chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: FLUZONE HD were administered to  patient post excursion with no reported adverse event; Initial information received on 23-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to 2024SA287726 (master case)  This case involves a 55 years old male patient who was administered influenza USP trival A-B high dose subvirion vaccine [Fluzone High Dose] post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, influenza USP trival A-B high dose subvirion vaccine (Suspension for injection in pre-filled syringe) (lot: K9XL5; expiry date: 30-Jun-2025) (strength: unknown) was administered to patient post excursion with no reported adverse event (poor quality product administered) (latency: same day) via unknown route in unknown administration site for prophylactic vaccination.   Reportedly, Office manager stated that all of their vaccines were involved including some of the other Sanofi products as well as non-Sanofi products but does not want to provide them specifically one by one as they know they need to discard the vaccines. She was calling as the FLUZONE HD were administered to 3 patients post excursion.  Reason:  Refrigerator malfunction (sensor not properly hooked but when it was fixed and all well it broke during the weekend)Max/Low Temperature reached: 3 F Duration out of labelled range: 48 hoursHuman Error: No Does extended stability data cover the excursion? No  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: FLUZONE HD were administered to  patient post excursion with no reported adverse event; Initial information received on 23-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to 2024SA287726 (master case)  This case involves a 79 years old male patient who was administered influenza USP trival A-B high dose subvirion vaccine [Fluzone High Dose] post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, influenza USP trival A-B high dose subvirion vaccine (Suspension for injection in pre-filled syringe) (lot: K9XL5; expiry date: 30-Jun-2025) (strength: unknown) was administered to patient post excursion with no reported adverse event (poor quality product administered) (latency: same day) via unknown route in unknown administration site for immunization.   Reportedly, Office manager stated that all of their vaccines were involved including some of the other Sanofi products as well as non-Sanofi products but does not want to provide them specifically one by one as they know they need to discard the vaccines. She was calling as the FLUZONE HD were administered to 3 patients post excursion.  Reason:  Refrigerator malfunction (sensor not properly hooked but when it was fixed and all well it broke during the weekend)Max/Low Temperature reached: 3 F Duration out of labelled range: 48 hours Human Error: No. Extended stability data does not cover the excursion.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: RAB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: inappropriate use due to potentially receiving an extra dose of imovax for previously immunized patient receiving post exposure dosing with no reported adverse event; Initial information received on 23-Sep-2024 regarding an unsolicited valid non-serious case received from a patient.  This case involves an unknown age female patient who had inappropriate use due to potentially receiving an extra dose of Rabies (HDC) Vaccine [Imovax Rabies] for previously immunized patient receiving post exposure dosing with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREDNISONE.  On an unknown date in Jun 2024 a bat hit the patient in the head, she then received the rabies immunoglobulin as well as full dosing of Rabies (HDC) Vaccine Powder and solvent for suspension for injection series (lot number, strength, dose, expiry not reported) via unknown route in unknown administration site as post exposure immunization. Also, patient was taking prednisone at the time of the rabies series and was not aware that the prednisone could lower her immune response.   Caller reports a second exposure to contact with a dead bat on 09-Sep-2024 and received another vaccination series with Rabies (HDC) Vaccine Powder and solvent for suspension for injection on 12-Sep-2024, 16-Sep-2024 respectively (lot number, strength, dose, expiry not reported) via unknown route in unknown administration site as post exposure immunization with no reported adverse event (extra dose administered) (Latency: same day).   It was reported "Caller was taking prednisone one month ago but due to her taking prednisone during her previous course of treatment she has been given 3  doses of IMOVAX and is scheduled for her 4th dose. Asked caller if any titers /antibody levels have been checked and caller denies that any titers have been checked."   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: accidentally administered daptacel to an adult patient with no reported adverse event; Initial information received on 23-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Adult and unknown gender patient who was accidentally administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]  with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, accidentally administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection, x1 (once) via unknown route in unknown administration site for Immunization (strength, dose, batch and expiry date unknown) to an adult patient with no reported adverse event (product administered to patient of inappropriate age) (same day latency).  Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Peripheral swelling, Rash
