chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abnormal loss of weight, Asthenia, Autonomic nervous system imbalance, Chest pain, Decreased appetite
Clinical narrative: Ringing ears dizziness irregular menses - After 1st injection  Headaches dysautonomia  Clinic PCP notes MRI Brain W/1AC Neurology records   Details 1/2024: Progressive complaints of chest pain, dizzy spells, headaches. Onset summer '22. Began following a house fire with complete loss of the home. Of note, also had her 3rd COVID vaccine a month prior.  The house fire was super stressful even and she is now battling PTSD symptoms followed by a counselor. She did battle anxiety and depression in the past. Notable childhood stress. However, noted that her mental health was doing much better following her 2018 pregnancy until this fire event. PCP and outside neurological evaluations. Work up in clinic. There was mention of lateralized left vestibular dysfunction. She was found to have very low blood pressure. Underwent vestibular rehab w/o benefit. Florinef trial for a month with modest benefit but unclear. Consideration for vestibular migraine and underwent a 3 month Depakote without much benefit and discontinued after weight gain. Brain MRI per PCP records indicate normal scan other than a few 'migraine spots.' Tilt table normal per records despite her feeling symptomatic during the study. Lost 20-30 lbs unintentionally. Husband endorses she is eating less than she used to.  Denies having an appetite.  Clonazepam was started shortly following the fire. Notes when she doesn't take it she feels notably worse. More shaky. Pan in the posterior head regions. Feels more stiff and worse dizzy spells.  The dizzy spells at first were episodic. Provoked by rapid head movement or with arising from a seated to standing position. Also triggered by lying down, unclear to lateralization. Bilateral tinnitus. Some events are vertiginous, typically these take place when lying down. She also has a whole body sensation of generalized body weakness. Has to sit and relax to recover. Legs will buckle if she doesn't sit. Can have associated nausea. SBP often found to be low. Cardiac work up normal. Since winter '23, the generalized weakness and lightheaded dizziness has improved. Still has some element of vertigo when lying flat.  The headache since onset has been near constant. Can be made worse during a dizzy spell. Holocephalic and migraine features. Variable severity.   03/19/24: Last visit obtained brain MRI IAC, results unremarkable. Started on amitriptyline titrated to 25 mg QHS to lessen her vertigo and headaches. No benefit appreciated. Still having a daily headache, migraine >8x/month lasting over 4 hours all present for over 3 months. Still has daily dizziness and feeling faint. Often provoked by postural challenge. Can't exercise given she will feel dizzy. Remains reliant on her clonazepam. Takes 2 mg each morning. If doesn't take, she feels a host of somatic symptoms.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Depression, Dizziness, Headache, Hypophagia, Hypotension
Clinical narrative: Ringing ears dizziness irregular menses - After 1st injection  Headaches dysautonomia  Clinic PCP notes MRI Brain W/1AC Neurology records   Details 1/2024: Progressive complaints of chest pain, dizzy spells, headaches. Onset summer '22. Began following a house fire with complete loss of the home. Of note, also had her 3rd COVID vaccine a month prior.  The house fire was super stressful even and she is now battling PTSD symptoms followed by a counselor. She did battle anxiety and depression in the past. Notable childhood stress. However, noted that her mental health was doing much better following her 2018 pregnancy until this fire event. PCP and outside neurological evaluations. Work up in clinic. There was mention of lateralized left vestibular dysfunction. She was found to have very low blood pressure. Underwent vestibular rehab w/o benefit. Florinef trial for a month with modest benefit but unclear. Consideration for vestibular migraine and underwent a 3 month Depakote without much benefit and discontinued after weight gain. Brain MRI per PCP records indicate normal scan other than a few 'migraine spots.' Tilt table normal per records despite her feeling symptomatic during the study. Lost 20-30 lbs unintentionally. Husband endorses she is eating less than she used to.  Denies having an appetite.  Clonazepam was started shortly following the fire. Notes when she doesn't take it she feels notably worse. More shaky. Pan in the posterior head regions. Feels more stiff and worse dizzy spells.  