chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Neutropenia, Obesity, Oropharyngeal pain, Pancytopenia, Platelet count normal
Clinical narrative: Patient is a 50 y.o. female with a history of Afib (on Eliquis), DM-2, HTN, ovarian cancer with bilateral oophorectomy, breast cancer with right mastectomy who is currently undergoing chemotherapy. She presented to ED 6/5/23 with sore throat, runny nose, headache and fatigue. Found to have COVID and neutropenia. She was transferred to Hospital 6/6/2023 for management. Completed Paxlovid. ANC improved with neupogen and >3K on 6/11/23. Discharged home on 6/12/23.  1. COVID 19 Infection: Pt immunocompromised as she is currently on chemo for breast cancer. S/p vaccinated and boosted x 1. Symptoms: sore throat, no fever, no hypoxia on admit. Paxlovid initiated 6/8/23; complete course on 6/12/23. ID following.  2. Neutropenia: ANC 540, in setting of chemotherapy. No fever on admit. ANC 380 on 6/7/23. Neutropenic precautions continued. Oncology added daily neupogen until ANC >3000; last dose given on 6/10/23. ANC improved to >3K on 6/11/23. 3. Pancytopenia: due to chemotherapy. Last chemo 1 week PTA. Hgb down to 6.8 on 6/7/23, transfused 1u pRBC 6/7/23 and again on 6/11/23. WBC and Plt counts stable.  4. AKI: mild to 1.19 on 6/11/23. Diuretics held on 6/11/23. Encouraged increased PO intake. Stable on 6/12/23.  5. Epistaxis: rhino rocket placed in L nare 6/8/23 per ENT; removed 6/9/23 per patient request. ENT recommended outpatient follow up. S/p Empiric keflex. 6. Breast Cancer: Triple Negative Invasive Ductal Carcinoma. S/p right mastectomy 10/2021 with Dr. (Breast Surgery). Follows with Dr. (Medical Oncology). Currently receiving adjuvant chemotherapy (missed session 6/6/23 and to hold on 6/13/23 per Dr.). Oncology followed.  7. Chronic HFrEF with Dilated Cardiomyopathy: Per history, initially related to postpartum cardiomyopathy 16 years ago. S/p AICD in 2012. NYHA Class II. Follows with Dr. (Cardiology). Continued home HDMT. Statin held while on paxlovid; OK to resume 6/15/23. 8. Pulmonary HTN: per history. Continued Tadalafil at reduced dose while on paxlovid; OK to resume home dose on 6/15/23. 9. Persistent Atrial Fibrillation: Continued home BB and Eliquis. (Eliquis dose reduced while on paxlovid; OK to resume home dose on 6/15/23) 10. Hypertension: continued home meds.  11. DM2: Uncontrolled, A1c 10 on 6/6/23. Insulin continued, oral agents resumed on DC.  12. History of Ovarian Cancer: History of yolk sac tumor/endodermal sinus tumor of the left ovary with right ovary serous cystadenoma ~28 years ago, received chemotherapy at that time. S/p bilateral oophorectomy (left 1994, right 2007).  13. Toenail Injury: to Left great toe nail from stubbed toe 1 week prior to admit. Toenail removed 6/7/23 by Dr. (podiatry). No sign of infection--OTA as noted 6/12/23. . 14. Obesity: BMI 36. Lifestyle modifications advised
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell transfusion, Rhinorrhoea, White blood cell count normal
Clinical narrative: Patient is a 50 y.o. female with a history of Afib (on Eliquis), DM-2, HTN, ovarian cancer with bilateral oophorectomy, breast cancer with right mastectomy who is currently undergoing chemotherapy. She presented to ED 6/5/23 with sore throat, runny nose, headache and fatigue. Found to have COVID and neutropenia. She was transferred to Hospital 6/6/2023 for management. Completed Paxlovid. ANC improved with neupogen and >3K on 6/11/23. Discharged home on 6/12/23.  1. COVID 19 Infection: Pt immunocompromised as she is currently on chemo for breast cancer. S/p vaccinated and boosted x 1. Symptoms: sore throat, no fever, no hypoxia on admit. Paxlovid initiated 6/8/23; complete course on 6/12/23. ID following.  2. Neutropenia: ANC 540, in setting of chemotherapy. No fever on admit. ANC 380 on 6/7/23. Neutropenic precautions continued. Oncology added daily neupogen until ANC >3000; last dose given on 6/10/23. ANC improved to >3K on 6/11/23. 3. Pancytopenia: due to chemotherapy. Last chemo 1 week PTA. Hgb down to 6.8 on 6/7/23, transfused 1u pRBC 6/7/23 and again on 6/11/23. WBC and Plt counts stable.  4. AKI: mild to 1.19 on 6/11/23. Diuretics held on 6/11/23. Encouraged increased PO intake. Stable on 6/12/23.  5. Epistaxis: rhino rocket placed in L nare 6/8/23 per ENT; removed 6/9/23 per patient request. ENT recommended outpatient follow up. S/p Empiric keflex. 6. Breast Cancer: Triple Negative Invasive Ductal Carcinoma. S/p right mastectomy 10/2021 with Dr. (Breast Surgery). Follows with Dr. (Medical Oncology). Currently receiving adjuvant chemotherapy (missed session 6/6/23 and to hold on 6/13/23 per Dr.). Oncology followed.  