chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: No adverse event
Clinical narrative: No adverse effects but patient was given the correct age dose 6mo-4yrs on 12/27/22 when he was 4 years old but he was given the 5yr-11yrs dose on 1/18/23 (he turned 5 yrs old on 12/31/22).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep apnoea syndrome, Symptom recurrence
Clinical narrative: SLEEP APNEA 4/1/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal pain upper, Decreased appetite, Eye pain, Fatigue
Clinical narrative: Tiredness, muscle pain (in arm where injected only), headache - to near migraine, fever - although I didn't actually take temp but head was warm and pain behind eyes, stomach pain - like sever bloating that couldn't release, slight nausea and loss of appetite.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Myalgia, Nausea, Pyrexia
Clinical narrative: Tiredness, muscle pain (in arm where injected only), headache - to near migraine, fever - although I didn't actually take temp but head was warm and pain behind eyes, stomach pain - like sever bloating that couldn't release, slight nausea and loss of appetite.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Tiredness, muscle pain (in arm where injected only), headache - to near migraine, fever - although I didn't actually take temp but head was warm and pain behind eyes, stomach pain - like sever bloating that couldn't release, slight nausea and loss of appetite.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Cough, Hypersensitivity, Swelling face, Urticaria, Wheezing
Clinical narrative: 6/1/2023 10:25: from mother, to inform of client developing allergic reaction after receipt of vaccines yesterday. Of note client received first dose of VAQTA Hepatitis A vaccine. Mother states at appx. 1630 client developed hives that started at head and spread to trunk and extremities (while at home). Facial swelling, cough and wheezing developed. Mom states she administered Loratadine PO and drove client to ER. Client was given steroids and Benadryl at ER where s/s improved. After monitor until appx 2200 client was sent home w/ script for oral steroids. Mother states she has also been giving Benadryl q 6 hours per ER physician instruction. Client f/u w/ by Dr, PCP this am.  Mother states client's s/s have continued to improve since yesterday afternoon. Mother states physician informed her allergic reaction was likely d/t receipt of Hepatitis A vaccine as no new foods, detergents, soaps, etc. had been introduced. Mother was instructed by PCP to not complete client's Hepatitis A series. This nurse discussed contraindications and description of VAQTA vaccination including neomycin component. Informed mom this nurse to submit report and update allergy list. Mother verbalized understanding and without further questions at this time.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Epilepsy, Hypoxia
Clinical narrative: EPILEPSY, UNSPECIFIED HYPOXIA
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, Underdose
Clinical narrative: The patient received the incorrect vaccine. She received 0.2ml of the magenta cap formulation (ndc: 80777-0283-02) instead of receiving 0.25ml of the blue cap formulation (ndc: 80777-0282-05).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Inflammatory bowel disease, Irritable bowel syndrome, Medical procedure, Pain in extremity
Clinical narrative: I had a sore arm for about a day after receiving the Moderna Dose 4 vaccine. Since receiving the first COVID-19 within two weeks, I have had both upper and lower gastrointestinal issues. I have had multiply procedure to diagnose and treat to my health issues. I have a history of gastrointestinal issues. As of yesterday, my doctor says I have irritable bowel syndrome and inflammatory disease.
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose, Wrong product administered
Clinical narrative: The patient received the incorrect vaccine. She recieved 0.2ml of the magenta cap [ndc: 80777-0283-02] instead of 0.25ml of the blue cap [ndc: 80777-0282-05]
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chronic respiratory failure, Epilepsy, Hypersensitivity, Myelitis transverse
Clinical narrative: TRANSVERSE MYELITIS EPILEPSY, UNSPECIFIED ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE ALLERGIC REACTION, INIT
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory failure
Clinical narrative: TRANSVERSE MYELITIS EPILEPSY, UNSPECIFIED ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE ALLERGIC REACTION, INIT
Age: 42.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received dose 3 of HPV series early. First dose administered 2/7/23. Second dose administered 4/19/23. Third dose administered 5/22/23. Patient has been rescheduled to repeat third dose in series in August. No adverse effects noted.
Age: 4.0
Sex: M
Vaccine: FLU4, MMR
Symptoms: Erythema, Peripheral swelling
Clinical narrative: . Parent reported the right hip to the knee to be swollen with mild redness,  symptoms starting on the evening of 5/30/2023. Denied leg or joint pain, skin oozing, or bleeding. Denied fever, chills, malaise/fatigue, dyspnea, vomiting, diarrhea, insect bites, or h/o leg trauma. Influenza and MMR were given on the right thigh where the reaction occurred. Kinrix and Varicella were given on the left side with no reaction.