The dizzy spells at first were episodic. Provoked by rapid head movement or with arising from a seated to standing position. Also triggered by lying down, unclear to lateralization. Bilateral tinnitus. Some events are vertiginous, typically these take place when lying down. She also has a whole body sensation of generalized body weakness. Has to sit and relax to recover. Legs will buckle if she doesn't sit. Can have associated nausea. SBP often found to be low. Cardiac work up normal. Since winter '23, the generalized weakness and lightheaded dizziness has improved. Still has some element of vertigo when lying flat.  The headache since onset has been near constant. Can be made worse during a dizzy spell. Holocephalic and migraine features. Variable severity.   03/19/24: Last visit obtained brain MRI IAC, results unremarkable. Started on amitriptyline titrated to 25 mg QHS to lessen her vertigo and headaches. No benefit appreciated. Still having a daily headache, migraine >8x/month lasting over 4 hours all present for over 3 months. Still has daily dizziness and feeling faint. Often provoked by postural challenge. Can't exercise given she will feel dizzy. Remains reliant on her clonazepam. Takes 2 mg each morning. If doesn't take, she feels a host of somatic symptoms.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head abnormal, Menstruation irregular, Migraine, Muscular weakness, Nausea
Clinical narrative: Ringing ears dizziness irregular menses - After 1st injection  Headaches dysautonomia  Clinic PCP notes MRI Brain W/1AC Neurology records   Details 1/2024: Progressive complaints of chest pain, dizzy spells, headaches. Onset summer '22. Began following a house fire with complete loss of the home. Of note, also had her 3rd COVID vaccine a month prior.  The house fire was super stressful even and she is now battling PTSD symptoms followed by a counselor. She did battle anxiety and depression in the past. Notable childhood stress. However, noted that her mental health was doing much better following her 2018 pregnancy until this fire event. PCP and outside neurological evaluations. Work up in clinic. There was mention of lateralized left vestibular dysfunction. She was found to have very low blood pressure. Underwent vestibular rehab w/o benefit. Florinef trial for a month with modest benefit but unclear. Consideration for vestibular migraine and underwent a 3 month Depakote without much benefit and discontinued after weight gain. Brain MRI per PCP records indicate normal scan other than a few 'migraine spots.' Tilt table normal per records despite her feeling symptomatic during the study. Lost 20-30 lbs unintentionally. Husband endorses she is eating less than she used to.  Denies having an appetite.  Clonazepam was started shortly following the fire. Notes when she doesn't take it she feels notably worse. More shaky. Pan in the posterior head regions. Feels more stiff and worse dizzy spells.  The dizzy spells at first were episodic. Provoked by rapid head movement or with arising from a seated to standing position. Also triggered by lying down, unclear to lateralization. Bilateral tinnitus. Some events are vertiginous, typically these take place when lying down. She also has a whole body sensation of generalized body weakness. Has to sit and relax to recover. Legs will buckle if she doesn't sit. Can have associated nausea. SBP often found to be low. Cardiac work up normal. Since winter '23, the generalized weakness and lightheaded dizziness has improved. Still has some element of vertigo when lying flat.  The headache since onset has been near constant. Can be made worse during a dizzy spell. Holocephalic and migraine features. Variable severity.   03/19/24: Last visit obtained brain MRI IAC, results unremarkable. Started on amitriptyline titrated to 25 mg QHS to lessen her vertigo and headaches. No benefit appreciated. Still having a daily headache, migraine >8x/month lasting over 4 hours all present for over 3 months. Still has daily dizziness and feeling faint. Often provoked by postural challenge. Can't exercise given she will feel dizzy. Remains reliant on her clonazepam. Takes 2 mg each morning. If doesn't take, she feels a host of somatic symptoms.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nervousness, Post-traumatic stress disorder, Stress, Tilt table test, Tinnitus
Clinical narrative: Ringing ears dizziness irregular menses - After 1st injection  Headaches dysautonomia  Clinic PCP notes MRI Brain W/1AC Neurology records   Details 1/2024: Progressive complaints of chest pain, dizzy spells, headaches. Onset summer '22. Began following a house fire with complete loss of the home. Of note, also had her 3rd COVID vaccine a month prior.  