chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This patient scheduled an appointment for a booster online. When she came in, I asked for her immunization card, which she did not have. I printed her records from the state that showed all of her vaccinations for Covid were given in 2021. After the immunization, she started talking about her last dose being in January. I told her I thought she was incorrect and all of her vaccinations were given in 2021. She said no, she got one this year with her flu shot on January 10, 2023. Subsequently, she was given a booster dose too soon. No adverse reactions were reported as I checked on her the next day.
Age: 11.0
Sex: M
Vaccine: COVID19, HPV9
Symptoms: Appendicectomy, Appendicitis perforated, Laparoscopic surgery
Clinical narrative: acute perforated appendicitis; symptom onset approximately 5:00 PM on 8-13-2022; laparoscopic appendectomy 8-15-2022
Age: 40.0
Sex: M
Vaccine: FLUR4, HEP, MMR, TDAP, VARCEL
Symptoms: Pallor, Presyncope, Seizure like phenomena
Clinical narrative: Patient started getting pale, almost fainted, and appeared to have a seizure for a few seconds. 911 was called in between, the seizure stopped before the response team came and patient was able to converse. When medical response team arrived, patient was checked for vitals and all was cleared. Patient was responsive, no SOB, able to walk on his own, full recovered. Called later in the afternoon, patient says he's perfectly fine.
Age: 2.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was administered a Pfizer Bivalent Vaccine, despite parents request for Moderna Booster. Since patient is under age five and received Moderna for both shots (1) and (2) in his primary series he was only eligible to receive a Moderna Booster. Therefore, this should classify as a vaccine administration error.
Age: 2.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Interchange of vaccine products
Clinical narrative: Patient was administered a Pfizer Bivalent Vaccine, despite parents request for Moderna Booster. Since patient is under age five and received Moderna for both shots (1) and (2) in his primary series he was only eligible to receive a Moderna Booster. Therefore, this should classify as a vaccine administration error.
Age: 0.5
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered, Wrong product administered
Clinical narrative: Patient was administered a Pfzier Bivalent Vaccine at just six months old when she had never received either of the Pfizer or any other Covid vaccine primary doses. Her parents had requested a Moderna initial primary series vaccine for patient.
Age: 0.5
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was administered a Pfzier Bivalent Vaccine at just six months old when she had never received either of the Pfizer or any other Covid vaccine primary doses. Her parents had requested a Moderna initial primary series vaccine for patient.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: swelling on the base left neck, injection swelling and soreness, nausea, fever, shivers, muscle aches, fatigue
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: swelling on the base left neck, injection swelling and soreness, nausea, fever, shivers, muscle aches, fatigue
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Local deltoid soreness persisting for 6 months. No redness or swelling
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Mechanical urticaria, Urticaria
Clinical narrative: dermatographia and occasional urticaria
Sex: M
Vaccine: COVID19-2
Symptoms: Illness
Clinical narrative: sickness; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (sickness) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     The patient's past medical history included Transcatheter aortic valve replacement (aortic valve replacement with a TAVR procedure), Dialysis and Fistula repair. Concurrent medical conditions included Immunocompromised, Renal disease, Atrial fibrillation, Coronary artery disease, Hyperlipidemia, Triglycerides high, Prostate cancer and Diabetes. Concomitant products included METOPROLOL TARTRATE for Atrial fibrillation, ROSUVASTATIN CALCIUM (CRESTOR) for Coronary artery disease and Hypertriglyceridaemia, EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA) for Diabetes, RANOLAZINE (RANEXA SR), APIXABAN (ELIQUIS), INSULIN LISPRO (HUMALOG), ESOMEPRAZOLE, VITAMIN D3, CLOPIDOGREL, CALCITRIOL, SODIUM ZIRCONIUM CYCLOSILICATE (LOKELMA), LEVOTHYROXINE SODIUM (SYNTHROID), CINACALCET, LANTHANUM CARBONATE, METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA (MIRCERA), SEVELAMER, FISH OIL, TOCOPHEROL, UBIDECARENONE (COENZYME Q10 PLUS) and INSULIN DETEMIR (LEVEMIR) for an unknown indication.    On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sickness). At the time of the report, ILLNESS (sickness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, Blood pressure measurement: low blood pressure after dialysis. On an unknown date, Blood triglycerides increased: Increased.