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient age was overlooked and he received a second bivalent booster even though he was only 62 years old. He was glad to have gotten it and we only realized that he should not have gotten it when he returned with his wife because she wanted it also and we said she was too young.  We followed up with patient at 1 and 5 days afterwards and he said he had no adverse reactions to the vaccine.
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, Underdose
Clinical narrative: Was using an outdated version of the clinic's covid vaccine administration guide as the new one from 05/12/23 hadn't been disrupted to the clinic yet. Following the decision-making process on the guide, as well as double checking with the vaccine coordinator verbally administered 0.2mL of Moderna covid vaccine to pt. One hour later the vaccine coordinator distributed to the clinic an updated decision-making guide which reflected current CDC covid vaccine guidelines which indicated the pt should have received 0.5mL of Moderna bivalent vaccine from a different color-coded vial. Pt received a lower dose then recommended by CDC by aprox 0.3mL. Dose needed to be drawn up from a different Moderna vial as well.
Age: 3.0
Sex: M
Vaccine: COVID19-2, COVID19-2, COVID19-2
Symptoms: Interchange of vaccine products
Clinical narrative: Patient was given the Moderna vaccine for the first 2 series of shots but the Pfizer for the 3rd.
Age: 16.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Mom states child had fever 104, headache, Chills, Nausea,  Fever comes down to 99.5 with motrin
Age: 0.25
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV1, DTPPVHBHPB, PNC13, RV1
Symptoms: Wrong product administered
Clinical narrative: only diluent was given to  patient
Age: 0.25
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV1, DTPPVHBHPB, PNC13, RV1
Symptoms: Product preparation error
Clinical narrative: only diluent was given to  patient
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Facial paresis, Symptom recurrence, Transient ischaemic attack
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE TRANSIENT CEREBRAL ISCHEMIA RIGHT FACIAL MUSCLE WEAKNESS 1/30/2023 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, SARS-CoV-2 test negative, Sputum discoloured
Clinical narrative: On 05/22/2023  in the early afternoon  I 've noticed a dry cough with yellow phlegm. I went to the urgent care when things started going down the hill. At the urgent care they prescribed me Antibiotics ( Amoxicillin)  and cough syrup Promethazine. After taking the medication my throat was calm . I took the last antibiotic pill yesterday but I feel better now.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION, INIT
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Angina pectoris
Clinical narrative: STABLE ANGINA ACUTE NON ST ELEVATION MI
Age: 1.92
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was at clinic for his 4th DTaP. He was inadvertently administered Kinrix DTaP+IPV. No adverse effects of the event have been reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Metastases to lymph nodes, Neoplasm malignant
Clinical narrative: HYPOXIA 12/12/2022 CANCER METASTATIC TO INTRATHORACIC LN
Age: 1.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: In October 2022, my blood pressure was high, 142/92, I was put on a monitor.  In April 2023, it was 152/96 and in May of 2023 it was 170/90.  I've been given a water pill to help and I have changed my diet and it has helped.  There are no symptoms.  The only way I know is when I check my pressure.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Client was given an adult Hepatitis B instead of Hepatitis B pediatric .  Client did not have a reaction.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, Arthritis, Glossopharyngeal neuralgia, Laboratory test, Pituitary tumour
Clinical narrative: Severe arthritis & tendonitis, glossopharyngeal neuralgia, pituitary tumor
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Tendonitis
Clinical narrative: Severe arthritis & tendonitis, glossopharyngeal neuralgia, pituitary tumor
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Epilepsy, Ischaemic stroke, Partial seizures
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE FOCAL MOTOR SEIZURE EPILEPSY, UNSPECIFIED ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Cardiac failure congestive, Chronic respiratory failure, Hypoxia, Myeloproliferative neoplasm
Clinical narrative: J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/18/2023 ANEMIA R09.02 HYPOXIA 11/1/2022 ANEMIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/18/2023 ANEMIA R09.02 HYPOXIA 11/1/2022 ANEMIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/18/2023 CHRONIC MYELOPROLIFERATIVE DISORDER R09.02 HYPOXIA 11/1/2022 CHRONIC MYELOPROLIFERATIVE DISORDER J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/18/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R09.02 HYPOXIA 11/1/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/18/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R09.02 HYPOXIA 11/1/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/18/2023 CHRONIC MYELOPROLIFERATIVE DISORDER R09.02 HYPOXIA 11/1/2022 CHRONIC MYELOPROLIFERATIVE DISORDER