The house fire was super stressful even and she is now battling PTSD symptoms followed by a counselor. She did battle anxiety and depression in the past. Notable childhood stress. However, noted that her mental health was doing much better following her 2018 pregnancy until this fire event. PCP and outside neurological evaluations. Work up in clinic. There was mention of lateralized left vestibular dysfunction. She was found to have very low blood pressure. Underwent vestibular rehab w/o benefit. Florinef trial for a month with modest benefit but unclear. Consideration for vestibular migraine and underwent a 3 month Depakote without much benefit and discontinued after weight gain. Brain MRI per PCP records indicate normal scan other than a few 'migraine spots.' Tilt table normal per records despite her feeling symptomatic during the study. Lost 20-30 lbs unintentionally. Husband endorses she is eating less than she used to.  Denies having an appetite.  Clonazepam was started shortly following the fire. Notes when she doesn't take it she feels notably worse. More shaky. Pan in the posterior head regions. Feels more stiff and worse dizzy spells.  The dizzy spells at first were episodic. Provoked by rapid head movement or with arising from a seated to standing position. Also triggered by lying down, unclear to lateralization. Bilateral tinnitus. Some events are vertiginous, typically these take place when lying down. She also has a whole body sensation of generalized body weakness. Has to sit and relax to recover. Legs will buckle if she doesn't sit. Can have associated nausea. SBP often found to be low. Cardiac work up normal. Since winter '23, the generalized weakness and lightheaded dizziness has improved. Still has some element of vertigo when lying flat.  The headache since onset has been near constant. Can be made worse during a dizzy spell. Holocephalic and migraine features. Variable severity.   03/19/24: Last visit obtained brain MRI IAC, results unremarkable. Started on amitriptyline titrated to 25 mg QHS to lessen her vertigo and headaches. No benefit appreciated. Still having a daily headache, migraine >8x/month lasting over 4 hours all present for over 3 months. Still has daily dizziness and feeling faint. Often provoked by postural challenge. Can't exercise given she will feel dizzy. Remains reliant on her clonazepam. Takes 2 mg each morning. If doesn't take, she feels a host of somatic symptoms.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vertigo, Vestibular disorder, Vestibular migraine
Clinical narrative: Ringing ears dizziness irregular menses - After 1st injection  Headaches dysautonomia  Clinic PCP notes MRI Brain W/1AC Neurology records   Details 1/2024: Progressive complaints of chest pain, dizzy spells, headaches. Onset summer '22. Began following a house fire with complete loss of the home. Of note, also had her 3rd COVID vaccine a month prior.  The house fire was super stressful even and she is now battling PTSD symptoms followed by a counselor. She did battle anxiety and depression in the past. Notable childhood stress. However, noted that her mental health was doing much better following her 2018 pregnancy until this fire event. PCP and outside neurological evaluations. Work up in clinic. There was mention of lateralized left vestibular dysfunction. She was found to have very low blood pressure. Underwent vestibular rehab w/o benefit. Florinef trial for a month with modest benefit but unclear. Consideration for vestibular migraine and underwent a 3 month Depakote without much benefit and discontinued after weight gain. Brain MRI per PCP records indicate normal scan other than a few 'migraine spots.' Tilt table normal per records despite her feeling symptomatic during the study. Lost 20-30 lbs unintentionally. Husband endorses she is eating less than she used to.  Denies having an appetite.  Clonazepam was started shortly following the fire. Notes when she doesn't take it she feels notably worse. More shaky. Pan in the posterior head regions. Feels more stiff and worse dizzy spells.  The dizzy spells at first were episodic. Provoked by rapid head movement or with arising from a seated to standing position. Also triggered by lying down, unclear to lateralization. Bilateral tinnitus. Some events are vertiginous, typically these take place when lying down. She also has a whole body sensation of generalized body weakness. Has to sit and relax to recover. Legs will buckle if she doesn't sit. Can have associated nausea. SBP often found to be low. Cardiac work up normal. Since winter '23, the generalized weakness and lightheaded dizziness has improved. Still has some element of vertigo when lying flat.  The headache since onset has been near constant. Can be made worse during a dizzy spell. Holocephalic and migraine features. Variable severity.   03/19/24: Last visit obtained brain MRI IAC, results unremarkable. Started on amitriptyline titrated to 25 mg QHS to lessen her vertigo and headaches. No benefit appreciated. Still having a daily headache, migraine >8x/month lasting over 4 hours all present for over 3 months. Still has daily dizziness and feeling faint. Often provoked by postural challenge. Can't exercise given she will feel dizzy. Remains reliant on her clonazepam. Takes 2 mg each morning. If doesn't take, she feels a host of somatic symptoms.