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient received his first Moderna Covid 19 vaccine primary series on January 13, 2021 Lot number 011J20A, second Moderna Covid 19 vaccine primary series dose February 10, 2021 Lot number 028L20A , third Moderna Covid 19 vaccine dose on August 31, 2021 Lot number 088D21A, first Moderna Covid 19 monovalent vaccine booster dose on February 23, 2022 Lot number 083J21A, second Moderna Covid 19 vaccine booster dose on Lot number July 25, 2022.   Patient had no Thyroid. In March or April of 2021 the patient developed Steal syndrome in his left hand.The patient has limited use of his left hand. The patient then developed complications with his dialysis fistula that lead to circulation issues in left hand. In July of 2021 the patient had a dialysis fistula repaired. In November of 2021 the patient had the dialysis fistula blocked off with a procedure at the hospital.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2023: Live significant Follow up appended: Added suspect product details, concomitant product details, relevant medical history and updated patient information
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Dizziness, Exposure during pregnancy, Tinnitus, Vision blurred, Visual impairment
Clinical narrative: Spotted vision,  blurry vision,  dizziness, ears ringing.  Pregnancy information: due date June 25, 2023. No complications thus far.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: patient states excruciating pain at injection site think at the joint advised to check with dr. reviewed with immunizer and was given in correct location to avoid shoulder joint
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Nausea, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Additional Details: Patient fainted and woke up within seconds. Father was with 18 year old patient and stated patient had not eaten nor drank anything that day. Vaccine was given around 4pm. Patient immediately instructed to sit down with head between legs and drank some orange juice. Patient immediately felt better. Emergency personel was called to check patient blood pressure, sugar and heart rate. All was within normal limits. Patient doing just fine after resting 20 minutes.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Fracture, Loss of consciousness
Clinical narrative: Blacked out, fell down, broke neck in half
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Fly like symptoms with fever, chills and muscle aches
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Aplasia pure red cell, Biopsy bone marrow abnormal, Blood test, Cancer screening, Fatigue
Clinical narrative: Following booster shot (roughly two months), I started to experience headaches, extreme fatigue, visual distortions, pulsatile tinnitus, near fainting, and other symptoms. Eventually a doctor ordered a blood test and I was admitted to emergency care while traveling. I was given several blood transfusions and returned immediately home. I have since undergone several different tests , including bone marrow biopsy which reveals a diagnosis of Pure Red Cell Aplasia. All known forms of cause of this have been tested and ruled out.  I continue to struggle with this condition and am on daily medication in attempt to control it. I have no history of blood disorders.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Foreign travel, Full blood count, Headache, Laboratory test, Parvovirus B19 test
Clinical narrative: Following booster shot (roughly two months), I started to experience headaches, extreme fatigue, visual distortions, pulsatile tinnitus, near fainting, and other symptoms. Eventually a doctor ordered a blood test and I was admitted to emergency care while traveling. I was given several blood transfusions and returned immediately home. I have since undergone several different tests , including bone marrow biopsy which reveals a diagnosis of Pure Red Cell Aplasia. All known forms of cause of this have been tested and ruled out.  I continue to struggle with this condition and am on daily medication in attempt to control it. I have no history of blood disorders.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope, Tinnitus, Transfusion, Visual impairment
Clinical narrative: Following booster shot (roughly two months), I started to experience headaches, extreme fatigue, visual distortions, pulsatile tinnitus, near fainting, and other symptoms. Eventually a doctor ordered a blood test and I was admitted to emergency care while traveling. I was given several blood transfusions and returned immediately home. I have since undergone several different tests , including bone marrow biopsy which reveals a diagnosis of Pure Red Cell Aplasia. All known forms of cause of this have been tested and ruled out.  I continue to struggle with this condition and am on daily medication in attempt to control it. I have no history of blood disorders.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chest pain, Dizziness, Electrocardiogram normal, Epstein-Barr virus infection