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory failure
Clinical narrative: J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/18/2023 ANEMIA R09.02 HYPOXIA 11/1/2022 ANEMIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/18/2023 ANEMIA R09.02 HYPOXIA 11/1/2022 ANEMIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/18/2023 CHRONIC MYELOPROLIFERATIVE DISORDER R09.02 HYPOXIA 11/1/2022 CHRONIC MYELOPROLIFERATIVE DISORDER J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/18/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R09.02 HYPOXIA 11/1/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/18/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R09.02 HYPOXIA 11/1/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/18/2023 CHRONIC MYELOPROLIFERATIVE DISORDER R09.02 HYPOXIA 11/1/2022 CHRONIC MYELOPROLIFERATIVE DISORDER
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Adjustment disorder with anxiety, Diabetic ketoacidosis, Epilepsy, Hyperglycaemia
Clinical narrative: EPILEPSY, UNSPECIFIED 1/26/2023 ALTERED MENTAL STATUS, UNSPECIFIED ACUTE RESPIRATORY FAILURE 2/28/2023 ALTERED MENTAL STATUS, UNSPECIFIED EPILEPSY, UNSPECIFIED 1/26/2023 ADJUSTMENT DISORDER W ANXIETY ACUTE RESPIRATORY FAILURE 2/28/2023 ADJUSTMENT DISORDER W ANXIETY EPILEPSY, UNSPECIFIED 1/26/2023 BRAIN MASS ACUTE RESPIRATORY FAILURE 2/28/2023 BRAIN MASS EPILEPSY, UNSPECIFIED 1/26/2023 ADJUSTMENT DISORDER W ANXIETY ACUTE RESPIRATORY FAILURE 2/28/2023 ADJUSTMENT DISORDER W ANXIETY EPILEPSY, UNSPECIFIED 1/26/2023 METABOLIC ENCEPHALOPATHY ACUTE RESPIRATORY FAILURE 2/28/2023 METABOLIC ENCEPHALOPATHY EPILEPSY, UNSPECIFIED 1/26/2023 DM 1 W KETOACIDOSIS ACUTE RESPIRATORY FAILURE 2/28/2023 DM 1 W KETOACIDOSIS EPILEPSY, UNSPECIFIED 1/26/2023 DM 1 W HYPERGLYCEMIA ACUTE RESPIRATORY FAILURE 2/28/2023 DM 1 W HYPERGLYCEMIA EPILEPSY, UNSPECIFIED 1/26/2023 BRAIN MASS ACUTE RESPIRATORY FAILURE 2/28/2023 BRAIN MASS
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Intracranial mass, Mental status changes, Metabolic encephalopathy, Type 1 diabetes mellitus
Clinical narrative: EPILEPSY, UNSPECIFIED 1/26/2023 ALTERED MENTAL STATUS, UNSPECIFIED ACUTE RESPIRATORY FAILURE 2/28/2023 ALTERED MENTAL STATUS, UNSPECIFIED EPILEPSY, UNSPECIFIED 1/26/2023 ADJUSTMENT DISORDER W ANXIETY ACUTE RESPIRATORY FAILURE 2/28/2023 ADJUSTMENT DISORDER W ANXIETY EPILEPSY, UNSPECIFIED 1/26/2023 BRAIN MASS ACUTE RESPIRATORY FAILURE 2/28/2023 BRAIN MASS EPILEPSY, UNSPECIFIED 1/26/2023 ADJUSTMENT DISORDER W ANXIETY ACUTE RESPIRATORY FAILURE 2/28/2023 ADJUSTMENT DISORDER W ANXIETY EPILEPSY, UNSPECIFIED 1/26/2023 METABOLIC ENCEPHALOPATHY ACUTE RESPIRATORY FAILURE 2/28/2023 METABOLIC ENCEPHALOPATHY EPILEPSY, UNSPECIFIED 1/26/2023 DM 1 W KETOACIDOSIS ACUTE RESPIRATORY FAILURE 2/28/2023 DM 1 W KETOACIDOSIS EPILEPSY, UNSPECIFIED 1/26/2023 DM 1 W HYPERGLYCEMIA ACUTE RESPIRATORY FAILURE 2/28/2023 DM 1 W HYPERGLYCEMIA EPILEPSY, UNSPECIFIED 1/26/2023 BRAIN MASS ACUTE RESPIRATORY FAILURE 2/28/2023 BRAIN MASS
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest X-ray abnormal, Chest pain, Cough, Dyspnoea, Fatigue
Clinical narrative: Around the end of April, I started out with what felt like a sinus infection. Then a cough started. I was taking Mucinex to help with symptoms. As the week went on, I developed a sore throat and it moved into my lungs. I started feeling shooting pain in my chest and I started having a bit of difficulty breathing. I also had really bad fatigue. I went to a local care spot. They took an x-ray and told me that it was a lung infection. They prescribed steroids and antibiotics. It took about 5 days to resolve.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lung disorder, Oropharyngeal pain, Pain, Pneumonia, SARS-CoV-2 test negative
Clinical narrative: Around the end of April, I started out with what felt like a sinus infection. Then a cough started. I was taking Mucinex to help with symptoms. As the week went on, I developed a sore throat and it moved into my lungs. I started feeling shooting pain in my chest and I started having a bit of difficulty breathing. I also had really bad fatigue. I went to a local care spot. They took an x-ray and told me that it was a lung infection. They prescribed steroids and antibiotics. It took about 5 days to resolve.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Streptococcus test negative