7. Chronic HFrEF with Dilated Cardiomyopathy: Per history, initially related to postpartum cardiomyopathy 16 years ago. S/p AICD in 2012. NYHA Class II. Follows with Dr. (Cardiology). Continued home HDMT. Statin held while on paxlovid; OK to resume 6/15/23. 8. Pulmonary HTN: per history. Continued Tadalafil at reduced dose while on paxlovid; OK to resume home dose on 6/15/23. 9. Persistent Atrial Fibrillation: Continued home BB and Eliquis. (Eliquis dose reduced while on paxlovid; OK to resume home dose on 6/15/23) 10. Hypertension: continued home meds.  11. DM2: Uncontrolled, A1c 10 on 6/6/23. Insulin continued, oral agents resumed on DC.  12. History of Ovarian Cancer: History of yolk sac tumor/endodermal sinus tumor of the left ovary with right ovary serous cystadenoma ~28 years ago, received chemotherapy at that time. S/p bilateral oophorectomy (left 1994, right 2007).  13. Toenail Injury: to Left great toe nail from stubbed toe 1 week prior to admit. Toenail removed 6/7/23 by Dr. (podiatry). No sign of infection--OTA as noted 6/12/23. . 14. Obesity: BMI 36. Lifestyle modifications advised
Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Injection site- redness, pain, heat, slight swelling and shivering several hours after dose . as of 7/25/2023 redness, pain, heat, slight swelling persist , feeling cold has passed, injection site now itches
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Injection site- redness, pain, heat, slight swelling and shivering several hours after dose . as of 7/25/2023 redness, pain, heat, slight swelling persist , feeling cold has passed, injection site now itches
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Anaemia of chronic disease, Angiogram pulmonary abnormal, Blood alkaline phosphatase increased, Blood iron decreased
Clinical narrative: Patient is a 42 y.o. female with a history of lymphoma, and tobacco abuse who presented to RMH 6/26/2023 with shortness of breath, fever, cough. Found to be COVID positive with pneumonitis on imaging. Treated with steroids/remdesivir with improvement in symptoms.    1. COVID-19 pneumonia: 2nd infection. Vaccinated and boosted. Immunocompromised. Onset of symptoms 6 days prior to admit. Started on Decadron IV and Remdesivir inpatient - discharged on Decadron to complete 10 day total course. As patient is immunocompromised likely will need to remain in isolation for total 20 days until 7/11/23. 2. Acute hypoxic respiratory failure: due to above. CTPA as above. Placed on NC O2. Weaned to room air as of 6/28/23.  3. Diarrhea: per patient started with above. Likely due to COVID. Monitored, improved inpatient.  4. Non-hodgkin's Lymphoma: h/o. Follows Dr. (oncology). Was on bendamustine. Currently on Rituxan.  5. Elevated LFTs: ALK 174. Likely due to above. CTPA on admit showed hepatic steatosis. Monitor for now.  6. Microcytic Anemia: Hb 10.9 on admit. Likely due to chemo. Iron studies suggestive of anemia of chronic disease. Monitor. 7. Hypokalemia: K 3.2. on admit. Replaced.  8. Tobacco abuse: current smoker. 0.5 PPD. Cessation encouraged.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium decreased, COVID-19, COVID-19 pneumonia, Chemotherapy, Cough
Clinical narrative: Patient is a 42 y.o. female with a history of lymphoma, and tobacco abuse who presented to RMH 6/26/2023 with shortness of breath, fever, cough. Found to be COVID positive with pneumonitis on imaging. Treated with steroids/remdesivir with improvement in symptoms.    1. COVID-19 pneumonia: 2nd infection. Vaccinated and boosted. Immunocompromised. Onset of symptoms 6 days prior to admit. Started on Decadron IV and Remdesivir inpatient - discharged on Decadron to complete 10 day total course. As patient is immunocompromised likely will need to remain in isolation for total 20 days until 7/11/23. 2. Acute hypoxic respiratory failure: due to above. CTPA as above. Placed on NC O2. Weaned to room air as of 6/28/23.  3. Diarrhea: per patient started with above. Likely due to COVID. Monitored, improved inpatient.  4. Non-hodgkin's Lymphoma: h/o. Follows Dr. (oncology). Was on bendamustine. Currently on Rituxan.  5. Elevated LFTs: ALK 174. Likely due to above. CTPA on admit showed hepatic steatosis. Monitor for now.  6. Microcytic Anemia: Hb 10.9 on admit. Likely due to chemo. Iron studies suggestive of anemia of chronic disease. Monitor. 7. Hypokalemia: K 3.2. on admit. Replaced.  8. Tobacco abuse: current smoker. 0.5 PPD. Cessation encouraged.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Electrolyte substitution therapy, Haemoglobin decreased, Hepatic steatosis