Sex: M
Vaccine: FLUX
Symptoms: Malaise, Vomiting
Clinical narrative: Reported Symptoms: 10047700:VOMITING;  Narrative: sick after shot Other Relevant HX:  Other:
Age: 21.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Urinary incontinence
Clinical narrative: Patient started feeling faint after receiving vaccine. He stayed seated, but after about a minute he fainted. He urinated during incident. EMS was called. It lasted about 30 seconds and patient was feeling better after. Paramedics took his vitals, which were all normal. Patient returned home following incident.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Patient did not exhibit any adverse reactions at the office following the COVID vaccine.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event occurred. Patient received the first dose of RotaTeq at their 4 month well child clinic visit. No adverse events noted. Provider notified patient's guardian of event.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Abdominal X-ray, Intestinal dilatation, Vomiting, X-ray abnormal
Clinical narrative: Patient developed vomiting with solid foods 1 day post vaccination.  Abdominal X-ray reveals: (THERE IS MILD SMALL BOWEL DILATATION WITH COLONIC AND RECTAL GAS PRESENT. MAY REPRESENT ADYNAMIC ILEUS VERSUS EARLY OR INCOMPLETE MECHANICAL SMALL BOWEL OBSTRUCTION.)
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Pallor, Palpitations
Clinical narrative: Following receiving her second dose, she went back to her unit she works at (ICU) and around 20 minutes later began to have heart palpitations, felt weak and was pale. Was monitored by ICU staff until the episode passed. She did not seek medical
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Blood pressure fluctuation, Blood pressure increased, Catheterisation cardiac, Dyspnoea, Stress echocardiogram
Clinical narrative: Blood pressure is extremely high and it fluctuates.  Having trouble breathing due to the high BP.  159/101 for example is what my BP was 2 days ago. Its been consistently 150/90 since taking the vaccine. It spikes higher at times.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Jaw clicking, Mastication disorder, Muscle tightness, Pain in extremity
Clinical narrative: two days after vaccination, left arm where vaccine was given, arm became very sore and left jaw became very tight, was not able to open mouth wide and started clicking.  Pain and soreness in left arm/jaw has resolved.  As of March 26, 2024, at time of visit, little improvement in ability to open jaw and still has clicking.  Using heat does help.  Jaw still feels tight and is hard to chew hard/crunchy foods.  Patient denies TMJ prior to vaccination.  This was patient's first Moderna vaccine.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Trismus, Vaccination site pain
Clinical narrative: two days after vaccination, left arm where vaccine was given, arm became very sore and left jaw became very tight, was not able to open mouth wide and started clicking.  Pain and soreness in left arm/jaw has resolved.  As of March 26, 2024, at time of visit, little improvement in ability to open jaw and still has clicking.  Using heat does help.  Jaw still feels tight and is hard to chew hard/crunchy foods.  Patient denies TMJ prior to vaccination.  This was patient's first Moderna vaccine.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Nurse missed calculating the due date for the vaccine.  The vaccine should have been given on/after 4/19/2024.  Vaccine will be given again 1 month.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: Approximately 4 minutes after vaccines were administered, patient and mother walked out of clinic room to the nurses' station to pay and patient passed out. He fell backwards and bumped the back of his head on the floor. He was in structed to bend knees and lay there until he was ready to try and sit up. He acknowledged the instructions as did mom (with interpreter). Patient was offered water, juice, and crackers as soon as he was able to sit up. He was eventually able to sit in chair where his head was assessed. No sign of injury was present. Mom was educated on signs and symptoms of concussion. Patient was reassessed at 11:30  and was able to ambulate out of clinic with assistance from mom.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, CSF test, Condition aggravated, Electromyogram normal, Headache
Clinical narrative: Chronic tension headache starting 8/2021 with left sided facial numbness. Patient had also been having some issues with balance and falls previously, though related to foot neuroma, but she began to have slowly progressive worsening of balance with accompanying neuropathy in all limbs around the same time as the headache. She is currently (3/28/2024) dependent on a walker whereas she was not dependent on any aid at time of vaccination.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Intervertebral disc disorder, Magnetic resonance imaging abnormal, Magnetic resonance imaging head normal, Magnetic resonance imaging neck
Clinical narrative: Chronic tension headache starting 8/2021 with left sided facial numbness. Patient had also been having some issues with balance and falls previously, though related to foot neuroma, but she began to have slowly progressive worsening of balance with accompanying neuropathy in all limbs around the same time as the headache. She is currently (3/28/2024) dependent on a walker whereas she was not dependent on any aid at time of vaccination.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuroma, Neuropathy peripheral, Tension headache, Walking aid user