Clinical narrative: Neurological symptoms started with feeling off balance, dizzy, light headed, and persistent headaches, then progressed to hemiplegic migraine, chest pain, neuralgia, and continued chronic headaches and abnormal nerve sensations throughout body.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hemiplegic migraine, Magnetic resonance imaging, Neuralgia, Neurological symptom
Clinical narrative: Neurological symptoms started with feeling off balance, dizzy, light headed, and persistent headaches, then progressed to hemiplegic migraine, chest pain, neuralgia, and continued chronic headaches and abnormal nerve sensations throughout body.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Arthritis reactive
Clinical narrative: Reactive arthritis in both knees , doctor indicated to wait longer to do second dose or to not get it at all , treatment - cut down on inflammatory foods
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Vaccination error, Wrong product administered
Clinical narrative: The patient received the wrong immunization; he was scheduled to receive the Pfizer-BioNTech COVID19 Bivalent Updated Booster vaccination, but received a dose of the Pfizer-BioNTech COVID19 Primary Series immunization by mistake. I discovered the error on 4/7/23 and informed the patient of the error the same day. He did not report any adverse events. I apologized to the patient for the mistake and informed him we would be receiving the Pfizer-BioNTech COVID19 Bivalent Updated Booster later on that day and if appropriate/if he was available we could administer the correct vaccine. He appreciated informing him of the error, however he informed that he was not available. I advised him we would verify the appropriate next steps and keep him updated of the situation.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Pain, Tenderness
Clinical narrative: patient is experiencing soreness, bruising and tenderness
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Coronary artery thrombosis, Haematochezia, Haemoptysis, Rectal haemorrhage, Thrombosis
Clinical narrative: Spitting up blood Hospitalized due to blood clots Rental bleeding
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient finished two series last year. I administered one dose  on 04/08/23 then realized patient already finished the series
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Cardiac monitoring abnormal, Chest discomfort, Computerised tomogram thorax abnormal, Dyspnoea
Clinical narrative: I experienced stress and tightness in chest. Something that I  would describe as a "blip" or a skip. and some labored breathing. This began while I was at altitude on vacation. When I returned I got a referral from my PCP for a cardiologist. After Visit, Dr. Prescribed a CT scan. Scan revealed some small calcium deposits on the left side of my heart. Wore a heart monitor, experienced a "blip" while wearing. They told me it did register but it was just a normal I was prescribed a statin and a baby aspirin. told I could return to regular exercise carefully. I have returned to exercise and am scheduled for a follow up next month.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial calcification, Stress
Clinical narrative: I experienced stress and tightness in chest. Something that I  would describe as a "blip" or a skip. and some labored breathing. This began while I was at altitude on vacation. When I returned I got a referral from my PCP for a cardiologist. After Visit, Dr. Prescribed a CT scan. Scan revealed some small calcium deposits on the left side of my heart. Wore a heart monitor, experienced a "blip" while wearing. They told me it did register but it was just a normal I was prescribed a statin and a baby aspirin. told I could return to regular exercise carefully. I have returned to exercise and am scheduled for a follow up next month.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Cellulitis developed at the injection site: pain, swelling, redness, warmth
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Inflammation, Injection site erythema, Injection site swelling
Clinical narrative: PER PT, STATED THAT SHE EXPERIENCED MOST SIGNS/SX OF INFLAMMATION: REDNESS, SWELLING, HEAT, PAIN. I ADVISED THAT IS EXPECTED FROM MOST VACCINES, BUT SHE INSISTED IT WAS WORSE THAN HER 1ST SHOT. PT'S ARM WAS VISIBLY RED FROM INJ SITE TO ELBOW, BUT SWELLING WAS LOCALIZED AT INJ SITE
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Swelling
Clinical narrative: PER PT, STATED THAT SHE EXPERIENCED MOST SIGNS/SX OF INFLAMMATION: REDNESS, SWELLING, HEAT, PAIN. I ADVISED THAT IS EXPECTED FROM MOST VACCINES, BUT SHE INSISTED IT WAS WORSE THAN HER 1ST SHOT. PT'S ARM WAS VISIBLY RED FROM INJ SITE TO ELBOW, BUT SWELLING WAS LOCALIZED AT INJ SITE
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: Pt received a 2nd dose of Shingrix too early, he was supposed to get 2nd dose of Twinrix
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Norovirus infection, Pulmonary embolism
Clinical narrative: I was diagnosed with a Pulmonary Embolism on Jan 7 2023.  Between the booster and the PE, I contracted a bad case of Norovirus and flew home when well enough (likely dehydrated.)
