoster vaccine live (ZOSTAVAX). As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). She also experience mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccination, she suffered serious, progressive, permanent, 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), the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: severe and debilitating shingles outbreak across her back and stomach, consisting of burning and stabbing pain; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On or around 23-AUG-2010, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (route of administration, lot# and expiration date were not reported) for the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a severe and debilitating shingles outbreak across her back and stomach, consisting of burning and stabbing pain. These symptoms lasted approximately six months and were caused by zoster vaccine live (ZOSTAVAX). As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccination, she suffered serious, progressive, permanent 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), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The event of shingles was considered to be disabling.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE reported; HBP calling to report a temperature excursion on PROQUAD, MMR II and VARIVAX / the vaccines were administered; This spontaneous report was received from an "HBP", referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies.  On 28-SEP-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliter (ml) (strength, vaccination scheme, anatomical site of injection, route of administration were not reported; lot number S027465, expiration date: 02-MAR-2021 and lot number S0317056, which is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot number S0317056 does not match any Company product as confirmed by Lot Verification team, expiration date reported as 06-APR-2021) as prophylaxis (product storage error). No other adverse effect (AE) reported.  The vaccine underwent a temperature excursion of 5.7 degrees Fahrenheit (F) for 14 hours, as recorded by a data logger. There was no previous temperature excursion.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: Physician is reporting that a patient was administered an expired ROTATEQ (11/11/2020) on 12/2/2020.; This spontaneous report was received from a physician, referring to a 8-weeks-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 02-DEC-2020, the patient received an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), administered by oral route, as prophylaxis (formulation, strength and vaccination scheme were not reported, lot number 1660951, which has been verified to be valid, expiration date reported and validated as 11-NOV-2020) (expired product administered).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC.; patient received an expired dose of PROQUAD; This spontaneous report was received from a office manager, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 03-DEC-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, 0.5 milliliter (ml) once (lot number S003868 which has been verified to be valid, expiration date reported and validated as 08-AUG-2020) (vaccination scheme, route of administration, and anatomical site of injection were not reported) as prophylaxis (expired product administered). No additional adverse events were reported in the patient.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information regarding current condition, historical condition or concomitant medication was not provided. In or about May 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose number, strength, route, batch/lot# and expiration date were unknown) by a healthcare provider at a physician's office for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a nurse practitioner (NP) for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue to 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 including 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 would continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspcted Vaccination failure; was free from shingles up until last week when she developed a case.; This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 7PS9E, expiry date 10th September 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 7295J, expiry date 17th October 2021) for prophylaxis.   The patient's past medical history included shingles.   On 22nd November 2019, the patient received the 2nd dose of Shingrix. On 20th September 2019, the patient received the 1st dose of Shingrix. In November 2020, between 1 and 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient had frequent cases of shingles prior to receipt of her Shingrix.  After vaccination, the patient was free from shingles up until last week when she developed a case. This case was considered to be a suspected vaccination failure case, as laboratory confirmation for shingles was unknown.
Sex: U
Vaccine: FLUX
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: arm is sore; hurt it Burns like crazy; hurt it Burns like crazy; Initial information received on 17-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient).  This case involved a 75 year old patient (unknown gender) who reported that arm is sore (Pain in extremity) and hurt it burns like crazy (Pain and Burning sensation), while the patient received Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, reported that arm is sore (Pain in extremity) and hurt it burns like crazy (Pain and Burning sensation) (Unknown latency) following the administration of influenza vaccine.  No laboratory test was reported.  It was not reported if the patient received any corrective treatment.  The event outcome was reported as unknown for all the events, at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Dizziness, Vomiting
Clinical narrative: Dizzy and throwing up; Dizzy and throwing up; Initial information received on 18-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to case 2020SA296074.  This case involves a patient who experienced dizzy and throwing up, while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious dizzy and throwing up (dizziness and vomiting) (Unknown latency) following the administration of INFLUENZA VACCINE.  Final diagnosis was dizziness and vomiting.   Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown for all events.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial information regarding an unsolicited valid non-serious social media case was received from a non-healthcare professional (husband of the patient) via social media on 22-Oct-2020.  This case involved a female patient of an unknown age who take these shots and end up going to the doctor for what the flu (Influenza), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), it was reported that the wife of the reporter takes these shots and end up going to the doctor for what the flu (Influenza). After patient stopped taking the shots, no flu.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event of influenza was unknown.  There will be no information available on the batch number for this case.