Clinical narrative: Around the end of April, I started out with what felt like a sinus infection. Then a cough started. I was taking Mucinex to help with symptoms. As the week went on, I developed a sore throat and it moved into my lungs. I started feeling shooting pain in my chest and I started having a bit of difficulty breathing. I also had really bad fatigue. I went to a local care spot. They took an x-ray and told me that it was a lung infection. They prescribed steroids and antibiotics. It took about 5 days to resolve.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Clostridium difficile colitis, Deep vein thrombosis, Focal dyscognitive seizures, Gait disturbance
Clinical narrative: G62.9 PERIPHERAL NEUROPATHY 6/27/2022 GAIT ABNORMALITY I82.441 ACUTE DVT OF RIGHT TIBIAL VEIN 8/28/2022 GAIT ABNORMALITY G62.9 PERIPHERAL NEUROPATHY 6/27/2022 HYPOXIA I82.441 ACUTE DVT OF RIGHT TIBIAL VEIN 8/28/2022 HYPOXIA G62.9 PERIPHERAL NEUROPATHY 6/27/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I82.441 ACUTE DVT OF RIGHT TIBIAL VEIN 8/28/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED G62.9 PERIPHERAL NEUROPATHY 6/27/2022 C DIFFICILE COLITIS, RECURRENT I82.441 ACUTE DVT OF RIGHT TIBIAL VEIN 8/28/2022 C DIFFICILE COLITIS, RECURRENT G62.9 PERIPHERAL NEUROPATHY 6/27/2022 WEAKNESS OF RIGHT LEG I82.441 ACUTE DVT OF RIGHT TIBIAL VEIN 8/28/2022 WEAKNESS OF RIGHT LEG G62.9 PERIPHERAL NEUROPATHY 6/27/2022 COMPLEX PARTIAL EPILEPSY I82.441 ACUTE DVT OF RIGHT TIBIAL VEIN 8/28/2022 COMPLEX PARTIAL EPILEPSY
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Hemiparesis, Hypoxia, Muscular weakness, Neuropathy peripheral
Clinical narrative: G62.9 PERIPHERAL NEUROPATHY 6/27/2022 GAIT ABNORMALITY I82.441 ACUTE DVT OF RIGHT TIBIAL VEIN 8/28/2022 GAIT ABNORMALITY G62.9 PERIPHERAL NEUROPATHY 6/27/2022 HYPOXIA I82.441 ACUTE DVT OF RIGHT TIBIAL VEIN 8/28/2022 HYPOXIA G62.9 PERIPHERAL NEUROPATHY 6/27/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I82.441 ACUTE DVT OF RIGHT TIBIAL VEIN 8/28/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED G62.9 PERIPHERAL NEUROPATHY 6/27/2022 C DIFFICILE COLITIS, RECURRENT I82.441 ACUTE DVT OF RIGHT TIBIAL VEIN 8/28/2022 C DIFFICILE COLITIS, RECURRENT G62.9 PERIPHERAL NEUROPATHY 6/27/2022 WEAKNESS OF RIGHT LEG I82.441 ACUTE DVT OF RIGHT TIBIAL VEIN 8/28/2022 WEAKNESS OF RIGHT LEG G62.9 PERIPHERAL NEUROPATHY 6/27/2022 COMPLEX PARTIAL EPILEPSY I82.441 ACUTE DVT OF RIGHT TIBIAL VEIN 8/28/2022 COMPLEX PARTIAL EPILEPSY
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, Arthritis, Blood test, Glossopharyngeal neuralgia, Magnetic resonance imaging
Clinical narrative: Severe arthritis & tendonitis, glossopharyngeal neuralgia, pituitary tumor
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pituitary tumour, Tendonitis
Clinical narrative: Severe arthritis & tendonitis, glossopharyngeal neuralgia, pituitary tumor
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE ACUTE HYPERCAPNIC RESPIRATORY FAILURE
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Symptom recurrence
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI 5/26/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic encephalopathy, Reversible ischaemic neurological deficit
Clinical narrative: REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME 11/11/2022 METABOLIC ENCEPHALOPATHY
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Dyskinesia, Headache, Hyperhidrosis, Immediate post-injection reaction, Immunisation reaction
Clinical narrative: Immediately following administration, while needle was being pulled out of right deltoid, patient reported headache, and subsequently fainted. She was supported into a lying position from a seated position on the exam table. She did not injure her head. Writer was called into the room and observed the patient in a lying position, eyes open with dilated pupils but unresponsive. She was diaphoretic, and exhibited jerking movements of her upper extremities. After a period of about 20 seconds, she regained consciousness. She was alert and oriented x 3, but pale and diaphoretic. She was assisted into a seated position, and vitals were normal for age. Heart rate and rhythm were regular. Pupils reduced back to original size. She reported some nausea, but otherwise no pain.  She was observed in office for a period of 30 minutes, and was released to mother with no further complications. Her mother was at the bedside the entire time. Diagnosis is vasovagal syncope as an adverse reaction to vaccination.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness, Mydriasis, Nausea, Pallor, Syncope