Clinical narrative: Patient is a 42 y.o. female with a history of lymphoma, and tobacco abuse who presented to RMH 6/26/2023 with shortness of breath, fever, cough. Found to be COVID positive with pneumonitis on imaging. Treated with steroids/remdesivir with improvement in symptoms.    1. COVID-19 pneumonia: 2nd infection. Vaccinated and boosted. Immunocompromised. Onset of symptoms 6 days prior to admit. Started on Decadron IV and Remdesivir inpatient - discharged on Decadron to complete 10 day total course. As patient is immunocompromised likely will need to remain in isolation for total 20 days until 7/11/23. 2. Acute hypoxic respiratory failure: due to above. CTPA as above. Placed on NC O2. Weaned to room air as of 6/28/23.  3. Diarrhea: per patient started with above. Likely due to COVID. Monitored, improved inpatient.  4. Non-hodgkin's Lymphoma: h/o. Follows Dr. (oncology). Was on bendamustine. Currently on Rituxan.  5. Elevated LFTs: ALK 174. Likely due to above. CTPA on admit showed hepatic steatosis. Monitor for now.  6. Microcytic Anemia: Hb 10.9 on admit. Likely due to chemo. Iron studies suggestive of anemia of chronic disease. Monitor. 7. Hypokalemia: K 3.2. on admit. Replaced.  8. Tobacco abuse: current smoker. 0.5 PPD. Cessation encouraged.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokalaemia, Immunodeficiency, Infection, Liver function test increased, Microcytic anaemia
Clinical narrative: Patient is a 42 y.o. female with a history of lymphoma, and tobacco abuse who presented to RMH 6/26/2023 with shortness of breath, fever, cough. Found to be COVID positive with pneumonitis on imaging. Treated with steroids/remdesivir with improvement in symptoms.    1. COVID-19 pneumonia: 2nd infection. Vaccinated and boosted. Immunocompromised. Onset of symptoms 6 days prior to admit. Started on Decadron IV and Remdesivir inpatient - discharged on Decadron to complete 10 day total course. As patient is immunocompromised likely will need to remain in isolation for total 20 days until 7/11/23. 2. Acute hypoxic respiratory failure: due to above. CTPA as above. Placed on NC O2. Weaned to room air as of 6/28/23.  3. Diarrhea: per patient started with above. Likely due to COVID. Monitored, improved inpatient.  4. Non-hodgkin's Lymphoma: h/o. Follows Dr. (oncology). Was on bendamustine. Currently on Rituxan.  5. Elevated LFTs: ALK 174. Likely due to above. CTPA on admit showed hepatic steatosis. Monitor for now.  6. Microcytic Anemia: Hb 10.9 on admit. Likely due to chemo. Iron studies suggestive of anemia of chronic disease. Monitor. 7. Hypokalemia: K 3.2. on admit. Replaced.  8. Tobacco abuse: current smoker. 0.5 PPD. Cessation encouraged.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonitis, Pulmonary imaging procedure abnormal, Pyrexia, SARS-CoV-2 test positive, Tobacco abuse
Clinical narrative: Patient is a 42 y.o. female with a history of lymphoma, and tobacco abuse who presented to RMH 6/26/2023 with shortness of breath, fever, cough. Found to be COVID positive with pneumonitis on imaging. Treated with steroids/remdesivir with improvement in symptoms.    1. COVID-19 pneumonia: 2nd infection. Vaccinated and boosted. Immunocompromised. Onset of symptoms 6 days prior to admit. Started on Decadron IV and Remdesivir inpatient - discharged on Decadron to complete 10 day total course. As patient is immunocompromised likely will need to remain in isolation for total 20 days until 7/11/23. 2. Acute hypoxic respiratory failure: due to above. CTPA as above. Placed on NC O2. Weaned to room air as of 6/28/23.  3. Diarrhea: per patient started with above. Likely due to COVID. Monitored, improved inpatient.  4. Non-hodgkin's Lymphoma: h/o. Follows Dr. (oncology). Was on bendamustine. Currently on Rituxan.  5. Elevated LFTs: ALK 174. Likely due to above. CTPA on admit showed hepatic steatosis. Monitor for now.  6. Microcytic Anemia: Hb 10.9 on admit. Likely due to chemo. Iron studies suggestive of anemia of chronic disease. Monitor. 7. Hypokalemia: K 3.2. on admit. Replaced.  8. Tobacco abuse: current smoker. 0.5 PPD. Cessation encouraged.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Tobacco user
