chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; pain; shingles; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and pain (Verbatim: pain). The outcome of the vaccination failure and pain were not reported and the outcome of the shingles was resolved (duration 1 week).   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine. It was unknown if the company considered the shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 30-AUG-2024 This case was reported by a patient via interactive digital media. The reporter reported that he/had received Shingles shots 4 or 5 years ago and he/she had shingles for about a week most painful thing he/she ever experienced. The doctor said the shot did not keep him/her from getting them it just prevents them from being so severe. The reporter he/she did not  think he/she would survive a bad case. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles infection were unknown at the time of reporting; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Shingles vaccine.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC15
Symptoms: Breath holding, Crying, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Addendum 8/28/29 10:40am. patient had a breath hoding spell after vaccines followed by syncopal episode. He woke up after being laid flat, was diaphoretic and crying. HR and RR normal. He was monitored in office until back to baseline, drank some water. Discussed breath holding and vasovagal syncope with parents, gave tips on how to handle if it happens again in future. Paient back to baseline when they left.
Age: 80.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Balance disorder, Brain fog, Fall, Fatigue
Clinical narrative: My wife and I both received COVID-19 and influenza shots at the same time. My wife experienced some "brain fog" the same day and sprained her ankle falling down the stairs. I had "brain fog" and fatigue the next day, as well as problems with balance. I fell out of my desk chair and had to be assisted to get up. We both feel that elderly individuals should not receive both vaccines at the same time, based on our own experience.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sudden death
Clinical narrative: Online report of sudden unexpected death in ??-year-old male EUA medical countermeasure recipient. According to on-line report victim received 3 innoculations in 2021.  DOSE#1 date 03/08/21 LOT#EN3203 DOSE#2 date 03/29/21 Lot#ER8735 DOSE#3 date 12/07/21 LOT# UNK. First two innoculations administered at clinic, third innoculation appears to have been administered by pharmacy since victim has a picture with a logo on his right deltoid. Unable to ascertain store number, victim age-DOB, post-innoculation adverse events or pre-existing conditions. Online photos indicate victim likely had a higher BMI and did not appear to be extremely athletic. Victim was a wine drinker
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Intense Joint Pain! Shoulders & Hip
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Body temperature increased, Erythema, Pain in extremity
Clinical narrative: That evening (8/16/24) pain in arm, redness. The next day temp of 102 resolved after 48 hrs. Redness and pain resolving after 72 hrs after injection administered
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Erythema, Fatigue, Feeling abnormal, Pruritus
Clinical narrative: Extreme swelling - Red - Hot Itchy - Painful - Took 2 Naproxen 07/24/24 @ 1:12, 07/25/24 @ 11:30 AM, 2 Benadryl 07/27/24 2:35 pm - 1 Naproxen 07/28/24 @ 9:50 2 Benadryl @ Noon 07/28/24 - Ice pack on shoulder. I had everyone of the side effects listed on your webpage. Wheals on my neck at my shoulders left side. Redness and Itchy for 2 weeks. Felt terrible, weak & exhausted
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm, Swelling, Urticaria
Clinical narrative: Extreme swelling - Red - Hot Itchy - Painful - Took 2 Naproxen 07/24/24 @ 1:12, 07/25/24 @ 11:30 AM, 2 Benadryl 07/27/24 2:35 pm - 1 Naproxen 07/28/24 @ 9:50 2 Benadryl @ Noon 07/28/24 - Ice pack on shoulder. I had everyone of the side effects listed on your webpage. Wheals on my neck at my shoulders left side. Redness and Itchy for 2 weeks. Felt terrible, weak & exhausted
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Gastrointestinal disorder, Headache, Injection site pain
Clinical narrative: Extreme swelling - Red - Hot Itchy - Painful - Took 2 Naproxen 07/24/24 @ 1:12, 07/25/24 @ 11:30 AM, 2 Benadryl 07/27/24 2:35 pm - 1 Naproxen 07/28/24 @ 9:50 2 Benadryl @ Noon 07/28/24 - Ice pack on shoulder. I had everyone of the side effects listed on your webpage. Wheals on my neck at my shoulders left side. Redness and Itchy for 2 weeks. Felt terrible, weak & exhausted
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Myalgia, Pyrexia, Sleep disorder
