chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Hypophagia, Lethargy, Malaise, Pneumonia, Pyrexia
Clinical narrative: 8/14/22 - 8/18/22 pt admitted to hosp with fever, confusion, and UTI sx; family states he had COVID 3 wks earlier and hasn't seemed to be well since; positive COVID test on admission; CT C/A shows right lower lobe infection; no acute distress related to COVID; DNR/DNI; was dc'd to home; 9/20/22 pt to ED with SOB and O2 saturations at home in low 80s; given breathing treatments with improved O2 levels; dc'd to home with hospice (name of hospice not in medical records); 10/23/22 - 10/28/22 pt in hospital with worsening swelling; lethargic, poor oral intake; malaise; transitioned to comfort measures and passed away in the hospital
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Swelling, Urinary tract disorder
Clinical narrative: 8/14/22 - 8/18/22 pt admitted to hosp with fever, confusion, and UTI sx; family states he had COVID 3 wks earlier and hasn't seemed to be well since; positive COVID test on admission; CT C/A shows right lower lobe infection; no acute distress related to COVID; DNR/DNI; was dc'd to home; 9/20/22 pt to ED with SOB and O2 saturations at home in low 80s; given breathing treatments with improved O2 levels; dc'd to home with hospice (name of hospice not in medical records); 10/23/22 - 10/28/22 pt in hospital with worsening swelling; lethargic, poor oral intake; malaise; transitioned to comfort measures and passed away in the hospital
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: dose given pass the beyond use date
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke  No pre-existing conditions prior to date of stroke. Two (2) day hospital stay and then released.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: dose given pass beyond use date.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ear pain, Feeling abnormal, Headache, Pain in extremity, Pruritus
Clinical narrative: swore arm started feeling bad headache and fever legs started itching  earache
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: swore arm started feeling bad headache and fever legs started itching  earache
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: dose given pass beyond use date.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Symptom recurrence
Clinical narrative: HYPOTENSION  4/29/2022,  6/2/2022,  12/30/2022 --  RECURRENCE OF SAME SYMPTOMS
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: dose given pass beyond use date
Age: 0.83
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Dtap given was expired on 4-30-23.  No adverse s/s.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: dose given pass beyond use date
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Catheter placement, Chest X-ray abnormal, Death
Clinical narrative: 3RD MODERNA COVID VACCINE DOSE GIVE 8/23/22, LOT # NOT RECORDED; 9/12/22 Pt had a positive COVID test; 10/20/22 - 10/22/22 pt to hospital with PNA and persistent positive COVID antigen test; dc'd on ABX and dexamethasone on RA; 10/25/22 pt back to hospital with Nausea/vomiting, weakness, hypotensive, lethargic, wet productive (green) cough; CXR showed left lower lobe pneumonia; given ABX, and fluids; BiPAP; Decadron; 11/1/22 - 11/4/22 hosp admission for worsening respiratory failure; intubated; large left tension PTX; Wayne catheter placement; transitioned to comfort care and passed away in the hospital
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Endotracheal intubation, Hypotension, Lethargy, Nausea, Pneumonia
Clinical narrative: 3RD MODERNA COVID VACCINE DOSE GIVE 8/23/22, LOT # NOT RECORDED; 9/12/22 Pt had a positive COVID test; 10/20/22 - 10/22/22 pt to hospital with PNA and persistent positive COVID antigen test; dc'd on ABX and dexamethasone on RA; 10/25/22 pt back to hospital with Nausea/vomiting, weakness, hypotensive, lethargic, wet productive (green) cough; CXR showed left lower lobe pneumonia; given ABX, and fluids; BiPAP; Decadron; 11/1/22 - 11/4/22 hosp admission for worsening respiratory failure; intubated; large left tension PTX; Wayne catheter placement; transitioned to comfort care and passed away in the hospital
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumothorax, Positive airway pressure therapy, Productive cough, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: 3RD MODERNA COVID VACCINE DOSE GIVE 8/23/22, LOT # NOT RECORDED; 9/12/22 Pt had a positive COVID test; 10/20/22 - 10/22/22 pt to hospital with PNA and persistent positive COVID antigen test; dc'd on ABX and dexamethasone on RA; 10/25/22 pt back to hospital with Nausea/vomiting, weakness, hypotensive, lethargic, wet productive (green) cough; CXR showed left lower lobe pneumonia; given ABX, and fluids; BiPAP; Decadron; 11/1/22 - 11/4/22 hosp admission for worsening respiratory failure; intubated; large left tension PTX; Wayne catheter placement; transitioned to comfort care and passed away in the hospital