Clinical narrative: Immediately following administration, while needle was being pulled out of right deltoid, patient reported headache, and subsequently fainted. She was supported into a lying position from a seated position on the exam table. She did not injure her head. Writer was called into the room and observed the patient in a lying position, eyes open with dilated pupils but unresponsive. She was diaphoretic, and exhibited jerking movements of her upper extremities. After a period of about 20 seconds, she regained consciousness. She was alert and oriented x 3, but pale and diaphoretic. She was assisted into a seated position, and vitals were normal for age. Heart rate and rhythm were regular. Pupils reduced back to original size. She reported some nausea, but otherwise no pain.  She was observed in office for a period of 30 minutes, and was released to mother with no further complications. Her mother was at the bedside the entire time. Diagnosis is vasovagal syncope as an adverse reaction to vaccination.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Unresponsive to stimuli
Clinical narrative: Immediately following administration, while needle was being pulled out of right deltoid, patient reported headache, and subsequently fainted. She was supported into a lying position from a seated position on the exam table. She did not injure her head. Writer was called into the room and observed the patient in a lying position, eyes open with dilated pupils but unresponsive. She was diaphoretic, and exhibited jerking movements of her upper extremities. After a period of about 20 seconds, she regained consciousness. She was alert and oriented x 3, but pale and diaphoretic. She was assisted into a seated position, and vitals were normal for age. Heart rate and rhythm were regular. Pupils reduced back to original size. She reported some nausea, but otherwise no pain.  She was observed in office for a period of 30 minutes, and was released to mother with no further complications. Her mother was at the bedside the entire time. Diagnosis is vasovagal syncope as an adverse reaction to vaccination.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient was given ProQuad and Varivax.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis, Hypotension, Rectal haemorrhage
Clinical narrative: I95.9 HYPOTENSION 2/11/2023 DIVERTICULITIS I95.9 HYPOTENSION 2/11/2023 RECTAL BLEEDING
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Acute respiratory failure, Cardiac failure congestive, Cardiogenic shock, Cardiomyopathy
Clinical narrative: ACUTE NON ST ELEVATION MI 1/29/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE RESPIRATORY FAILURE 2/4/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/22/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/9/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/24/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE CARDIOGENIC SHOCK 12/29/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE NON ST ELEVATION MI 1/29/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED ACUTE RESPIRATORY FAILURE 2/4/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/22/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/9/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/24/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED CARDIOGENIC SHOCK 12/29/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED ACUTE NON ST ELEVATION MI 1/29/2023 CARDIOMYOPATHY, UNSPECIFIED ACUTE RESPIRATORY FAILURE 2/4/2023 CARDIOMYOPATHY, UNSPECIFIED ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/22/2022 CARDIOMYOPATHY, UNSPECIFIED  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/9/2022 CARDIOMYOPATHY, UNSPECIFIED RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/24/2022 CARDIOMYOPATHY, UNSPECIFIED CARDIOGENIC SHOCK 12/29/2022 CARDIOMYOPATHY, UNSPECIFIED ACUTE NON ST ELEVATION MI 1/29/2023 ACUTE EXACERBATION OF COPD ACUTE RESPIRATORY FAILURE 2/4/2023 ACUTE EXACERBATION OF COPD ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/22/2022 ACUTE EXACERBATION OF COPD CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/9/2022 ACUTE EXACERBATION OF COPD RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/24/2022 ACUTE EXACERBATION OF COPD CARDIOGENIC SHOCK 12/29/2022 ACUTE EXACERBATION OF COPD  ACUTE NON ST ELEVATION MI 1/29/2023 CARDIOGENIC SHOCK ACUTE RESPIRATORY FAILURE 2/4/2023 CARDIOGENIC SHOCK ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/22/2022 CARDIOGENIC SHOCK CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/9/2022 CARDIOGENIC SHOCK RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/24/2022 CARDIOGENIC SHOCK CARDIOGENIC SHOCK 12/29/2022 CARDIOGENIC SHOCK ACUTE NON ST ELEVATION MI 1/29/2023 PNEUMONIA ACUTE RESPIRATORY FAILURE 2/4/2023 PNEUMONIA ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/22/2022 PNEUMONIA  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/9/2022 PNEUMONIA RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/24/2022 PNEUMONIA CARDIOGENIC SHOCK 12/29/2022 PNEUMONIA
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Chronic respiratory failure, Condition aggravated, Pneumonia, Respiratory failure