Clinical narrative: Patient is a 42 y.o. female with a history of lymphoma, and tobacco abuse who presented to RMH 6/26/2023 with shortness of breath, fever, cough. Found to be COVID positive with pneumonitis on imaging. Treated with steroids/remdesivir with improvement in symptoms.    1. COVID-19 pneumonia: 2nd infection. Vaccinated and boosted. Immunocompromised. Onset of symptoms 6 days prior to admit. Started on Decadron IV and Remdesivir inpatient - discharged on Decadron to complete 10 day total course. As patient is immunocompromised likely will need to remain in isolation for total 20 days until 7/11/23. 2. Acute hypoxic respiratory failure: due to above. CTPA as above. Placed on NC O2. Weaned to room air as of 6/28/23.  3. Diarrhea: per patient started with above. Likely due to COVID. Monitored, improved inpatient.  4. Non-hodgkin's Lymphoma: h/o. Follows Dr. (oncology). Was on bendamustine. Currently on Rituxan.  5. Elevated LFTs: ALK 174. Likely due to above. CTPA on admit showed hepatic steatosis. Monitor for now.  6. Microcytic Anemia: Hb 10.9 on admit. Likely due to chemo. Iron studies suggestive of anemia of chronic disease. Monitor. 7. Hypokalemia: K 3.2. on admit. Replaced.  8. Tobacco abuse: current smoker. 0.5 PPD. Cessation encouraged.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Osteoarthritis
Clinical narrative: I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 4/10/2023 OSTEOARTHRITIS OF BILAT KNEES
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was supposed to receive Meningococcal B but Meningococcal A was given by mistake. The patient did not develop any adverse effects from the incorrect vaccine given and was notified of the mistake so he could receive the correct vaccine.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Cardiac failure congestive, Cerebellar syndrome, Cerebrovascular disorder, Condition aggravated
Clinical narrative: ACUTE RESPIRATORY FAILURE 4/8/2023 DYSPNEA ACUTE RESPIRATORY FAILURE 4/8/2023 CHF EXACERBATION, UNSPECIFIED ACUTE RESPIRATORY FAILURE 4/8/2023 LATE EFFECT OF STROKE ACUTE RESPIRATORY FAILURE 4/8/2023 MIDDLE CEREBRAL ARTERY SYNDROME ACUTE RESPIRATORY FAILURE 4/8/2023 ELEVATED LIVER FUNCTION TEST
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Liver function test increased
Clinical narrative: ACUTE RESPIRATORY FAILURE 4/8/2023 DYSPNEA ACUTE RESPIRATORY FAILURE 4/8/2023 CHF EXACERBATION, UNSPECIFIED ACUTE RESPIRATORY FAILURE 4/8/2023 LATE EFFECT OF STROKE ACUTE RESPIRATORY FAILURE 4/8/2023 MIDDLE CEREBRAL ARTERY SYNDROME ACUTE RESPIRATORY FAILURE 4/8/2023 ELEVATED LIVER FUNCTION TEST
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Fall, Gait inability, Magnetic resonance imaging, Muscular weakness
Clinical narrative: Patient reports weakness in the legs that started a few days after receiving the vaccine that led to the inability to walk. She reports falling around 5 times due the weakness in her legs. She has notified her PCP and is seeing a specialist.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient Deceased
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Laboratory test
Clinical narrative: Hospitalized for atrial previlation.    Site vaccinated: facility
Age: 9.0
Sex: F
Vaccine: HEP, IPV, TD
Symptoms: Loss of consciousness
Clinical narrative: PATIENT PASSED OUT IN THE LOBBY. WAS FOUND LAYING DOWN WITH HER BROTHER HOLDING HER. SHE WAS CONSCIOUS WHEN I ARRIVED TO HER. APPLIED A COLD PACK AND FANNED COOL AIR ON HER. WE GAVE HER A LOLLIPOP TO EAT. MOTHER STATED SHE HAD NOT EATEN BREAKFAST TODAY.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chronic respiratory failure, Respiratory failure
Clinical narrative: CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Respiratory failure
Clinical narrative: ACUTE HYPERCAPNIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Syncope
Clinical narrative: Patient had brief syncopal episode about 2 minutes after the vaccine was administered causing her to fall out of the chair on to the floor. Episode only lasted about 10-15 seconds. She was previously asked to wait in our office 15 minutes after administration, therefore, she was waiting in our exam room at the time of incident. Patient rested x 20 minutes and given Powerade after the incident. She returned to baseline and was sent home with mom with recommended observation.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: ACUTE DVT, UNSPECIFIED VEIN ACUTE DVT OF RIGHT POPLITEAL VEIN ACUTE PULMONARY EMBOLISM
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administered past the 10  week beyond use date of 07/05/23 - no adverse events reported
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Rash
Clinical narrative: Patient came in for a well child check and was due for multiple vaccines. Patients parents agreed with provider to get Varicella, MMR, and Pediarix. Varicella was administered on the right vastus lateralis, MMR and Pediarix was administered on the left vastus lateralis. Patient got vaccinated on 7/18/23 and went to ED on 7/23/23 because of a rash.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperglycaemia, Obstructive sleep apnoea syndrome, Type 2 diabetes mellitus
Clinical narrative: OBSTRUCTIVE SLEEP APNEA 4/12/2023 DM 2 W HYPERGLYCEMIA
Age: 42.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Chest pain, Dyspnoea, Rash
