chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Back pain, Cardiac imaging procedure abnormal, Catheterisation cardiac normal, Chest X-ray normal, Chest discomfort
Clinical narrative: Patient reports no history of heart problems or history of cardiac symptoms.  She said she has not been under any recent stress.  Patient typically walks 6 miles every day.  On 05/12,  she went out for her normal walk.  She said about 4 miles into the walk, she noticed that her chest was feeling tight, but she continued.  They finished the walk.  She went home.  She took a shower.  She started to have some low back pain.  She said she continued to have some chest tightness.  She said that she had a phone call with the nurse about her recent bladder surgery, and while they were having that conversation, she mentioned the chest tightness and was told to go right away to the hospital.  They went to a HCF.  She said on the way to the HCF, her left arm went numb.  She said when she got to the emergency room, the chest pain was very severe and felt like there was a knife in her chest.  It looks like her initial troponin was 0, and then went up to 1.13.  D-dimer was negative.  Chest x-ray was normal.  EKG showed ST depression in leads 3 and possibly AVF.  She was given aspirin.  A heparin drip was started.  She was taken to the cath lab.  She had no coronary disease.  She had a transthoracic echo that was consistent with Takotsubo with an EF of 38%.  She was started on atorvastatin 40 a day, indomethacin 25 mg 3 a day.  Her carvedilol was stopped, and she was switched to metoprolol 12.5 a day.  They decreased her losartan from 50 a day to 12.5 a day.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Chest pain, Diastolic dysfunction, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram ST segment depression
Clinical narrative: Patient reports no history of heart problems or history of cardiac symptoms.  She said she has not been under any recent stress.  Patient typically walks 6 miles every day.  On 05/12,  she went out for her normal walk.  She said about 4 miles into the walk, she noticed that her chest was feeling tight, but she continued.  They finished the walk.  She went home.  She took a shower.  She started to have some low back pain.  She said she continued to have some chest tightness.  She said that she had a phone call with the nurse about her recent bladder surgery, and while they were having that conversation, she mentioned the chest tightness and was told to go right away to the hospital.  They went to a HCF.  She said on the way to the HCF, her left arm went numb.  She said when she got to the emergency room, the chest pain was very severe and felt like there was a knife in her chest.  It looks like her initial troponin was 0, and then went up to 1.13.  D-dimer was negative.  Chest x-ray was normal.  EKG showed ST depression in leads 3 and possibly AVF.  She was given aspirin.  A heparin drip was started.  She was taken to the cath lab.  She had no coronary disease.  She had a transthoracic echo that was consistent with Takotsubo with an EF of 38%.  She was started on atorvastatin 40 a day, indomethacin 25 mg 3 a day.  Her carvedilol was stopped, and she was switched to metoprolol 12.5 a day.  They decreased her losartan from 50 a day to 12.5 a day.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Electrocardiogram abnormal, Fibrin D dimer normal, Hypoaesthesia, Left atrial dilatation, Left ventricular dilatation
Clinical narrative: Patient reports no history of heart problems or history of cardiac symptoms.  She said she has not been under any recent stress.  Patient typically walks 6 miles every day.  On 05/12,  she went out for her normal walk.  She said about 4 miles into the walk, she noticed that her chest was feeling tight, but she continued.  They finished the walk.  She went home.  She took a shower.  She started to have some low back pain.  She said she continued to have some chest tightness.  She said that she had a phone call with the nurse about her recent bladder surgery, and while they were having that conversation, she mentioned the chest tightness and was told to go right away to the hospital.  They went to a HCF.  She said on the way to the HCF, her left arm went numb.  She said when she got to the emergency room, the chest pain was very severe and felt like there was a knife in her chest.  It looks like her initial troponin was 0, and then went up to 1.13.  D-dimer was negative.  Chest x-ray was normal.  EKG showed ST depression in leads 3 and possibly AVF.  She was given aspirin.  A heparin drip was started.  She was taken to the cath lab.  She had no coronary disease.  She had a transthoracic echo that was consistent with Takotsubo with an EF of 38%.  She was started on atorvastatin 40 a day, indomethacin 25 mg 3 a day.  Her carvedilol was stopped, and she was switched to metoprolol 12.5 a day.  They decreased her losartan from 50 a day to 12.5 a day.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Left ventricular dysfunction, Magnetic resonance imaging heart, Mitral valve incompetence, Myocardial injury, Myocarditis