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Injection site pain, Magnetic resonance imaging, Pain in extremity, X-ray limb
Clinical narrative: Pain in left arm and shoulder.  No mobility of arm.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood test normal, Computerised tomogram head normal, Condition aggravated, Exercise tolerance decreased
Clinical narrative: Within 7-8 months after receiving the second dose of Moderna Covid vaccine, I started having seizures. Prior to getting Covid vaccines I have never had a seizure, no family history seizures. Since my first dose of the Covid vaccine which was given 10/02/21, I became lactose intolerant, developed frequent and severe headaches and my anxiety has worsened and my immune system has weakened, cause I always seem to be sick with some kind of cold. My doctors have yet to find a cause for any of my symptoms, as all my blood work and head/brain CT scans have come back normal. I personally believe these seizures have developed as a result of receiving the Covid moderna vaccines since prior to vaccination, i was very athletic participating in horse shows, going for daily walks. I had no preexisting medical conditions, and have no family history of neurological disorders. These adverse events/illness have significantly impacted my career, I work as a firefighter and EMT and since having the seizures my ability to perform my job has been severely affected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immune system disorder, Impaired work ability, Lactose intolerance, Mobility decreased
Clinical narrative: Within 7-8 months after receiving the second dose of Moderna Covid vaccine, I started having seizures. Prior to getting Covid vaccines I have never had a seizure, no family history seizures. Since my first dose of the Covid vaccine which was given 10/02/21, I became lactose intolerant, developed frequent and severe headaches and my anxiety has worsened and my immune system has weakened, cause I always seem to be sick with some kind of cold. My doctors have yet to find a cause for any of my symptoms, as all my blood work and head/brain CT scans have come back normal. I personally believe these seizures have developed as a result of receiving the Covid moderna vaccines since prior to vaccination, i was very athletic participating in horse shows, going for daily walks. I had no preexisting medical conditions, and have no family history of neurological disorders. These adverse events/illness have significantly impacted my career, I work as a firefighter and EMT and since having the seizures my ability to perform my job has been severely affected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Seizure
Clinical narrative: Within 7-8 months after receiving the second dose of Moderna Covid vaccine, I started having seizures. Prior to getting Covid vaccines I have never had a seizure, no family history seizures. Since my first dose of the Covid vaccine which was given 10/02/21, I became lactose intolerant, developed frequent and severe headaches and my anxiety has worsened and my immune system has weakened, cause I always seem to be sick with some kind of cold. My doctors have yet to find a cause for any of my symptoms, as all my blood work and head/brain CT scans have come back normal. I personally believe these seizures have developed as a result of receiving the Covid moderna vaccines since prior to vaccination, i was very athletic participating in horse shows, going for daily walks. I had no preexisting medical conditions, and have no family history of neurological disorders. These adverse events/illness have significantly impacted my career, I work as a firefighter and EMT and since having the seizures my ability to perform my job has been severely affected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia, Laboratory test, Pain, Rash
Clinical narrative: headaches, body aches, severe insomnia, occasional rash on right hand.