Clinical narrative: Chronic tension headache starting 8/2021 with left sided facial numbness. Patient had also been having some issues with balance and falls previously, though related to foot neuroma, but she began to have slowly progressive worsening of balance with accompanying neuropathy in all limbs around the same time as the headache. She is currently (3/28/2024) dependent on a walker whereas she was not dependent on any aid at time of vaccination.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient came in for Covid vaccine, requesting Moderna. Mother wrote on paperwork that patient was 12 years old. Patient was given Moderna 12+ years old vaccine. After administration, online form shows patient is 11 years old, her birthday is in a few days. Patient was given incorrect dose as she was technically 11 years old at this time. No adverse reactions noted. Patient had no S/s 20 minutes post vaccine. Mother notified of error.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: pt stated that her arm started hurting 1 week after she recieved the vaccine. she waited it out and took ibuprofen, norco that she currently is already on and ice packs.  her arm got so she was unable to lift it and then went to the doctor to have them look at it.  she was informed they thought that the person giving the immunization may have given the shot to high in the arm.  it has been almost 3 months and pt still is unable to lift her arm
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Headache, Pain in extremity
Clinical narrative: HA, dizziness, right arm pain.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Injected limb mobility decreased, Neck pain, Pain in extremity
Clinical narrative: couple days severe pain in my arm from the shot. I couldn't lift my arm. It subsided into my shoulder and neck. It is very painful and can't really lift my arm more than half way.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: couple days severe pain in my arm from the shot. I couldn't lift my arm. It subsided into my shoulder and neck. It is very painful and can't really lift my arm more than half way.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: Rash started on arm of injection several hours after vaccine and then started to spread to face, abdomen, other arm, and upper thighs. Steroid injection given in ER. Taking Benadryl every 6 hours.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Injection site haemorrhage, Syncope
Clinical narrative: Patient was given his first TDap vaccination.  Patent did have 5 previous DTap vaccines as an infant.  Patient was on the exam table, sit well for vaccination. patient looked down at his site and say the blood and states "hey there's blood", then stated "he was tired".   Patient laid back on the table he was sitting on and fainted from the shot. Patients mother was in the room at the time and come to where he was.  Patient became alert after a couple of seconds.   I did have a RN revaluated patient took vitals, provider was notified and checked on patient. Patients mother states that his older brother was just in two days ago and the same thing happened to him, many times.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: There has been no adverse event, i am only reporting i gave the wrong age group vaccine.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Anti-GAD antibody, Benign fasciculation syndrome, Blood test, Ceruloplasmin, Electromyogram
Clinical narrative: The day after my TDAP shot, I woke up with muscle twitching all over my body and it has not stopped since. After many doctors appointments, I was diagnosed with BFS that the neurologists claimed was likely caused by the shot. Along with my BFS, I have had a serious sleep issue. Every single time I try to fall asleep, my limbs twitch out of control and I have giant jolts that wake me up. I have seen a sleep doctor several times and I have a sleep study scheduled for August 1 2024. Before the TDAP shot, I did not have any of these issues. Because of the sleep issues and constant muscle twitching, it has effected my day to day and quality of life.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Magnetic resonance imaging head, Muscle twitching, Quality of life decreased, Sleep disorder, Urine copper
Clinical narrative: The day after my TDAP shot, I woke up with muscle twitching all over my body and it has not stopped since. After many doctors appointments, I was diagnosed with BFS that the neurologists claimed was likely caused by the shot. Along with my BFS, I have had a serious sleep issue. Every single time I try to fall asleep, my limbs twitch out of control and I have giant jolts that wake me up. I have seen a sleep doctor several times and I have a sleep study scheduled for August 1 2024. Before the TDAP shot, I did not have any of these issues. Because of the sleep issues and constant muscle twitching, it has effected my day to day and quality of life.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: I gave the wrong covid vaccine to the pt. Instead of the 6 mo- 4 yo covid vaccine i gave her the 12 year old and over covid vaccine.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Sensitive skin
Clinical narrative: Hives presented on backs of both hands and wrists. Started 7 hours after injection. Still present at writing of report. Muscle aches, skin sensitivity, chills, headache, fatigue present for duration of 24 hours.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives presented on backs of both hands and wrists. Started 7 hours after injection. Still present at writing of report. Muscle aches, skin sensitivity, chills, headache, fatigue present for duration of 24 hours.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: TINNITUS
Age: 8.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No observed response - DTap given at age 8.  Error is in age range.