Clinical narrative: Patient reports no history of heart problems or history of cardiac symptoms.  She said she has not been under any recent stress.  Patient typically walks 6 miles every day.  On 05/12,  she went out for her normal walk.  She said about 4 miles into the walk, she noticed that her chest was feeling tight, but she continued.  They finished the walk.  She went home.  She took a shower.  She started to have some low back pain.  She said she continued to have some chest tightness.  She said that she had a phone call with the nurse about her recent bladder surgery, and while they were having that conversation, she mentioned the chest tightness and was told to go right away to the hospital.  They went to a HCF.  She said on the way to the HCF, her left arm went numb.  She said when she got to the emergency room, the chest pain was very severe and felt like there was a knife in her chest.  It looks like her initial troponin was 0, and then went up to 1.13.  D-dimer was negative.  Chest x-ray was normal.  EKG showed ST depression in leads 3 and possibly AVF.  She was given aspirin.  A heparin drip was started.  She was taken to the cath lab.  She had no coronary disease.  She had a transthoracic echo that was consistent with Takotsubo with an EF of 38%.  She was started on atorvastatin 40 a day, indomethacin 25 mg 3 a day.  Her carvedilol was stopped, and she was switched to metoprolol 12.5 a day.  They decreased her losartan from 50 a day to 12.5 a day.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Pericardial effusion, Pleural effusion, Stress cardiomyopathy, Systolic dysfunction, Tricuspid valve calcification
Clinical narrative: Patient reports no history of heart problems or history of cardiac symptoms.  She said she has not been under any recent stress.  Patient typically walks 6 miles every day.  On 05/12,  she went out for her normal walk.  She said about 4 miles into the walk, she noticed that her chest was feeling tight, but she continued.  They finished the walk.  She went home.  She took a shower.  She started to have some low back pain.  She said she continued to have some chest tightness.  She said that she had a phone call with the nurse about her recent bladder surgery, and while they were having that conversation, she mentioned the chest tightness and was told to go right away to the hospital.  They went to a HCF.  She said on the way to the HCF, her left arm went numb.  She said when she got to the emergency room, the chest pain was very severe and felt like there was a knife in her chest.  It looks like her initial troponin was 0, and then went up to 1.13.  D-dimer was negative.  Chest x-ray was normal.  EKG showed ST depression in leads 3 and possibly AVF.  She was given aspirin.  A heparin drip was started.  She was taken to the cath lab.  She had no coronary disease.  She had a transthoracic echo that was consistent with Takotsubo with an EF of 38%.  She was started on atorvastatin 40 a day, indomethacin 25 mg 3 a day.  Her carvedilol was stopped, and she was switched to metoprolol 12.5 a day.  They decreased her losartan from 50 a day to 12.5 a day.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Tricuspid valve incompetence, Troponin increased, Ventricular hypokinesia, Wall motion score index abnormal
Clinical narrative: Patient reports no history of heart problems or history of cardiac symptoms.  She said she has not been under any recent stress.  Patient typically walks 6 miles every day.  On 05/12,  she went out for her normal walk.  She said about 4 miles into the walk, she noticed that her chest was feeling tight, but she continued.  They finished the walk.  She went home.  She took a shower.  She started to have some low back pain.  She said she continued to have some chest tightness.  She said that she had a phone call with the nurse about her recent bladder surgery, and while they were having that conversation, she mentioned the chest tightness and was told to go right away to the hospital.  They went to a HCF.  She said on the way to the HCF, her left arm went numb.  She said when she got to the emergency room, the chest pain was very severe and felt like there was a knife in her chest.  It looks like her initial troponin was 0, and then went up to 1.13.  D-dimer was negative.  Chest x-ray was normal.  EKG showed ST depression in leads 3 and possibly AVF.  She was given aspirin.  A heparin drip was started.  She was taken to the cath lab.  She had no coronary disease.  She had a transthoracic echo that was consistent with Takotsubo with an EF of 38%.  She was started on atorvastatin 40 a day, indomethacin 25 mg 3 a day.  Her carvedilol was stopped, and she was switched to metoprolol 12.5 a day.  They decreased her losartan from 50 a day to 12.5 a day.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: The patient is complaining of arm soreness since the Shingrix injection on 3/9/23. As of today (5/26/23), she is still experiencing some arm soreness. We recommended that she talks to her doctor.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Feeling abnormal, Headache
Clinical narrative: I started having headaches, dizziness, stomachaches, diarrhea and generally feeling really bad. I was having tingling as well, muscle aches and leg cramps.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Paraesthesia
Clinical narrative: I started having headaches, dizziness, stomachaches, diarrhea and generally feeling really bad. I was having tingling as well, muscle aches and leg cramps.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Asthma
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/4/2023 ASTHMA, UNSPECIFIED
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product preparation error
Clinical narrative: The Bivalent Pfizer COVID-19 vaccine for ages 6month-<5 years was given at 0.2ml but the vial was not diluted.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Adult T-cell lymphoma/leukaemia, Febrile neutropenia, Hypertension
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/20/2022 HTN (HYPERTENSION) J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/20/2022 NEUTROPENIC FEVER, UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/20/2022 ADULT T-CELL LEUKEMIA W LYMPHOMA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/20/2022 NEUTROPENIC FEVER, UNSPECIFIED
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Hypovolaemic shock
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOVOLEMIC SHOCK
Age: 56.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Patient came to clinic for 1st Monopox vaccine. Vaccine given IM instead of Subq route. Patient was then contacted and updated. Patient denied any reaction to vaccine.
Age: 7.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Patient with swelling, pain, tenderness, and erythema on the left arm. Benadryl, Clindamycin, and Ibuprofen were prescribed. Advise applying cool compresses
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Acute respiratory failure, Cardiogenic shock
Clinical narrative: ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 1 MI 10/28/2022 ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 1 MI ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/28/2022 ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 1 MI CARDIOGENIC SHOCK 10/28/2022 ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 1 MI
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Pulmonary embolism
Clinical narrative: SADDLE PULMONARY EMBOLISM HYPOXIA
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic arteriosclerosis, Atrial fibrillation, Cardiac failure congestive, Dysphagia, Hypotension
Clinical narrative: I95.9 HYPOTENSION 9/26/2022 SEVERE PROTEIN CALORIE MALNUTRITION I95.9 HYPOTENSION 9/26/2022 DYSPHAGIA I95.9 HYPOTENSION 9/26/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I95.9 HYPOTENSION 9/26/2022 ATRIAL FIBRILLATION, UNSPECIFIED I95.9 HYPOTENSION 9/26/2022 ATHEROSCLEROSIS OF AORTA I95.9 HYPOTENSION 9/26/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I95.9 HYPOTENSION 9/26/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Malnutrition
Clinical narrative: I95.9 HYPOTENSION 9/26/2022 SEVERE PROTEIN CALORIE MALNUTRITION I95.9 HYPOTENSION 9/26/2022 DYSPHAGIA I95.9 HYPOTENSION 9/26/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I95.9 HYPOTENSION 9/26/2022 ATRIAL FIBRILLATION, UNSPECIFIED I95.9 HYPOTENSION 9/26/2022 ATHEROSCLEROSIS OF AORTA I95.9 HYPOTENSION 9/26/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I95.9 HYPOTENSION 9/26/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Age: 45.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site erythema, Injection site reaction, Monkeypox, Pustule, Rash
Clinical narrative: Patient developed red, welt-like area around injection site on left forearm that faded by the evening of the day of vaccination (05/16/2023). Patient woke up 05/17/2023 and saw that area surrounding injection site on left forearm was red and welt-like again; no itching or pain.  On 05/17/2023, he also developed a red bump closer to the antecubital fossa on media aspect of left forearm. On 05/18/2023, patient developed 3 more smaller, red bumps on right upper arm and on the morning of 05/19/2023, he noticed 3-4 similar bumps on forehead. Bumps are itchy and started out as red bumps that then welted up and then turned in small white pustules. He went to a hospital emergency department out of state and was told the lesions were due to a mild case of  mpox associated with the vaccine! (I informed him this was not possible.) These lesions started to improve on about 05/20/2023 or 05/21/2023, such that by the time I saw them on 05/23/2023, they were less erythematous, smaller, and mainly non-pustular. Lesions were not well-circumscribed, umbilicated, or deep-seated. Patient had no identifiable risks for mpox exposure in the prior month plus. No associated flu-like symptoms, no fever, no LAD.  Therefore, they were not tested for mpox. No other known contacts with same. H/o varicella as child.
Age: 45.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Rash erythematous, Rash pruritic, Skin lesion, Urticaria
Clinical narrative: Patient developed red, welt-like area around injection site on left forearm that faded by the evening of the day of vaccination (05/16/2023). Patient woke up 05/17/2023 and saw that area surrounding injection site on left forearm was red and welt-like again; no itching or pain.  On 05/17/2023, he also developed a red bump closer to the antecubital fossa on media aspect of left forearm. On 05/18/2023, patient developed 3 more smaller, red bumps on right upper arm and on the morning of 05/19/2023, he noticed 3-4 similar bumps on forehead. Bumps are itchy and started out as red bumps that then welted up and then turned in small white pustules. He went to a hospital emergency department out of state and was told the lesions were due to a mild case of  mpox associated with the vaccine! (I informed him this was not possible.) These lesions started to improve on about 05/20/2023 or 05/21/2023, such that by the time I saw them on 05/23/2023, they were less erythematous, smaller, and mainly non-pustular. Lesions were not well-circumscribed, umbilicated, or deep-seated. Patient had no identifiable risks for mpox exposure in the prior month plus. No associated flu-like symptoms, no fever, no LAD.  Therefore, they were not tested for mpox. No other known contacts with same. H/o varicella as child.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Mouth injury, Palate injury, Pulmonary embolism, Shock
Clinical narrative: I26.92 SADDLE PULMONARY EMBOLISM 1/28/2023 PALATE LACERATION, INIT I26.99 ACUTE PULMONARY EMBOLISM 1/23/2023 PALATE LACERATION, INIT J96.00 ACUTE RESPIRATORY FAILURE 1/28/2023 PALATE LACERATION, INIT J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/23/2023 PALATE LACERATION, INIT R57.9 SHOCK, UNSPECIFIED 1/28/2023 PALATE LACERATION, INIT
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, CREST syndrome, Hypoxia
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/20/2022 CREST SYNDROME R09.02 HYPOXIA 6/3/2022 CREST SYNDROME J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/20/2022 CREST SYNDROME R09.02 HYPOXIA 6/3/2022 CREST SYNDROME
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Infant was given Hep B vaccination today. Was inadvertently administered adult formulation of vaccine at 10mcg  (1cc) versus pediatric 5mcg  (0.5cc), no adverse reactions occurred at time of administration.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypoxia
Clinical narrative: Moderna vaccine was administered outside of the clinic - reported by patient ? NO LOT NUMBER WERE SUPPLIED ----------------------------------------------------------------------------------------------------------------------------- HYPOXIA 9/23/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Aphasia, Epilepsy, Glioblastoma multiforme, Intracranial mass
Clinical narrative: G40.802 APHASIA W EPILEPSY 12/18/2022 BRAIN MASS G40.909 EPILEPSY, UNSPECIFIED 11/8/2022 BRAIN MASS J96.00 ACUTE RESPIRATORY FAILURE 12/17/2022 BRAIN MASS G40.802 APHASIA W EPILEPSY 12/18/2022 GLIOBLASTOMA MULTIFORME, TEMPORAL LOBE G40.909 EPILEPSY, UNSPECIFIED 11/8/2022 GLIOBLASTOMA MULTIFORME, TEMPORAL LOBE J96.00 ACUTE RESPIRATORY FAILURE 12/17/2022 GLIOBLASTOMA MULTIFORME, TEMPORAL LOBE G40.802 APHASIA W EPILEPSY 12/18/2022 APHASIA W EPILEPSY G40.909 EPILEPSY, UNSPECIFIED 11/8/2022 APHASIA W EPILEPSY J96.00 ACUTE RESPIRATORY FAILURE 12/17/2022 APHASIA W EPILEPSY G40.802 APHASIA W EPILEPSY 12/18/2022 GLIOBLASTOMA MULTIFORME, TEMPORAL LOBE G40.909 EPILEPSY, UNSPECIFIED 11/8/2022 GLIOBLASTOMA MULTIFORME, TEMPORAL LOBE J96.00 ACUTE RESPIRATORY FAILURE 12/17/2022 GLIOBLASTOMA MULTIFORME, TEMPORAL LOBE
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Symptom recurrence
Clinical narrative: HYPOXIA 3/2/2022 &  8/10/2022  --  RECURRENCE OF SAME SYMPTOMS
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anticoagulant therapy, Blood test, Computerised tomogram, Dyspnoea, Electrocardiogram
Clinical narrative: I had pain and swelling of the right leg with shortness of breath. It was determined that there was a blood clot in my right leg, I was placed in hospital for one night for observation. I was placed on blood thinners.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Peripheral swelling, Thrombosis, Ultrasound scan
Clinical narrative: I had pain and swelling of the right leg with shortness of breath. It was determined that there was a blood clot in my right leg, I was placed in hospital for one night for observation. I was placed on blood thinners.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Coronary artery disease
Clinical narrative: ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 9/1/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: ACUTE DVT, UNSPECIFIED VEIN
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Rash maculo-papular, Scab, Skin lesion
Clinical narrative: 5/24/22 patient had mild macular-papular rash. This progressed and patient was seen again on 5/26/2023 where he had crusted lesions across his entire body, on face, and in mouth.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic arteriosclerosis, Cellulitis, Coagulopathy, Deep vein thrombosis, Hypotension
Clinical narrative: D68.9 COAGULOPATHY, UNSPECIFIED TYPE 8/19/2022 CANCER METASTATIC TO BONE I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 2/18/2023 CANCER METASTATIC TO BONE I95.89 CHRONIC HYPOTENSION 10/11/2022 CANCER METASTATIC TO BONE I95.9 HYPOTENSION 2/18/2023 CANCER METASTATIC TO BONE D68.9 COAGULOPATHY, UNSPECIFIED TYPE 8/19/2022 SEPSIS DUE TO UTI I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 2/18/2023 SEPSIS DUE TO UTI I95.89 CHRONIC HYPOTENSION 10/11/2022 SEPSIS DUE TO UTI I95.9 HYPOTENSION 2/18/2023 SEPSIS DUE TO UTI D68.9 COAGULOPATHY, UNSPECIFIED TYPE 8/19/2022 CELLULITIS I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 2/18/2023 CELLULITIS I95.89 CHRONIC HYPOTENSION 10/11/2022 CELLULITIS I95.9 HYPOTENSION 2/18/2023 CELLULITIS D68.9 COAGULOPATHY, UNSPECIFIED TYPE 8/19/2022 ATHEROSCLEROSIS OF AORTA I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 2/18/2023 ATHEROSCLEROSIS OF AORTA I95.89 CHRONIC HYPOTENSION 10/11/2022 ATHEROSCLEROSIS OF AORTA I95.9 HYPOTENSION 2/18/2023 ATHEROSCLEROSIS OF AORTA D68.9 COAGULOPATHY, UNSPECIFIED TYPE 8/19/2022 NECK PAIN I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 2/18/2023 NECK PAIN I95.89 CHRONIC HYPOTENSION 10/11/2022 NECK PAIN I95.9 HYPOTENSION 2/18/2023 NECK PAIN
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Metastases to bone, Neck pain, Neoplasm malignant, Sepsis, Urinary tract infection
Clinical narrative: D68.9 COAGULOPATHY, UNSPECIFIED TYPE 8/19/2022 CANCER METASTATIC TO BONE I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 2/18/2023 CANCER METASTATIC TO BONE I95.89 CHRONIC HYPOTENSION 10/11/2022 CANCER METASTATIC TO BONE I95.9 HYPOTENSION 2/18/2023 CANCER METASTATIC TO BONE D68.9 COAGULOPATHY, UNSPECIFIED TYPE 8/19/2022 SEPSIS DUE TO UTI I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 2/18/2023 SEPSIS DUE TO UTI I95.89 CHRONIC HYPOTENSION 10/11/2022 SEPSIS DUE TO UTI I95.9 HYPOTENSION 2/18/2023 SEPSIS DUE TO UTI D68.9 COAGULOPATHY, UNSPECIFIED TYPE 8/19/2022 CELLULITIS I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 2/18/2023 CELLULITIS I95.89 CHRONIC HYPOTENSION 10/11/2022 CELLULITIS I95.9 HYPOTENSION 2/18/2023 CELLULITIS D68.9 COAGULOPATHY, UNSPECIFIED TYPE 8/19/2022 ATHEROSCLEROSIS OF AORTA I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 2/18/2023 ATHEROSCLEROSIS OF AORTA I95.89 CHRONIC HYPOTENSION 10/11/2022 ATHEROSCLEROSIS OF AORTA I95.9 HYPOTENSION 2/18/2023 ATHEROSCLEROSIS OF AORTA D68.9 COAGULOPATHY, UNSPECIFIED TYPE 8/19/2022 NECK PAIN I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 2/18/2023 NECK PAIN I95.89 CHRONIC HYPOTENSION 10/11/2022 NECK PAIN I95.9 HYPOTENSION 2/18/2023 NECK PAIN
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Atrial flutter, Cardiac ablation, Cardiac device implantation, Cardiac monitoring abnormal
Clinical narrative: Since 2020, I have had occurrences of Atrial Flutter/Atrial Fibrillation and have undergone 2 ablations on 7/22/2020 & 9/23/2020 and the installation of the heart device on 7/20/2021. I continue to wear a cardiac monitor. A Monitor report generated this April showed only occasional PACs or rare instances of atrial flutter prior to the last vaccination. After vaccination, the report shows daily occurrences of either Atrial Flutter, Atrial Fibrillation or Tachycardia. I now take Metoprolol Tartrate 2x/day and will undergo another ablation (scheduled for June 7th) to correct it.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Left atrial appendage closure implant, Supraventricular extrasystoles, Tachycardia
Clinical narrative: Since 2020, I have had occurrences of Atrial Flutter/Atrial Fibrillation and have undergone 2 ablations on 7/22/2020 & 9/23/2020 and the installation of the heart device on 7/20/2021. I continue to wear a cardiac monitor. A Monitor report generated this April showed only occasional PACs or rare instances of atrial flutter prior to the last vaccination. After vaccination, the report shows daily occurrences of either Atrial Flutter, Atrial Fibrillation or Tachycardia. I now take Metoprolol Tartrate 2x/day and will undergo another ablation (scheduled for June 7th) to correct it.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Obesity
Clinical narrative: R09.02 HYPOXEMIA 2/12/2023 OBESITY, BMI 30-34.9, ADULT
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Cough, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Day after receiving vaccination, right arm had intermittent pain (lower and upper arm), both right and left hands were intermittently tingling, fingers on both hands stiff.  Took ibuprofen.  Had a few other common side effects from the bivalent booster: low energy, general body aches, some coughing. All symptoms resolved on their own by the following day (about 36 hours after injection).
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Paraesthesia
Clinical narrative: Day after receiving vaccination, right arm had intermittent pain (lower and upper arm), both right and left hands were intermittently tingling, fingers on both hands stiff.  Took ibuprofen.  Had a few other common side effects from the bivalent booster: low energy, general body aches, some coughing. All symptoms resolved on their own by the following day (about 36 hours after injection).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic arteriosclerosis, Atrial fibrillation, Cardiac failure congestive, Chronic left ventricular failure, Hypoxia
Clinical narrative: HYPOXEMIA 1/15/2023 ATRIAL FIBRILLATION, UNSPECIFIED HYPOXEMIA 1/15/2023 SYSTOLIC HEART FAILURE, CHRONIC HYPOXEMIA 1/15/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED HYPOXEMIA 1/15/2023 JAUNDICE HYPOXEMIA 1/15/2023 ATHEROSCLEROSIS OF AORTA
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Jaundice
Clinical narrative: HYPOXEMIA 1/15/2023 ATRIAL FIBRILLATION, UNSPECIFIED HYPOXEMIA 1/15/2023 SYSTOLIC HEART FAILURE, CHRONIC HYPOXEMIA 1/15/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED HYPOXEMIA 1/15/2023 JAUNDICE HYPOXEMIA 1/15/2023 ATHEROSCLEROSIS OF AORTA
Age: 1.25
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: This 15 month old was given a Kinrix(DTap/IPV) instead of Infanrix (DTaP). Mom and provider notified.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reactions reported at this time.
Age: 1.58
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: NO ADVERSE EVENTS FOR PATIENT.  MEDICAL ASSISTANT ACCIDENTALLY ADMINISTERED MONOVALENT PFIZER COVID 6 MONTHS - 4 YEARS DOSE INSTEAD OF BIVALENT PFIZER DOSE.
Age: 1.25
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix (DTaP/IPV)  given to a 15 month old instead of Infanrix (DTaP).Mom and doctor notified
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Heart rate increased, Palpitations, Sleep disorder
Clinical narrative: Pt.  reported  05/26/23 that on 5/11/23 at 5am she woke up and her heart was beating hard, and rapidly.  States occurrence ended about 10 hours later.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: immediate localized reaction: swelling around injection site that lasted throughout duration of visit. Patient was given an ice pack to try to reduce swelling. Patient denied pain, dizziness, or nausea.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Atrial fibrillation, Syncope
Clinical narrative: STABLE ANGINA 3/24/2022 SYNCOPE STABLE ANGINA 3/24/2022 ATRIAL FIBRILLATION, PAROXYSMAL
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: WARM AND SORE INJECTION AREA
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: ATRIAL FIBRILLATION, PAROXYSMAL
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Thoracic appearing rash. Patient denied pain, itching, or discomfort 24 hrs after receiving pneumococcal vaccine. Patient denies respiratory distress.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary artery disease, Neuropathy peripheral, Speech disorder
Clinical narrative: Pfizer vaccine was administered outside of source - reported by patient- ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------- G62.9 NEUROPATHY 4/12/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA G62.9 NEUROPATHY 4/12/2022 SPEECH PROBLEM
Age: 83.0
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt states she had pneumonia vac. on 5/25 in her R arm- Pt states that her are started hurting that night. When she woke up her shoulder was the size of a softball and warm to touch. Pt rated pain at 10 on 0-10 scale.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Periarthritis, X-ray
Clinical narrative: frozen shoulder in the arm receiving vaccine
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory distress syndrome, Acute respiratory failure, Angina pectoris, Polyneuropathy
Clinical narrative: G62.0 DRUG INDUCED POLYNEUROPATHY 1/3/2023 ACUTE RESPIRATORY DISTRESS I20.8 STABLE ANGINA 1/3/2023 ACUTE RESPIRATORY DISTRESS J96.00 ACUTE RESPIRATORY FAILURE 9/28/2022 ACUTE RESPIRATORY DISTRESS
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Acute respiratory failure
Clinical narrative: Moderna vaccine was administered outside of source - reported by patient ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------------- I21.4 ACUTE NON ST ELEVATION MI 2/16/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/16/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test normal, Eye allergy, Eye irritation, Eye pain, Headache
Clinical narrative: About the third or fourth week of January I had pain and burning in both eyes. I was thinking I may just need prescription glasses. The pain radiated up to my temple and sinus area. I made an appointment to see the doctor, who thought it was just allergies, and gave me prescription eye drops. This did not help, and I was still in pain, I made another appointment with the doctor as well with the eye doctor. The eye doctor did see, feel this was allergy related and prescribed prednisone eye drop that really did help to improve what was going on with my eyes. The second visit with the doctor I was given an oral antibiotic. I am not completely recovered but I am feeling better.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Sinus pain
Clinical narrative: About the third or fourth week of January I had pain and burning in both eyes. I was thinking I may just need prescription glasses. The pain radiated up to my temple and sinus area. I made an appointment to see the doctor, who thought it was just allergies, and gave me prescription eye drops. This did not help, and I was still in pain, I made another appointment with the doctor as well with the eye doctor. The eye doctor did see, feel this was allergy related and prescribed prednisone eye drop that really did help to improve what was going on with my eyes. The second visit with the doctor I was given an oral antibiotic. I am not completely recovered but I am feeling better.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Adrenal insufficiency, Chronic obstructive pulmonary disease, Chronic respiratory failure, Hypoxia
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 1/6/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 3/6/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/6/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 1/6/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 1/14/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED R09.02 HYPOXEMIA 2/1/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 1/6/2023 ACUTE RESPIRATORY FAILURE J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 3/6/2023 ACUTE RESPIRATORY FAILURE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/6/2023 ACUTE RESPIRATORY FAILURE J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 1/6/2023 ACUTE RESPIRATORY FAILURE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 1/14/2023 ACUTE RESPIRATORY FAILURE R09.02 HYPOXEMIA 2/1/2023 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 1/6/2023 COPD STAGE 3 SEVERE (FEV1 30-49%) J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 3/6/2023 COPD STAGE 3 SEVERE (FEV1 30-49%) J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/6/2023 COPD STAGE 3 SEVERE (FEV1 30-49%) J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 1/6/2023 COPD STAGE 3 SEVERE (FEV1 30-49%) J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 1/14/2023 COPD STAGE 3 SEVERE (FEV1 30-49%) R09.02 HYPOXEMIA 2/1/2023 COPD STAGE 3 SEVERE (FEV1 30-49%) J96.00 ACUTE RESPIRATORY FAILURE 1/6/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 3/6/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/6/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 1/6/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 1/14/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED R09.02 HYPOXEMIA 2/1/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 1/6/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 3/6/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/6/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 1/6/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 1/14/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED R09.02 HYPOXEMIA 2/1/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory failure
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 1/6/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 3/6/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/6/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 1/6/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 1/14/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED R09.02 HYPOXEMIA 2/1/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 1/6/2023 ACUTE RESPIRATORY FAILURE J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 3/6/2023 ACUTE RESPIRATORY FAILURE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/6/2023 ACUTE RESPIRATORY FAILURE J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 1/6/2023 ACUTE RESPIRATORY FAILURE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 1/14/2023 ACUTE RESPIRATORY FAILURE R09.02 HYPOXEMIA 2/1/2023 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 1/6/2023 COPD STAGE 3 SEVERE (FEV1 30-49%) J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 3/6/2023 COPD STAGE 3 SEVERE (FEV1 30-49%) J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/6/2023 COPD STAGE 3 SEVERE (FEV1 30-49%) J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 1/6/2023 COPD STAGE 3 SEVERE (FEV1 30-49%) J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 1/14/2023 COPD STAGE 3 SEVERE (FEV1 30-49%) R09.02 HYPOXEMIA 2/1/2023 COPD STAGE 3 SEVERE (FEV1 30-49%) J96.00 ACUTE RESPIRATORY FAILURE 1/6/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 3/6/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/6/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 1/6/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 1/14/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED R09.02 HYPOXEMIA 2/1/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 1/6/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 3/6/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/6/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 1/6/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 1/14/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED R09.02 HYPOXEMIA 2/1/2023 ADRENAL INSUFFICIENCY, UNSPECIFIED
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported injection site reaction of redness, swelling, slight burning, and soreness for about 1 week.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a 2nd bivalent booster when it was not recommended or due- No harm to patient and no adverse reactions
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Pain in extremity
Clinical narrative: Pt experienced pain in the knee down to her calf. Redness around injections site that went away.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE/PQC; Inbound call from a medical assistant who reported that improperly stored vaccines were administered. The caller was not sure which ones were administered.  MA to declined to report the AE at this time.  Limited information provided. No additional AE; This spontaneous report was received from the medical assistant and refers to a patient of an unknown age or gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-APR-2023, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter, lot #W010661, expiration date: 19-OCT-2024 (strength, route of administration were not provided) as prophylaxis following a temperature excursion of -40 degree Fahrenheit for 8 hours and 25 minutes, there was mentioned that not previous temperature excursions occurred. No additional adverse event was reported.  This is one from several case from the same reporter. ; Sender's Comments:  US-009507513-2305USA000730:02380645 US-009507513-2305USA008830:
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event, Product dispensing error
Clinical narrative: No additional AE reported; Patient was administered Expired PNEUMOVAX 23 on 04/11/2023; indicate at which point in the process the medication error occurred: dispensing; This spontaneous report was received from a pharmacist and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 11-APR-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, expiration date: 25-MAR-2023, administered for prophylaxis (strength, dose lot #, and route of administration were not provided) (expired product administered). No additional adverse event (AE) was reported.  This case was considered as non-valid due to lack of patient's identifiers.  Follow-up information has been received from a clinic manager referring to the 81-year-old male patient on 18-MAY-2023.  On 11-APR-2023, the patient was vaccinated with the first dose (number of previous doses reported as no) pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot# U027357, expiration date 25-MAR-2023, strength and dose were not reported) intramuscularly at right deltoid for prophylaxis.  The operator of vaccine was a healthcare professional, and the operator was trained. The vaccine was used according to the instruction leaflet. The suspect vaccine had not been involved in any temperature excursions through the date of administration. The suspect vaccine was available for return/evaluation. The suspect vaccine had been returned to distributor.   It was reported that the medication error occurred at the dispensing (product dispensing error). There was no product quality complaint. This adverse event had been reported to doctor previously.   The case became valid because patient's identifier was added.
Sex: U
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: No additional AEs were reported; An expired MMR II was administered to a patient.   MMR II had a temperature excursion in 10/2022 and it was given on 5/15/2023.   The diluent did not have temperature excursion and was not expired.   No additional AEs were reported. No further inform; MMR II had a temperature excursion in 10/2022; Description: An expired MMR II was administered to a patient.   MMR II had a temperature excursion in 10/2022 and it was given on 5/15/2023.   The diluent did not have temperature excursion and was not expired.   No additional AEs were reported. No further information provided.  No PQC.  This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      In October 2022, the vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot number u013036, expiration date 23-APR-2023 had a temperature excursion and was administered on 15-MAY-2023 (dose and route of administration not reported)(product storage error and expired product administered). The sterile diluent used to reconstitute the vaccine had no excursions and was no expired. No adverse event was reported.  The excursion was of 50 degrees Fahrenheit for 4 hours. No previous excursions were reported.
Age: 54.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP called to report inadvertent administration of an expired dose of MMR II.  No adverse effects reported.  MMR II expired 2/26/2023 and patient was administered the vaccine today, 5/16/2023.  HCP also asked about the need for revaccination.  Post E; This spontaneous report as received from a nurse referring to a 54-year-old patient of unreported gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 16-MAY-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot number U006485, expiration date 26-FEB-2023, 0.5 milliliter (route of administration not reported) for prophylaxis (expired product administered). No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; HBP with responsibility for vaccine storage calling to report a temperature excursion for MMR II, VARIVAX and PROQUAD. 1 dose of VARIVAX given. No additional AEs. No PQCs.    ?    Names of vaccines involved (including lot/exp) VARIVAX U025202 08/13; This spontaneous report was received from an other referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 16-MAY-2023, the patient was vaccinated with varicella virus vaccine live an improperly stored dose of (oka/merck)(VARIVAX) lot number U025202, expiration date 13-AUG-2023 (dose and route of administration not reported) for prophylaxis. Other vaccines involved in the temperature excursion were measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) however, these las t vaccines were not administered (product storage error). No adverse event was reported.  No information regarding the temperature excursion was reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical assistant called to report a T/E and reported that MMRII that experienced a temperature excursion was administered to one patient. No side effects or symptoms reported. No Additional AE/No PQC.  Names of vaccines involved (including lot/expir; No side effects or symptoms reported; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot number W019425, expiration date 07-JAN-2024 (dose, route of administration not reported) for prophylaxis (product storage error). No adverse event was provided.   The vaccine underwent a temperature excursion of 60.44 degrees Fahrenheit for 1 hour and 10 minutes. No previous excursions were detected.   The call was due to digital data logger.
Sex: M
Vaccine: HPV9
Symptoms: Intentional product misuse, No adverse event
Clinical narrative: His 2nd dose was given on 4/2021. He had decided to skip the 3rd dose due to side effects he was reading; No additional AE; This spontaneous report as received from a consumer, referring to 43-year-old male patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On unknown day in April 2021, the patient was vaccinated with his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis. He had decided to skip the third dose due to side effects he was reading (Intentional misuse in product use duration). Customer provided limited information. No additional adverse event (AE) reported. No product quality complaint (PQC) reported.
Age: 5.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient has not experienced any symptoms or side effects at this time.; Inbound call from nurse who reports they accidentally administered GARDASIL 9 to a 5 year old patient yesterday 22MAY2023.; This spontaneous report was received from a nurse and refers to a 5-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 22-MAY-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (valid lot number W001494 [expiration date 15-SEP-2024]), administered for prophylaxis (dose, dose number, frequency, vaccination scheme, route of administration and anatomical location were not provided) administered for prophylaxis. The vaccine was intended for the 10-year-old brother of the patient, and they got it mixed up prior to administration (product administered to patient of inappropriate age). The patient has not experienced any symptoms or side effects at this time (no adverse event).