Age: 4.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administration error, Product use issue
Clinical narrative: COVID vaccine was administered in error prior to vaccine authorization for this age group.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Cough, Death, Dyspnoea
Clinical narrative: 3RD DOSE COVID VACCINE (FPIZER) GIVEN 01/21/2022, BD#33025; pt brought to ED 8/22/22 with worsening SOB and cough that's been there x 4 wks; initially pt was treated outpatient with a Z-Pak and Cefdinir without a change in sx; in ED pt's O2 saturation is 89% on RA, was negative for COVID; CXR showed pneumonia; given IV ABX and admitted; 9/5/22 pt had a positive COVID test; given dexamethasone and remdesivir; respiratory status worsened; ICU and intubated; pt's condition deteriorated more and comfort measures were followed; pt passed away in the hospital
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Endotracheal intubation, General physical health deterioration, Intensive care, Pneumonia, Respiratory disorder
Clinical narrative: 3RD DOSE COVID VACCINE (FPIZER) GIVEN 01/21/2022, BD#33025; pt brought to ED 8/22/22 with worsening SOB and cough that's been there x 4 wks; initially pt was treated outpatient with a Z-Pak and Cefdinir without a change in sx; in ED pt's O2 saturation is 89% on RA, was negative for COVID; CXR showed pneumonia; given IV ABX and admitted; 9/5/22 pt had a positive COVID test; given dexamethasone and remdesivir; respiratory status worsened; ICU and intubated; pt's condition deteriorated more and comfort measures were followed; pt passed away in the hospital
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 3RD DOSE COVID VACCINE (FPIZER) GIVEN 01/21/2022, BD#33025; pt brought to ED 8/22/22 with worsening SOB and cough that's been there x 4 wks; initially pt was treated outpatient with a Z-Pak and Cefdinir without a change in sx; in ED pt's O2 saturation is 89% on RA, was negative for COVID; CXR showed pneumonia; given IV ABX and admitted; 9/5/22 pt had a positive COVID test; given dexamethasone and remdesivir; respiratory status worsened; ICU and intubated; pt's condition deteriorated more and comfort measures were followed; pt passed away in the hospital
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood immunoglobulin G, Epstein-Barr virus antibody, Epstein-Barr virus infection, Fatigue, Lymphadenopathy
Clinical narrative: Epstein-Barr (upset and concerned); Not doing very well; This non-serious case was reported by a consumer via call center representative and described the occurrence of epstein-barr virus infection in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-MAR-2023, the patient received the 1st dose of Shingrix (left arm). On 28-MAR-2023, 14 days after receiving Shingrix, the patient experienced epstein-barr virus infection (Verbatim: Epstein-Barr (upset and concerned)) and unwell (Verbatim: Not doing very well). The outcome of the epstein-barr virus infection and unwell were not resolved.   It was unknown if the reporter considered the epstein-barr virus infection and unwell to be related to Shingrix.     It was unknown if the company considered the epstein-barr virus infection and unwell to be related to Shingrix.   Additional Information: GSK Receipt date: 29-MAR-2023 The reporter was the patient. The patient got his dose of shingrix vaccine at a local pharmacy. The patient reports that the vaccine was administered in the left arm. The vaccine lot and expiry date are unknown. The patient was not sure of the date the vaccine was administered.  The patient believed it was on 14th March 2023, but he was not sure.  The patient reported that he was upset and concerned because he was informed that he has Epstein-Barr a day ago, after the shingrix vaccine was administered. The patient reports he really not doing very well. This was potential legal case. Not all information is available. Patient states about consent to follow up not sure. The reporter did not consent to follow up.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Epstein-Barr (upset and concerned); Not doing very well; This non-serious case was reported by a consumer via call center representative and described the occurrence of epstein-barr virus infection in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-MAR-2023, the patient received the 1st dose of Shingrix (left arm). On 28-MAR-2023, 14 days after receiving Shingrix, the patient experienced epstein-barr virus infection (Verbatim: Epstein-Barr (upset and concerned)) and unwell (Verbatim: Not doing very well). The outcome of the epstein-barr virus infection and unwell were not resolved.   It was unknown if the reporter considered the epstein-barr virus infection and unwell to be related to Shingrix.     It was unknown if the company considered the epstein-barr virus infection and unwell to be related to Shingrix.   Additional Information: GSK Receipt date: 29-MAR-2023 The reporter was the patient. The patient got his dose of shingrix vaccine at a local pharmacy. The patient reports that the vaccine was administered in the left arm. The vaccine lot and expiry date are unknown. The patient was not sure of the date the vaccine was administered.  The patient believed it was on 14th March 2023, but he was not sure.  The patient reported that he was upset and concerned because he was informed that he has Epstein-Barr a day ago, after the shingrix vaccine was administered. The patient reports he really not doing very well. This was potential legal case. Not all information is available. Patient states about consent to follow up not sure. The reporter did not consent to follow up.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Emotional distress, Epstein-Barr virus infection, Malaise
Clinical narrative: Epstein-Barr (upset and concerned); Not doing very well; This non-serious case was reported by a consumer via call center representative and described the occurrence of epstein-barr virus infection in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-MAR-2023, the patient received the 1st dose of Shingrix (left arm). On 28-MAR-2023, 14 days after receiving Shingrix, the patient experienced epstein-barr virus infection (Verbatim: Epstein-Barr (upset and concerned)) and unwell (Verbatim: Not doing very well). The outcome of the epstein-barr virus infection and unwell were not resolved.   It was unknown if the reporter considered the epstein-barr virus infection and unwell to be related to Shingrix.     It was unknown if the company considered the epstein-barr virus infection and unwell to be related to Shingrix.   Additional Information: GSK Receipt date: 29-MAR-2023 The reporter was the patient. The patient got his dose of shingrix vaccine at a local pharmacy. The patient reports that the vaccine was administered in the left arm. The vaccine lot and expiry date are unknown. The patient was not sure of the date the vaccine was administered.  The patient believed it was on 14th March 2023, but he was not sure.  The patient reported that he was upset and concerned because he was informed that he has Epstein-Barr a day ago, after the shingrix vaccine was administered. The patient reports he really not doing very well. This was potential legal case. Not all information is available. Patient states about consent to follow up not sure. The reporter did not consent to follow up.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Cardiac function test, Dyspnoea, Pulmonary function test
Clinical narrative: shortness of breath; can barely walk half a block; Progressively worse with each shot; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (shortness of breath), GAIT DISTURBANCE (can barely walk half a block) and CONDITION AGGRAVATED (Progressively worse with each shot) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath), GAIT DISTURBANCE (can barely walk half a block) and CONDITION AGGRAVATED (Progressively worse with each shot). At the time of the report, DYSPNOEA (shortness of breath) had not resolved and GAIT DISTURBANCE (can barely walk half a block) and CONDITION AGGRAVATED (Progressively worse with each shot) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not reported.  It was reported that patient received Moderna COVID-19 vaccine dose 1 on unknown date, dose 2 on 25-Feb-2021 intramuscular route. Dose 3 on 11-Nov-2021 intramuscular route, dose 4 on 09-Apr-2022 intramuscular route. Batch number was unknown for all the doses. Patient had Shortness of Breath. Over time developed into severe shortness of breath. Now at point patient can barely walk half a block. People keep asking if in need of help. Progressively worse with each shot. Started shortly after first short and worse after each shot. It was unknown if the patient experienced any additional symptoms/events.   Treatment medications were not reported.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Condition aggravated, Dyspnoea, Gait disturbance
Clinical narrative: shortness of breath; can barely walk half a block; Progressively worse with each shot; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (shortness of breath), GAIT DISTURBANCE (can barely walk half a block) and CONDITION AGGRAVATED (Progressively worse with each shot) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath), GAIT DISTURBANCE (can barely walk half a block) and CONDITION AGGRAVATED (Progressively worse with each shot). At the time of the report, DYSPNOEA (shortness of breath) had not resolved and GAIT DISTURBANCE (can barely walk half a block) and CONDITION AGGRAVATED (Progressively worse with each shot) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not reported.  It was reported that patient received Moderna COVID-19 vaccine dose 1 on unknown date, dose 2 on 25-Feb-2021 intramuscular route. Dose 3 on 11-Nov-2021 intramuscular route, dose 4 on 09-Apr-2022 intramuscular route. Batch number was unknown for all the doses. Patient had Shortness of Breath. Over time developed into severe shortness of breath. Now at point patient can barely walk half a block. People keep asking if in need of help. Progressively worse with each shot. Started shortly after first short and worse after each shot. It was unknown if the patient experienced any additional symptoms/events.   Treatment medications were not reported.