Age: 6.0
Sex: F
Vaccine: DTAP, UNK, UNK
Symptoms: No adverse event, Wrong patient received product, Wrong product administered
Clinical narrative: On Wednesday 3/27/2024 I had a incident occur. I was a vaccinator at site. I was given a number and vaccine card by the registration and told this child would be next in line. I then called the child's name and number and the parent walked up with her child. This family was speaking so I showed the mom the shot card and asked if this was her child she replied yes. I then repeated the child name the mom again replied yes. I checked the child in system using the shot record. I verified the vaccines needed and compared the shot card to the chart. Everything appeared to line up. I asked the necessary questions. I administered the vaccine, gave mom the record, and sent her over to post vac. I call the next number 2 because I don't have record for the next child. A mom then comes over and gives me the name of the child I just vaccinated.  I call over the mom who child was just vaccinated from post vac. At this post our logistic person who is walks in. I ask him to ask the mother if it was ok for him to translate and she agrees. I tell him to ask her if she is the child in question,she again tells him yes.  He ask her to tell him the child full name and it was then I realized it wasn't the right child. The children had very similar first names and the same last name. Due to the language barrier mom thought it was her child's name. I had (logistics) to explain to mom what the mix up was and let her know that her child received a Hepatitis A when she needed a DTAP. Mom expressed understanding and agreed to let her child receive the needed vaccine DTAP. Education was given via translator. No signs and symptoms of any adverse reaction after vaccines administerd. Monitored patied for 15 min in post vaccination.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Abdominal pain upper, Abdominal tenderness, Arthralgia, Asthenia, Discomfort
Clinical narrative: Rash at injection site.  Headache, stomach tenderness and pain, muscle pain and weakness, knee swelling and pain, increased joint pain,  pain under collar bones, very fatigued, body and limbs feel very heavy. Overall sick feeling.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Fatigue, Headache, Injection site rash, Joint swelling, Limb discomfort
Clinical narrative: Rash at injection site.  Headache, stomach tenderness and pain, muscle pain and weakness, knee swelling and pain, increased joint pain,  pain under collar bones, very fatigued, body and limbs feel very heavy. Overall sick feeling.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Malaise, Myalgia, Supraclavicular fossa pain
Clinical narrative: Rash at injection site.  Headache, stomach tenderness and pain, muscle pain and weakness, knee swelling and pain, increased joint pain,  pain under collar bones, very fatigued, body and limbs feel very heavy. Overall sick feeling.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Arthralgia, Injected limb mobility decreased
Clinical narrative: Right shoulder became very painful and difficult to lift. After 3 days of icing and nsaids, no improvement
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction, Pain
Clinical narrative: Intermittent throbbing from injection site years after event
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose normal, Dizziness, Hyperhidrosis, Pain in extremity
Clinical narrative: Patient stated he felt woozy and his arm hurt within one minute after administering immunization. Mom felt child and he was "sweaty" so she cheeked his blood sugar using his Dexcom glucose monitor which showed his blood sugar dropping but was currently at 112.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient receive a vaccine that had expired 4 days prior
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: PATIENT REPORTED BEING SICK, LOW GRADE FEVER AFTER INJECTION, AND FEEL WELL FOR  5 DAYS
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received a vaccine that expired 3 days prior to administering
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: patient's arm became swollen, painful and itchy. patient felt extremely tired.  pain is still present now, but less than at first. patient has used ice packs for the arm swelling.
Age: 81.0
Sex: M
Vaccine: TDAP
Symptoms: Feeling hot
Clinical narrative: Right hand feeling warm after receiving the vaccine
Age: 1.25
Sex: F
Vaccine: HIBV, PNC20
Symptoms: Altered state of consciousness, Febrile convulsion, Tremor
Clinical narrative: Immunization provided in clinic on 3/27/24 in AM session of clinic. Noted to have nasal congestion. recent febrile seizure 1.5 weeks prior.  That evening, was seen in ED for 5-6 minute "whole body shaking" followed by 10 minute period of being "out of it"  prior to returning to baseline per ED documentation. Reassuring exam. Passed PO trial, provided with antipyretics. Discharged home. Aferbile in ED. Discharge diagnosis "simple febrile seizure.."