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 3RD MODERNA COVID VACCINE DOSE GIVE 8/23/22, LOT # NOT RECORDED; 9/12/22 Pt had a positive COVID test; 10/20/22 - 10/22/22 pt to hospital with PNA and persistent positive COVID antigen test; dc'd on ABX and dexamethasone on RA; 10/25/22 pt back to hospital with Nausea/vomiting, weakness, hypotensive, lethargic, wet productive (green) cough; CXR showed left lower lobe pneumonia; given ABX, and fluids; BiPAP; Decadron; 11/1/22 - 11/4/22 hosp admission for worsening respiratory failure; intubated; large left tension PTX; Wayne catheter placement; transitioned to comfort care and passed away in the hospital
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: The patient was seen in the office today because she thinks she might of had a reaction to a pneumococcal vaccine. She got her PCV 20 on April 26. Yesterday she started noticing a redness and itching of the left arm. She took some Benadryl but today the symptoms were worse. She has no idea how long she had the rash. She first noticed it yesterday. She states she does have a history of having reactions to her allergy shots in the past. She has not had any fever or chills
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pfizer Bivalent dose given too soon.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Atrioventricular block complete, Lacunar stroke
Clinical narrative: I21.09 ACUTE ST ELEVATION MI, ANTERIOR WALL 7/6/2021 ACUTE ST ELEVATION MI, INFERIOR WALL I21.19 ACUTE ST ELEVATION MI, INFERIOR WALL 7/7/2021 ACUTE ST ELEVATION MI, INFERIOR WALL I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 7/7/2021 ACUTE ST ELEVATION MI, INFERIOR WALL I21.09 ACUTE ST ELEVATION MI, ANTERIOR WALL 7/6/2021 AV BLOCK, COMPLETE I21.19 ACUTE ST ELEVATION MI, INFERIOR WALL 7/7/2021 AV BLOCK, COMPLETE I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 7/7/2021 AV BLOCK, COMPLETE
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Fatigue, Lethargy, Paranasal sinus hypersecretion
Clinical narrative: I felt very tired, I had chills, sinus drainage, I knew I had something I just wasn't sure what it was, I took a home COVID-19 test that came back positive. I called my doctor to discuss my positive test and symptoms, we decided I would take the antiviral Paxlovid. I was able to start the medication the next day.  It took me took weeks to completely get over being lethargic. Even after having finished the five-day regimen, I felt tired, I did not want to do anything.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I felt very tired, I had chills, sinus drainage, I knew I had something I just wasn't sure what it was, I took a home COVID-19 test that came back positive. I called my doctor to discuss my positive test and symptoms, we decided I would take the antiviral Paxlovid. I was able to start the medication the next day.  It took me took weeks to completely get over being lethargic. Even after having finished the five-day regimen, I felt tired, I did not want to do anything.
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mechanical urticaria, Pruritus, Scratch
Clinical narrative: Started itching in Nov.  Dermatographia occurs with scratching  itchy areas. Itching has continued since shot. Saw allergy doctor and she hade change allergy medicine to Zyrtec. I'm taking 30 mg daily with intermittent improvement.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Chronic respiratory failure, Coronary artery disease, Respiratory failure
Clinical narrative: Pfizer vaccine was administered  - reported by patient- ? NO LOT NUMBER WERE SUPPLIED  SLEEP APNEA 6/25/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA SLEEP APNEA 6/25/2021 HX OF LUNG CANCER ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 HX OF LUNG CANCER SLEEP APNEA 6/25/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 CHRONIC HYPOXEMIC RESPIRATORY FAILURE SLEEP APNEA 6/25/2021 COVID-19 DISEASE ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 COVID-19 DISEASE
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep apnoea syndrome
Clinical narrative: Pfizer vaccine was administered  - reported by patient- ? NO LOT NUMBER WERE SUPPLIED  SLEEP APNEA 6/25/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA SLEEP APNEA 6/25/2021 HX OF LUNG CANCER ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 HX OF LUNG CANCER SLEEP APNEA 6/25/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 CHRONIC HYPOXEMIC RESPIRATORY FAILURE SLEEP APNEA 6/25/2021 COVID-19 DISEASE ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 COVID-19 DISEASE
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Bivalent vaccine given too early. No Signs or Symptoms
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Deep vein thrombosis, Hypoxia, Ischaemic stroke, Metabolic encephalopathy
Clinical narrative: ACUTE PULMONARY EMBOLISM 11/26/2021 OSTEOPENIA ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 11/26/2021 OSTEOPENIA ACUTE DVT OF RIGHT POPLITEAL VEIN 11/26/2021 OSTEOPENIA ACUTE RESPIRATORY FAILURE 11/10/2021 OSTEOPENIA HYPOXIA 10/15/2021 OSTEOPENIA ACUTE PULMONARY EMBOLISM 11/26/2021 METABOLIC ENCEPHALOPATHY ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 11/26/2021 METABOLIC ENCEPHALOPATHY ACUTE DVT OF RIGHT POPLITEAL VEIN 11/26/2021 METABOLIC ENCEPHALOPATHY ACUTE RESPIRATORY FAILURE 11/10/2021 METABOLIC ENCEPHALOPATHY HYPOXIA 10/15/2021 METABOLIC ENCEPHALOPATHY ACUTE PULMONARY EMBOLISM 11/26/2021 ACUTE RESPIRATORY FAILURE ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 11/26/2021 ACUTE RESPIRATORY FAILURE ACUTE DVT OF RIGHT POPLITEAL VEIN 11/26/2021 ACUTE RESPIRATORY FAILURE ACUTE RESPIRATORY FAILURE 11/10/2021 ACUTE RESPIRATORY FAILURE HYPOXIA 10/15/2021 ACUTE RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM 11/26/2021 ACUTE DVT OF RIGHT POPLITEAL VEIN ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 11/26/2021 ACUTE DVT OF RIGHT POPLITEAL VEIN ACUTE DVT OF RIGHT POPLITEAL VEIN 11/26/2021 ACUTE DVT OF RIGHT POPLITEAL VEIN ACUTE RESPIRATORY FAILURE 11/10/2021 ACUTE DVT OF RIGHT POPLITEAL VEIN HYPOXIA 10/15/2021 ACUTE DVT OF RIGHT POPLITEAL VEIN
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Osteopenia, Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM 11/26/2021 OSTEOPENIA ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 11/26/2021 OSTEOPENIA ACUTE DVT OF RIGHT POPLITEAL VEIN 11/26/2021 OSTEOPENIA ACUTE RESPIRATORY FAILURE 11/10/2021 OSTEOPENIA HYPOXIA 10/15/2021 OSTEOPENIA ACUTE PULMONARY EMBOLISM 11/26/2021 METABOLIC ENCEPHALOPATHY ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 11/26/2021 METABOLIC ENCEPHALOPATHY ACUTE DVT OF RIGHT POPLITEAL VEIN 11/26/2021 METABOLIC ENCEPHALOPATHY ACUTE RESPIRATORY FAILURE 11/10/2021 METABOLIC ENCEPHALOPATHY HYPOXIA 10/15/2021 METABOLIC ENCEPHALOPATHY ACUTE PULMONARY EMBOLISM 11/26/2021 ACUTE RESPIRATORY FAILURE ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 11/26/2021 ACUTE RESPIRATORY FAILURE ACUTE DVT OF RIGHT POPLITEAL VEIN 11/26/2021 ACUTE RESPIRATORY FAILURE ACUTE RESPIRATORY FAILURE 11/10/2021 ACUTE RESPIRATORY FAILURE HYPOXIA 10/15/2021 ACUTE RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM 11/26/2021 ACUTE DVT OF RIGHT POPLITEAL VEIN ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 11/26/2021 ACUTE DVT OF RIGHT POPLITEAL VEIN ACUTE DVT OF RIGHT POPLITEAL VEIN 11/26/2021 ACUTE DVT OF RIGHT POPLITEAL VEIN ACUTE RESPIRATORY FAILURE 11/10/2021 ACUTE DVT OF RIGHT POPLITEAL VEIN HYPOXIA 10/15/2021 ACUTE DVT OF RIGHT POPLITEAL VEIN
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Nausea
Clinical narrative: headache and nausea
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthma, COVID-19, Computerised tomogram normal, Condition aggravated, Cough
Clinical narrative: On 3/17/2023, I started to get a cough. By the next morning, I had cough and some fatigue. I did a home PCR test and got a positive result. I became increasingly fatigued. I started to wheeze and have asthma symptoms. I had continuous cough and shortness of breath. I had no fever, and my blood oxygen was never below 98%. On 3/18/2023, I began using PRN albuterol inhaler, a SEREVENT inhaler, and a QVAR inhaler. I continued to use these for the duration of my illness. On 3/19/2023, I pretty much had the same symptoms. On 3/20/2023, I had increasing fatigue and shortness of breath. I had to sleep sitting up on account of my trouble breathing. I called my doctor, who prescribed me PAXLOVID. I began taking PAXLOVID on the morning of 3/21/2023. I had begun to feel even worse that morning, with the cough and shortness of breath. After I began taking the PAXLOVID, I began to improve by the afternoon of 3/22/2023. I had less coughing and shortness of breath, plus I was able to lie flatter. I generally continued to improve. My cough almost resolved by 3/29/2023, and I was able to lie flat, but I was still very fatigued. I still experienced shortness of breath, but only with exertion. I saw the doctor on the early morning of 3/30/2023. I had a normal EKG and exam. I was sent for a chest CT scan, which I underwent that afternoon. The result of the CT scan was also normal. I was given metformin for possible long COVID-19 on 3/30/2023. I took the metformin for ten days, mainly to treat the shortness of breath and profound fatigue. It was effective. I had another two or three weeks of shortness of breath and fatigue, which have resolved at the time of this writing. Once I was able to be active again, which was around 4/19/2023, my proprioception was off. I really had no sense of my position in space. Today is the first day that I have had a marked improvement in my proprioception.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea, Dyspnoea exertional, Electrocardiogram normal, Fatigue, Illness