Clinical narrative: ACUTE NON ST ELEVATION MI 1/29/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE RESPIRATORY FAILURE 2/4/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/22/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/9/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/24/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE CARDIOGENIC SHOCK 12/29/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE NON ST ELEVATION MI 1/29/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED ACUTE RESPIRATORY FAILURE 2/4/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/22/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/9/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/24/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED CARDIOGENIC SHOCK 12/29/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED ACUTE NON ST ELEVATION MI 1/29/2023 CARDIOMYOPATHY, UNSPECIFIED ACUTE RESPIRATORY FAILURE 2/4/2023 CARDIOMYOPATHY, UNSPECIFIED ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/22/2022 CARDIOMYOPATHY, UNSPECIFIED  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/9/2022 CARDIOMYOPATHY, UNSPECIFIED RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/24/2022 CARDIOMYOPATHY, UNSPECIFIED CARDIOGENIC SHOCK 12/29/2022 CARDIOMYOPATHY, UNSPECIFIED ACUTE NON ST ELEVATION MI 1/29/2023 ACUTE EXACERBATION OF COPD ACUTE RESPIRATORY FAILURE 2/4/2023 ACUTE EXACERBATION OF COPD ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/22/2022 ACUTE EXACERBATION OF COPD CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/9/2022 ACUTE EXACERBATION OF COPD RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/24/2022 ACUTE EXACERBATION OF COPD CARDIOGENIC SHOCK 12/29/2022 ACUTE EXACERBATION OF COPD  ACUTE NON ST ELEVATION MI 1/29/2023 CARDIOGENIC SHOCK ACUTE RESPIRATORY FAILURE 2/4/2023 CARDIOGENIC SHOCK ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/22/2022 CARDIOGENIC SHOCK CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/9/2022 CARDIOGENIC SHOCK RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/24/2022 CARDIOGENIC SHOCK CARDIOGENIC SHOCK 12/29/2022 CARDIOGENIC SHOCK ACUTE NON ST ELEVATION MI 1/29/2023 PNEUMONIA ACUTE RESPIRATORY FAILURE 2/4/2023 PNEUMONIA ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/22/2022 PNEUMONIA  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/9/2022 PNEUMONIA RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/24/2022 PNEUMONIA CARDIOGENIC SHOCK 12/29/2022 PNEUMONIA
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Hypersomnia, Productive cough, Pyrexia
Clinical narrative: I started to have a runny nose. 3/25 tested with at home COVID-19 test, positive. Televisit with doctor. Prescribed PAXLOVID, ADVIL, MUCINEX, and CORICIDIN D. I had a little bit of a fever and lots of fatigue. These symptoms lasted about 2 days where I mostly slept. After that, I had just a slight, periodic cough what was productive. The cough lingered about 8 weeks.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I started to have a runny nose. 3/25 tested with at home COVID-19 test, positive. Televisit with doctor. Prescribed PAXLOVID, ADVIL, MUCINEX, and CORICIDIN D. I had a little bit of a fever and lots of fatigue. These symptoms lasted about 2 days where I mostly slept. After that, I had just a slight, periodic cough what was productive. The cough lingered about 8 weeks.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Adenocarcinoma pancreas, Anaemia, Back pain, Hypotension, Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM 2/27/2023 ANEMIA HYPOTENSION 2/22/2023 ANEMIA ACUTE PULMONARY EMBOLISM 2/27/2023 ACUTE PULMONARY EMBOLISM HYPOTENSION 2/22/2023 ACUTE PULMONARY EMBOLISM ACUTE PULMONARY EMBOLISM 2/27/2023 ADENOCARCINOMA, PANCREAS, UNSPECIFIED SITE HYPOTENSION 2/22/2023 ADENOCARCINOMA, PANCREAS, UNSPECIFIED SITE ACUTE PULMONARY EMBOLISM 2/27/2023 SUBACUTE LOW BACK PAIN 1 - 3 MONTHS HYPOTENSION 2/22/2023 SUBACUTE LOW BACK PAIN 1 - 3 MONTHS
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Dementia Alzheimer's type
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 2/21/2023 ALZHEIMERS DISEASE
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram abdomen, Computerised tomogram thorax, Lumbar puncture, Magnetic resonance imaging head
Clinical narrative: Got COVID in December of 20022 then got a diagnosis of Multiple Sclerosis in March of 2023. Questioning if connected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging spinal, Multiple sclerosis
Clinical narrative: Got COVID in December of 20022 then got a diagnosis of Multiple Sclerosis in March of 2023. Questioning if connected.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypotension, Pneumoperitoneum
Clinical narrative: I95.9 HYPOTENSION 2/7/2023 PNEUMOPERITONEUM J96.00 ACUTE RESPIRATORY FAILURE 2/7/2023 PNEUMOPERITONEUM
Age: 1.08
Sex: F
Vaccine: HEP
Symptoms: Erythema multiforme, Fall, Gait disturbance, Laboratory test, Rash
Clinical narrative: Vomiting, falling , walking into walls, turning into a rash that developed slowly overtime. Eventually being diagnosed as erythema multiforme.