Age: 22.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: No adverse event; Patient received the bivalent booster without receiving the primary series; She has received a single dose of the Moderna COVID-19 vaccines on 6APR2023 without having completed vaccination with a primary, monovalent covid-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the bivalent booster without receiving the primary series), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She has received a single dose of the Moderna COVID-19 vaccines on 6APR2023 without having completed vaccination with a primary, monovalent covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 22-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Apr-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the bivalent booster without receiving the primary series) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She has received a single dose of the Moderna COVID-19 vaccines on 6APR2023 without having completed vaccination with a primary, monovalent covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the bivalent booster without receiving the primary series), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She has received a single dose of the Moderna COVID-19 vaccines on 6APR2023 without having completed vaccination with a primary, monovalent covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Patient received the bivalent booster without receiving the primary series) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She has received a single dose of the Moderna COVID-19 vaccines on 6APR2023 without having completed vaccination with a primary, monovalent covid-19 vaccine).    No concomitant medications was reported. It was reported that patient has not any side effects at present. No treatment drug details was reported.
Age: 22.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received the bivalent booster without receiving the primary series; She has received a single dose of the Moderna COVID-19 vaccines on 6APR2023 without having completed vaccination with a primary, monovalent covid-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the bivalent booster without receiving the primary series), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She has received a single dose of the Moderna COVID-19 vaccines on 6APR2023 without having completed vaccination with a primary, monovalent covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 22-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Apr-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the bivalent booster without receiving the primary series) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She has received a single dose of the Moderna COVID-19 vaccines on 6APR2023 without having completed vaccination with a primary, monovalent covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the bivalent booster without receiving the primary series), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She has received a single dose of the Moderna COVID-19 vaccines on 6APR2023 without having completed vaccination with a primary, monovalent covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Patient received the bivalent booster without receiving the primary series) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She has received a single dose of the Moderna COVID-19 vaccines on 6APR2023 without having completed vaccination with a primary, monovalent covid-19 vaccine).    No concomitant medications was reported. It was reported that patient has not any side effects at present. No treatment drug details was reported.
Sex: U
Vaccine: PNC15
Symptoms: Device leakage, Incorrect dose administered, No adverse event, Syringe issue, Underdose
Clinical narrative: no adverse event; small amount of vaccine leaked out from the top of the Luer lock attachment where the needle screws on. This occurred during administration. Nurse states there is no visible crack or any broken component. patient may not have received a full dose.; small amount of vaccine leaked out from the top of the Luer lock attachment where the needle screws on.; they noticed the Luer lock attachment was broken off the syringe barrel. No AE associated with this PQC; This spontaneous report was received from nurse regarding a patient of unspecified age and gender. The patient's medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  The nurse reported that on an unspecified date in March 2023, as soon as they opened a new box and newtray of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (INJ) 0.5 mL 1DS X 10 syringes, lot number W021512 (expiration date: 08-OCT-2023) they noticed that the luer lock attachment of one of the syringes was broken off the barrel, hence it was broken in 2 pieces while it was still on the tray, but there was no liquid or dried residue in it and the syringe cap was still attached, also the tray was intact and undamaged upon receipt, the cellophane cover was completely sealed, and the carton was not damaged; nevertheless, this syringe was no administered to any patient. However, on 14-MAR-2023, while vaccinating the patient with 1 dose of pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) 0.5 mL 1DS X 10 syringes, of the same lot number (W021512 [expiration date: 08-OCT-2023]) for prophylaxis (dose and route of administration not reported), a small amount of the vaccine leaked out from the top of the luer lock attachment where the needle screws on and the patient might not have received a full dose (Incomplete dose administered) (Leak at device connection) (Leak at device connection). Moreover, the nurse stated that there was no visible crack or any broken component in the syringe that could explain the leaking and the needle was securely attached to the syringe while giving the injection. Additionally, they used BD safety glide needles 23G 1 and the damaged pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) syringes were retrieved. The adverse events (AE) were filled as related to a quality product complain (PQC). No further AE or PQC reported (No adverse event).