Clinical narrative: Extreme swelling - Red - Hot Itchy - Painful - Took 2 Naproxen 07/24/24 @ 1:12, 07/25/24 @ 11:30 AM, 2 Benadryl 07/27/24 2:35 pm - 1 Naproxen 07/28/24 @ 9:50 2 Benadryl @ Noon 07/28/24 - Ice pack on shoulder. I had everyone of the side effects listed on your webpage. Wheals on my neck at my shoulders left side. Redness and Itchy for 2 weeks. Felt terrible, weak & exhausted
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain, Computerised tomogram abdomen normal, Computerised tomogram thorax normal, Myocardial necrosis marker normal, Nausea
Clinical narrative: Nausea, ACUTE abdominal pain
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RSV
Symptoms: No adverse event
Clinical narrative: No adverse reactions noted
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Pallor, Staring
Clinical narrative: Client was given the Men B and MCV4-Quad IM in both arms. She tolerated injections well. Immediately after client began staring at the floor, became pale and diaphoretic. Her feet were elevated, cool compresses applied to back of neck and forehead. Fan was directed towards her face for air movement, and she was given water. Client c/o of dizziness and desired to lie down. She was transported to exam room via rolling chair and placed on exam table. Cold compresses were reapplied to neck and forehead and fan redirected to her face. Client remained lying down for 15 min. under her mother's supervision. She was checked on by nursing staff several times and vital signs were stable. Client then stated she was feeling better. She sat up on exam table with no issues then brought to a standing position with no issue. She was subsequently released into the care of her mother.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea, Musculoskeletal pain
Clinical narrative: Pain at mid-back, medial to left scapula (at middle portion of scapula horizontally).  Caused pain severe enough to cause difficulty taking a deep breath. Improved partially after 1000 mg PO Tylenol.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test positive, Chills, Headache, Myalgia, Nausea
Clinical narrative: Within 12 hrs of my immunization, I awoke at 2 am with the exact same symptoms as I had with my initial bout of Covid 19 in 8/2020. They were high fever, chills, muscular aches, severe headache, nausea. Duration of this reaction was approximately 36 hrs.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Within 12 hrs of my immunization, I awoke at 2 am with the exact same symptoms as I had with my initial bout of Covid 19 in 8/2020. They were high fever, chills, muscular aches, severe headache, nausea. Duration of this reaction was approximately 36 hrs.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Amyloidosis, Atrial fibrillation, Blepharitis, Blindness unilateral, Blood test
Clinical narrative: He got his vaccine, he was tired a lot, he did not have too bad of a sore arm, had no other health problems other than hypothyroidism which was under control.  He had COVID after he got the shot and he went to the doctor and was away  July 4th weekend in 2022, and could not walk the steps and was short of breath.  He came back and went to the doctor and was referred to a cardiologist.  They found out that he had to have an ablation as he was in a-Fib.  He did have the ablation and during that he had a stroke.  Then they found out that he had amyloidosis and came home and had another stroke.  He is 95% recovered from the stroke, he is blind in one eye now.  He never took any medicine other than the Synthroid for 25 years, and had never had to go to the doctor for anything.  He has been to 5 doctors for his eye and now is with infectious disease to see what is going on with him.  They felt it was blephritis and maybe some other process and still trying to figure out what is going on.  He has been to 18 different doctors for his condition.  He has been hospitalized twice since the vaccine for pneumonia and the flu where he could not breath.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac ablation, Cerebrovascular accident, Dyspnoea, Fatigue
Clinical narrative: He got his vaccine, he was tired a lot, he did not have too bad of a sore arm, had no other health problems other than hypothyroidism which was under control.  He had COVID after he got the shot and he went to the doctor and was away  July 4th weekend in 2022, and could not walk the steps and was short of breath.  He came back and went to the doctor and was referred to a cardiologist.  They found out that he had to have an ablation as he was in a-Fib.  He did have the ablation and during that he had a stroke.  Then they found out that he had amyloidosis and came home and had another stroke.  He is 95% recovered from the stroke, he is blind in one eye now.  He never took any medicine other than the Synthroid for 25 years, and had never had to go to the doctor for anything.  He has been to 5 doctors for his eye and now is with infectious disease to see what is going on with him.  They felt it was blephritis and maybe some other process and still trying to figure out what is going on.  He has been to 18 different doctors for his condition.  He has been hospitalized twice since the vaccine for pneumonia and the flu where he could not breath.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Influenza, Laboratory test, Pain in extremity, Pneumonia