Age: 1.08
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Vomiting, falling , walking into walls, turning into a rash that developed slowly overtime. Eventually being diagnosed as erythema multiforme.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral
Clinical narrative: Hearing loss in the right ear 3 days after vaccination.  This was confirmed by an audiologist.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Organ failure, Sepsis
Clinical narrative: ACUTE RESPIRATORY FAILURE 12/20/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION ACUTE RESPIRATORY FAILURE 12/20/2022 HOSPICE CARE
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Swelling, Urticaria
Clinical narrative: Patient received both Zoster (Shingrix) and Flublok quad 2022-2023 PFS on 9/27/22 intramuscularly in her left deltoid.  She called the pharmacy on 6/1/23 to make aware that she experienced immediate swelling and hives on 9/27/22 and the hives have remained on her skin ever since.  She said her doctor has had her on steroids, allegra, and pepcid AC for awhile but she still has the swelling.  She asked about the inactive ingredients in the vaccines because she was concerned they may have had an effect.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperlipidaemia, Hypotension
Clinical narrative: HYPOTENSION 2/12/2023 HYPERLIPIDEMIA
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Erythema, Fatigue, Pain, Swelling
Clinical narrative: within 24 hours of receiving the vaccine, noticed being tired and achy. 2nd toe on the Right foot was swollen and red.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient reported to clinic for Influenza vaccination.  After vaccine was administered, it was discovered that patiet had already had athe same vaccine on 11/04/2022.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, BRCA1 gene mutation, BRCA1 gene mutation assay, Coronary artery disease, Gene mutation identification test positive
Clinical narrative: ACUTE RESPIRATORY FAILURE 2/24/2023 ESOPHAGEAL CANCER, UNSPECIFIED SITE ACUTE RESPIRATORY FAILURE 2/24/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA ACUTE RESPIRATORY FAILURE 2/24/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA ACUTE RESPIRATORY FAILURE 2/24/2023 BRCA1 GENE MUTATION POSITIVE
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Oesophageal carcinoma
Clinical narrative: ACUTE RESPIRATORY FAILURE 2/24/2023 ESOPHAGEAL CANCER, UNSPECIFIED SITE ACUTE RESPIRATORY FAILURE 2/24/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA ACUTE RESPIRATORY FAILURE 2/24/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA ACUTE RESPIRATORY FAILURE 2/24/2023 BRCA1 GENE MUTATION POSITIVE
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Embolic stroke, End stage renal disease, Intestinal mass, Lacunar stroke
Clinical narrative: ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 2/6/2023 DUODENAL MASS ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 2/16/2023 DUODENAL MASS ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 2/6/2023 MALIGNANT NEUROENDOCRINE TUMOR, DUODENUM ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 2/16/2023 MALIGNANT NEUROENDOCRINE TUMOR, DUODENUM ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 2/6/2023 ABDOMINAL PAIN ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 2/16/2023 ABDOMINAL PAIN ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 2/6/2023 ESRD (END STAGE RENAL DISEASE) ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 2/16/2023 ESRD (END STAGE RENAL DISEASE)
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Small intestine carcinoma, Small intestine neuroendocrine tumour
Clinical narrative: ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 2/6/2023 DUODENAL MASS ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 2/16/2023 DUODENAL MASS ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 2/6/2023 MALIGNANT NEUROENDOCRINE TUMOR, DUODENUM ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 2/16/2023 MALIGNANT NEUROENDOCRINE TUMOR, DUODENUM ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 2/6/2023 ABDOMINAL PAIN ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 2/16/2023 ABDOMINAL PAIN ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 2/6/2023 ESRD (END STAGE RENAL DISEASE) ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 2/16/2023 ESRD (END STAGE RENAL DISEASE)
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash
Clinical narrative: Developed rash like symptoms on face and back
Age: 7.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age, Skin papilloma
Clinical narrative: the physician stated the warts on her face were cleared; The physician gave three doses of GARDASIL 9, over an unspecified time frame, to the patient prior to her reaching 9 years old,; This spontaneous report was received from Physician and refers to a 7-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On an unknown date, the patient was vaccinated with the first, second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, vaccination scheme, frequency, lot number, expiration date, and route of administration were not provided) administered for prophylaxis. She was approximately 7 years old (product administered to patient of inappropriate age), with facial warts, and on 24-MAY-2023, the physician stated warts on her face were cleared (therapeutic response unexpected). The outcome of the event was not provided.  The causality assessment between the event Therapeutic response unexpected and the suspect vaccines was not reported.
Sex: U
Vaccine: HEP
Symptoms: Viral titre decreased
Clinical narrative: Immunity Titer Low After Series; Initial Report Received on 14-Feb-2023  A registered nurse reported that a patient (age, gender, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and his/her immunity was still low after the 2-dose series.  Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On unknown dates, the patient received the first and second dose of HEPLISAV-B vaccine (details not provided).   On an unknown date after completing a 2-dose regimen of HEPLISAV-B, the patient's I"mmunity titer was still low after the series."  No further information as provided. Additional information was requested.   Company Comment: The company assessed the event as non-serious. The case is not immunologically confirmed as the dosing interval, titer and time to titer were not specified.; Sender's Comments: The company assessed the event as non-serious. The case is not immunologically confirmed as the dosing interval, titer and time to titer were not specified.
Sex: M
Vaccine: VARZOS
Symptoms: COVID-19, Herpes zoster, Vaccination failure
Clinical narrative: had shingles outbreaks  / Suspected vaccination faliure; has had shingles outbreaks; Covid; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: had shingles outbreaks  / Suspected vaccination faliure) (serious criteria GSK medically significant), shingles (Verbatim: has had shingles outbreaks) and covid-19 (Verbatim: Covid). The outcome of the vaccination failure was unknown and the outcome of the shingles and covid-19 were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles and covid-19 to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-MAY-2023 The patient received Shingrix vaccine two or three years ago from reporting. The patient had shingles outbreaks after contracting covid.  The physician could not remember patient's name and was going to have research. The physician would see the patient back in office in 2 to 3 weeks. The reporter consented to follow-up. 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.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: I had shingles a few months before/ suspected vaccination failure; I had shingles a few months before; Miserable; made me tired; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: I had shingles a few months before/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I had shingles a few months before), feeling miserable (Verbatim: Miserable) and tiredness (Verbatim: made me tired). The outcome of the vaccination failure was unknown and the outcome of the shingles and feeling miserable were not reported and the outcome of the tiredness was resolved.  The reporter considered the vaccination failure, shingles, feeling miserable and tiredness to be possibly related to Shingrix.  The company considered the vaccination failure, shingles, feeling miserable and tiredness to be possibly related to Shingrix.  Additional Information: GSK Receipt Date: 25-MAY-2023 This case was reported by the patient via interactive digital media. The patient had reported that, it made her tired for a couple of hours.  She had shingled a few months before and it was miserable.  She had considered her shingles to have been a lighter case.  She highly recommends getting the vaccine as she had a terrible case.  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. The reporter thought that the event might had been related to product/device. Follow-up would not possible, as no contact, details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination faliure; shingles; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination faliure) (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 reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-MAY-2023 The patient received Shingrix vaccine and developed Shingles. No further information was provided. The reporter did not consented to follow-up. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccine 4 years ago and just got shingles/ suspected vaccination failure; had the vaccine 4 years ago and just got shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: had the vaccine 4 years ago and just got shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had the vaccine 4 years ago and just got 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 Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-MAY-2023 The patient self-reported the case. The patient asked why was the vaccine not effective in some peoples. The patient had the vaccine 4 years ago and just got shingles. It was the worst case patient's physician had seen with someone being vaccinated. 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.
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: soreness at injection sites; Fever; Body aches; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included BIVALENT COVID-19 BOOSTER VACCINE for prophylaxis.   On 19-MAY-2023, the patient received Shingrix and BIVALENT COVID-19 BOOSTER VACCINE. On 19-MAY-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: soreness at injection sites), fever (Verbatim: Fever) and general body pain (Verbatim: Body aches). On 22-MAY-2023, the outcome of the injection site pain, fever and general body pain were resolved (duration 3 days).   It was unknown if the reporter considered the injection site pain, fever and general body pain to be related to Shingrix.     It was unknown if the company considered the injection site pain, fever and general body pain to be related to Shingrix.   Additional Information: GSK receipt date: 27-May-2023 This case was self reported by the patient. This report was submitted submitted by public reporting reference. This report was submitted via the online direct entry reporting system. The patient received Shingrix and Covid Bivalent vaccines manufacturer unspecified other products and dates for other products various routine medicine Started unspecified date and was ongoing. The patient experienced fever, soreness at injection sites, body aches. The symptoms was not treated. The patient did not gave permission to contact. It was unknown if the reporter considered the events to be related to bivalent covid-19 booster vaccine.