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site swelling, Peripheral swelling, Ultrasound Doppler
Clinical narrative: left shoulder pain, site swelling; now persisting to this date with decreased ROM and intermittent swelling of arm
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray limb normal
Clinical narrative: left shoulder pain, site swelling; now persisting to this date with decreased ROM and intermittent swelling of arm
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Antibody test abnormal, Biopsy peripheral nerve normal, C-reactive protein increased, Decreased appetite, Electromyogram normal
Clinical narrative: muscle weakness, excessive sweating, severe neuralgia, severe nausea, severe loss of appetite with significant weight loss, burning and tingling sensation on skin, night sweats, sensation of heart pounding and body throbbing
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hyperhidrosis, Magnetic resonance imaging normal, Muscular weakness, Nausea, Neuralgia
Clinical narrative: muscle weakness, excessive sweating, severe neuralgia, severe nausea, severe loss of appetite with significant weight loss, burning and tingling sensation on skin, night sweats, sensation of heart pounding and body throbbing
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neurological examination normal, Night sweats, Palpitations, Paraesthesia, Sensory disturbance
Clinical narrative: muscle weakness, excessive sweating, severe neuralgia, severe nausea, severe loss of appetite with significant weight loss, burning and tingling sensation on skin, night sweats, sensation of heart pounding and body throbbing
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Skin burning sensation, Weight decreased
Clinical narrative: muscle weakness, excessive sweating, severe neuralgia, severe nausea, severe loss of appetite with significant weight loss, burning and tingling sensation on skin, night sweats, sensation of heart pounding and body throbbing
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient's father reported redness below vaccination site on Thursday March 28th, 2024 at 11 am. Patient received Tdap and Meningococcal ACWY vaccine on Tuesday March 26th, 2024. Left arm presented with redness and warm to the touch below vaccination site. No pain, no fever, no inflamation. Patient complained about some minimal itchiness. Father stated to applied cold compress one time only.
Age: 0.33
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE; inadvertently administered a dose of PNEUMOVAX 23 instead of PCV 20 to a 4 month old patient; inadvertently administered a dose of PNEUMOVAX 23 instead of PCV 20 to a 4 month old patient; This spontaneous report was received from a medical assistant and refers to a 4-month-old patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. Historical vaccine included pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) (PCV 20).  On 19-MAR-2024, pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection was inadvertently administered to 4-month-old patient (1 dose (dosage form), lot #X014729, expiration date: 22-NOV-2024, strength, anatomical location and route of administration were not provided) instead of pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) (PCV 20) administered for prophylaxis (Wrong product administered; Product administered to patient of inappropriate age). It was stated this should have been the patient's 2nd dose of PCV 20. No patient's symptoms have been reported. No additional adverse event (AE) reported (No adverse event).
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Patient still got shingles after vaccination/Suspected vaccination failure; Shingles; Patient had three shots of vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Patient still got shingles after vaccination/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and extra dose administered (Verbatim: Patient had three shots of vaccine). The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 21-MAR-2024 This case was reported by patient via interactive digital media. The reporter stated that had all three shots. Still got shingles. Had all covid shots. Just got over a week with that. Who could believe in shots anymore. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pruritus, Vaccination failure
Clinical narrative: Shingles broke out in eye; Shingles on nose, on back legs and arm; Spots itching; This serious case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (Verbatim: Shingles broke out in eye) (serious criteria GSK medically significant), shingles (Verbatim: Shingles on nose, on back legs and arm) and pruritus (Verbatim: Spots itching). The outcome of the ophthalmic herpes zoster, shingles and pruritus were not reported.   It was unknown if the reporter considered the ophthalmic herpes zoster, shingles and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the ophthalmic herpes zoster, shingles and pruritus to be related to Shingles vaccine.   Additional Information: This case was reported by a patient via interactive digital media. The patient stated that he/she tot the shot, 2 weeks later it broke out on the eye and nose a month later. The patient was broke out on back legs and arm in spots itching in some areas but not to bad so shot must have helped some. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Vaccine shot hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Vaccine shot hurt). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she took the first dose. The shot hurt. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Legs hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of leg pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced leg pain (Verbatim: Legs hurt). The outcome of the leg pain was not reported.   It was unknown if the reporter considered the leg pain to be related to Shingles vaccine.     It was unknown if the company considered the leg pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that if you know about that, then you know that you had to had chicken pox before you got it. Know the truth about shot before taking it. Legs hurts 6 or early after taking vaccine and not a little. The patient stated that some guys gave up walking or working and government did not give disability. The patient stated that it was your fault for taking the vaccine. The patient stated you leds family to get around or going to see the doctor and it be a lot of visits after one shot.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms for two days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In MAR-2024, the patient received the 1st dose of Shingles vaccine. In MAR-2024, less than a week after receiving Shingles vaccine, the patient experienced influenza-like symptoms (Verbatim: flu like symptoms for two days). The outcome of the influenza-like symptoms was resolved (duration 2 days).   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.     It was unknown if the company considered the influenza-like symptoms to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2024AMR033363   Additional Information: GSK Receipt Date: 05-MAR-2024 This case was reported by a patient via interactive digital media. The patient reported that after receiving 1st dose had flu like symptoms for 2 days. For tolerance of 2nd dose refer case US2024AMR033363, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR033363:same patient, different dose
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site warmth, Nausea
Clinical narrative: hard spot the size of an egg at injection site; So this time fever; Nausea; tiredness; sore arm with a bright red hot; a rash on both legs; sore arm with a bright red hot; sore arm with a bright red hot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site induration in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine with an associated reaction of influenza like illness (1st dose received on an unknown date, for tolerance refer linked case US2024AMR033290).   In MAR-2024, the patient received the 2nd dose of Shingles vaccine. In MAR-2024, less than a week after receiving Shingles vaccine, the patient experienced injection site induration (Verbatim: hard spot the size of an egg at injection site), fever (Verbatim: So this time fever), nausea (Verbatim: Nausea), tiredness (Verbatim: tiredness), pain in arm (Verbatim: sore arm with a bright red hot), rash on leg (Verbatim: a rash on both legs), erythema of extremities (Verbatim: sore arm with a bright red hot) and extremities hot feeling of (Verbatim: sore arm with a bright red hot). The outcome of the injection site induration, fever, nausea, tiredness, rash on leg, erythema of extremities and extremities hot feeling of were resolving and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the injection site induration, fever, nausea, tiredness, pain in arm, rash on leg, erythema of extremities and extremities hot feeling of to be related to Shingles vaccine.   It was unknown if the company considered the injection site induration, fever, nausea, tiredness, pain in arm, rash on leg, erythema of extremities and extremities hot feeling of to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2024AMR033290   Additional Information: GSK Receipt Date: 13-MAR-2024 This case was reported by a patient via interactive digital media. The patient got his/her second shot 4 days ago. The patient had fever, nausea, tiredness, sore arm with a bright red hot, hard spot the size of an egg at injection site plus a rash on both legs this time. At the time of reporting the patient felt better but arm still sore. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2024AMR033290:same patient, different dose
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: hard spot the size of an egg at injection site; So this time fever; Nausea; tiredness; sore arm with a bright red hot; a rash on both legs; sore arm with a bright red hot; sore arm with a bright red hot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site induration in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine with an associated reaction of influenza like illness (1st dose received on an unknown date, for tolerance refer linked case US2024AMR033290).   In MAR-2024, the patient received the 2nd dose of Shingles vaccine. In MAR-2024, less than a week after receiving Shingles vaccine, the patient experienced injection site induration (Verbatim: hard spot the size of an egg at injection site), fever (Verbatim: So this time fever), nausea (Verbatim: Nausea), tiredness (Verbatim: tiredness), pain in arm (Verbatim: sore arm with a bright red hot), rash on leg (Verbatim: a rash on both legs), erythema of extremities (Verbatim: sore arm with a bright red hot) and extremities hot feeling of (Verbatim: sore arm with a bright red hot). The outcome of the injection site induration, fever, nausea, tiredness, rash on leg, erythema of extremities and extremities hot feeling of were resolving and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the injection site induration, fever, nausea, tiredness, pain in arm, rash on leg, erythema of extremities and extremities hot feeling of to be related to Shingles vaccine.   It was unknown if the company considered the injection site induration, fever, nausea, tiredness, pain in arm, rash on leg, erythema of extremities and extremities hot feeling of to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2024AMR033290   Additional Information: GSK Receipt Date: 13-MAR-2024 This case was reported by a patient via interactive digital media. The patient got his/her second shot 4 days ago. The patient had fever, nausea, tiredness, sore arm with a bright red hot, hard spot the size of an egg at injection site plus a rash on both legs this time. At the time of reporting the patient felt better but arm still sore. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2024AMR033290:same patient, different dose