Clinical narrative: He got his vaccine, he was tired a lot, he did not have too bad of a sore arm, had no other health problems other than hypothyroidism which was under control.  He had COVID after he got the shot and he went to the doctor and was away  July 4th weekend in 2022, and could not walk the steps and was short of breath.  He came back and went to the doctor and was referred to a cardiologist.  They found out that he had to have an ablation as he was in a-Fib.  He did have the ablation and during that he had a stroke.  Then they found out that he had amyloidosis and came home and had another stroke.  He is 95% recovered from the stroke, he is blind in one eye now.  He never took any medicine other than the Synthroid for 25 years, and had never had to go to the doctor for anything.  He has been to 5 doctors for his eye and now is with infectious disease to see what is going on with him.  They felt it was blephritis and maybe some other process and still trying to figure out what is going on.  He has been to 18 different doctors for his condition.  He has been hospitalized twice since the vaccine for pneumonia and the flu where he could not breath.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: He got his vaccine, he was tired a lot, he did not have too bad of a sore arm, had no other health problems other than hypothyroidism which was under control.  He had COVID after he got the shot and he went to the doctor and was away  July 4th weekend in 2022, and could not walk the steps and was short of breath.  He came back and went to the doctor and was referred to a cardiologist.  They found out that he had to have an ablation as he was in a-Fib.  He did have the ablation and during that he had a stroke.  Then they found out that he had amyloidosis and came home and had another stroke.  He is 95% recovered from the stroke, he is blind in one eye now.  He never took any medicine other than the Synthroid for 25 years, and had never had to go to the doctor for anything.  He has been to 5 doctors for his eye and now is with infectious disease to see what is going on with him.  They felt it was blephritis and maybe some other process and still trying to figure out what is going on.  He has been to 18 different doctors for his condition.  He has been hospitalized twice since the vaccine for pneumonia and the flu where he could not breath.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Presyncope
Clinical narrative: vasovagal reaction. Water. Sugar intake. Lasted 1 min in time.
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Immediate post-injection reaction, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient stated that at time of receiving the flu vaccine on 08/26/2024 at 1:35pm, they felt an immediate sharp pain and burning sensation and screamed out loud.  Patient stopped by the pharmacy initially on 08/29/2024 and complained of soreness of the arm and lack of mobility. Then on 09/04/2024, the patient stopped by again and stated they still are experiencing pain and lack of mobility. They can't raise their arm like normal and hurts when trying to raise to a 45 degree angle. Also lack of movement in backwards direction. Experiences pain during this type of movement.
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Screaming
Clinical narrative: Patient stated that at time of receiving the flu vaccine on 08/26/2024 at 1:35pm, they felt an immediate sharp pain and burning sensation and screamed out loud.  Patient stopped by the pharmacy initially on 08/29/2024 and complained of soreness of the arm and lack of mobility. Then on 09/04/2024, the patient stopped by again and stated they still are experiencing pain and lack of mobility. They can't raise their arm like normal and hurts when trying to raise to a 45 degree angle. Also lack of movement in backwards direction. Experiences pain during this type of movement.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Cerebrovascular stenosis, Computerised tomogram head abnormal, Condition aggravated, Dysarthria
Clinical narrative: Difficulty thinking clearly, articulating thoughts, words, names, drooped left side of mouth, taken to ER, BP-231/123, CT scan of brain showed narrowing of posterior brain vessels, kept at Hospital for 3 days. BP came down symptoms resolved.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Laboratory test, Magnetic resonance imaging, Mental impairment
Clinical narrative: Difficulty thinking clearly, articulating thoughts, words, names, drooped left side of mouth, taken to ER, BP-231/123, CT scan of brain showed narrowing of posterior brain vessels, kept at Hospital for 3 days. BP came down symptoms resolved.