Age: 0.33
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported.; 4 month old patient was administered GARDASIL 9 today, 21-MAR-2023; This spontaneous report has been received from a licensed practical nurse (L.P.N.) referring to a 4-month-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 21-MAR-2023, the patient was administered with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (0.5 milliliter (mL), lot# U031051, expiration date 14-JUN-2024, strength, route of administration and anatomical location were unknown) for prophylaxis (product administered to patient of inappropriate age). No additional adverse event (AE) reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: shingles; other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 06-JAN-2011, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose, and route not specified) by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently (date unknown), the patient was treated by a physician for the following injuries resulting from ZOSTAVAX: shingles and other zoster-related injuries (ill-defined disorder). The outcome of the events was unknown. The causality between both events and ZOSTAVAX was considered to be related.
Sex: U
Vaccine: UNK
Symptoms: Blindness
Clinical narrative: went blind; This serious case was reported by a consumer via market research programs and described the occurrence of blind in a patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   On an unknown date, the patient received Hz/su + AS01B. On an unknown date, an unknown time after receiving Hz/su + AS01B, the patient experienced blind (Verbatim: went blind) (serious criteria GSK medically significant). The outcome of the blind was not reported.   The reporter considered the blind to be possibly related to Hz/su + AS01B.   The company considered the blind to be possibly related to Hz/su + AS01B.   Additional Information: GSK Receipt date: 03-Apr-2023. This case was reported by a consumer via market research programs. Reporter stated that a friend went blind after getting the vaccine. The reporter think that the event might have been related to the product/device. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR049411:same reporter - reporter´s case
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: given a 3rd shot instead of Tetanus; Shingrix given instead of Tetanus; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: given a 3rd shot instead of Tetanus) and wrong vaccine administered (Verbatim: Shingrix given instead of Tetanus). The outcome of the extra dose administered and wrong vaccine administered were unknown.   Additional Information: GSK receipt date: 28-MAR-2023/29-MAR-2023 The reporter was retired pharmacist (patient's friend). The reporter clarified verbally that the patient had received the first two doses in accordance with the label, but then about a year later was inadvertently given a third dose. The patient went to the pharmacy to get a Tetanus vaccine recently, but was inadvertently given a third Shingrix dose. The pharmacist granted permission for safety to follow up at the following updated mailing address. No further details provided. The patient was given by mistake Shingrix(3rd dose) instead of Tetanus, which led to extra dose administered and wrong vaccine administered.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix given to a 1-year-old; Kinrix given instead of Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   On 20-DEC-2022, the patient received Kinrix. On 20-DEC-2022, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix given to a 1-year-old) and wrong vaccine administered (Verbatim: Kinrix given instead of Infanrix). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   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: 16-MAR-2023 The licensed vocational nurse (LVN) reported administration of Kinrix vaccine to a 1 year 3 month old patient instead of Infanrix.  No adverse reaction noted with patient. The reporter consented to follow up. The patient received Kinrix vaccine instead of Infanrix at inappropriate age, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Age: 28.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: given a dose reconstituted with MMR diluent; given a dose reconstituted with MMR diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 28-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA721A, expiry date 31-AUG-2023) for prophylaxis.   On 17-MAR-2023, the patient received Menveo. On 17-MAR-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: given a dose reconstituted with MMR diluent) and inappropriate dose of vaccine administered (Verbatim: given a dose reconstituted with MMR diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-MAR-2023 The supervisor reported one of her employees administered a dose of Menveo to a patient, reconstituting the dose with MMR diluent instead of the supplied CYW-135 liquid conjugate.   At the time of reporting, a repeat dose had not been administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient was given a dose reconstituted with MMR diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.