Clinical narrative: Spoke with pt. the day after she received the vaccines. States appx. 4-5 hours after vaccine administration, experienced rash, chest pain, trouble breathing. Took oral benadryl.  Did not use epipen, did not see provider. At the time I spoke with the pt., she stated her symptoms had resolved.  Also followed up with pt. 4 days later, stated no further symptoms.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Colon cancer, Obstructive sleep apnoea syndrome
Clinical narrative: G47.33 OBSTRUCTIVE SLEEP APNEA 1/27/2023 COLON CANCER, SIGMOID
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Pulmonary embolism, Symptom recurrence
Clinical narrative: ACUTE RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM 2/4/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chronic obstructive pulmonary disease, Hypoxia, Obstructive sleep apnoea syndrome, Respiratory failure
Clinical narrative: OBSTRUCTIVE SLEEP APNEA 3/11/2022 COPD STAGE 2 MODERATE (FEV1 50-79%) ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/18/2023 COPD STAGE 2 MODERATE (FEV1 50-79%) HYPOXIA 4/18/2023 COPD STAGE 2 MODERATE (FEV1 50-79%)
Age: 14.0
Sex: F
Vaccine: HEP, HPV9, IPV, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Pt noted briefly passing out for less than 15 seconds after final vaccine administration but cam to quickly.  Pt noted pale and requested water.  Pt baseline vitals all WNL.  BP taken after episode noted WNL @ 107/64.  Pt observation continued another 15 minutes and Pt regained color.  Pt denied HA, dizziness, nausea.  Pt stated feeling much better after observation and final BP taken also WNL @ 117/77.  Pt exited with parents, ambulating without difficulty.
Age: 59.0
Sex: F
Vaccine: PNC20, UNK
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria
Clinical narrative: Pt reports big red spot/hive to left arm going down to elbow, itchy and sore to touch.
Age: 59.0
Sex: F
Vaccine: PNC20, UNK
Symptoms: Erythema, Injection site erythema
Clinical narrative: Pt reports big red spot/hive to left arm going down to elbow, itchy and sore to touch.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administered past the 10  week beyond use date of 07/05/23 - no adverse events reported
Age: 15.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Body temperature increased, Seizure
Clinical narrative: 15 year old female came into clinic for ordered vaccines, Menveo and HPV (Gardasil).  Patient was monitored for the usual 15 minutes past the vaccine, showing do signs of reaction, the MA that administered the vaccine discharged her with family to the lobby.  The mother of the patient had to stop and make a phone call and remained in the lobby a few minutes longer with her daughter.  The patient started seizing, in a tonic clonic manner.  2 RNs and an MD were called to the lobby. EMS was called, the patient was laid on the floor. The seizing resolved. The patient's VS were a sudden onset temperature of 100.6, BP 76/42, HR 41, RR 24.  98% on RA. Her blood sugar was 108 (taken by paramedics).  The patient was laid on the floor to await the paramedics.  The repeat VS were BP 70/37, HR 48.  the patient was loaded onto the ambulance without further incident.
Age: 61.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Blood test, Cerebrovascular accident, Confusional state, Dysstasia, Feeling abnormal
Clinical narrative: He got his vaccine, everyting was OK, he went home.  He had some reaction to it, lethargy, fever, headache and that was pretty much for that and lasted for a day.  Then on 12/30/22 he was sitting on the couch, watching TV and the next thing he knows he was on the floor, had passed out. He had trouble getting up and after he got up he was spaced out, could not figure out how to use his cell phone, was trying to call 9-1-1 with the TV remote and really out of it.  Things started coming around and was able to call 9-1-1 and call his wife.  He was taken to the hospital, checked him out.  They did an MRI, sent him home and then after the next day they called him up and told him to come back to the hospital. They told him that he had had 3 strokes, all at the same time.  They were pretty much minor strokes, but has bad weakness to the right arm, some limp and due to this the DMV took his drivers license and not able to drive, not able to work and as he was 62 decided to retire.  He then saw a neurologist on 12/30/22 at the local ER. A Dr. at Neurology Dept.  He asked him in the ER if this could have been caused by the COVID shot, but he did not want to say but told him that it was possible.  He is now on a baby aspirin as a blood thinner and he continues to take his BP medicines.   He went to the ER at hospital locally initially.