Age: 40.0
Sex: F
Vaccine: FLUR4
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Administered two FluBlok vaccines in error rather than FluBlok and Boostrix - no adverse effects
Age: 15.0
Sex: F
Vaccine: UNK
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: No adverse event. System administrator for vaccine processing noticed software error for vaccine input (age-based hard-stop) was not activated enteprise wide. So, patient's under the age of 18 would not be able to receive flu shots if selection was Flublok Trivalent vs, Fluzone Trivalent. Error update resolved 9/5/24.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Dehydration, Enema administration, Intussusception, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Patient developed bilious emesis / dehydration on 8/27 - 8/28 and was sent to ER. Found to have intussusception that was reduced by air enema on 8/28. Observed in hospital until 8/30 to ensure tolerating feeds and normal BMs.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Injection site hypoaesthesia, Injection site pain, Musculoskeletal pain, Paraesthesia
Clinical narrative: Initially there was numbness and pain around the injection site. Then on August 3rd, the pain at the injection site spread into the left shoulder blade area and became very severe.  He sent a message to the clinic after having severe pain in his shoulder for one week. He was taking Aleve regularly to try and alleviate the pain. He went to the doctor's office 8/20 due to the severity of the pain . He was prescribed muscle relaxers and a 6 day steroid pack. He is still having pain periodically in the left arm/shoulder blade. Around 8/24 he developed intense tingling senstaion between left elbow and fingertips that comes and goes without any trigger or association with other symptoms. The pain and tingling is still ongoing persistently. The pain has lessened so he does not use OTC pain meds but will just wait for the pain to pass on its own.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Asthenia, Cyanosis, Diarrhoea, Gaze palsy, Lethargy
Clinical narrative: Pt   had been lethargic with decreased energy all day-at 6:30 pt was sitting next to mom and suddenly eyes rolled up and right, fast strong tonic clonic movmenent noted with arching, blue lips and abnormal breathing.  Episode lasted approximately 20 sec, 911 was called and patient had more shaking with eyes open looking at mom but not responsive.  After patent had prolonged post ictal phase. Pt had mild nonbloody loose stool, no fever, acting well. No travel . Cat in home. no illness at home
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Polymerase chain reaction negative, Respiration abnormal, Tonic clonic movements, Tremor, Unresponsive to stimuli
Clinical narrative: Pt   had been lethargic with decreased energy all day-at 6:30 pt was sitting next to mom and suddenly eyes rolled up and right, fast strong tonic clonic movmenent noted with arching, blue lips and abnormal breathing.  Episode lasted approximately 20 sec, 911 was called and patient had more shaking with eyes open looking at mom but not responsive.  After patent had prolonged post ictal phase. Pt had mild nonbloody loose stool, no fever, acting well. No travel . Cat in home. no illness at home
Age: 2.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Administration error. Patient was not due for boostrix as it cannot be given until 10 years of age. No adverse reaction noted or reported by parents
Age: 1.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Menquadfi vaccine was given in error. Patient should have received MMR vaccine.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Covid infection resulting in hospitalization after vaccination
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Dyspnoea, Fatigue, Immediate post-injection reaction, Syncope
Clinical narrative: Immediately administration the patient syncopized and had involuntary movements for about 5-10 seconds . After regaining consciousness the patient complained of dizziness, shortness of breath and fatigue. 0.3mg of epinephrine SQ was administered. Patient was observed for 30 min and improved back to baseline.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to metals, Dental prosthesis removal, Denture wearer, Device allergy, Hypersensitivity
Clinical narrative: Having sudden allergic reactions to dentures. Removed. Seeing dentist tomorrow
Age: 64.0
Sex: M
Vaccine: DTAP
Symptoms: Asthenia, Influenza like illness, Pain
Clinical narrative: Pain and weakness in are appx 3 days after admin. flu like systems, symptoms come and go depending on activity levels. symptoms improving after 3 weeks but still present.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Chills, Dizziness, Dyskinesia, Immediate post-injection reaction, Nausea
Clinical narrative: Immediately after administration the patient syncopized and had involuntary jerking movements for 5-10 seconds. After regaining consciousness the patient complained of dizziness, nausea, chills. Observed in office for about 30 min with return to patient's baseline.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Immediately after administration the patient syncopized and had involuntary jerking movements for 5-10 seconds. After regaining consciousness the patient complained of dizziness, nausea, chills. Observed in office for about 30 min with return to patient's baseline.
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient past 5h birthday, not correct age for vaccine
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: pt inadvertently received an additional dose
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: covid infection after vaccination
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: covid infection after vaccination
Age: 43.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site reaction
Clinical narrative: Patient described a knot in the muscle at the injection site that lasted for 3 days before subsiding.
Age: 5.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient not correct age for vaccine given, past her 5th birthday
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: covid infection after vaccination
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Needle issue
Clinical narrative: faulty needle, unable to inject. had to exchange needle and reinject patient
Age: 61.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Neuropathy peripheral, Pain
Clinical narrative: Patient received immunizations in left deltoid 4/23/2024. She reported months later when picking up medications for her arm that she thinks she experienced side effects from the vaccines. She denied any issue the initial weeks following immunization. Since the issues began, she has used NSAIDs, muscle relaxers, and tapered steroids to help with soreness, pain, and neuropathy and has seen multiple providers.