Clinical narrative: On 3/17/2023, I started to get a cough. By the next morning, I had cough and some fatigue. I did a home PCR test and got a positive result. I became increasingly fatigued. I started to wheeze and have asthma symptoms. I had continuous cough and shortness of breath. I had no fever, and my blood oxygen was never below 98%. On 3/18/2023, I began using PRN albuterol inhaler, a SEREVENT inhaler, and a QVAR inhaler. I continued to use these for the duration of my illness. On 3/19/2023, I pretty much had the same symptoms. On 3/20/2023, I had increasing fatigue and shortness of breath. I had to sleep sitting up on account of my trouble breathing. I called my doctor, who prescribed me PAXLOVID. I began taking PAXLOVID on the morning of 3/21/2023. I had begun to feel even worse that morning, with the cough and shortness of breath. After I began taking the PAXLOVID, I began to improve by the afternoon of 3/22/2023. I had less coughing and shortness of breath, plus I was able to lie flatter. I generally continued to improve. My cough almost resolved by 3/29/2023, and I was able to lie flat, but I was still very fatigued. I still experienced shortness of breath, but only with exertion. I saw the doctor on the early morning of 3/30/2023. I had a normal EKG and exam. I was sent for a chest CT scan, which I underwent that afternoon. The result of the CT scan was also normal. I was given metformin for possible long COVID-19 on 3/30/2023. I took the metformin for ten days, mainly to treat the shortness of breath and profound fatigue. It was effective. I had another two or three weeks of shortness of breath and fatigue, which have resolved at the time of this writing. Once I was able to be active again, which was around 4/19/2023, my proprioception was off. I really had no sense of my position in space. Today is the first day that I have had a marked improvement in my proprioception.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Loss of proprioception, SARS-CoV-2 test positive, Wheezing
Clinical narrative: On 3/17/2023, I started to get a cough. By the next morning, I had cough and some fatigue. I did a home PCR test and got a positive result. I became increasingly fatigued. I started to wheeze and have asthma symptoms. I had continuous cough and shortness of breath. I had no fever, and my blood oxygen was never below 98%. On 3/18/2023, I began using PRN albuterol inhaler, a SEREVENT inhaler, and a QVAR inhaler. I continued to use these for the duration of my illness. On 3/19/2023, I pretty much had the same symptoms. On 3/20/2023, I had increasing fatigue and shortness of breath. I had to sleep sitting up on account of my trouble breathing. I called my doctor, who prescribed me PAXLOVID. I began taking PAXLOVID on the morning of 3/21/2023. I had begun to feel even worse that morning, with the cough and shortness of breath. After I began taking the PAXLOVID, I began to improve by the afternoon of 3/22/2023. I had less coughing and shortness of breath, plus I was able to lie flatter. I generally continued to improve. My cough almost resolved by 3/29/2023, and I was able to lie flat, but I was still very fatigued. I still experienced shortness of breath, but only with exertion. I saw the doctor on the early morning of 3/30/2023. I had a normal EKG and exam. I was sent for a chest CT scan, which I underwent that afternoon. The result of the CT scan was also normal. I was given metformin for possible long COVID-19 on 3/30/2023. I took the metformin for ten days, mainly to treat the shortness of breath and profound fatigue. It was effective. I had another two or three weeks of shortness of breath and fatigue, which have resolved at the time of this writing. Once I was able to be active again, which was around 4/19/2023, my proprioception was off. I really had no sense of my position in space. Today is the first day that I have had a marked improvement in my proprioception.
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: On 04/29/2023, patient received first dose of Pfizer 12 year +, patient should have received Pfizer 5year to 11 year dose.  Incident was discovered on 05/02.2023.  No adverse reactions were reported.
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident
Age: 7.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration error
Clinical narrative: Monovalent COVID-19 vaccine was administered to a patient after monovalent vaccines were no longer authorized by FDA (April 18), this is considered a vaccine administration error. Incorrectly administered monovalent instead of 2nd bivalent booster. Patient experienced no adverse events
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Infection, Malaise, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: 2/01/2023 Sinus and nasal congestion intensified. 2/6 I went to see the doctor, Rapid COVID-19 test. Positive. Doctor proscribed Paxlovid, and to treat symptomatically with Nasacort. Symptoms did not diminish and have provided a round of antibiotics to treat a secondary sinus infection, but symptoms remain to time of reporting.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Sinus congestion, Sinusitis
Clinical narrative: 2/01/2023 Sinus and nasal congestion intensified. 2/6 I went to see the doctor, Rapid COVID-19 test. Positive. Doctor proscribed Paxlovid, and to treat symptomatically with Nasacort. Symptoms did not diminish and have provided a round of antibiotics to treat a secondary sinus infection, but symptoms remain to time of reporting.
Age: 0.58
Sex: F
Vaccine: COVID19, DTAPIPVHIB, FLU4
Symptoms: Unevaluable event
Clinical narrative: Patient received monovalent vaccine on Friday, 4/21/23 after the FDA deauthorized use of monovalent vaccines.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was administered 2 ml's of Pfizer bivalent. The vial was a small vial with multi doses. Patient waited the 15 mins after receiving the vaccine. Medical Assistant was unaware that the vial was a multi dose. Patient was contacted as soon as the issue was acknowledged and Patient was feeling well. No symptoms or concerns were reported by the Patient.
Age: 15.0
Sex: M
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: Wrong vaccination
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Seizure
Clinical narrative: Patient with  a history of a focal seizure disorder on anticonvulsants was given Tdap and Menveo for 11 year well check. Per mom, went home and had a 20 second seizure and has been acting fine since. She notified her neurologist through the Clinic.
Age: 1.58
Sex: M
Vaccine: COVID19, FLU4
Clinical narrative: Patient received monovalent vaccine on Friday, 4/21/23 after the FDA deauthorized use of monovalent vaccines.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acoustic stimulation tests abnormal, Deafness bilateral, Tinnitus
Clinical narrative: In late January 2023 I realized I had the sound of crickets in my ears. I made an appointment with urgent care. I was referred to an ENT. I saw them today. A had a hearing test on April 6, 2023. It showed I had bilateral moderately- severe hearing loss. It also showed I have tinnitus in both ears. I was advised that others get hearing aids to help. I was told it is possible that the tinnitus is occurring to make up for the hearing loss.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Coagulopathy, Lower respiratory tract infection
Clinical narrative: D68.9 COAGULOPATHY, UNSPECIFIED TYPE 2/2/2022 ACUTE LOWER RESPIRATORY INFECTION J96.00 ACUTE RESPIRATORY FAILURE 6/8/2022 ACUTE LOWER RESPIRATORY INFECTION J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/8/2022 ACUTE LOWER RESPIRATORY INFECTION J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 6/8/2022 ACUTE LOWER RESPIRATORY INFECTION
Age: 16.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Atrophy, Gait disturbance, Guillain-Barre syndrome, Hypotonia, Influenza
Clinical narrative: It started off with a bad flu then 4 days later I could not urinate from a swollen prostate. A week after my prostate swelling went down I had trouble walking which later in the day I could not walk on my own.  After 3 MRI's and a spinal tap I was diagnosed with Guillaine Barre Syndrome. This led to my legs never recovering  and had to go through life suffering major atrophy in my legs. Leaving me with  limp legs forever. This has caused many problems in my even 2 back surgeries.
Age: 16.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Lumbar puncture, Magnetic resonance imaging, Procedural complication, Prostatomegaly, Spinal operation
Clinical narrative: It started off with a bad flu then 4 days later I could not urinate from a swollen prostate. A week after my prostate swelling went down I had trouble walking which later in the day I could not walk on my own.  After 3 MRI's and a spinal tap I was diagnosed with Guillaine Barre Syndrome. This led to my legs never recovering  and had to go through life suffering major atrophy in my legs. Leaving me with  limp legs forever. This has caused many problems in my even 2 back surgeries.
Age: 16.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Urinary retention
Clinical narrative: It started off with a bad flu then 4 days later I could not urinate from a swollen prostate. A week after my prostate swelling went down I had trouble walking which later in the day I could not walk on my own.  After 3 MRI's and a spinal tap I was diagnosed with Guillaine Barre Syndrome. This led to my legs never recovering  and had to go through life suffering major atrophy in my legs. Leaving me with  limp legs forever. This has caused many problems in my even 2 back surgeries.
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pathological fracture
Clinical narrative: I82.431 ACUTE DVT OF RIGHT POPLITEAL VEIN 2/25/2021 LEFT HUMERUS PATHOLOGICAL FX, ROUT SUBSEQ
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac disorder, Cardiac flutter, Cardiac monitoring, SARS-CoV-2 test negative
Clinical narrative: My heart issue began  on 02/2023. I fainted in the morning and was taken to the ER. I had AFIV, and heart Flutter. My cardiologist came there and put me on a heart monitor for 30 days.  They gave me Aliquots, Hydralazine, Doxazosin and Metoprolol.   During the 30 days I had another episode of heart issue again i fainted but I had sense this time and they admitted for 1 day at ER. They have the heart issue  controlled with medication but I will be going to the ER back on 03/16/2023  to be corrected with heart abrasion.   I don't think its related but I just let you know.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Spondylitis, Syncope
Clinical narrative: My heart issue began  on 02/2023. I fainted in the morning and was taken to the ER. I had AFIV, and heart Flutter. My cardiologist came there and put me on a heart monitor for 30 days.  They gave me Aliquots, Hydralazine, Doxazosin and Metoprolol.   During the 30 days I had another episode of heart issue again i fainted but I had sense this time and they admitted for 1 day at ER. They have the heart issue  controlled with medication but I will be going to the ER back on 03/16/2023  to be corrected with heart abrasion.   I don't think its related but I just let you know.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Metabolic encephalopathy
Clinical narrative: I95.9 HYPOTENSION 6/24/2022 METABOLIC ENCEPHALOPATHY
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Dysphagia, Fatigue, Foreign travel
Clinical narrative: 12/07/2023, After I had the vaccine, I had a terrible pain in my left arm for the next few days. With all the other Pfizer shots I did not have that reaction or any reaction.  On 01/26/2023, I left on a trip for several days with friend. After a few different flights. After a flight on 02/7/2023, a few days after the flight, I started notice symptoms. I started feeling like I was getting a cold, sore throat, and my nose was running, and I was somewhat fatigued. And then it got worse. 02/11/2023, I decided to do a COVID-19 Home test. The negative line was very strong and there was a very faint positive line. So, I retested on 02/13/2023, the positive line was much stronger. I began to self-isolate. I saw a doctor on a ship and he did another COVID-19 test and the result was positive on 02/13/2023.  The doctor said I should self-isolate, and he gave me some antihistamine pills. The next day, 02/14/2023 I went back to see him again because the sore throat got worse. It was difficult to swallow. And the doctor just gave me sore throat lozenges.  The doctor tested the functionality of my lungs, he said that my lungs were clear. 12/07/2023, After I had the vaccine, I had a terrible pain in my left arm the next few days. With all the other Pfizer shots I did not have that reaction or any reaction.  I seem to have more muscle aches when I get up in the morning or if I have been sitting for a while, when I get up.  I am not sure if it is an effect of the COVID-19 infection. I had a checkup, mid-March, with my doctor and he said that was common after a COVID-19 infection. I am still gradually gaining my strength back to take long walks.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Myalgia, Nasopharyngitis, Oropharyngeal pain, Pain in extremity, Pulmonary function test normal
Clinical narrative: 12/07/2023, After I had the vaccine, I had a terrible pain in my left arm for the next few days. With all the other Pfizer shots I did not have that reaction or any reaction.  On 01/26/2023, I left on a trip for several days with friend. After a few different flights. After a flight on 02/7/2023, a few days after the flight, I started notice symptoms. I started feeling like I was getting a cold, sore throat, and my nose was running, and I was somewhat fatigued. And then it got worse. 02/11/2023, I decided to do a COVID-19 Home test. The negative line was very strong and there was a very faint positive line. So, I retested on 02/13/2023, the positive line was much stronger. I began to self-isolate. I saw a doctor on a ship and he did another COVID-19 test and the result was positive on 02/13/2023.  The doctor said I should self-isolate, and he gave me some antihistamine pills. The next day, 02/14/2023 I went back to see him again because the sore throat got worse. It was difficult to swallow. And the doctor just gave me sore throat lozenges.  The doctor tested the functionality of my lungs, he said that my lungs were clear. 12/07/2023, After I had the vaccine, I had a terrible pain in my left arm the next few days. With all the other Pfizer shots I did not have that reaction or any reaction.  I seem to have more muscle aches when I get up in the morning or if I have been sitting for a while, when I get up.  I am not sure if it is an effect of the COVID-19 infection. I had a checkup, mid-March, with my doctor and he said that was common after a COVID-19 infection. I am still gradually gaining my strength back to take long walks.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rhinorrhoea
Clinical narrative: 12/07/2023, After I had the vaccine, I had a terrible pain in my left arm for the next few days. With all the other Pfizer shots I did not have that reaction or any reaction.  On 01/26/2023, I left on a trip for several days with friend. After a few different flights. After a flight on 02/7/2023, a few days after the flight, I started notice symptoms. I started feeling like I was getting a cold, sore throat, and my nose was running, and I was somewhat fatigued. And then it got worse. 02/11/2023, I decided to do a COVID-19 Home test. The negative line was very strong and there was a very faint positive line. So, I retested on 02/13/2023, the positive line was much stronger. I began to self-isolate. I saw a doctor on a ship and he did another COVID-19 test and the result was positive on 02/13/2023.  The doctor said I should self-isolate, and he gave me some antihistamine pills. The next day, 02/14/2023 I went back to see him again because the sore throat got worse. It was difficult to swallow. And the doctor just gave me sore throat lozenges.  The doctor tested the functionality of my lungs, he said that my lungs were clear. 12/07/2023, After I had the vaccine, I had a terrible pain in my left arm the next few days. With all the other Pfizer shots I did not have that reaction or any reaction.  I seem to have more muscle aches when I get up in the morning or if I have been sitting for a while, when I get up.  I am not sure if it is an effect of the COVID-19 infection. I had a checkup, mid-March, with my doctor and he said that was common after a COVID-19 infection. I am still gradually gaining my strength back to take long walks.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypoxia
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/14/2021 HYPOXIA R09.02 HYPOXIA 9/14/2021 HYPOXIA
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chronic respiratory failure, Coronary artery disease, Respiratory failure
Clinical narrative: J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/1/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/1/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Cellulitis approximately 2 inches below the injection site -- First appearance about the size of a quarter, red, hard, hot and tender to the touch.  Involved area expanded over the next 24 hours. Resolved within 48 hours.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Ascites, Hypotension, Varices oesophageal
Clinical narrative: Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------------  HYPOTENSION 6/2/2021 ASCITES  HYPOTENSION 6/2/2021 ESOPHAGEAL VARICES
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Pain
Clinical narrative: I95.9 HYPOTENSION 2/17/2022 CHRONIC PAIN TREATMENT PLAN
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Vaccine was administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 11-APR-2023, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (lot # W004694, expiration date: 08-AUG-2023) 1 time dose for prophylaxis (strength and route of administration were not reported) after temperature excursion that the vaccine had been stored at -13.7 degrees Celsius for 19 hours (product storage error). There was a previous temperature excursion which was reported as 8.2 degrees Celsius for 21 hours and 51 minutes. No additional adverse events (AEs) or product quality complaints (PQCs) were reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient received the first dose of GARDASIL 9 on 11/10/2021 and did not get the second dose yet.; No additional AEs were reported.; This spontaneous report was received from a pharmacist referring to a 41-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 10-NOV-2021, the patient was vaccinated the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection for prophylaxis (dose, strength, lot #, expiration date and route of administration were not provided) and did not get the second dose yet (inappropriate schedule of product administration) (also reported as "the patient's hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) schedule was interrupted"). No additional adverse events were reported (no adverse event).
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Burning sensation, Dermatitis allergic, Hypersensitivity, Pruritus
Clinical narrative: Maculopapular rash; Somewhat burning; rash over 75 percent of body, allergic rashes; Somewhat itching; allergic reaction, urgent care ER; rash over 75 percent of body, allergic rashes; This serious case was reported by a consumer and described the occurrence of maculopapular rash in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.  Concurrent medical conditions included cholesterol. Concomitant products included atorvastatin calcium.  On 01-APR-2023, the patient received the 1st dose of Shingrix. On 07-APR-2023, 6 days after receiving Shingrix, the patient experienced maculopapular rash (Verbatim: Maculopapular rash) (serious criteria clinically significant/intervention required). In APR-2023, the patient experienced burning sensation (Verbatim: Somewhat burning) (serious criteria clinically significant/intervention required), allergic rash (Verbatim: rash over 75 percent of body, allergic rashes), pruritus (Verbatim: Somewhat itching), allergic reaction (Verbatim: allergic reaction, urgent care ER) and rash (Verbatim: rash over 75 percent of body, allergic rashes). The patient was treated with prednisolone and methylprednisolone. The outcome of the maculopapular rash, burning sensation, allergic rash, pruritus, allergic reaction and rash were not resolved.  It was unknown if the reporter considered the maculopapular rash, burning sensation, allergic rash, pruritus, allergic reaction and rash to be related to Shingrix.  It was unknown if the company considered the maculopapular rash, burning sensation, allergic rash, pruritus, allergic reaction and rash to be related to Shingrix.  Additional Information: GSK receipt date: 25-APR-2023 The patient self-reported this case. The reporter stated that while recognizing there were many causes for allergic rashes, the first Shingrix vaccination seems to require some investigation as a cause. Been to urgent care a dermatologist, no real diagnosis beyond an allergic reaction. Methylprednisone injection was given, rash over 75 percent of the patient's body. Somewhat itching. Somewhat burning. The symptoms were still there after almost 3 weeks. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Maculopapular rash; Somewhat burning; rash over 75 percent of body, allergic rashes; Somewhat itching; allergic reaction, urgent care ER; rash over 75 percent of body, allergic rashes; This serious case was reported by a consumer and described the occurrence of maculopapular rash in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.  Concurrent medical conditions included cholesterol. Concomitant products included atorvastatin calcium.  On 01-APR-2023, the patient received the 1st dose of Shingrix. On 07-APR-2023, 6 days after receiving Shingrix, the patient experienced maculopapular rash (Verbatim: Maculopapular rash) (serious criteria clinically significant/intervention required). In APR-2023, the patient experienced burning sensation (Verbatim: Somewhat burning) (serious criteria clinically significant/intervention required), allergic rash (Verbatim: rash over 75 percent of body, allergic rashes), pruritus (Verbatim: Somewhat itching), allergic reaction (Verbatim: allergic reaction, urgent care ER) and rash (Verbatim: rash over 75 percent of body, allergic rashes). The patient was treated with prednisolone and methylprednisolone. The outcome of the maculopapular rash, burning sensation, allergic rash, pruritus, allergic reaction and rash were not resolved.  It was unknown if the reporter considered the maculopapular rash, burning sensation, allergic rash, pruritus, allergic reaction and rash to be related to Shingrix.  It was unknown if the company considered the maculopapular rash, burning sensation, allergic rash, pruritus, allergic reaction and rash to be related to Shingrix.  Additional Information: GSK receipt date: 25-APR-2023 The patient self-reported this case. The reporter stated that while recognizing there were many causes for allergic rashes, the first Shingrix vaccination seems to require some investigation as a cause. Been to urgent care a dermatologist, no real diagnosis beyond an allergic reaction. Methylprednisone injection was given, rash over 75 percent of the patient's body. Somewhat itching. Somewhat burning. The symptoms were still there after almost 3 weeks. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Burning sensation, Rash, Rash pruritic
Clinical narrative: Maculopapular rash; Somewhat burning; rash over 75 percent of body, allergic rashes; Somewhat itching; allergic reaction, urgent care ER; rash over 75 percent of body, allergic rashes; This serious case was reported by a consumer and described the occurrence of maculopapular rash in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.  Concurrent medical conditions included cholesterol. Concomitant products included atorvastatin calcium.  On 01-APR-2023, the patient received the 1st dose of Shingrix. On 07-APR-2023, 6 days after receiving Shingrix, the patient experienced maculopapular rash (Verbatim: Maculopapular rash) (serious criteria clinically significant/intervention required). In APR-2023, the patient experienced burning sensation (Verbatim: Somewhat burning) (serious criteria clinically significant/intervention required), allergic rash (Verbatim: rash over 75 percent of body, allergic rashes), pruritus (Verbatim: Somewhat itching), allergic reaction (Verbatim: allergic reaction, urgent care ER) and rash (Verbatim: rash over 75 percent of body, allergic rashes). The patient was treated with prednisolone and methylprednisolone. The outcome of the maculopapular rash, burning sensation, allergic rash, pruritus, allergic reaction and rash were not resolved.  It was unknown if the reporter considered the maculopapular rash, burning sensation, allergic rash, pruritus, allergic reaction and rash to be related to Shingrix.  It was unknown if the company considered the maculopapular rash, burning sensation, allergic rash, pruritus, allergic reaction and rash to be related to Shingrix.  Additional Information: GSK receipt date: 25-APR-2023 The patient self-reported this case. The reporter stated that while recognizing there were many causes for allergic rashes, the first Shingrix vaccination seems to require some investigation as a cause. Been to urgent care a dermatologist, no real diagnosis beyond an allergic reaction. Methylprednisone injection was given, rash over 75 percent of the patient's body. Somewhat itching. Somewhat burning. The symptoms were still there after almost 3 weeks. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got shingles but take shot/suspected vaccination failure; got shingles; hurt; 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: got shingles but take shot/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got shingles) and pain (Verbatim: hurt). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 24-Mar-2023 The case was received from the patient via interactive digital media. The patient stated that what he or she got shingles but he or she did took the shot and so hurt. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had the shot and still got them/suspected vaccination failure; got them; painful; 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.   The patient's past medical history included normal birth (had two babies natural childbirth).   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: had the shot and still got them/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got them) and pain (Verbatim: painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 24-Mar-2023 The case was received from the patient via interactive digital media. The patient had the shot and still got them. The patient this was more painful. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shot didn't work, got them now/suspected vaccination failure; got them now; 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. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: shot didn't work, got them now/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got them now). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 24-Mar-2023 The case was received from the patient's friend via interactive digital media. The reporter stated that the shot did not work for the patient and he/she got them now (at the time of reporting). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR059663, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR059663:Same reporter