Age: 61.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Gait disturbance, Headache, Impaired driving ability, Impaired work ability, Lethargy
Clinical narrative: He got his vaccine, everyting was OK, he went home.  He had some reaction to it, lethargy, fever, headache and that was pretty much for that and lasted for a day.  Then on 12/30/22 he was sitting on the couch, watching TV and the next thing he knows he was on the floor, had passed out. He had trouble getting up and after he got up he was spaced out, could not figure out how to use his cell phone, was trying to call 9-1-1 with the TV remote and really out of it.  Things started coming around and was able to call 9-1-1 and call his wife.  He was taken to the hospital, checked him out.  They did an MRI, sent him home and then after the next day they called him up and told him to come back to the hospital. They told him that he had had 3 strokes, all at the same time.  They were pretty much minor strokes, but has bad weakness to the right arm, some limp and due to this the DMV took his drivers license and not able to drive, not able to work and as he was 62 decided to retire.  He then saw a neurologist on 12/30/22 at the local ER. A Dr. at Neurology Dept.  He asked him in the ER if this could have been caused by the COVID shot, but he did not want to say but told him that it was possible.  He is now on a baby aspirin as a blood thinner and he continues to take his BP medicines.   He went to the ER at hospital locally initially.
Age: 61.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Loss of consciousness, Magnetic resonance imaging, Muscular weakness, Pyrexia
Clinical narrative: He got his vaccine, everyting was OK, he went home.  He had some reaction to it, lethargy, fever, headache and that was pretty much for that and lasted for a day.  Then on 12/30/22 he was sitting on the couch, watching TV and the next thing he knows he was on the floor, had passed out. He had trouble getting up and after he got up he was spaced out, could not figure out how to use his cell phone, was trying to call 9-1-1 with the TV remote and really out of it.  Things started coming around and was able to call 9-1-1 and call his wife.  He was taken to the hospital, checked him out.  They did an MRI, sent him home and then after the next day they called him up and told him to come back to the hospital. They told him that he had had 3 strokes, all at the same time.  They were pretty much minor strokes, but has bad weakness to the right arm, some limp and due to this the DMV took his drivers license and not able to drive, not able to work and as he was 62 decided to retire.  He then saw a neurologist on 12/30/22 at the local ER. A Dr. at Neurology Dept.  He asked him in the ER if this could have been caused by the COVID shot, but he did not want to say but told him that it was possible.  He is now on a baby aspirin as a blood thinner and he continues to take his BP medicines.   He went to the ER at hospital locally initially.
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: hospitalized and treated for covid; fully vaccinated with 2 boosters
Age: 0.33
Sex: F
Vaccine: DTAP, UNK
Symptoms: Decreased eye contact, Fatigue, Infant irritability, Scratch, Staring
Clinical narrative: When she received Dtap and Hib on 5/30/23 she was tired after her vaccine. Within 12 hours- right hand scratching her chest and this occurred for 2 weeks. After 2 weeks the episodes were slowing down and then had resolved after 1 month. This was occurring all of the time, but they did not see it while she was sleeping.  No rashes or dryness at the time on her chest or anywhere else on her body. No redness anywhere on the body. She was more fussy the first night.   The 2nd night her father went to pick her up and was walking with her and she was staring at a wall and had her eyes wide open and her father could not bring her out of that.  He tried talking to her and getting her attention, but she continued to stare at the wall. She had small head movements back and forth. Father reported that she looked scared.  Then the father brought her in to breast feed and she was biting on mother's nipple and the breast feeding calmed her down.  She felt tired and fussy for a few days.  No tonic clonic movements noted.  No deviation of her eyes. She did not have as good eye contact the next couple days after the vaccine per parents.  No concerns around the injection site. No viral illnesses reported. No other symptoms noted. She was waking up every 2 hours for 5 weeks at night, which was different for her
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 3/2/21 lot# EN6200 ; Pfizer 3/3/21 lo# EN6208 ; Pfizer 12/16/21 Lot# FD0809
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA
Age: 94.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 5 vaccines  Moderna 1/14/21 lot# 012L20A;  Moderna 2/11/21 Lot# 010L20A;  Moderna 11/17/21 lot# 939909;  MOderna 5/18/22 lot# 056M21A;  Moderna 10/19/22 lot# 062F22A
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient Deceased
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypotension, Symptom recurrence
Clinical narrative: HYPOTENSION 1/23/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 3/30/21  lot# ER8730;  04/20/21 Pfizer lot# Ew0162
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 2/23/21 LOt# EN6200;  Pfizer 3/16/21 lot# EN6207;  Pfizer 11/8/21 lot# FH8028
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines Pfizer 3/3/21 lot# EN6205;  Pfizer 3/24/21 lot# EN6204;  Pfizer 8/16/21 lot# FK9895;  Pfizer 3/30/22 lot# FK9895
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 2/27/21 lot# 025A21A ; Moderna 3/23/21 lot# 045A21A
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines  Moderna 4/20/21 lot# 007C21A;  Moderna 5/18/21 lot# 033B21A
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Moderna 1/20/21 lot# 025J20A'  Moderna 2/17/21 lot# 004M20A'  Moderna 12/4/21 NO LOT#
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: PATIENT WAS GIVEN PFIZER COVID 19 VACCINE FOR 11 AND UP AND PATIENT WAS 10YRS AND 10 MONTHES OLD. NO ADVERSE REACTION WAS NOTED.
Age: 86.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Chronic respiratory failure, Hypoxia, Respiratory failure
Clinical narrative: CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 3/27/21 lot# Er8732; Pfizer 4/17/21 lot# EW0169;  Pfizer 11/16/21 lot# FH8030
Age: 79.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administered past the 10  week beyond use date of 07/05/23 - no adverse events reported
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines Moderna 1/29/21 lot# 004M20A;  Moderna 5/26/21 lot# 005C21A;  MOderna 11/5/21 lot# 076C21A;  Moderna 4/21/22 lot# 056M21A
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Rash
Clinical narrative: Patient was given the vaccine 3 days past the expiration. His mother called his provider on 4/26 for a rash that was on his leg and groin that she thought was due to the vaccine. He did not have any other symptoms so was not scheduled to come in until the next day, but his mother was concerned and mentioned she would likely take him to the ED that day. No other encounters have been made regarding this rash, but the provider does not think it was due to the vaccine given the time frame.
Age: 87.0
Sex: M
Vaccine: COVID19-2, VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Covid vaccine was administered past the 10  week beyond use date of 07/05/23 - no adverse events reported
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 5 vaccines Moderna 3/2/21 lot# 025A21A;  Moderna 3/30/21 lot# 028A21A;  Moderna 10/28/21 lot# 939903;  Moderna 5/9/22 lot# 004M21A;  Moderna 9/15/22 lot# AB7145B
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient Deceased
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO ADVERSE EVENT - Vaccine was given past expiration date - No harm to patient.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 3/3/21 lot# EN6199;  Pfizer 3/24/21 lot# ER8732;  Pfizer 11/12/21 no lot#
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: ACUTE DVT OF RIGHT FEMORAL VEIN ACUTE PULMONARY EMBOLISM
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Patient developed a fever and a rash around and near the injection site
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Moderna 3/15/21 lot# 044A21A;  Moderna 4/14/21 lot# 031B21A;  Moderna 10/26/21 lot# 032F21A
Age: 49.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administered past the 10  week beyond use date of 07/05/23 - no adverse events reported
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Hypersensitivity
Clinical narrative: ACUTE NON ST ELEVATION MI ALLERGIC REACTION, SEQUELA
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Pain of skin, Skin burning sensation
Clinical narrative: Less than 24 hours after receiving the injection in the left harm I woke the next morning with severe pain and burning in my skin in my right chest, under my right arm, and in my right shoulder blade down to about mid-back. This lasted for three days and eventually dissipated.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 3/9/21 lot# EN6206;  Pfizer 3/30/21 lot# ER2613;  Pfizer 10/15/21 Lot# FF8841
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No data from temp logger in fridge from feb 2023 - june 2023, vaccines were past beyond use date, reached out to manufacturer for further stability assessment  patient was administered a dose (0.3ml) of GK1337 on  07/11/2023 however no signs or symptoms were reported after administration, patient has not experienced anything regarding a negative reaction or side effect
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No adverse outcomes or side effects were reported or observed by the patients; HCP (nurse) called to report TE for VARIVAX (lot: W031813 expiration: 10/05/2024) that occurred on 05/11/2023 but she was not made aware by the VFC until today (06/26/2023).  The product was stored at 10.8F for 8 hours, 23 minutes and 0 seconds with; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 11-MAY-2023, varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot number W031813 was verified to be valid, expiration date reported and confirmed as 05-OCT-2024) suffered a temperature excursion (TE).   On 20-JUN-2023, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 mL via injection (lot number W031813, expiration date 05-OCT-2024), administered as prophylaxis (route of administration and anatomical location were not provided) (product storage error). The reporter was not made aware of the TE until 26-JUN-2023 (reported as "today"). The product was stored at 10.8F for 8 hours, 23 minutes and 0 seconds with a supported TE stability evaluation, and there were not any previous excursions, and 8 doses total were administered. No adverse outcomes or side effects were reported or observed by the patient (no adverse event), who received the administered dose by an experienced health care professional (HCP). Permission received to follow up with primary HCP (pediatrician).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA012362: US-009507513-2306USA012702: US-009507513-2306USA012560: US-009507513-2306USA012318: US-009507513-2306USA012351: US-009507513-2306USA012355: US-009507513-2306USA012732: US-009507513-2306USA012753:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines  Moderna 1/2/21 lot# 011L20A;  Moderna 1/30/21 lot# 012L20A;  Pifzer 11/9/21 lot# FG3527;  MOderna 6/30/22 Lot# 014B22A
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient Deceased
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angioedema
Clinical narrative: ANGIOEDEMA, INIT ANGIOEDEMA, SUBSEQ ANGIOEDEMA, SEQUELA
Age: 91.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient Deceased
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ischaemic stroke
Clinical narrative: ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 8/12/21 lot# 052E21A;  Moderna 9/7/21 lot# 043B21A
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Patient was needing MMR vaccine for school based on titer results. She was given the correct vaccine but it was expired. The patient was called and informed of the error and has said she will go back to the clinic in 28 days to get it again.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ischaemic stroke, Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 3/4/21 lot# EN6206;  Pfizer 3/22/21 lot# EN6206;  Pfizer 7/20/22 lot# FP7135
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 1/15/21 lot# 037K20A;  Moderna 2/12/21 lot# 037K20A
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Coagulopathy
Clinical narrative: COAGULOPATHY, UNSPECIFIED TYPE
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 3/11/21 lot# En6207;  Pfizer 4/1/21 lot# ER8732;  12/14/21 Pfizer lot#33130BA
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Myalgia, Palpitations
Clinical narrative: heart palpaltations, muscle aches, diiness, headaxhes, joint paint
Age: 1.08
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient Deceased
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Given Kinrix (dtap/polio) early. Regular 12 month vaccines given (mmr, varicella, hep A, Pcv).  Mom and provider aware.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Moderna 3/11/21 lot# 002B21A;  Moderna 4/8/21 lot# 040B21A;  Moderna 11/2/21 lot# 032F
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angina pectoris
Clinical narrative: ANGINA, UNSPECIFIED
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 5/18/21 lot# Ew0183;  Pfizer 6/8/21 lot# Ew0178;  Pfizer 12/21/21 lot# FD7218
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Accidental exposure to product, Incorrect dose administered, No adverse event
Clinical narrative: No further AE details; HCP called to report that while giving an MMR II vaccine the needle prematurely contracted into the safety syringe, and an unspecified amount remaining in the syringe emptied onto the patient's thigh.; and an unspecified amount remaining in the syringe emptied onto the patient's thigh; MMR II vaccine the needle prematurely contracted into the safety syringe,; This spontaneous report was received from an other health professional and referred to a 30-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-JUN-2023, the patient was vaccinated with measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (rHA) (M-M-R II) injection, 0.5 milliliter, once, lot #W034714, expiration date: 18-OCT-2023, administered subcutaneously at right thigh for prophylaxis (strength was not provided); and also with sterile diluent solution for injection/infusion (strength, dose, frequency, lot #, expiry date, route of administration and indication were not provided). On that day, while giving the vaccine, the needle prematurely contracted into the safety syringe (Device safety feature issue), and an unspecified amount remaining in the syringe emptied onto the patient's thigh (Accidental exposure to product) (Incorrect dose administered) (AE description also reported as "Vaccine "med." came out from. The syringes were vanish point. Needle connected to the syringe"). No further AE details (No adverse event). The patient would be revaccination.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines  Pfizer 2/2/21 lot3 EN5318;  Pfizer 2/25/21 lot# En6202;  Pfizer 12/22/21 lo# FE3594
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lacunar stroke
Clinical narrative: ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines  Moderna 3/9/21 lot# 010A21A;  Moderna 4/6/21 lot# 025B21A;  Moderna 2/20/22 lot# 046L21A
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood alkaline phosphatase, C-reactive protein normal, Differential white blood cell count, Eosinophil count normal, Erythema
Clinical narrative: vaccines received on 6/5, on 6/10 patient awoke from nap screaming. Mom noted Rt knee was red swollen and appeared to be tender. An hour later mom noticed B elbows were red and swollen , patient was fussy. Parents took him to the ED-- upon arrival B ankles, knees, and elbows were red, swollen and appeared to be painful. No fevers during that time. Patient was discharged home with tylenol/motrin following blood work and joint u/s. Symptoms resolved by noon on 6/11.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Full blood count, Haemoglobin, Irritability, Joint swelling, Lymphocyte percentage increased
Clinical narrative: vaccines received on 6/5, on 6/10 patient awoke from nap screaming. Mom noted Rt knee was red swollen and appeared to be tender. An hour later mom noticed B elbows were red and swollen , patient was fussy. Parents took him to the ED-- upon arrival B ankles, knees, and elbows were red, swollen and appeared to be painful. No fevers during that time. Patient was discharged home with tylenol/motrin following blood work and joint u/s. Symptoms resolved by noon on 6/11.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Metabolic function test, Monocyte percentage, Neutrophil percentage decreased, Oedema peripheral, Platelet count increased
Clinical narrative: vaccines received on 6/5, on 6/10 patient awoke from nap screaming. Mom noted Rt knee was red swollen and appeared to be tender. An hour later mom noticed B elbows were red and swollen , patient was fussy. Parents took him to the ED-- upon arrival B ankles, knees, and elbows were red, swollen and appeared to be painful. No fevers during that time. Patient was discharged home with tylenol/motrin following blood work and joint u/s. Symptoms resolved by noon on 6/11.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Screaming, Ultrasound joint abnormal
Clinical narrative: vaccines received on 6/5, on 6/10 patient awoke from nap screaming. Mom noted Rt knee was red swollen and appeared to be tender. An hour later mom noticed B elbows were red and swollen , patient was fussy. Parents took him to the ED-- upon arrival B ankles, knees, and elbows were red, swollen and appeared to be painful. No fevers during that time. Patient was discharged home with tylenol/motrin following blood work and joint u/s. Symptoms resolved by noon on 6/11.