Age: 72.0
Sex: F
Vaccine: FLUN4
Symptoms: No adverse event, Underdose
Clinical narrative: Staff was 72 years old at time of receiving the medication, which is only indicated for adults 49 years of age and younger. No adverse reactions reported. This error was just disccovered. Staff RN crossed out the manufacturer and lot number on the consent form, and indicated staff received Sanofi flu vaccine via injection. Staff states this is incorrect, and that she did receive the intranasal FluMist.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient developed gives one hour after flu vaccine. Patient has egg allergy.
Age: 25.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN. PATIENT NOTIFIED IMMEDIATELY. UNEXPIRED VACCINE GIVEN DIRECTLY AFTER MISTAKE WAS NOTICED.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Acoustic stimulation tests abnormal, Deafness, Deafness transitory, Hearing aid user
Clinical narrative: After receiving the vaccine I started going deaf until I completely lost my hearing for about 8 days.  I went to an urgent care because it was the weekend,, then to a hearing clinic, then to a specialist where she administered Steriods.  Some of my left ear hearing returned, not all, and most of my right received little hearing back.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: After I had the COVID and flu shot in my left arm at 11:30 am on Tuesday, September 3rd, I started feeling tired and congested at 5:30 pm; by 7:00 or 8:00 pm, I started coughing, then started coughing during the night, thinking I might have bronchitis. The next day, I went to Urgent Care, and saw Dr. on Wednesday, September 4th, at 12:30 pm. I had no fever; the doctor did a nasal test and gave me an inhaler and cough medicine. That same day, she called me at 5:00 pm with the results and said I tested positive for COVID. Note: I was fine up until I had the shot in my left arm several hours later and ended up being positive for COVID-19.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Cardiac stress test, Chest discomfort, Discomfort
Clinical narrative: I was reading into an article I saw that the CDC posted. A few years ago when I worked at a hydraulic cylinder manufacturing company I had to get the vaccine. That was around the same time that the government made everyone, right before they ruled it unconstitutional. I recieved both my doses and it wasn?t long after that I would be at work and get super uncomfortable. I would start to have a tight chest and I would have to take deeper inhales to feel better. That was all find and dandy but it started to get progressively worse despite me trying to ignore it. I would get odd feelings in my palm and would occasionally get a light stabbing sensation in my chest. I continued to ignore it. There was one day in particular that I was at work and I went to grab a freshly cut rod off the saw I ran. My heart palpated and I almost dropped the rod. My anxiety kicked into overdrive at the new feeling I just had and I started to get queasy. I put my head down and panicked while trying to keep my composure but my boss noticed me and how pale I was and let me go to the doctor. They dismissed it as generalized anxiety and I was just having panic attacks. I have always knew that it was more than panic attacks ( which I have never in my life experienced) I had to go to the ER one 4 different occasions, they ran my blood, did a cardiac stress test, and multiple other things before putting me on a prescription and sending me off. I to this day take the meds but I still get the chest pains. I never trusted the vaccine but I was put into a position where it was essentially my job or the vaccine.  I want my time back, I want my peace of mind back, but instead im stuck here reaping again, what the government has done to us.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pallor, Palpitations, Sensory disturbance
Clinical narrative: I was reading into an article I saw that the CDC posted. A few years ago when I worked at a hydraulic cylinder manufacturing company I had to get the vaccine. That was around the same time that the government made everyone, right before they ruled it unconstitutional. I recieved both my doses and it wasn?t long after that I would be at work and get super uncomfortable. I would start to have a tight chest and I would have to take deeper inhales to feel better. That was all find and dandy but it started to get progressively worse despite me trying to ignore it. I would get odd feelings in my palm and would occasionally get a light stabbing sensation in my chest. I continued to ignore it. There was one day in particular that I was at work and I went to grab a freshly cut rod off the saw I ran. My heart palpated and I almost dropped the rod. My anxiety kicked into overdrive at the new feeling I just had and I started to get queasy. I put my head down and panicked while trying to keep my composure but my boss noticed me and how pale I was and let me go to the doctor. They dismissed it as generalized anxiety and I was just having panic attacks. I have always knew that it was more than panic attacks ( which I have never in my life experienced) I had to go to the ER one 4 different occasions, they ran my blood, did a cardiac stress test, and multiple other things before putting me on a prescription and sending me off. I to this day take the meds but I still get the chest pains. I never trusted the vaccine but I was put into a position where it was essentially my job or the vaccine.  I want my time back, I want my peace of mind back, but instead im stuck here reaping again, what the government has done to us.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest X-ray, Laboratory test, Paraesthesia, Paraesthesia oral, Tachycardia