Clinical narrative: I had an allergic reaction to flu shot- entire arm blew up and rashes; This spontaneous case  initially received on 23-Sep-2024, was reported by a non-health professional and concerns a patient of unknown age/gender.  Drug history included amoxicillin (Reaction: drug allergy), cipro (Reaction: Drug allergy), aspirin (Reaction: Drug allergy). At the time of the event the patient had allergic to gluten, allergic to peanut, Allergic to penicillin, allergic to dairy eggs, Allergic to egg ingredients, Allergic to treenut, Allergic to coconut, Allergic to avocado, Allergic to strawberry. Product complaint was selected as no.  Administration of company suspect drug(s): On an unknown date, the patient received Influenza virus vaccine for Indication not reported, Dosing regimen: Not reported, route of administration: not reported, Lot number: No batch number available and would be requested upon follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced I had an allergic reaction to flu shot- entire arm blew up and rashes (outcome: Unknown). The patient had a question about their flu shot. The patient was wondering what the ingredients were because last year patient had an allergic reaction to your flu shot. The patient was not sure if it was one of the ingredients in there, but patient's entire arm blew up and rashes that's never happened before the patient was allergic to gluten, dairy eggs, egg ingredients, peanut, tree nut, coconut, avocado and strawberry. The patient was also allergic all to penicillin and amoxicillin along with the cipro and aspirin. The patient was wondering if it was free from all these because patient called pharmacy and they are concerned that there might be some sort of egg derivative in there so patient needed to make sure it was free from there and the patient was wondering if they  can send over a copy of your flu shot because the patient could die if something was in there that patient was allergic to.   Influenza virus vaccine action taken: Not Applicable  Reporter's assessment: The reporter did not provide the seriousness and causality assessment.; Reporter's Comments: The event I had an allergic reaction to your flu shot considered as related to the administration of Influenza virus vaccine.
Sex: F
Vaccine: COVID19, FLU3
Symptoms: COVID-19, Malaise, Sneezing
Clinical narrative: Got sick with COVID/Tried and check with antigen testing kit twice and the results does shows both positive, both results are positive (Covid positive); Had five Pfizer vaccines (Covid-19); Not feeling well; I was sneezing a lot; This spontaneous case, initially received on 20-Sep-2024, was reported by a health professional and concerns a female patient.  Administration of company suspect drug: On 01-Oct-2023, the patient received Fluad (TIV) for Indication not reported., Lot number: No batch number available and would be and will be requested upon follow-up.  Non-company suspect drugs: COVID-19 vaccine (COVID-19 vaccine), Indication: COVID-19. Paxlovid (Nirmatrelvir, Ritonavir), Indication: COVID-19.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Got sick with COVID/Tried and check with antigen testing kit twice and the results does shows both positive, both results are positive (Covid positive); Had five Pfizer vaccines (Covid-19) (outcome: Unknown), Not feeling well (outcome: Unknown), I was sneezing a lot (outcome: Unknown).  On October 1st of last fall of 2023. At the same on the same time as my flu shot in the other arm. Flu shot name: Consumer stated, Fluad, because she used the senior version. If Pfizer product: Consumer stated, I do not know. Product details (LOT#, Expiration, NDC# and UPC#) for Fluad: Consumer stated, no, again it was. The department Public health, they used to be able to access everything online all your shots and she looked a week ago and she cannot find my shots and she used to be able to well. Start date and stop date, dose, route, formulation and frequency (Paxlovid): Consumer stated, she using the two by 150 with the extra 100 milligram a Ritonavir. So, she received full strength not the half dose, twice daily and she started last Monday evening. So, she took eighth dose this morning, had two more to go. Treatment: Consumer stated, Only Advil when she was not feeling well and some antihistamines occasionally. Well, early on when she was sneezing a lot and that was not now. If still taking Antihistamines: Consumer stated, No, not now. If still taking Advil: Consumer stated, yes maybe once a day now and I am not regularly, no. she do not remember when last took some, maybe earlier yesterday. Reassurance: Consumer stated, no, nothing.  Fluad (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide a seriousness or causality assessment.; Reporter's Comments: Company causality: All the events are related to Fluad (TIV).
Sex: U
Vaccine: UNK
Symptoms: Chest pain, Dyspnoea, Muscle spasms
Clinical narrative: Shortness of breath; Chest pain; Leg cramping; This spontaneous case, initially received on 28-Sep-2024, was reported by a non health professional (patient)and concerns a patient of unknown age/gender.  Administration of company suspect drug: On an unknown date, the patient received Flucelvax (TIV) for an unknown indication, Dose regimen: not reported, Route of administration: not reported, Lot number: No batch number available, would be requested with follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Shortness of breath (Hospitalized, outcome: Not Reported), Chest pain (Hospitalized, outcome: Not Reported), Leg cramping (Hospitalized, outcome: Not Reported).  The patient received the Flucelvax Triv 2024-2025 and suffered a bad reaction. The patient had shortness of breath, chest pain, and leg cramping which landed the patient in the emergency room which then in turn got the patient admitted and the patient was still in the hospital. The patient was not sure what was in the vaccine that had the patient have such a reaction.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide a seriousness or causality assessment.; Reporter's Comments: Causality:Unassessable. The information provided is insufficient to perform a more in-depth analysis.(Product start date, event onset date, relevant medical history and concomitant medication details not provided).
Sex: M
Vaccine: FLUX
Symptoms: Acute myocardial infarction, Back pain, Blood creatinine increased, C-reactive protein increased, Catheterisation cardiac abnormal
Clinical narrative: Acute pericarditis; Pericardial effusion; Pleural effusions; Pulmonary edema; retrosternal chest pain with radiation to back; ST-elevation; This literature report (initial receipt: 24-Sep-2024) concerns an elderly male patient recently immunized for influenza.  The patient with a history of hypertension, hyperlipidemia, type-2 diabetes, a remote history of COVID-19 infection, recently immunized for influenza (trade name, manufacturer and lot number not reported - to be requested upon follow up) presented to our ED (Emergency Department) with sudden onset retrosternal chest pain with radiation to his back. EKG (Electrocardiogram) on arrival was notable for new ST-elevations in II, III, avF. Initial troponin was 0.01 ng/ml. He was loaded with aspirin 324mg and was started on a heparin infusion. Given his risk factors, STEMI (ST-elevation myocardial infarction) alert was called, and the patient was transported for emergent coronary catheterization. Cardiology noted diffusely patent coronary vasculature. Following PCI (percutaneous coronary intervention), he was transferred to the ICU (Intensive Care Unit) and his troponin increased to 0.06 ng/ml with a peak of 0.23 ng/ml. His chest pain changed in character and had a distinct postural element which was worse lying flat, but asymptomatic when semi-recumbent with some reproducibility on palpation of the right chest wall. His subsequent EKGs began to show diffuse ST elevations. Additionally, his labs were notable for CRP (C-Reactive Protein) of 234 mg/L, WBC (White Blood Cell) 11.9, creatinine 1.35 mg/dl. CT (Computed Tomography) chest/abdomen/pelvis with contrast showed trace pericardial effusion, pleural effusions, and mild pulmonary edema. He underwent transthoracic echocardiography which showed LVEF (Left Ventricular Ejection Fraction) 60-65% with no wall abnormality. He was treated with colchicine and prednisone. Over the following days his symptoms completely resolved, and he was discharged home after 2-days in hospital.  Author's Comment: The causes for pericarditis in this case include Covid-19 pericarditis and post-vaccination pericarditis.; Reporter's Comments: Causality: Related due to plausible temporal relationship (recently immunized for influenza) and in agreement with reporter causality. However, patient's elderly age and underlying condition of hypertension, hyperlipidemia, type-2 diabetes, a remote history of COVID-19 infection act as confounders in event causation.
Sex: M
Vaccine: FLUX
Symptoms: Chest pain, Computerised tomogram abdomen abnormal, Computerised tomogram thorax abnormal, Echocardiogram, Echocardiogram normal
Clinical narrative: Acute pericarditis; Pericardial effusion; Pleural effusions; Pulmonary edema; retrosternal chest pain with radiation to back; ST-elevation; This literature report (initial receipt: 24-Sep-2024) concerns an elderly male patient recently immunized for influenza.  The patient with a history of hypertension, hyperlipidemia, type-2 diabetes, a remote history of COVID-19 infection, recently immunized for influenza (trade name, manufacturer and lot number not reported - to be requested upon follow up) presented to our ED (Emergency Department) with sudden onset retrosternal chest pain with radiation to his back. EKG (Electrocardiogram) on arrival was notable for new ST-elevations in II, III, avF. Initial troponin was 0.01 ng/ml. He was loaded with aspirin 324mg and was started on a heparin infusion. Given his risk factors, STEMI (ST-elevation myocardial infarction) alert was called, and the patient was transported for emergent coronary catheterization. Cardiology noted diffusely patent coronary vasculature. Following PCI (percutaneous coronary intervention), he was transferred to the ICU (Intensive Care Unit) and his troponin increased to 0.06 ng/ml with a peak of 0.23 ng/ml. His chest pain changed in character and had a distinct postural element which was worse lying flat, but asymptomatic when semi-recumbent with some reproducibility on palpation of the right chest wall. His subsequent EKGs began to show diffuse ST elevations. Additionally, his labs were notable for CRP (C-Reactive Protein) of 234 mg/L, WBC (White Blood Cell) 11.9, creatinine 1.35 mg/dl. CT (Computed Tomography) chest/abdomen/pelvis with contrast showed trace pericardial effusion, pleural effusions, and mild pulmonary edema. He underwent transthoracic echocardiography which showed LVEF (Left Ventricular Ejection Fraction) 60-65% with no wall abnormality. He was treated with colchicine and prednisone. Over the following days his symptoms completely resolved, and he was discharged home after 2-days in hospital.  Author's Comment: The causes for pericarditis in this case include Covid-19 pericarditis and post-vaccination pericarditis.; Reporter's Comments: Causality: Related due to plausible temporal relationship (recently immunized for influenza) and in agreement with reporter causality. However, patient's elderly age and underlying condition of hypertension, hyperlipidemia, type-2 diabetes, a remote history of COVID-19 infection act as confounders in event causation.
Sex: M
Vaccine: FLUX
Symptoms: Ejection fraction normal, Electrocardiogram ST segment elevation, Intensive care, Pain, Percutaneous coronary intervention
Clinical narrative: Acute pericarditis; Pericardial effusion; Pleural effusions; Pulmonary edema; retrosternal chest pain with radiation to back; ST-elevation; This literature report (initial receipt: 24-Sep-2024) concerns an elderly male patient recently immunized for influenza.  The patient with a history of hypertension, hyperlipidemia, type-2 diabetes, a remote history of COVID-19 infection, recently immunized for influenza (trade name, manufacturer and lot number not reported - to be requested upon follow up) presented to our ED (Emergency Department) with sudden onset retrosternal chest pain with radiation to his back. EKG (Electrocardiogram) on arrival was notable for new ST-elevations in II, III, avF. Initial troponin was 0.01 ng/ml. He was loaded with aspirin 324mg and was started on a heparin infusion. Given his risk factors, STEMI (ST-elevation myocardial infarction) alert was called, and the patient was transported for emergent coronary catheterization. Cardiology noted diffusely patent coronary vasculature. Following PCI (percutaneous coronary intervention), he was transferred to the ICU (Intensive Care Unit) and his troponin increased to 0.06 ng/ml with a peak of 0.23 ng/ml. His chest pain changed in character and had a distinct postural element which was worse lying flat, but asymptomatic when semi-recumbent with some reproducibility on palpation of the right chest wall. His subsequent EKGs began to show diffuse ST elevations. Additionally, his labs were notable for CRP (C-Reactive Protein) of 234 mg/L, WBC (White Blood Cell) 11.9, creatinine 1.35 mg/dl. CT (Computed Tomography) chest/abdomen/pelvis with contrast showed trace pericardial effusion, pleural effusions, and mild pulmonary edema. He underwent transthoracic echocardiography which showed LVEF (Left Ventricular Ejection Fraction) 60-65% with no wall abnormality. He was treated with colchicine and prednisone. Over the following days his symptoms completely resolved, and he was discharged home after 2-days in hospital.  Author's Comment: The causes for pericarditis in this case include Covid-19 pericarditis and post-vaccination pericarditis.; Reporter's Comments: Causality: Related due to plausible temporal relationship (recently immunized for influenza) and in agreement with reporter causality. However, patient's elderly age and underlying condition of hypertension, hyperlipidemia, type-2 diabetes, a remote history of COVID-19 infection act as confounders in event causation.
Sex: M
Vaccine: FLUX
Symptoms: Pericardial effusion, Pericarditis, Pleural effusion, Pulmonary oedema, Scan with contrast abnormal
Clinical narrative: Acute pericarditis; Pericardial effusion; Pleural effusions; Pulmonary edema; retrosternal chest pain with radiation to back; ST-elevation; This literature report (initial receipt: 24-Sep-2024) concerns an elderly male patient recently immunized for influenza.  The patient with a history of hypertension, hyperlipidemia, type-2 diabetes, a remote history of COVID-19 infection, recently immunized for influenza (trade name, manufacturer and lot number not reported - to be requested upon follow up) presented to our ED (Emergency Department) with sudden onset retrosternal chest pain with radiation to his back. EKG (Electrocardiogram) on arrival was notable for new ST-elevations in II, III, avF. Initial troponin was 0.01 ng/ml. He was loaded with aspirin 324mg and was started on a heparin infusion. Given his risk factors, STEMI (ST-elevation myocardial infarction) alert was called, and the patient was transported for emergent coronary catheterization. Cardiology noted diffusely patent coronary vasculature. Following PCI (percutaneous coronary intervention), he was transferred to the ICU (Intensive Care Unit) and his troponin increased to 0.06 ng/ml with a peak of 0.23 ng/ml. His chest pain changed in character and had a distinct postural element which was worse lying flat, but asymptomatic when semi-recumbent with some reproducibility on palpation of the right chest wall. His subsequent EKGs began to show diffuse ST elevations. Additionally, his labs were notable for CRP (C-Reactive Protein) of 234 mg/L, WBC (White Blood Cell) 11.9, creatinine 1.35 mg/dl. CT (Computed Tomography) chest/abdomen/pelvis with contrast showed trace pericardial effusion, pleural effusions, and mild pulmonary edema. He underwent transthoracic echocardiography which showed LVEF (Left Ventricular Ejection Fraction) 60-65% with no wall abnormality. He was treated with colchicine and prednisone. Over the following days his symptoms completely resolved, and he was discharged home after 2-days in hospital.  Author's Comment: The causes for pericarditis in this case include Covid-19 pericarditis and post-vaccination pericarditis.; Reporter's Comments: Causality: Related due to plausible temporal relationship (recently immunized for influenza) and in agreement with reporter causality. However, patient's elderly age and underlying condition of hypertension, hyperlipidemia, type-2 diabetes, a remote history of COVID-19 infection act as confounders in event causation.
Sex: M
Vaccine: FLUX
Symptoms: Troponin increased, White blood cell count increased
Clinical narrative: Acute pericarditis; Pericardial effusion; Pleural effusions; Pulmonary edema; retrosternal chest pain with radiation to back; ST-elevation; This literature report (initial receipt: 24-Sep-2024) concerns an elderly male patient recently immunized for influenza.  The patient with a history of hypertension, hyperlipidemia, type-2 diabetes, a remote history of COVID-19 infection, recently immunized for influenza (trade name, manufacturer and lot number not reported - to be requested upon follow up) presented to our ED (Emergency Department) with sudden onset retrosternal chest pain with radiation to his back. EKG (Electrocardiogram) on arrival was notable for new ST-elevations in II, III, avF. Initial troponin was 0.01 ng/ml. He was loaded with aspirin 324mg and was started on a heparin infusion. Given his risk factors, STEMI (ST-elevation myocardial infarction) alert was called, and the patient was transported for emergent coronary catheterization. Cardiology noted diffusely patent coronary vasculature. Following PCI (percutaneous coronary intervention), he was transferred to the ICU (Intensive Care Unit) and his troponin increased to 0.06 ng/ml with a peak of 0.23 ng/ml. His chest pain changed in character and had a distinct postural element which was worse lying flat, but asymptomatic when semi-recumbent with some reproducibility on palpation of the right chest wall. His subsequent EKGs began to show diffuse ST elevations. Additionally, his labs were notable for CRP (C-Reactive Protein) of 234 mg/L, WBC (White Blood Cell) 11.9, creatinine 1.35 mg/dl. CT (Computed Tomography) chest/abdomen/pelvis with contrast showed trace pericardial effusion, pleural effusions, and mild pulmonary edema. He underwent transthoracic echocardiography which showed LVEF (Left Ventricular Ejection Fraction) 60-65% with no wall abnormality. He was treated with colchicine and prednisone. Over the following days his symptoms completely resolved, and he was discharged home after 2-days in hospital.  Author's Comment: The causes for pericarditis in this case include Covid-19 pericarditis and post-vaccination pericarditis.; Reporter's Comments: Causality: Related due to plausible temporal relationship (recently immunized for influenza) and in agreement with reporter causality. However, patient's elderly age and underlying condition of hypertension, hyperlipidemia, type-2 diabetes, a remote history of COVID-19 infection act as confounders in event causation.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Injected limb mobility decreased, Joint noise
Clinical narrative: Patient is experiencing shoulder pain, cannot lift right arm well, is having "clicking and pain" in right shoulder.  Patient thinks that she got the shot too high in her arm.
Age: 32.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient started to experience redness, swelling, tenderness, warm to touch and itchiness just around the injection site about 3 hours after receiving the vaccine. Patient presented to pharmacy on 10/7/24 at 3pm and had a bruise and slight redness around the injection site. Still warm to touch and itchy. Patient not presenting with any other signs or symptoms. Pt states that reaction has gotten worse each day. Patient put ice on injection site around 2:30pm on 10/7/24 but did not report any improvement in reaction. Patient was instructed to put a circle around the current redness site so progress/improvement can be monitored and measured. Patient will continue to monitor and address accordingly.
Age: 32.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site warmth
Clinical narrative: Patient started to experience redness, swelling, tenderness, warm to touch and itchiness just around the injection site about 3 hours after receiving the vaccine. Patient presented to pharmacy on 10/7/24 at 3pm and had a bruise and slight redness around the injection site. Still warm to touch and itchy. Patient not presenting with any other signs or symptoms. Pt states that reaction has gotten worse each day. Patient put ice on injection site around 2:30pm on 10/7/24 but did not report any improvement in reaction. Patient was instructed to put a circle around the current redness site so progress/improvement can be monitored and measured. Patient will continue to monitor and address accordingly.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient had passed out after receiving the vaccine. Patient stated that he felt a little light headed and then passed out. The pharmacist was able to get him to lay down and so the patient did not injure themself.
Sex: F
Vaccine: HEP
Symptoms: Contusion, Headache, Nausea, Pruritus
Clinical narrative: Employee stating the area is itching, area is bruised, she has been feeling nauseous and has had a headache
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: After administration, it was discovered patient had already received Fluzone HD vaccine on 8/31/24.
Age: 9.0
Sex: M
Vaccine: CHIK
Symptoms: Erythema, Hypersensitivity, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Paien experienced an allergic reaction on his arm; pain, swelling, and warm o the touch. Pt's mom took child to urgent care at a different location  because she  was concerned about the reaction.  Pt was given Mupirocin 2% ointment and Cephalexin 10 ml. RN called to follow up on Pt to see how he was doing after the reaction per chart notes.  Pt was feeling better and the redness and reaction was going away.
Age: 0.58
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was due to receive Pediarix. However the medical assistant administered Kinrix instead.  No adverse reactions reported by the parent.
Age: 33.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness
Clinical narrative: patient said she was afraid of needles but said she will not look as she is getting vaccine-after shots were administered she said she needs to lie down because feeling faint-i helped her on floor and called to get an ambulance as she seemed to be fainting-i stayed with her gave her water(she did not drink) and made sure she doesnt loose consciousness. Ambulance came right away but she did not want to go to the hospital-she walked to the car parked in front of store-she was checked out and she was ok to drive home according to emt
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Patient was vaccinated with an adult dose of Pfizer 12+ covid 2024-25 season vaccine instead of the age appropriate vaccine of  covid 5 years - 11 years.  Patient was presented by mom with significant anxiety as most children present. The primary RN did not verify the age of the child present as part of the questions and based on his height and weight thought the child was age appropriate.  Spoke with parent (Mother) on 10/7/24 - child presented with no unusual post vaccine side effects in the 72 hours post vaccine. Slight sore arm and treated with Tylenol. No verbalized fever, no verbalized malaise. Child went about his day without any change in presentation according to mother.  Child went to school on Oct 7th 2024, without any difficulty or verbalized complaints throughout the day.  This dose was part of the yearly vaccine and has already received the required doses since 2020.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: pt was given a second flu vaccine after receiving one on 8/11/2024. The patient does not report any symptoms or adverse effects at this time
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Eye discharge, Ocular hyperaemia
Clinical narrative: Approximately two hours after I got the Covid-19 and Fluarix vaccines in my right arm, my right eye began to secrete a gooey discharge and the whites of my eye turned pinkish.
Age: 16.0
Sex: F
Vaccine: CHOL
Symptoms: Chest discomfort, Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal, Full blood count, Laboratory test
Clinical narrative: After an appointment on September 11th (received menquadfi vaccine), the patient developed a sore throat, congestion, and chest discomfort around 2 days later on September 13th. Although the initial chest discomfort improved, it has worsened over the past few days, making it difficult for the patient to focus on school activities. pt had EKG done and Holter monitor which showed frequent PVCs (24% of the time).
Age: 16.0
Sex: F
Vaccine: CHOL
Symptoms: Loss of personal independence in daily activities, Metabolic function test, Oropharyngeal pain, Respiratory tract congestion, SARS-CoV-2 antibody test positive
Clinical narrative: After an appointment on September 11th (received menquadfi vaccine), the patient developed a sore throat, congestion, and chest discomfort around 2 days later on September 13th. Although the initial chest discomfort improved, it has worsened over the past few days, making it difficult for the patient to focus on school activities. pt had EKG done and Holter monitor which showed frequent PVCs (24% of the time).
Age: 16.0
Sex: F
Vaccine: CHOL
Symptoms: Serum ferritin decreased, Ventricular extrasystoles
Clinical narrative: After an appointment on September 11th (received menquadfi vaccine), the patient developed a sore throat, congestion, and chest discomfort around 2 days later on September 13th. Although the initial chest discomfort improved, it has worsened over the past few days, making it difficult for the patient to focus on school activities. pt had EKG done and Holter monitor which showed frequent PVCs (24% of the time).
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient received vaccine 10/07/24 around 3pm. Patient called pharmacy back after 4pm reporting left side tingling, numbness. Patient did not report droop in face that they could see. Patient also stated was not experiencing swelling, or difficulty breathing. I talked with patient about possible nervous system side effects (considered rare). She did state she had a reaction to Covid vaccine in past that included throat swelling and migraine headache. Her reaction to Covid would not prevent her from getting other vaccines.  At time of our conversation she wasn't experiencing hypersensitivity/anaphylaxis symptoms. I told patient she should report her symptoms to her doctor and I would also report on pharmacy side. I also talked about signs /symptoms that would call for seeking emergency medical treatment.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt was mistakenly given an adult vaccine, pt suffered no negative outcomes or symptoms.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Fluzone High dose given to patient age 61. no adverse event
Age: 15.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, UNK
Symptoms: Dizziness, Hypoacusis, Injection site pain, Loss of consciousness
Clinical narrative: Patient reported second vaccine (novavax) hurt more than the Flucelvax. She got up after the vaccine and was about 25 feet away from the pharmacy and had a muffled sound in her ears. She then felt dizzy. Her mom reported she passed out for about 5 to 10 seconds. I grabbed the emergency kit and by the time I got to her less than a minute later she regained consciousness. I had her elevated her feet higher than her heart, placed an ice pack behind her head. After 15 minutes she was feeling better and she left. I spoke with mother an hour later and she said she was fine.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain, front and left side of heart
Age: 43.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: I (CMA) administered the incorrect dose of Hep A and Hep B to an adult patient. I administered a pediatric dose  to the 43 year old patient.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 67.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site swelling, Pain in extremity, Rash
Clinical narrative: Redness & swelling of left arm (Shingrix injection site). Arm warm to the touch. Patient went to urgent care after about a week, they sent him to emergency department due to concern for potential heart attack or arm injury due to sore arm. Patient was treated with pain medication and steroids. Two days following treatment at ED, patient reports he got shingles rash on arms and back at which time he contacted his primary care physician and get medication for supportive care of shingles.
Age: 67.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Skin warm
Clinical narrative: Redness & swelling of left arm (Shingrix injection site). Arm warm to the touch. Patient went to urgent care after about a week, they sent him to emergency department due to concern for potential heart attack or arm injury due to sore arm. Patient was treated with pain medication and steroids. Two days following treatment at ED, patient reports he got shingles rash on arms and back at which time he contacted his primary care physician and get medication for supportive care of shingles.
Age: 60.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site bruising, Injection site pain, Product administered at inappropriate site
Clinical narrative: Patient reports the vaccinations were given in her shoulder. She still has a bruise at the site more than three weeks later. She is concerned because she still has soreness and some pain. She is concerned about future issues with her shoulder.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside "Best By" date. patient notified. No reaction stated.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: patient was administered a second flu vaccine on 10/5/24
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best BY" date. Patient notified. No reaction stated
Age: 41.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Dyspnoea, Hyperhidrosis, Hypoaesthesia, Mobility decreased, Pallor
Clinical narrative: Patient began sweating profusely to the point where it was dripping onto his sleeves and the floor. Complaints of tingling and numbness in the hands, and subsequently reported having difficulty moving his arm. Patient was shaking and extremely pale. Reported having some difficulties breathing, but was able to take deep breaths until EMTs arrived. IV fluids were given and patient transported onto ambulance where further care was administered. Outcome is unknown.
Age: 41.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Paraesthesia, Tremor
Clinical narrative: Patient began sweating profusely to the point where it was dripping onto his sleeves and the floor. Complaints of tingling and numbness in the hands, and subsequently reported having difficulty moving his arm. Patient was shaking and extremely pale. Reported having some difficulties breathing, but was able to take deep breaths until EMTs arrived. IV fluids were given and patient transported onto ambulance where further care was administered. Outcome is unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By: date".  Patient notified.  No reaction stated.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Blood pressure increased, Dizziness, Feeling hot, Nausea
Clinical narrative: Patient felt faint, warm and nauseous about 3 minutes after immunization. Laid on waiting area bench with cold pack on her neck and wrists till she felt better. Took her blood pressure and was very low (100/58), then became a little high (150/80) approximately 5 minutes later. Patient had experienced similar reactions in other settings, mostly medical related, for about three years.
Age: 18.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Immunizing nurse accidentally administered a high dose flu shot to an 18 year old.  No adverse events are known from this incident.
Age: 1.5
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Vaccine was not diluted as noted on the instructions and one entire vial was administered to patient by Medical Assistant
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 1.83
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Vaccine was not diluted as noted on the instructions and one entire vial was administered to patient by Medical Assistant
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Chest discomfort, Chest pain, Heart rate increased, Hypertension
Clinical narrative: patient states tingles across chest, chest pains, rapid pulse and high blood pressure. States she felt like wanted to jump out of skin. she saw a pa and also went to the er and all tests and full heart workup were flawless/negative. she said she has been stressed about her husband procedure but that she believes this is due to the vaccine. Received the vaccine on 9/27 and symptoms started 9/28 which they were mild and ramped up each day. She felt better on 10/5. Now she just has chest tightness. md states she can go for stress test or heart monitor but she has declined at this time.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test abnormal, Paraesthesia
Clinical narrative: patient states tingles across chest, chest pains, rapid pulse and high blood pressure. States she felt like wanted to jump out of skin. she saw a pa and also went to the er and all tests and full heart workup were flawless/negative. she said she has been stressed about her husband procedure but that she believes this is due to the vaccine. Received the vaccine on 9/27 and symptoms started 9/28 which they were mild and ramped up each day. She felt better on 10/5. Now she just has chest tightness. md states she can go for stress test or heart monitor but she has declined at this time.
Age: 46.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Abdominal pain upper, Diarrhoea, Malaise, Nausea, Vomiting
Clinical narrative: patient states that she had severe  nausea and vomiting. patient states being severely ill  with severe diarrhea  and stomach pains.  patient asked  us to report it
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By' date. Patient notified. No reaction stated
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: PATIENT WAS ADMINISTERED BOTH A PFIZER COVID SHOT AND A HIGH DOSE FLU SHOT WHEN ONLY INTENDING TO GET A FLU SHOT.  PATIENT STATED THIS ONLY AFTER RECEIVING THE FIRST SHOT WHICH WAS THE COVID SHOT. PATIENT WAS DUE FOR A COVID BOOSTER AND WAS OK AFTER WE UPDATED HER COVID CARD. PATIENT HAAD NO ADVERSE REACTION TO EITHER VACCINE,
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. patient notified. No reaction stated.
Age: 34.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Product substitution error
Clinical narrative: At about 1:17pm, while trying to enter the vaccine in system we noticed that the order did not match the vaccine administered. I checked the vaccine on the inventory log, and I realized that a Hepatitis B Vaccine was inadvertently pulled and administered. Patient was already gone when the error was noticed.  Both the Site Lead and Nurse Practitioner were notified of the error. Patient was called and was informed of the error and asked to come in to get another dose of Hep B.  Patient said she would not be able to get back to the site today (site open until 2pm depart by 3pm).   She asked if she could get the dose elsewhere as our clinics are not conveniently located to her and we are not returning to that site this week.  She was told yes.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Tremor
Clinical narrative: Patient received vaccine around 12:40 PM on 10/7/24.  Around 6:00 PM on 10/7/24 patients wife called to report that patient was feeling unwell and shaking all over. During the phone call the patients daughter called the ambulance and the patient was taken to the ER by ambulance.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated