chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chronic respiratory failure, Respiratory failure
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 5/7/2022 CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.10 CHRONIC RESPIRATORY FAILURE 9/10/2022 CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 5/16/2022 CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 9/15/2022 CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/6/2022 CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 1.25
Sex: F
Vaccine: COVID19, VARCEL
Symptoms: Underdose
Clinical narrative: Received yellow cap 0.2mL/10ug instead of 0.25ml/25 ug dose-Lower than authorized dose
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: The patient experienced sever vomiting and diarrhea following administration of the vaccine.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: N/A- Vaccine administration error only- patient given Pfizer Bivalent Booster after the BUD.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood chloride normal, Blood magnesium normal, Bundle branch block left, Dyspnoea, Electrocardiogram abnormal
Clinical narrative: At about 3 AM on 5/17/2023, I woke up short of breath. I could feel that I had a very fast pulse. I got up and got my pulse oximeter. My pulse at the time was 105, and my blood oxygen level was 95. I was nervous at the time. The pulse stayed at around 100 (give or take) for about an hour. Over the next fifteen minutes, the pulse dropped into the high 80s. During the entire time, my blood oxygen stayed between 93 and 96. After my pulse dropped to the high 80s, I went back to bed. When I woke up, I was okay. At around 2:30 PM, I saw my NP and spoke to him about my situation. He examined my blood pressure, pulse, and oxygen saturation and conducted a complete ECG. He ordered bloodwork. The basic metabolic panel indicated that everything was within range, except chloride, which was 106. My magnesium level was normal. The ECG indicated normal sinus rhythm. A left anterior fascicular block was indicated by the ECG. The doctor instructed me to call back if I have a repetition of the event. He also told me that if I had chest pain or difficulty breathing, I should go to the ER.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Heart rate decreased, Heart rate increased, Metabolic function test, Nervousness
Clinical narrative: At about 3 AM on 5/17/2023, I woke up short of breath. I could feel that I had a very fast pulse. I got up and got my pulse oximeter. My pulse at the time was 105, and my blood oxygen level was 95. I was nervous at the time. The pulse stayed at around 100 (give or take) for about an hour. Over the next fifteen minutes, the pulse dropped into the high 80s. During the entire time, my blood oxygen stayed between 93 and 96. After my pulse dropped to the high 80s, I went back to bed. When I woke up, I was okay. At around 2:30 PM, I saw my NP and spoke to him about my situation. He examined my blood pressure, pulse, and oxygen saturation and conducted a complete ECG. He ordered bloodwork. The basic metabolic panel indicated that everything was within range, except chloride, which was 106. My magnesium level was normal. The ECG indicated normal sinus rhythm. A left anterior fascicular block was indicated by the ECG. The doctor instructed me to call back if I have a repetition of the event. He also told me that if I had chest pain or difficulty breathing, I should go to the ER.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Received yellow cap 0.2mL/10ug instead of 0.25ml/25 ug dose-Lower than authorized dose
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site pain, Insomnia, Joint stiffness
Clinical narrative: Painful arm at injection site.  Continued to pain in gland in left armpit - to become throbing pain overnight and through the next day. Difficulty lifting arm or extneding to pick up items.   Fever, shivers and general muscle pain starting 11:00 pm.  Joint pain in hands, general pain in various areas in muscles.  Skin tenderness on head (slightly painful to the touch).  Unable to sleep until after 7 am following day from injection.  Day 2 still have swollen painful gland in left armpit, other glands slighty swollen but no pain.  Joint stiffnes and slight pain in hands, fever and chills continues but as a lesser severity (severity dropped at about 6:00 am}.  Some 'pings' of pain in forearm and other spots not consistent to spot or type.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymph node pain, Lymphadenopathy, Mobility decreased, Muscular weakness, Myalgia
Clinical narrative: Painful arm at injection site.  Continued to pain in gland in left armpit - to become throbing pain overnight and through the next day. Difficulty lifting arm or extneding to pick up items.   Fever, shivers and general muscle pain starting 11:00 pm.  Joint pain in hands, general pain in various areas in muscles.  Skin tenderness on head (slightly painful to the touch).  Unable to sleep until after 7 am following day from injection.  Day 2 still have swollen painful gland in left armpit, other glands slighty swollen but no pain.  Joint stiffnes and slight pain in hands, fever and chills continues but as a lesser severity (severity dropped at about 6:00 am}.  Some 'pings' of pain in forearm and other spots not consistent to spot or type.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pain of skin, Pyrexia
Clinical narrative: Painful arm at injection site.  Continued to pain in gland in left armpit - to become throbing pain overnight and through the next day. Difficulty lifting arm or extneding to pick up items.   Fever, shivers and general muscle pain starting 11:00 pm.  Joint pain in hands, general pain in various areas in muscles.  Skin tenderness on head (slightly painful to the touch).  Unable to sleep until after 7 am following day from injection.  Day 2 still have swollen painful gland in left armpit, other glands slighty swollen but no pain.  Joint stiffnes and slight pain in hands, fever and chills continues but as a lesser severity (severity dropped at about 6:00 am}.  Some 'pings' of pain in forearm and other spots not consistent to spot or type.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling below injection site of Kinrix Vaccine. roughly 1.5 inch in diameter.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Computerised tomogram, Dysphagia, Lymphadenopathy, Magnetic resonance imaging
Clinical narrative: Swollen lymph nodes in neck, difficulty swallowing, shooting pains and discomfort in neck, sometimes discomfort in upper chest and can feel connection into neck
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Pain, Ultrasound scan
Clinical narrative: Swollen lymph nodes in neck, difficulty swallowing, shooting pains and discomfort in neck, sometimes discomfort in upper chest and can feel connection into neck
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Hypoxia, Pneumonia influenzal
Clinical narrative: R09.02 HYPOXIA 12/14/2022 INFLUENZA PNEUMONIA R09.02 HYPOXIA 12/14/2022 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE)
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Condition aggravated, Fatigue, Hypertension, Malaise
Clinical narrative: I did have an adverse reaction to the vaccine. I began not feeling well on 04/09/2023 with a fever and fatigue. I tested positive for COVID-19 on 04/12/2023. I contacted my doctor, and we decided not to take Paxlovid. I was given two other prescriptions. I tolerated the medications without any complications. As of today, I still have congestion, high blood pressure and heart palpitations.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Palpitations, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I did have an adverse reaction to the vaccine. I began not feeling well on 04/09/2023 with a fever and fatigue. I tested positive for COVID-19 on 04/12/2023. I contacted my doctor, and we decided not to take Paxlovid. I was given two other prescriptions. I tolerated the medications without any complications. As of today, I still have congestion, high blood pressure and heart palpitations.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: N/A- Vaccine administration error only- patient given Pfizer Bivalent Booster after the BUD.
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: The Health Department reported our refrigerator had a excursion and the vaccine was nonviable.
Age: 0.5
Sex: M
Vaccine: COVID19, DTAPHEPBIP, PNC15, RV1
Symptoms: Underdose
Clinical narrative: Received yellow cap 0.2mL/10ug instead of 0.25ml/25 ug dose-Lower than authorized dose
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Atrial fibrillation, Coronary artery disease, Hypotension
Clinical narrative: I95.9 HYPOTENSION 2/4/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA I95.9 HYPOTENSION 2/4/2022 WEAKNESS I95.9 HYPOTENSION 2/4/2022 ATRIAL FIBRILLATION, PAROXYSMAL
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered on 5/3/23.  Vaccine viability ended on 5/1/23.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial ischaemia, Obstructive sleep apnoea syndrome, Syncope
Clinical narrative: G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 11/18/2022 SYNCOPE I24.8 DEMAND ISCHEMIA 10/16/2022 SYNCOPE G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 11/18/2022 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE I24.8 DEMAND ISCHEMIA 10/16/2022 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: N/A- Vaccine administration error only- patient given Pfizer Bivalent Booster after the BUD.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Cardiomegaly, Respiratory failure
Clinical narrative: J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 11/20/2022 CARDIOMEGALY J96.92 HYPERCAPNIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 11/19/2022 CARDIOMEGALY
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Coagulation test normal, Platelet count decreased, Purpura, Thrombocytopenia
Clinical narrative: Purpura and thrombocytopenia (platelet count of 24,000).  All other cell lines normal.  Coagulation studies normal.  Platelet count recovered with a pulse of oral steroids.  Patient didn't suffer any other complications as a result of the thrombocytopenia.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: I tested positive for COVID-19 on April 10, 2023, My symptoms were severe sore throat, tiredness, I was taking Tylenol and Paxlovid for my symptoms.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthritis, Nodule
Clinical narrative: Arthritis first appeared as nodules on my hands. Then I noticed them on my forearms, and I got one on my foot. PCP suggested this might be rheumatoid arthritis and referred me to a Rheumatologist that I can't get into see until September. Every day I discover a new knot.
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: N/A- Vaccine administration error only- patient given Pfizer Bivalent Booster after the BUD.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen upper arm at injection site.  Patient stated the swollen area is the size of a softball.  She said that she is also experiencing headache, chills, body aches and feeling exhausted ever since receiving the shingles vaccine.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Red, swollen upper arm at injection site.  Patient stated the swollen area is the size of a softball.  She said that she is also experiencing headache, chills, body aches and feeling exhausted ever since receiving the shingles vaccine.
Age: 3.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Adverse reaction, No adverse event, Product administration error, Underdose
Clinical narrative: NOT AN ADVERSE EVENT.  Reporting procedural error only.   Unvaccinated 3YO child presented for first COVID-19 dose at  field clinic.  Child erroneously received 0.25mL from Moderna Bivalent vial for 6months-5years (Moderna Pink Vial).  Error was discovered immediately after injection.  This injection equalled an under-dose yielding only 12.5micrograms.  To remedy on the same day, another 0.25mL was administered from another Moderna Bivalent vial for 6months-5years (Moderna Pink Vial).  Child was observed for 15minutes after both injections and was released with no adverse reactions.  At telephone follow-up 1 week later, guardian stated that child only experienced the mild, expected side effects.  This type of error may be predisposed from current structure of vaccination schedule for children under 6years receiving Moderna Bivalent.  Reporting for surveillance and QI purposes.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: N/A- Vaccine administration error only- patient given Pfizer Bivalent Booster after the BUD.
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: N/A- Vaccine administration error only- patient given Pfizer Bivalent Booster after the BUD.
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: COVID vaccine administered was no longer viable.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chronic respiratory failure, Hypertensive urgency, Hypoxia, Oesophageal achalasia
Clinical narrative: ACUTE RESPIRATORY FAILURE 11/7/2022 HYPERTENSIVE URGENCY  ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/12/2022 HYPERTENSIVE URGENCY  ACUTE HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 HYPERTENSIVE URGENCY  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/26/2022 HYPERTENSIVE URGENCY  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 HYPERTENSIVE URGENCY  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/26/2022 HYPERTENSIVE URGENCY  ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 HYPERTENSIVE URGENCY  HYPOXIA 12/26/2022 HYPERTENSIVE URGENCY  ACUTE RESPIRATORY FAILURE 11/7/2022 ACHALASIA  ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/12/2022 ACHALASIA  ACUTE HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 ACHALASIA  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/26/2022 ACHALASIA  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 ACHALASIA  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/26/2022 ACHALASIA  ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 ACHALASIA  HYPOXIA 12/26/2022 ACHALASIA  ACUTE RESPIRATORY FAILURE 11/7/2022 ACUTE HYPERCAPNIC RESPIRATORY FAILURE  ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/12/2022 ACUTE HYPERCAPNIC RESPIRATORY FAILURE  ACUTE HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 ACUTE HYPERCAPNIC RESPIRATORY FAILURE  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/26/2022 ACUTE HYPERCAPNIC RESPIRATORY FAILURE  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 ACUTE HYPERCAPNIC RESPIRATORY FAILURE  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/26/2022 ACUTE HYPERCAPNIC RESPIRATORY FAILURE  ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 ACUTE HYPERCAPNIC RESPIRATORY FAILURE  HYPOXIA 12/26/2022 ACUTE HYPERCAPNIC RESPIRATORY FAILURE  ACUTE RESPIRATORY FAILURE 11/7/2022 ACUTE RESPIRATORY FAILURE  ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/12/2022 ACUTE RESPIRATORY FAILURE  ACUTE HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 ACUTE RESPIRATORY FAILURE  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/26/2022 ACUTE RESPIRATORY FAILURE  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 ACUTE RESPIRATORY FAILURE  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/26/2022 ACUTE RESPIRATORY FAILURE  ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 ACUTE RESPIRATORY FAILURE  HYPOXIA 12/26/2022 ACUTE RESPIRATORY FAILURE  ACUTE RESPIRATORY FAILURE 11/7/2022 PULMONARY EDEMA  ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/12/2022 PULMONARY EDEMA  ACUTE HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 PULMONARY EDEMA  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/26/2022 PULMONARY EDEMA  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 PULMONARY EDEMA  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/26/2022 PULMONARY EDEMA  ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 PULMONARY EDEMA  HYPOXIA 12/26/2022 PULMONARY EDEMA
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary oedema, Respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE 11/7/2022 HYPERTENSIVE URGENCY  ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/12/2022 HYPERTENSIVE URGENCY  ACUTE HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 HYPERTENSIVE URGENCY  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/26/2022 HYPERTENSIVE URGENCY  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 HYPERTENSIVE URGENCY  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/26/2022 HYPERTENSIVE URGENCY  ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 HYPERTENSIVE URGENCY  HYPOXIA 12/26/2022 HYPERTENSIVE URGENCY  ACUTE RESPIRATORY FAILURE 11/7/2022 ACHALASIA  ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/12/2022 ACHALASIA  ACUTE HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 ACHALASIA  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/26/2022 ACHALASIA  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 ACHALASIA  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/26/2022 ACHALASIA  ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 ACHALASIA  HYPOXIA 12/26/2022 ACHALASIA  ACUTE RESPIRATORY FAILURE 11/7/2022 ACUTE HYPERCAPNIC RESPIRATORY FAILURE  ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/12/2022 ACUTE HYPERCAPNIC RESPIRATORY FAILURE  ACUTE HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 ACUTE HYPERCAPNIC RESPIRATORY FAILURE  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/26/2022 ACUTE HYPERCAPNIC RESPIRATORY FAILURE  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 ACUTE HYPERCAPNIC RESPIRATORY FAILURE  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/26/2022 ACUTE HYPERCAPNIC RESPIRATORY FAILURE  ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 ACUTE HYPERCAPNIC RESPIRATORY FAILURE  HYPOXIA 12/26/2022 ACUTE HYPERCAPNIC RESPIRATORY FAILURE  ACUTE RESPIRATORY FAILURE 11/7/2022 ACUTE RESPIRATORY FAILURE  ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/12/2022 ACUTE RESPIRATORY FAILURE  ACUTE HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 ACUTE RESPIRATORY FAILURE  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/26/2022 ACUTE RESPIRATORY FAILURE  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 ACUTE RESPIRATORY FAILURE  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/26/2022 ACUTE RESPIRATORY FAILURE  ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 ACUTE RESPIRATORY FAILURE  HYPOXIA 12/26/2022 ACUTE RESPIRATORY FAILURE  ACUTE RESPIRATORY FAILURE 11/7/2022 PULMONARY EDEMA  ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/12/2022 PULMONARY EDEMA  ACUTE HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 PULMONARY EDEMA  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/26/2022 PULMONARY EDEMA  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 PULMONARY EDEMA  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/26/2022 PULMONARY EDEMA  ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/26/2022 PULMONARY EDEMA  HYPOXIA 12/26/2022 PULMONARY EDEMA
Age: 65.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Provider ordered PPSV23 during patient's visit, but HPV was administered.  Provider immediately assessed patient.  Patient did not report any discomfort or concern. Provider cleared patient and addressed all questions
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: Poor quality product administered
Clinical narrative: COVID vaccine was no longer viable at time of administration
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cyanosis, Pallor, Syncope
Clinical narrative: My daughter got the vaccines, we left and went to the store, 20 min later my daughter fainted. Turn completely pale and her lips starting turning blue. She was in and out for about 2 mins. I took her back to see the dr and he was surprise that the nurse that gave the vaccine didn?t have us wait since it was her first time getting the meningitis vaccines.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cortisol, Chills, Decreased appetite, Dyspnoea, Dyspnoea exertional
Clinical narrative: After getting my COVID-19 shot I was having fever symptoms and chills and then would be burning up. I was nauseated and had no appetite. About a week later I was feeling like I could not catch my breath no matter what I did and then I was having horrible headaches as well. Nothing would take that headache away either. I was not able to really do anything. I was supposed to be hosting family gatherings and I was just exhausted, I took a COVID-19 but they were never positive. I did have some low-grade temperatures and I was just unwell. I then started being unable to take a deep breath and it was like I could not fill my lungs up with air. I was also getting out of breath with anything that I did. I saw my PCP and an ENT and this led to nothing helpful. I then went back to my PCP and I was put on an inhaler and that seemed to help I saw a huge difference with my symptoms and started feeling a little better. I am still not back to normal but the inhaler seems to help.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Headache, Laboratory test, Malaise
Clinical narrative: After getting my COVID-19 shot I was having fever symptoms and chills and then would be burning up. I was nauseated and had no appetite. About a week later I was feeling like I could not catch my breath no matter what I did and then I was having horrible headaches as well. Nothing would take that headache away either. I was not able to really do anything. I was supposed to be hosting family gatherings and I was just exhausted, I took a COVID-19 but they were never positive. I did have some low-grade temperatures and I was just unwell. I then started being unable to take a deep breath and it was like I could not fill my lungs up with air. I was also getting out of breath with anything that I did. I saw my PCP and an ENT and this led to nothing helpful. I then went back to my PCP and I was put on an inhaler and that seemed to help I saw a huge difference with my symptoms and started feeling a little better. I am still not back to normal but the inhaler seems to help.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: After getting my COVID-19 shot I was having fever symptoms and chills and then would be burning up. I was nauseated and had no appetite. About a week later I was feeling like I could not catch my breath no matter what I did and then I was having horrible headaches as well. Nothing would take that headache away either. I was not able to really do anything. I was supposed to be hosting family gatherings and I was just exhausted, I took a COVID-19 but they were never positive. I did have some low-grade temperatures and I was just unwell. I then started being unable to take a deep breath and it was like I could not fill my lungs up with air. I was also getting out of breath with anything that I did. I saw my PCP and an ENT and this led to nothing helpful. I then went back to my PCP and I was put on an inhaler and that seemed to help I saw a huge difference with my symptoms and started feeling a little better. I am still not back to normal but the inhaler seems to help.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Atrial flutter, Cardiac ablation, Cardiac pacemaker insertion, Cardioversion
Clinical narrative: In 2013, I underwent a successful heart ablation to treat atrial fibrillation and atrial flutter. On 12/26/2022, I checked my heartrate, which was at about 152 BPM, so my wife took me to the ER. I was admitted to the hospital, and I stayed overnight. I was taken off of hydrochlorothiazide, and my diltiazem dosage was increased. I was observed, and when I left the hospital, I still had atrial fibrillation and atrial flutter. I underwent a cardioversion on 1/18/2023. I underwent another heart ablation as an outpatient on 3/19/2023. After I was sent home, my heartrate dropped from 50 BPM to 36 BPM overnight, and I ended up going to another hospital on 3/20/2023. At the hospital, I was monitored overnight. On 3/21/2023, my doctor installed a pacemaker. On 3/22/2023, I was sent home. Since I got the pacemaker, things have been much better. I saw a NP on 5/4/2023. He indicated that I still had occasional atrial flutter and atrial fibrillation, but they are much more controlled now. He also said that it could take up to three months before they are resolved.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Condition aggravated, Heart rate decreased, Therapy change
Clinical narrative: In 2013, I underwent a successful heart ablation to treat atrial fibrillation and atrial flutter. On 12/26/2022, I checked my heartrate, which was at about 152 BPM, so my wife took me to the ER. I was admitted to the hospital, and I stayed overnight. I was taken off of hydrochlorothiazide, and my diltiazem dosage was increased. I was observed, and when I left the hospital, I still had atrial fibrillation and atrial flutter. I underwent a cardioversion on 1/18/2023. I underwent another heart ablation as an outpatient on 3/19/2023. After I was sent home, my heartrate dropped from 50 BPM to 36 BPM overnight, and I ended up going to another hospital on 3/20/2023. At the hospital, I was monitored overnight. On 3/21/2023, my doctor installed a pacemaker. On 3/22/2023, I was sent home. Since I got the pacemaker, things have been much better. I saw a NP on 5/4/2023. He indicated that I still had occasional atrial flutter and atrial fibrillation, but they are much more controlled now. He also said that it could take up to three months before they are resolved.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Tinnitus
Clinical narrative: Woke up several days after the vaccination with severe tinnitus in both ears. Reported the tinnitus to my GP and was told simply to use a decongestant as there was nothing she could do. The tinnitus has never stopped since that day. Sometimes it is severe enough to interfere with conversation.  The tinnitus appears to be worse in my left ear. Since it has never receded since the onset, which is now many months, I can only assume this is now permanent.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Health Department informed up we had an excursion with our refrigerator and that our vaccine was nonviable at the time.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cyanosis, Malaise
Clinical narrative: Pt had 2 x episodes of feeling unwell associated with cyanosis of the lips. Self resolved after 5 minutes or less. Has no known risk factors for cyanosis such as methemaglobinemia
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Health Department let us know that their was a excursion with our refrigerator and the vaccine was nonviable
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Back pain, Dizziness, Pain
Clinical narrative: After leaving here on Monday - went ot work but had low back pain-burnng. thought it might be the shot. Pain makes him dizzy. Pain is on both sides all the way up and down his back. For previous injury, patient reports previous injury to lumbar region "years ago".  For prior imaging, patient reports ct scan. For location, patient reports thoracic and lumbar. For alleviating factors, patient reports rest and relieved by changing position. For associated symptoms, patient reports no fever, no tingling, no chills, and no bowel/bladder symptoms.
Age: 48.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered
Clinical narrative: One of two vials given (rather than two vials mixed and then given)
Age: 6.0
Sex: M
Vaccine: DTAPIPV, FLU4, HEP, HEPA, MMRV
Symptoms: Fluid intake reduced, Glossodynia, Hypophagia, Oral disorder, Oropharyngeal pain
Clinical narrative: onset of symptoms 5/16/2023 sore throat and tongue with white patch covering tongue and small lesions on tongue. Unable to eat solid food due to pain on affected area and difficulty drinking liquids due to soreness of throat and tongue. Temp 99 Fahrenheit source oral on 5/28/23
Age: 6.0
Sex: M
Vaccine: DTAPIPV, FLU4, HEP, HEPA, MMRV
Symptoms: Pain, Tongue coated
Clinical narrative: onset of symptoms 5/16/2023 sore throat and tongue with white patch covering tongue and small lesions on tongue. Unable to eat solid food due to pain on affected area and difficulty drinking liquids due to soreness of throat and tongue. Temp 99 Fahrenheit source oral on 5/28/23
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Pain in extremity, Pyrexia
Clinical narrative: NO MAJOR ADVERSE EVENT REPORTED BY PATIENT. In this case, Comirnaty (mono-valent) covid vaccine was administered instead of Bi-valent vaccine that was due.She was due for a booster and a previous moderna Bi-Valent dose on 12/17/22. Patient reported a sore arm for a day or two and feeling slightly feverish the next day. I contacted the patient regarding  the immunization and we will schedule a Bi-Valent covid vaccine in the future per timing protocol.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Eye pruritus, Nasal congestion, Pain
Clinical narrative: At about 6 AM on 5/5/2023, I had minor nasal stuffiness, itchy eyes, chills, and minor aches. I felt like I was developing a cold. I took a home antigen test and got a positive result. I called my doctor's office and had virtual visit with a PA that afternoon, and I was prescribed Paxlovid. She also advised me that I could take OTC medicines if I needed to, but I needed to cease taking the atorvastatin while I was on Paxlovid. I began taking Paxlovid that night and took it for the entire five-day course. I began to feel better after 24 hours. The aches and chills were gone, and the stuffiness and itchy eyes were less severe. At one point, I had been sneezing a lot, also, but that went away after I took the Paxlovid. The only issues I had at this point were the mild stuffiness, itchy eyes, minor fatigue, and the aftertaste caused by the medication. At the end of the five days, I tested positive again, though the line was very faint. I tested again on 5/12/2023 and 5/14/2023 and got a negative result. On the night of 5/15/2023, I began to get stuffiness and itchy eyes again. On 5/16/2023, I tested positive again, though the line was very faint. I had a virtual visit with my doctor later that day. We decided that I should not take Paxlovid again, unless my symptoms worsened in the following 48 hours. Since then, my symptoms have gotten better. At the present time, I feel pretty good. I have very little stuffiness and no itchy eyes or fatigue.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Sneezing
Clinical narrative: At about 6 AM on 5/5/2023, I had minor nasal stuffiness, itchy eyes, chills, and minor aches. I felt like I was developing a cold. I took a home antigen test and got a positive result. I called my doctor's office and had virtual visit with a PA that afternoon, and I was prescribed Paxlovid. She also advised me that I could take OTC medicines if I needed to, but I needed to cease taking the atorvastatin while I was on Paxlovid. I began taking Paxlovid that night and took it for the entire five-day course. I began to feel better after 24 hours. The aches and chills were gone, and the stuffiness and itchy eyes were less severe. At one point, I had been sneezing a lot, also, but that went away after I took the Paxlovid. The only issues I had at this point were the mild stuffiness, itchy eyes, minor fatigue, and the aftertaste caused by the medication. At the end of the five days, I tested positive again, though the line was very faint. I tested again on 5/12/2023 and 5/14/2023 and got a negative result. On the night of 5/15/2023, I began to get stuffiness and itchy eyes again. On 5/16/2023, I tested positive again, though the line was very faint. I had a virtual visit with my doctor later that day. We decided that I should not take Paxlovid again, unless my symptoms worsened in the following 48 hours. Since then, my symptoms have gotten better. At the present time, I feel pretty good. I have very little stuffiness and no itchy eyes or fatigue.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Irritable bowel syndrome
Clinical narrative: Stomach upset, diarrhea, irritable bowels, loose stool
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Varivax was given less than 28 days from patient's last MMR vaccine, which was administered on 5/11/2023.  Patient did not report any adverse effects.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Hypotension, Syncope
Clinical narrative: Pt experienced a syncopal episode 10 minutes after vaccine administration. Pt reported dizziness and lightheadedness before syncope and was alert again after 10 seconds w/ low blood pressure. Pt evaluated by MD and felt better after legs being elevated and being given juice and crackers. Pt BP improved and pt was discharged home w/ follow up visit w/ PCP scheduled for later date.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ear discomfort, Ear swelling, Erythema
Clinical narrative: Left ear cartilage red, swollen, burning, back and front of external ear
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Diarrhoea, Fatigue, Muscle spasms, Nausea
Clinical narrative: Arm swelling, pain along veins, violent cramps, nausea, liquid diarrhea, exhaustion, confusion
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vascular pain
Clinical narrative: Arm swelling, pain along veins, violent cramps, nausea, liquid diarrhea, exhaustion, confusion
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cardiac dysfunction, Chest pain, Dyspnoea, Echocardiogram abnormal, Fatigue
Clinical narrative: I noticed a week after I received the shot that I was short of breath and fatigued. It got increasingly worse and I developed chest pain and hypertension. Eventually I had an echocardiogram which showed reduced cardiac function of 40%. I was told the most likely explanation was myocarditis from the vaccine. My last echo was 54%, I am taking metoprolol for the hypertension which has improved and my symptoms are also much better though still present.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypertension, Myocarditis
Clinical narrative: I noticed a week after I received the shot that I was short of breath and fatigued. It got increasingly worse and I developed chest pain and hypertension. Eventually I had an echocardiogram which showed reduced cardiac function of 40%. I was told the most likely explanation was myocarditis from the vaccine. My last echo was 54%, I am taking metoprolol for the hypertension which has improved and my symptoms are also much better though still present.
Age: 68.0
Sex: F
Vaccine: HEPAB, PNC20
Symptoms: Hypoaesthesia, Orthosis user
Clinical narrative: Patient received both IMZ in the same arm. After administration of Twinrx that patient stated her arm felt numb from her finger tips through her shoulder. I offered her an ice pack which she accepted. Monitored her for 20 minutes (policy is 30 minutes but patient did not want to stay because she was feeling better/loosened her wrist brace which happened to also be on the left arm). I called her to follow up 4-6 hours later (7:30pm) to see how she was doing. She said she was doing much better and thanked me for calling.
Age: 31.0
Sex: F
Vaccine: HPV9
Symptoms: Bell's palsy, Cheilitis, Eye pain, Headache, Lip swelling
Clinical narrative: Left eye pain, left jaw pain, swollen lip and rash on lip and cheek, headaches, nausea. Given a Bell's Palsy diagnosis so far.
Age: 31.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Pain in jaw, Rash
Clinical narrative: Left eye pain, left jaw pain, swollen lip and rash on lip and cheek, headaches, nausea. Given a Bell's Palsy diagnosis so far.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Bell's palsy, Facial paralysis, Lacrimation increased
Clinical narrative: Drooping of face on right side to include jaw line and right eye, running watery right eye - Diagnosis: Bell's Palsy
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Blister, Blood test normal, Injection site discolouration, Pain, Pyrexia
Clinical narrative: Shot given 5/4 - Fever immediately during night/next day which continued prolonged high Temp of 102/103 for several days, Injection site discoloration kept spreading out, very hot to touch and pain worsened, Discoloration dark purple and a ring formed which turned into Blisters like a 3rd Degree burn. Resulted in needing to take to the ER within 48hrs of shot. Site still not healed up.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Skin warm, Ultrasound scan normal, Urine analysis normal
Clinical narrative: Shot given 5/4 - Fever immediately during night/next day which continued prolonged high Temp of 102/103 for several days, Injection site discoloration kept spreading out, very hot to touch and pain worsened, Discoloration dark purple and a ring formed which turned into Blisters like a 3rd Degree burn. Resulted in needing to take to the ER within 48hrs of shot. Site still not healed up.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Improperly stored vaccine was administered to patient; This spontaneous report was received from a medical assistant referring to a 4 years old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On 27-DEC-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) in the right thigh for prophylaxis (lot # W019628, expiration date: 19-DEC-2023; strength, dose and route of administration were not reported) (product storage error). According to digital data logger, the vaccine had a temperature excursion on 10-DEC-2022 (also reported as 05-DEC-2022) that it was stored under -14 to -10 degrees Celsius for 1 hour. The vaccine was stored in the clinical practice, it was unknown if there was previous temperature excursion. No additional adverse event was reported.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; Administered PROQUAD with a temperature excursion; PROQUAD administered intramuscularly; This spontaneous report was received a health professional referring to a 4-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 09-FEB-2023, the patient was vaccinated with a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection that suffered a temperature excursion; lot #W019627, expiration date on 19-DEC-2023, administered intramuscularly in the right thigh, for prophylaxis (product storage error, incorrect route of product administration).  The temperature excursion occurred on 20-JAN-2023 through a reading of a digital data logger, which lasted one hour at a temperature range between -14°C and -10°C. No additional adverse event was reported.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: temperature excursion; This spontaneous report was received from a other health professional referring to a 4 year old male patient. Information regarding the patient medical history, concurrent conditions, drug allergies or reactions were not provided.       On 01-FEB-2023, the patient was vaccinated with a improper stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # W019627, intramuscular in the right thigh for prophylaxis (product storage error).
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; PROQUAD that had undergone temperature excursion was administered; This spontaneous report was received from a medical assistant and referred to a 4-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  Temperature excursion occurred on 10-DEC-2022. On 22-DEC-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status: recombinant Human albumin (rHA)), anatomical location: right thigh, lot #W019628, expiration date: 19-DEC-2023; strength, and dose were not reported) intramuscularly for prophylaxis, which undergone temperature excursion (product storage error). There was no adverse event. There was no product complaint.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; PROQUAD that had undergone temperature excursion was administered; This spontaneous report was received from a medical assistant and referred to a 4-year-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  Temperature excursion occurred on 05-DEC-2022. On 27-DEC-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status: recombinant Human albumin (rHA)), anatomical location: right thigh, lot #W019628, expiration date: 19-DEC-2023; strength, and dose were not reported) intramuscularly for prophylaxis, which undergone temperature excursion (product storage error). There was no adverse event. There was no product complaint.
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; PROQUAD was inadvertently administered to the following patient after its labeled expiry date.; This spontaneous report was received from a nurse referring to a 6-year-old female patient. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On 28-APR-2023, the patient was inadvertently vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rhA]) (PROQUAD) injection, lot #U029321, expiration date: 19-MAR-2023, administered for prophylaxis (strength, dose, and route of administration were not provided) (Expired product administered). The vaccine had not undergone any temperature excursions. No additional AE reported (No adverse event).  This is one of three reports received from the same reporter.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; given a dose of VAQTA after the dose was stored improperly; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 02-MAY-2023, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, formulation established as vial, 0.5 milliliter, lot #X003791, expiration date: 01-JUN-2024 (administration site, and route of administration were not provided) administered for prophylaxis. On 02-MAY-2023, the vaccine experienced the temperature excursion of 34 Fahrenheit degrees for 7 hours (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient received her doses at 0, 2, and 3 months instead of the recommended 0, 2, and 6 months; No additional AE's were reported; This spontaneous report has been received from a physician via Company representative concerning a 17-year-old female patient (also reported as her by reporter). Her concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unspecified date, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administered as prophylaxis (dosage regimen, route of administration, lot number and expiration date were not provided). According to the reporter the patient was administered HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) outside recommended dosing schedule, the patient received her doses at 0, 2 and 3 months instead of the recommended 0, 2 and 6 months (Inappropriate schedule of product administration). No additional adverse events were provided (No adverse event).
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event in patient; Temperature excursion; This spontaneous report was received from an office manager concerning a 12-year-old male patient. His concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 27-SEP-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #U032681, expiration date: 26-OCT-2023; lot #1780876, expiration date: 09-NOV-2023; and lot #W009829, expiration date: 19-OCT-2024; however, it was not specified which one was received by the patient) (dosage regimen, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2304USA002221:
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: Product storage error
Clinical narrative: Storage in clinical practice; No adverse event on patient; This spontaneous report was received from an office manager, referring to a 12-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unspecified date, the patient was vaccinated with an improperly storage human papillomavirus (HPV) rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (valid lot #1775811, expiration date: 07-DEC-2023; valid lot #1775827, expiration date: 27-JUN-2024, valid lot #U032681, expiration date: 26-OCT-2023, valid lot #1780876, expiration date: 09-NOV-2023, valid lot #W009829, expiration date: 19-OCT-2024) administered for prophylaxis (dose, frequency, strength, anatomical location and route of administration were not provided). Temperature excursion occurred during a total time of 25 minutes. Three excursions were reported (on 09-SEP-2022 for 8 minutes, on 16-SEP-2023 for 5 minutes, and on 03-JAN-2023 for 12 minutes). Excursions were not noted until after the fact, due to employee error of cleaning data logger more than once a day. At the reporting time, the outcome of the event was unknown.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221: