chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient was given undiluted dose of Pfizer Bivalent Covid Vaccine 5y-11y 0.2ml
Age: 62.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Fatigue, Oropharyngeal pain, SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: First, sore throat, congested sinus up above my head. I tested positive with a rapid home COVID-19 test and it was positive on 03/21/2023. On 03/23/2023 I called my doctor in the morning. The doctor called in a PAXLOVID prescription, if I needed it. I never filled the prescription. That went on for 5 or 6 days. I drank ginger tea, lemon and honey and lots of sleep. I stayed home for 7 days from work then it was Spring break, After the 10 days, I felt normal, I was just tired. I tested and it was still positive after 10 days. I did not test anymore after that.
Age: 45.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose, Vaccination error
Clinical narrative: 45 y.o. received pediatric dose for Hep A, noted prior to patient leaving the facility Pediatric dose was given. Patient can receive another Pediatric dose if the error is discovered on the same clinic day. Patient agreed to receive a 2nd Pediatric dose before leaving the facility to equate to one adult dose.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 1/20/2021 ACUTE RESPIRATORY FAILURE
Age: 66.0
Sex: M
Vaccine: FLUC4
Symptoms: Extra dose administered
Clinical narrative: Patient advised he had yet to received flu vaccine and asked if we could give him his vaccine. Gave patient flu vaccine quadrivalent. Discovered patient was given flu vaccine in September of 2022. Advised medical lead, who contacted (Medical/Program director) to advise. Medical Lead advised no additional observation time for patient and that patient was ok to go home. Wrote comment in Prep Mod explaining incident and action taken after.   Patient was advised of adverse event and informed that we would be writing a VAERS report.
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: CLIENT WAS ADMINISTERED INCORRECT VACCINE PRODUCT FOR AGE. NO REPORTED ABNORMAL EFFECTS FOLLOWING VACCINATION.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: My symptoms started on March 30, 2021 I experienced an extreme red itch I had a really bad rash. I was using hydrocortisone which did not help.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: none
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nasopharyngitis, Pyrexia, Upper respiratory tract infection
Clinical narrative: Mild cold symptoms and low grade fever 99-100.2- unsure if related to recent vaccination. Patient also received flu vaccine during this visit. Vaccination was given at clinics. Provider filling out this form saw patient for upper respiratory infection/common cold. Completing VAERS based on recent vaccination.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Feeling hot, Headache, Increased viscosity of upper respiratory secretion
Clinical narrative: I had a sore that started on 01/31/2023, that continued until the next day. I did not sleep well, I was congested, a slight headache. On 02/02/203, I took a home COVID-19 test that came back inconclusive, the next day I was feeling warmer the mucus was green. I took use another home COVID-19 test this one came back positive. I went to a urgent care on 02/04/2023, by then I was sneezing, coughing, very thick green mucus. They performed a PCR Rapid COVID-19 test that came back positive. I was advised that I needed to stop taking Flonase while I was on Paxlovid. I took the five-day course of Paxlovid and felt fine but once it was gone the inflammation to my sinuses came back. I am not sure if this is because I stopped the Flonase. I did have mild tiredness for two weeks after completing the Paxlovid.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Insomnia, Paranasal sinus inflammation, Productive cough, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I had a sore that started on 01/31/2023, that continued until the next day. I did not sleep well, I was congested, a slight headache. On 02/02/203, I took a home COVID-19 test that came back inconclusive, the next day I was feeling warmer the mucus was green. I took use another home COVID-19 test this one came back positive. I went to a urgent care on 02/04/2023, by then I was sneezing, coughing, very thick green mucus. They performed a PCR Rapid COVID-19 test that came back positive. I was advised that I needed to stop taking Flonase while I was on Paxlovid. I took the five-day course of Paxlovid and felt fine but once it was gone the inflammation to my sinuses came back. I am not sure if this is because I stopped the Flonase. I did have mild tiredness for two weeks after completing the Paxlovid.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Skin ulcer, Sneezing, Sputum discoloured
Clinical narrative: I had a sore that started on 01/31/2023, that continued until the next day. I did not sleep well, I was congested, a slight headache. On 02/02/203, I took a home COVID-19 test that came back inconclusive, the next day I was feeling warmer the mucus was green. I took use another home COVID-19 test this one came back positive. I went to a urgent care on 02/04/2023, by then I was sneezing, coughing, very thick green mucus. They performed a PCR Rapid COVID-19 test that came back positive. I was advised that I needed to stop taking Flonase while I was on Paxlovid. I took the five-day course of Paxlovid and felt fine but once it was gone the inflammation to my sinuses came back. I am not sure if this is because I stopped the Flonase. I did have mild tiredness for two weeks after completing the Paxlovid.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, COVID-19, Deafness, Diarrhoea, Ear infection
Clinical narrative: I had flu like symptoms, low grade fever, body aches. I went to see my doctor and got tested and I was positive for COVID-19 on 02/07/2023. I was given a prescription for PAXLOVID. They tested me for flu and tested and tested negative for these exams. I also had some stomach upset and diarrhea after I took PAXLOVID. I can say I have recovered from my COVID-9 symptoms but two weeks after I ended up with an ear infection and have hearing loss.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Influenza like illness, Influenza virus test negative, Malaise, Pain, Pyrexia
Clinical narrative: I had flu like symptoms, low grade fever, body aches. I went to see my doctor and got tested and I was positive for COVID-19 on 02/07/2023. I was given a prescription for PAXLOVID. They tested me for flu and tested and tested negative for these exams. I also had some stomach upset and diarrhea after I took PAXLOVID. I can say I have recovered from my COVID-9 symptoms but two weeks after I ended up with an ear infection and have hearing loss.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had flu like symptoms, low grade fever, body aches. I went to see my doctor and got tested and I was positive for COVID-19 on 02/07/2023. I was given a prescription for PAXLOVID. They tested me for flu and tested and tested negative for these exams. I also had some stomach upset and diarrhea after I took PAXLOVID. I can say I have recovered from my COVID-9 symptoms but two weeks after I ended up with an ear infection and have hearing loss.
Age: 37.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Intermenstrual bleeding
Clinical narrative: Menstrual spotting randomly between cycles,  between 2-7 days the past few months up to February.
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: none
Age: 75.0
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Amyotrophic lateral sclerosis, Blood test, Dropped head syndrome, Gait disturbance, Nerve conduction studies
Clinical narrative: Neuromuscular symptoms of excess saliva, dropped neck, shuffling, eventually diagnosed with ALS on 8/29/2022.
Age: 75.0
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Neuromyopathy, Salivary hypersecretion
Clinical narrative: Neuromuscular symptoms of excess saliva, dropped neck, shuffling, eventually diagnosed with ALS on 8/29/2022.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Bacteraemia, Hypotension, Hypoxia, Metastases to liver, Neoplasm malignant
Clinical narrative: Pfizer vaccine was administered - reported by patient  I95.9 HYPOTENSION 6/7/2021 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION R09.02 HYPOXIA 7/18/2021 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION I95.9 HYPOTENSION 6/7/2021 BACTEREMIA R09.02 HYPOXIA 7/18/2021 BACTEREMIA I95.9 HYPOTENSION 6/7/2021 CANCER METASTATIC TO LIVER R09.02 HYPOXIA 7/18/2021 CANCER METASTATIC TO LIVER
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Organ failure, Sepsis
Clinical narrative: Pfizer vaccine was administered - reported by patient  I95.9 HYPOTENSION 6/7/2021 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION R09.02 HYPOXIA 7/18/2021 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION I95.9 HYPOTENSION 6/7/2021 BACTEREMIA R09.02 HYPOXIA 7/18/2021 BACTEREMIA I95.9 HYPOTENSION 6/7/2021 CANCER METASTATIC TO LIVER R09.02 HYPOXIA 7/18/2021 CANCER METASTATIC TO LIVER
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash, Rash pruritic
Clinical narrative: Rash on my side?moving to my back and other side  after 4 days of getting the vaccine   The rash was painful and itchy It?s been over 30 days .
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Brain stem stroke, Cardiac failure congestive, Cardiogenic shock, Coronary artery disease, Haematuria
Clinical narrative: ACUTE STROKE OF BRAINSTEM, UNSPECIFIED TYPE AND ARTERY 2/11/2022 CARDIOGENIC SHOCK  HYPOTENSION 5/16/2022 CARDIOGENIC SHOCK  CARDIOGENIC SHOCK 9/14/2022 CARDIOGENIC SHOCK  ACUTE STROKE OF BRAINSTEM, UNSPECIFIED TYPE AND ARTERY 2/11/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED  HYPOTENSION 5/16/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED  CARDIOGENIC SHOCK 9/14/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED  ACUTE STROKE OF BRAINSTEM, UNSPECIFIED TYPE AND ARTERY 2/11/2022 HEMATURIA  HYPOTENSION 5/16/2022 HEMATURIA  CARDIOGENIC SHOCK 9/14/2022 HEMATURIA  ACUTE STROKE OF BRAINSTEM, UNSPECIFIED TYPE AND ARTERY 2/11/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA  HYPOTENSION 5/16/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA  CARDIOGENIC SHOCK 9/14/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: ACUTE STROKE OF BRAINSTEM, UNSPECIFIED TYPE AND ARTERY 2/11/2022 CARDIOGENIC SHOCK  HYPOTENSION 5/16/2022 CARDIOGENIC SHOCK  CARDIOGENIC SHOCK 9/14/2022 CARDIOGENIC SHOCK  ACUTE STROKE OF BRAINSTEM, UNSPECIFIED TYPE AND ARTERY 2/11/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED  HYPOTENSION 5/16/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED  CARDIOGENIC SHOCK 9/14/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED  ACUTE STROKE OF BRAINSTEM, UNSPECIFIED TYPE AND ARTERY 2/11/2022 HEMATURIA  HYPOTENSION 5/16/2022 HEMATURIA  CARDIOGENIC SHOCK 9/14/2022 HEMATURIA  ACUTE STROKE OF BRAINSTEM, UNSPECIFIED TYPE AND ARTERY 2/11/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA  HYPOTENSION 5/16/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA  CARDIOGENIC SHOCK 9/14/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Atrial fibrillation, Respiratory failure
Clinical narrative: vaccine was administered outside of Facility - reported by patient  J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 6/2/2021 ATRIAL FIBRILLATION, UNSPECIFIED J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/2/2021 ATRIAL FIBRILLATION, UNSPECIFIED
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Immunisation reaction, Infection, Pyrexia
Clinical narrative: I had vaccination on 09/07/2022. On 03/19/2023 I started to have a scratchy throat feverish and fatigue. I tested COVID-19 positive on 03/20/2023. I previously had COVID-19 on 05/2020 and I had had long haulers. I called my doctor right away and was prescribed an anti-viral. I feel like I have recovered on 04/19/2023 except for an infection on my wrist. I am unsure if related to COVID-19 as I did have COVID toes etc.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Throat irritation
Clinical narrative: I had vaccination on 09/07/2022. On 03/19/2023 I started to have a scratchy throat feverish and fatigue. I tested COVID-19 positive on 03/20/2023. I previously had COVID-19 on 05/2020 and I had had long haulers. I called my doctor right away and was prescribed an anti-viral. I feel like I have recovered on 04/19/2023 except for an infection on my wrist. I am unsure if related to COVID-19 as I did have COVID toes etc.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Influenza virus test negative, Malaise, Mucosal inflammation, Nasal crusting, Nasopharyngitis
Clinical narrative: I contracted a virus in January 2023 and was feeling unwell for about 5 weeks. It started with cold symptoms and progressed to having a severe sore throat. I ended up having a sore throat for about 3 weeks and developed crusty sores in my nose. I ended up going to urgent care 2x and, finally, my primary care physician, which helped with my sore throat as she was able to provide me with antibiotics. I was able to see an ENT PA to help with the sores in my nose and she provided me with a cream antibiotic to use in my nose and nasal spray and which helped heal my sores.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, SARS-CoV-2 test negative, Streptococcus test negative, Viral infection
Clinical narrative: I contracted a virus in January 2023 and was feeling unwell for about 5 weeks. It started with cold symptoms and progressed to having a severe sore throat. I ended up having a sore throat for about 3 weeks and developed crusty sores in my nose. I ended up going to urgent care 2x and, finally, my primary care physician, which helped with my sore throat as she was able to provide me with antibiotics. I was able to see an ENT PA to help with the sores in my nose and she provided me with a cream antibiotic to use in my nose and nasal spray and which helped heal my sores.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received a monovalent instead of bivalent.
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: none
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: none
Age: 66.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Computerised tomogram abdomen abnormal, Hernia, Ovarian cancer, Ovarian disorder, Ovarian neoplasm
Clinical narrative: I went in to have a hernia evaluated, my doctor ordered a CT scan to see just how bad it was. The CT scan revealed that I had something abnormal going on with ovaries, the size of the tumor on my ovaries presented cancer. I underwent surgery to remove the cancerous tumor and tissue. I am now receiving radiation treatment.
Age: 66.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Ovarian neoplasm surgery, Radiotherapy
Clinical narrative: I went in to have a hernia evaluated, my doctor ordered a CT scan to see just how bad it was. The CT scan revealed that I had something abnormal going on with ovaries, the size of the tumor on my ovaries presented cancer. I underwent surgery to remove the cancerous tumor and tissue. I am now receiving radiation treatment.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary mass
Clinical narrative: 8x7 cm lump under arm/axilla. Monitor for any symptoms or fever, increase in swelling, redness, warmth. Keflex 500 mg PO tid X 10 days
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Latent autoimmune diabetes in adults
Clinical narrative: I had my vaccination on 11/2022. In 02/15/2023 I was newly diagnosed with Type 1.5 Diabetes. Latent autoimmune diabetes in adults. I started insulin treatments during this time.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypotension, Hypoxia, Organ failure, Sepsis
Clinical narrative: HYPOTENSION 1/22/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION ACUTE RESPIRATORY FAILURE 1/23/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION HYPOXIA 2/5/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, COVID-19, SARS-CoV-2 test positive
Clinical narrative: After receiving my last dose I contracted  COVID-19  on the month of August, after that I started experiencing memory loss. I don't even remember anything. My sister told me that I was doing so many weird thigs.  I was walking out.  I was locked up in the Alzheimer's unit. I kept asking questions. I didn't know who I was or what I was doing.  I also spoke with my doctor who said they  don't know the what it can be or what cause me the memory loss. As of today I am getting my memory back but very slowly. I still don't remember much. My son told me that it might be from me having COVID-19 infection but know one knows for sure.
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: none
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Adult failure to thrive, Chest pain, Nausea, Neuropathy peripheral
Clinical narrative: G45.9 TRANSIENT CEREBRAL ISCHEMIA 6/3/2021 INTRACTABLE NAUSEA AND VOMITING G62.9 PERIPHERAL NEUROPATHY 6/3/2021 INTRACTABLE NAUSEA AND VOMITING I21.4 ACUTE NON ST ELEVATION MI 11/16/2021 INTRACTABLE NAUSEA AND VOMITING G45.9 TRANSIENT CEREBRAL ISCHEMIA 6/3/2021 CHEST PAIN G62.9 PERIPHERAL NEUROPATHY 6/3/2021 CHEST PAIN I21.4 ACUTE NON ST ELEVATION MI 11/16/2021 CHEST PAIN G45.9 TRANSIENT CEREBRAL ISCHEMIA 6/3/2021 ACUTE NON ST ELEVATION MI G62.9 PERIPHERAL NEUROPATHY 6/3/2021 ACUTE NON ST ELEVATION MI I21.4 ACUTE NON ST ELEVATION MI 11/16/2021 ACUTE NON ST ELEVATION MI G45.9 TRANSIENT CEREBRAL ISCHEMIA 6/3/2021 FAILURE TO THRIVE SYNDROME, ADULT G62.9 PERIPHERAL NEUROPATHY 6/3/2021 FAILURE TO THRIVE SYNDROME, ADULT I21.4 ACUTE NON ST ELEVATION MI 11/16/2021 FAILURE TO THRIVE SYNDROME, ADULT G45.9 TRANSIENT CEREBRAL ISCHEMIA 6/3/2021 GASTRIC MASS G62.9 PERIPHERAL NEUROPATHY 6/3/2021 GASTRIC MASS I21.4 ACUTE NON ST ELEVATION MI 11/16/2021 GASTRIC MASS
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Stomach mass, Transient ischaemic attack, Vomiting
Clinical narrative: G45.9 TRANSIENT CEREBRAL ISCHEMIA 6/3/2021 INTRACTABLE NAUSEA AND VOMITING G62.9 PERIPHERAL NEUROPATHY 6/3/2021 INTRACTABLE NAUSEA AND VOMITING I21.4 ACUTE NON ST ELEVATION MI 11/16/2021 INTRACTABLE NAUSEA AND VOMITING G45.9 TRANSIENT CEREBRAL ISCHEMIA 6/3/2021 CHEST PAIN G62.9 PERIPHERAL NEUROPATHY 6/3/2021 CHEST PAIN I21.4 ACUTE NON ST ELEVATION MI 11/16/2021 CHEST PAIN G45.9 TRANSIENT CEREBRAL ISCHEMIA 6/3/2021 ACUTE NON ST ELEVATION MI G62.9 PERIPHERAL NEUROPATHY 6/3/2021 ACUTE NON ST ELEVATION MI I21.4 ACUTE NON ST ELEVATION MI 11/16/2021 ACUTE NON ST ELEVATION MI G45.9 TRANSIENT CEREBRAL ISCHEMIA 6/3/2021 FAILURE TO THRIVE SYNDROME, ADULT G62.9 PERIPHERAL NEUROPATHY 6/3/2021 FAILURE TO THRIVE SYNDROME, ADULT I21.4 ACUTE NON ST ELEVATION MI 11/16/2021 FAILURE TO THRIVE SYNDROME, ADULT G45.9 TRANSIENT CEREBRAL ISCHEMIA 6/3/2021 GASTRIC MASS G62.9 PERIPHERAL NEUROPATHY 6/3/2021 GASTRIC MASS I21.4 ACUTE NON ST ELEVATION MI 11/16/2021 GASTRIC MASS
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received a monovalent instead of a bivalent vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Patient woke up 6 days after vaccine with a red warm arm injection site reaction.  Her arm was sore after vaccine for a few days but it became red 4-19-23.
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: none
Age: 1.0
Sex: M
Vaccine: MMR, PNC15, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE/PQC.; HCP called to state that the patient was given VARIVAX after a TE event.  Reference AE case numbers 02356234, 02356417,02356418, 02356419, 02356420, 02356421, 02356422, 02356423, 02356425 . no additional AE/PQC.; This spontaneous report was received from a nurse and referred to a 12-month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot #W001519, expiration date: 13-JAN-2024, subcutaneously administered at right thigh for prophylaxis (strength were not provided); and  pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot #W027250, expiration date: 09-JUL-2024, administered intramuscularly at left thigh  for prophylaxis (strength was not provided). On 16-MAR-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W021740, expiration date: 10-JUL-2024, administered subcutaneously at right thigh for prophylaxis (strength was not provided).  On an unknown date, HCP called to state that the patient was given varicella virus vaccine live (oka/merck) (VARIVAX), after a temperature excursion event. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from medical assistant and referred to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported. On 17-FEB-2023, the patient was administered a dose of VARIVAX (valid lot #W021740 with the expiration date: 10-JUL-2024) for prophylaxis (strength, dose, route of administration, and anatomical location were not provided). This vaccine was involved in a temperature excursion, at a temperature of 14.7F for a time frame of 1 hour and 3 minutes. There was no previous temperature excursion. No additional clarifying statements or adverse event (AE) details were provided (No adverse event). This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2303USA008911: US-009507513-2303USA008836: US-009507513-2303USA008836: US-009507513-2303USA008981.
Age: 48.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional ae; Product expired; This spontaneous report was received from a pharmacist referring to a 48-year-old male patient. Information about the patient's concurrent conditions, historical conditions, concomitant medications and drug reactions/allergies were not reported.  On 29-MAR-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, unk, lot #W004865, expiration date: 02-MAR-2023, administered intramuscularly (strength and anatomical site of administration not provided) for prophylaxis (expired product administered). Product did not undergo any previous temperature excursions. No additional adverse event (AE) (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; that the patient was administered a dose of GARDASIL 9 after it expired; This spontaneous report was received from a medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 27-MAR-2023, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml intramuscularly, lot #T029522, expiration date: 13-MAR-2023, intramuscularly for prophylaxis (strength was not provided). The patient was administered this dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) after it expired (expired product administered). No additional adverse event reported (no adverse event).
Sex: M
Vaccine: HPV9
Symptoms: Body temperature increased, Cheilitis, Exposure to communicable disease, High risk sexual behaviour, Limb mass
Clinical narrative: Patient experienced 102F after vaccination; palm tenderness; he could not grip or open anything; white bumps only on the back of hands and top of his lips; white bumps only on the back of hands and top of his lips; was exposed to HPV through unprotected sex and was then given GARDASIL 9 vaccine; This spontaneous report was received from a nurse practitioner via a company representative referring to a 33-year-old male patient. The patient's medical history, drug reactions/allergies and concomitant therapies were not reported.   On an unspecified date in March 2023 (reported as 2-3 weeks ago), the patient was exposed to human papillomavirus (HPV) through unprotected sex; then, on an unknown date in 2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose intramuscularly (strength, lot #, and expiration date were not provided) (Product use in unapproved indication).   On an unknown date in 2023, the patient experienced 102 degrees Fahrenheit after vaccination (Body temperature abnormal), within 48-72 hours later the patient experienced palm tenderness (Tenderness) to the point that "he could not grip or open anything" (Musculoskeletal disorder). Patient also developed white bumps only on the back of hands (Limb mass) and top of his lips (Lip disorder). It was not reported whether the patient had sought medical attention or received any treatments. The outcome of the events was unknown.   The causal relationship between the events of body temperature abnormal, tenderness, musculoskeletal disorder, limb mass and lip disorder and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: M
Vaccine: HPV9
Symptoms: Lip disorder, Motor dysfunction, Musculoskeletal disorder, Product use in unapproved indication, Rash
Clinical narrative: Patient experienced 102F after vaccination; palm tenderness; he could not grip or open anything; white bumps only on the back of hands and top of his lips; white bumps only on the back of hands and top of his lips; was exposed to HPV through unprotected sex and was then given GARDASIL 9 vaccine; This spontaneous report was received from a nurse practitioner via a company representative referring to a 33-year-old male patient. The patient's medical history, drug reactions/allergies and concomitant therapies were not reported.   On an unspecified date in March 2023 (reported as 2-3 weeks ago), the patient was exposed to human papillomavirus (HPV) through unprotected sex; then, on an unknown date in 2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose intramuscularly (strength, lot #, and expiration date were not provided) (Product use in unapproved indication).   On an unknown date in 2023, the patient experienced 102 degrees Fahrenheit after vaccination (Body temperature abnormal), within 48-72 hours later the patient experienced palm tenderness (Tenderness) to the point that "he could not grip or open anything" (Musculoskeletal disorder). Patient also developed white bumps only on the back of hands (Limb mass) and top of his lips (Lip disorder). It was not reported whether the patient had sought medical attention or received any treatments. The outcome of the events was unknown.   The causal relationship between the events of body temperature abnormal, tenderness, musculoskeletal disorder, limb mass and lip disorder and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: M
Vaccine: HPV9
Symptoms: Sexually transmitted disease, Tenderness
Clinical narrative: Patient experienced 102F after vaccination; palm tenderness; he could not grip or open anything; white bumps only on the back of hands and top of his lips; white bumps only on the back of hands and top of his lips; was exposed to HPV through unprotected sex and was then given GARDASIL 9 vaccine; This spontaneous report was received from a nurse practitioner via a company representative referring to a 33-year-old male patient. The patient's medical history, drug reactions/allergies and concomitant therapies were not reported.   On an unspecified date in March 2023 (reported as 2-3 weeks ago), the patient was exposed to human papillomavirus (HPV) through unprotected sex; then, on an unknown date in 2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose intramuscularly (strength, lot #, and expiration date were not provided) (Product use in unapproved indication).   On an unknown date in 2023, the patient experienced 102 degrees Fahrenheit after vaccination (Body temperature abnormal), within 48-72 hours later the patient experienced palm tenderness (Tenderness) to the point that "he could not grip or open anything" (Musculoskeletal disorder). Patient also developed white bumps only on the back of hands (Limb mass) and top of his lips (Lip disorder). It was not reported whether the patient had sought medical attention or received any treatments. The outcome of the events was unknown.   The causal relationship between the events of body temperature abnormal, tenderness, musculoskeletal disorder, limb mass and lip disorder and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Age: 73.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; excursion of 72 hours 0 minutes 0 seconds at 46.7F (47F); This spontaneous report was received from a healthcare professional (HCP) referring to a 73-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.  On 03-MAR-2023, per data logs, the temperature of the stored vaccines was up to 46.7 F (product storage error). On 03-MAR-2023, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection (0.5 mL, lot#: W027449, expiration date: 25-SEP-2024; route of administration, and anatomical location were not reported) for prophylaxis. No additional adverse event (AE) was reported (no adverse event).   This is one of the 12 reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002746: US-009507513-2304USA002750:
Age: 31.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: the area was red and swollen at the injection site; the area was red and swollen at the injection site; It's feels like a big knot and feels tender just like the last time; It's feels like a big knot and feels tender just like the last time; the area was red and swollen at the injection site; the area was red and swollen at the injection site; It's feels like a big knot and feels tender just like the last time; It's feels like a big knot and feels tender just like the last time; This spontaneous report was received from a medical assistant and refers to a 31-year-old patient of unknown gender. The patient's concurrent conditions included allergy to ceftriaxone sodium (ROCEPHIN). Concomitant medications included metformin and birth control pills. He/she had no pertinent medical history.   On 15-FEB-2023 and 12-APR-2023, the patient was vaccinated with the first and second doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter, (lot # W013165, expiration date: 14-DEC-2024 [for both doses]) administered as prophylaxis (route of administration was not provided).   The reporter stated the patient developed injection site reaction after receiving the first and second doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient mentioned to the medical assistant that the area was red and swollen at the injection site, and that it felt like a big knot and tender just like the last time. At the reporting time, the patient had not recovered from vaccination site erythema, vaccination site pain, vaccination site swelling or vaccination site induration (onset date: April 2023).  The reporter did not provide a causal assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No additional AEs reported; had a previous temperature excursion; expired vaccine was administered; This spontaneous report was received from a registered nurse and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 14-APR-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (strength: 50 dosage form, 1 mL, lot #U036184, expiration date: 02-MAR-2023, administered intramuscularly through deltoid (unspecified) for prophylaxis (expired product administered). The suspect vaccine had had a previous temperature excursion (product storage error). The detail of temperature excursion was not reported. No additional adverse event reported (no adverse event).
Age: 28.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AEs; HCP reported that a 28 year old patient received their second dose of GARDASIL 9 before the 2 month mark. HCP reports the patient received their first dose on 3/13/23 and second dose on 4/17/23. No further information was provided to further clarify; This spontaneous report was received from a pharmacist concerning a 28-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-MAR-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered for prophylaxis (dose, strength, lot #, expiry date, anatomical location and route of administration were not provided). On 17-APR-2023, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), which was before the 2 months mark (Inappropriate schedule of product administration). No adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: got the prick and got shingles/Suspected Vaccination Failure; got shingles; pain; itching; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the prick and got shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: got shingles), pain (Verbatim: pain) and pruritus (Verbatim: itching). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain and pruritus were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-MAR-2023 This case was reported by a patient via interactive digital media. The reporter got the shingles they said. The doctor said he/she was probably had good timing because you could not get shingles from the shingles shot. Therefore, he/she got the prick and then the pain and itching.  The reporter did shingles vaccine and got shingles.  The reporter stated that he/she wished he/she was that lucky at the lottery.  The reporter stated that did not get shingles shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Have shingles and had all tha vaccines/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Have shingles and had all tha vaccines/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received all the shingles vaccines and experienced shingles. The patient stated that the vaccine did not work. The patient received treatment but it was did not work. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot and have had it/suspected vaccination failure; had it terrible; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the shot and have had it/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had it terrible). The outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved (duration 1 month).   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 20-Mar-2023 The case was received from the patient via interactive digital media. The patient stated that the shingles shot was no guarantee that you would not get them. The patient had the shot and have had them about a month terrible. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: had shingles shot had them/suspected vaccination failure; had them left lower stomach and thigh; itched terrible; did not hurt that much; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shingles shot had them/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: had them left lower stomach and thigh), pruritus (Verbatim: itched terrible) and pain (Verbatim: did not hurt that much). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported and the outcome of the pruritus was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pruritus and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 20-MAR-2023 The case  was received from the patient via interactive digital media. The patient had them on the left side of lower stomach in the crease of his/her thigh did not hurt.  That much but itched terrible and he/she still got itch there. The patient had the Shingles shot some years ago and thought that helped him/her.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Eating disorder, Herpes zoster, Pain, Vaccination failure
Clinical narrative: had both shingle shot, into outbreak/suspected vaccination failure; large outbreak around waist into back; Worst pain ever; couldn´t eat; weak; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had both shingle shot, into outbreak/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: large outbreak around waist into back), pain (Verbatim: Worst pain ever), eating disorder (Verbatim: couldn´t eat) and weakness (Verbatim: weak). The patient was treated with non-drug therapy (Physical Therapy). The outcome of the vaccination failure was unknown and the outcome of the shingles, eating disorder and weakness were not reported and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, eating disorder and weakness to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain, eating disorder and weakness to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 20-Mar-2023 The case was received from the patient via interactive digital media. The patient had both shingles shots 3 years ago and month into large outbreak around waist all the way into back.  The patient stated still had worst pain he or she ever.  The patient could not eat and got so weak.  Now had nurses, physical therapy, occupational therapy coming weekly to get the patient's strength back.  This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got it from medication side effects/suspected vaccination failure; got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got it from medication side effects/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 20-MAR-2023 The case  was received from the patient via interactive digital media. The patient got it from medication side effects. The patient had the Shingles shot some years ago and thought that helped him/her.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: not as bad if I didn´t get the shot/suspected vaccination failure; came down with shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included shingles (patient's son had them).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: not as bad if I didn´t get the shot/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: came down with shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 20-Mar-2023 The case was received from the patient via interactive digital media. The patient heard about shingles because his or her son had them so, he or she wanted to get the vaccine to prevent coming down with shingles. The physician wrote it up wrong so it cost the patient 400 dollars. 2 or 3 weeks later, the patient came down with shingles. The patient stated that but not as bad if he or she did not get the shot. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.