Clinical narrative: THIS WAS A TRIVALENT NOT QUADRIVALENT. Tachycardia, tingling /prickly feeling of extremities and tongue. Began half hour after administration of vaccine
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Used pediatric dose on adult patient
Age: 57.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient's arm was swollen and red
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: SKIN RASH IN THE  NECK AND CHEST AREA
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: Bad neck pain post vaccination & neck stiffness. Pain w/ ROM of neck. Started 1 day post-vaccination, persistent at time of pt visit 9/5
Age: 4.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV, MMRV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Development of redness and swelling at the injection site of the DTAP/IPV vaccine, mesuring 3 inches by 3.5 inches. Full use of the arm, no fevers. Started today 9/5/2024 (48 hours later from initial dose injection on 9/3/2024)
Age: 48.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site bruising, Injection site mass
Clinical narrative: little bruise at the site of the injection, started as a bump just underneath the bruise. Was raised about a quarter of an inch with an oval shaped bump the size of a plum. took Ibuprofen and the bump reduced in size the next morning. Shoulder is sore and couldn't lift until a few days later.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Screaming
Clinical narrative: Inconsolable screaming the day following vaccine; unsure which Hepatitis A vaccine was given.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There was no adverse reaction . Database has last dose adm. on 8-17-2022. we gave a dose on 08-28-2024 and we received a call from the Health Dept.  who said this patient also received a HPV Vaccine on 11-2-23 and 01-10-23 which is not reflected on database.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: small red raised bumps to bilateral wrists, palms and lower legs/ankles noticed the day after vaccine
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Injection site haemorrhage, Pain, Swelling
Clinical narrative: Patient stated at the time they received the shot it bled a lot and then afterwards they were very sore and got a large bump and bruise afterwards.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram heart, Detoxification, Echocardiogram, Electrocardiogram, Immunisation reaction
Clinical narrative: PFIZER #1 2/24/2021 PFIZER #2 3/17/2021 PFIZER #3 11/12/2021 DEVELOPED COVID VACCINE SUBCLINICAL MYOPERICARDITIS AND POST-EXERTIONAL MALAISE.  TREATED WITH COLCHICINE AND PROTOCOL.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Myopericarditis
Clinical narrative: PFIZER #1 2/24/2021 PFIZER #2 3/17/2021 PFIZER #3 11/12/2021 DEVELOPED COVID VACCINE SUBCLINICAL MYOPERICARDITIS AND POST-EXERTIONAL MALAISE.  TREATED WITH COLCHICINE AND PROTOCOL.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Product use issue
Clinical narrative: Patient was taking Methotrexate 12.5 mg PO weekly for Rheumatoid Arthritis and has been for a long time per the patient, and she was 70 years old.  She wanted the yellow fever vaccine knowing the risks for travel.  She stated her physician was aware of her travel plans and the need for the Yellow Fever vaccine.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Diarrhoea, Nausea
Clinical narrative: Upset stomach, diarrhea, nausea that lasted 4 days. Treated at home with oral fluids and rest.
Age: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Erythema, Feeling hot
Clinical narrative: He go this vaccine, no problems.  That evening he noticed pain in his upper left arm.  Next day he had redness, swelling and worse pain in that arm.  It was  hot to touch.  By evening he had an upset stomach, loss of appetite.  The next day he had shaking chills with no noticeable fever, but hotness in the arm itself.  He then started to gradually improve with the system illness, starting gaining appetite again, no more chills.  He has continued to have redness, swelling and pain in his left arm.  It is decreased from the maximum but is still present.  He has been taking Tylenol 500 mg 3 times a day for this.  He has not called his doctor and has been treating it himself and waiting for it to go away.  The swelilng and redness did extend down to his elbow, but it is decreasing and not as painful.   He genreally has no reactions to vaccines.
Age: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Illness, Pain in extremity, Peripheral swelling, Skin warm, Tremor
Clinical narrative: He go this vaccine, no problems.  That evening he noticed pain in his upper left arm.  Next day he had redness, swelling and worse pain in that arm.  It was  hot to touch.  By evening he had an upset stomach, loss of appetite.  The next day he had shaking chills with no noticeable fever, but hotness in the arm itself.  He then started to gradually improve with the system illness, starting gaining appetite again, no more chills.  He has continued to have redness, swelling and pain in his left arm.  It is decreased from the maximum but is still present.  He has been taking Tylenol 500 mg 3 times a day for this.  He has not called his doctor and has been treating it himself and waiting for it to go away.  The swelilng and redness did extend down to his elbow, but it is decreasing and not as painful.   He genreally has no reactions to vaccines.
Age: 31.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pruritus, Rash, Skin swelling
Clinical narrative: Presented on 30 Aug reporting itching with bumps on back, stomach and right leg starting 1245 on 29th.  Screened by  RN.  Visualized raised areas on individuals lower back and middle upper abdomen that were no larger than the size of an eraser of a #2 pencil eraser.  No rash present.  No drainage present.  VS WNL.  Denied SOB, swelling, numbness/tingling of extremities.  Denied swelling of tongue.  Denied tightness of throat or chest.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Rash
Clinical narrative: normal immune response for 36 hours - low-grade fever, body aches, fatigue.   Rash appeared on both forearms and upper trunk on 9/2 c.0 900.  Contacted after-hours phone for primary care physician.  Nurse on-call recommended in-person visit.    Examnined by NP on 9/4.  Rash had largely resolved.   Received guidance to contact primary care team before having any subsequent COVID vaccinations
Age: 4.0
Sex: M
Vaccine: FLUC4
Symptoms: Administration site erythema, Administration site swelling, Pyrexia
Clinical narrative: Parent report fever of 101 degrees starting the night of vaccination accompanied by redness and swelling of the administration site. Parent gave 1 dose aech of OTC tylenol and motrin, but fever persisted 48 hours later.
Age: 0.17
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given at wrong age
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Underdose, Vomiting
Clinical narrative: Patient vomited while administering medication. Patient did not receive the full dose.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Blood glucose, Dizziness, Syncope
Clinical narrative: Patient received vaccines and became lightheaded and fainted for a few seconds. Patient came to and was observed, hydrated, vitals were taken, blood sugar level was taken.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain, Injection site rash, Rhinorrhoea
Clinical narrative: Patient states she started with flu-like symptoms (runny nose, chills, slight muscle aches in injection arm) and a rash under her right arm the day after the injection. She has to take Benadryl to keep the rash from becoming unbearable. These side effects are still occurring over a month later. She saw her doctor who told her to call us at the pharmacy to report.
Age: 54.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse happen at the time of event. Pt stated he does not feel anything wrong. Pt received a 3rd dose of MPOX at the time of event which is not recommended. Pt stated he never received an MPOX when asked.  He had 2 doses already back in 08/2022.  He stated he did not know that he received MPOX on the said date.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Nausea, Vertigo, Vomiting
Clinical narrative: SEVERE VERTIGO SYMPTOMS- NAUSEA, VOMITING AND NO APPETITE AFTER RECEIVING NEW COVID BOOSTER (COMIRNATY- PFIZER BRAND)
Age: 47.0
Sex: M
Vaccine: HEPAB
Symptoms: Extra dose administered
Clinical narrative: Pt had completed HepA series in 2019, and now received an additional dose of HepA vaccine from the Twinrix. This was found out when  updating information on the website. Provider and administering facility have been notifed.
Age: 86.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient has a red rash going down her arm that itches. This started one day after vaccination. She went into the provider and they don't know what it is, but told her if it gets worse to go back to the provider. Gave the patient hydroxyzine to help with the itching.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site nodule, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: At left deltoid injection site: 1" x 2" red rash, raised swollen hard skin, raised nodule at injection site, painful to pressure. Observed the next morning after the Moderna Spikevax vaccination. No treatment necessary, just endured the side effects. Resolution expected within a week.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: At left deltoid injection site: 1" x 2" red rash, raised swollen hard skin, raised nodule at injection site, painful to pressure. Observed the next morning after the Moderna Spikevax vaccination. No treatment necessary, just endured the side effects. Resolution expected within a week.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Pain in jaw, Toothache
Clinical narrative: By day 2 injection side and top of back quite sore. The adverse event was severe pain in the left jaw bone, and upper and lower molars (teeth).  I start taking Ibuprofen 24 hrs a day for 5 days. The pain started weakening on Day 4.  I have never had this type of pain before in my life.
Age: 29.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Weight decreased
Clinical narrative: PATIENT STATES HER WEIGH LOSS IS INTENTIONAL FOR A HEALTHIER LIFE STYLE DONOR STATES SHE KICK BOXES REGULARLY, CUT OUT POP SUGAR AND NOW CONSUMES WATER ONLY .PATIENT SUITABLE TO CONTINUE PATIENT APPEARS HEALTHY AND HYDRATED
Age: 29.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Hypoaesthesia, Injection site pain, Injection site swelling, Pain, Pain in extremity
Clinical narrative: PATIENT STATES HER WEIGH LOSS IS INTENTIONAL FOR A HEALTHIER LIFE STYLE DONOR STATES SHE KICK BOXES REGULARLY, CUT OUT POP SUGAR AND NOW CONSUMES WATER ONLY .PATIENT SUITABLE TO CONTINUE PATIENT APPEARS HEALTHY AND HYDRATED
Age: 93.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Mental status changes, Periorbital swelling, Skin lesion
Clinical narrative: open lesions; altered mental status; swelling around the eyes; redness around the eyes; This serious case was reported by a physician via sales rep and described the occurrence of periocular swelling in a 93-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number AN3B9) for prophylaxis.   On 23-AUG-2024, the patient received the 1st dose of Arexvy. On 23-AUG-2024, 24 hrs after receiving Arexvy, the patient experienced periocular swelling (Verbatim: swelling around the eyes) (serious criteria hospitalization) and erythema periorbital (Verbatim: redness around the eyes) (serious criteria hospitalization). On 24-AUG-2024, the patient experienced skin lesion (Verbatim: open lesions) (serious criteria hospitalization) and mental status changes (Verbatim: altered mental status) (serious criteria hospitalization). The outcome of the periocular swelling and erythema periorbital were not reported and the outcome of the skin lesion and mental status changes were not resolved.   It was unknown if the reporter considered the periocular swelling, erythema periorbital, skin lesion and mental status changes to be related to Arexvy.     The company considered the periocular swelling, erythema periorbital, skin lesion and mental status changes to be related to Arexvy.   Additional Information: GSK Receipt Date: 30-AUG-2024 After vaccination within 24 hours, redness and swelling around the eyes. Then 24 to 48 hours later developed open lesions and altered mental status. The reporter reported the patient was hospitalized.; Sender's Comments: Periorbital swelling, Erythema, Skin lesion and  Mental status changes are unlisted events due to the following criteria (temporal relationship) are considered related to GSK vaccines Arexvy.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles/got over shingles; some lingering deep pains in back; 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.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles/got over shingles) and back pain (Verbatim: some lingering deep pains in back). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved and the outcome of the back pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and back pain to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and back pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 29-AUG-2024 The case was received from the patient via interactive digital media. The patient was reporter. The patient had just got over shingles.  The reporter reported that it was a nightmare even tho a patient had both shots.  The patient had still have some lingering deep pains. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1 ) and Shingles vaccine (dose 2).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2024 The case was received from the patient via (social media) interactive digital media. The patient was reporter's aunt. The patient got the Shingrix vaccine and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Age: 70.0
Sex: F
Vaccine: HEPAB
Symptoms: Hepatitis B
Clinical narrative: at the time of the getting the first dose that he had the hepatitis B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug use for unapproved indication in a 70-year-old female patient who received HAB (Twinrix) (batch number B9279, expiry date 12-SEP-2026) for prophylaxis.   Concurrent medical conditions included hepatitis b.   On 25-JUL-2024, the patient received the 1st dose of Twinrix. On 25-JUL-2024, an unknown time after receiving Twinrix, the patient experienced drug use for unapproved indication (Verbatim: at the time of the getting the first dose that he had the hepatitis B). The outcome of the drug use for unapproved indication was not reported.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-AUG-2024 and 27-AUG-2024 The pharmacist reported that the patient did not disclose to them at the time of the getting the first dose that he had the hepatitis B and so, it was administered and then it was not disclosed until they called for her second shot and her daughter disclosed at that time that the patient already had the hepatitis B and should not get the hepatitis B which was contained in the Twinrix, which led to drug use for unapproved indication.  The pharmacist wanted to find out was there guidance from GlaxoSmithKline with regard to someone who already had hepatitis B receiving the vaccine.