chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: I got my shot and got sick; Initial information was received on 30-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves a patient with unknown demographics who got shot and got sick after being vaccinated with Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, route, administration site, lot number and expiration date) for prophylactic vaccination and got sick (illness) a few months later (unknown latency).  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 30-Nov-2022 regarding an unsolicited valid social media non-serious case received from via consumer/non-hcp.  This case involves patient of unspecified demographics who experienced flu while receiving vaccine Influenza Vaccine (flu shot).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for flu vaccination.  Information regarding batch and expiry date requested.  On an unknown date, the patient developed a non-serious flu (influenza) at unknown latency following the administration of Influenza Vaccine.  It was reported that "I got flu shot and still ended up getting the flu".   Action taken: Not applicable.  Corrective treatment: not reported.  At time of reporting, the outcome was Unknown for the event flu.
Sex: M
Vaccine: RAB
Symptoms: Extra dose administered, Incorrect dose administered, No adverse event
Clinical narrative: Patient was given between 10 to 12 IMOVAX rabies vaccines during a 4.5 month time frame with no reported adverse event; Initial information was received on 30-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age male patient who reported patient was given between 10 to 12 imovax rabies vaccines during a 4.5 month time frame with no reported adverse event after receiving rabies (HDC) vaccine [Imovax Rabies].  The patient's past medical history included Animal bite. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect rabies (HDC) vaccine (Powder and solvent for suspension for injection) (lot number, expiry date, strength, frequency was unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient had a non-serious event patient was given between 10 to 12 imovax rabies vaccines during a 4.5 month time frame with no reported adverse event (incorrect dose administered) (unknown latency) following the administration of rabies (HDC) vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  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: 71.0
Sex: F
Vaccine: DTAP
Symptoms: Dyspnoea, Erythema, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: shortness of breath; nausea; swelling and redness all over her arm; redness all over her arm; high fever; Initial information received on 01-Dec-2022 regarding an unsolicited valid non-serious case received from patient.  This case involves a 71 years old female patient who experienced shortness of breath, nausea, swelling and redness all over her arm, redness all over her arm and high fever after receiving vaccine diphtheria, tetanus and acellular pertussis vaccine.  The patient's past medical history included mole biopsied (Biopsy) and allergic to red dye. The patient's past medical treatment included Patient found out she was allergic to red dye when she started taking prenatal medications and also stated that she has to take a Benadryl each time she takes an antibiotic due to her lactose allergy. The patient's past vaccination(s) included pnuemonia-23 shot with horrible headache and cellulitis on her arm. The patient's past family history was not provided. At the time of the event, the patient had ongoing allergies and believes both her and her daughter may have HaT syndrome (Hypersensitivity) and lactose allergy (Lactose intolerance).  On an unknown date, the patient received a dose of suspect diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient had shortness of breath (dyspnoea), nausea, swelling and redness all over her arm (peripheral swelling), redness all over her arm (erythema) and high fever (pyrexia) (unknown latency) following the administration of diphtheria and tetanus and acellular pertussis vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (shortness of breath, nausea, swelling and redness all over her arm, redness all over her arm, high fever).  At time of reporting, the outcome was Unknown for the events.
Age: 2.0
Sex: F
Vaccine: FLUC3
Symptoms: Influenza, Influenza virus test positive, Pyrexia, Vaccination failure
Clinical narrative: Tested positive for the flu; Tested positive for the flu/Lack of efficacy; This spontaneous case was received on 23-Nov-2022 other healthcare professional via Regulatory Communications (reference number: SEQW22-06038) and concerned a 2-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 11-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration and anatomical location: not reported) for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and B. The batch number reported was 348368 and expiry date was 30-Jun-2023.  On 22-Nov-2022, 1 month and 11 days after receiving Flucelvax Quadrivalent, the patient developed fever in daycare.   On 23-Nov-2022, the patient was taken to her primary care doctor to make sure it was not an ear infection. The patient was subjected to a flu test which turned out positive (explicitly coded as 'Vaccination failure').  On an unspecified date in Nov-2022, the patient took 'fever reduction' Tylenol (paracetamol) and was prescribed Tamiflu (oseltamivir phosphate). The patient was presently on Tamiflu at the time of report.   At the time of initial repoting on 23-Nov-2022, the patient had not recovered from the event of flu.   The reporter did not provide a causality assessment.  The event of 'flu' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 2-year-old, female patient was vaccinated with Flucelvax Quadrivalent. 1 month and 11 days after vaccination, the patient developed fever. Next day, the patient was subjected to a flu test which turned out positive (explicitly coded as 'Vaccination failure'). The patient's medical history and concomitant medications were not reported. Based on provided information, causal role of the suspect product is assessed as possibly related for both events, influenza and vaccination failure.; Sender's Comments: A 2-year-old, female patient was vaccinated with Flucelvax Quadrivalent. 1 month and 11 days after vaccination, the patient developed fever. Next day, the patient was subjected to a flu test which turned out positive (explicitly coded as 'Vaccination failure'). The patient's medical history and concomitant medications were not reported. Based on provided information, causal role of the suspect product is assessed as possibly related for both events, influenza and vaccination failure.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Cervical vertebral fracture, Fall, Paralysis, Quadriplegia
Clinical narrative: paralyzed/quadriplegic; fractured a cervical vertebrae; fall; Initial information was received on 01-Dec-2022 regarding an unsolicited valid serious case received from a consumer/non-health-care professional.  This case involves 60 years old male patient who reported paralyzed/quadriplegic, fractured a cervical vertebrae and fall after receiving influenza quadrival A-B vaccine [Fluzone quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 21-Feb-2022, the patient received an unknown dose of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot: UJ493AAA, expiry date: 30-Jun-2021) (strength, frequency was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had a serious event paralyzed/quadriplegic (Quadriplegia) and fractured a cervical vertebrae (cervical vertebral fracture) (unknown latency) following the administration of influenza quadrival A-B vaccine.  On an unknown date the patient had a non-serious event fall (unknown latency) following the administration of influenza quadrival A-B vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.  Seriousness Criteria: Medically significant and disability for event paralyzed/quadriplegic. Medically significant for fractured a cervical vertebrae.; Sender's Comments: Sanofi Company Comment dated 05-Dec-2022: This case involves 60 years old male patient who reported paralyzed/quadriplegic, fractured a cervical vertebrae and fall after receiving influenza quadrival A-B vaccine [Fluzone quadrivalent]. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of past and concomitant medication, vaccination history, family history and any relevant medical history of patient, any concurrent conditions and lab investigations precludes comprehensive case assessment.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: I signed up  to get the Flu shot during a work sponsored Flu/Covid vaccination event.  I sat down to get the Flu shot and was given the Covid Vaccine by accident by the pharmacy employee.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Flushing, Hyperhidrosis, Injection site pain, Nausea
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Patient received a flu vaccine, then a few minutes later did not feel well and vomited twice. The patient then drank some water and laid down. They felt better after about 15 minutes and went home.
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Per pt, had soreness at the site of injection the day of the shot, but expected it to fade after 24 hours,  unfortunately the pain  has not subsided even after 2 weeks. The pain spreads down arm when pt moves. Range of motion is limited. Contacted patient to follow up, however, pt refuesed to give any information.
Age: 19.0
Sex: F
Vaccine: COVID19-2
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: faint for 5 seconds then recover saying fear of needles
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Additional Details: still has pain in left shoulder  will be seeing orthopod for shoulder pain as per followup with patient
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Additional Details: ptient has swollen red arm
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Peripheral swelling, Rash
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Additional Details: ptient has swollen red arm
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: injection side hard and hot. Feel burning on the injection side. baseball size. No fever.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: injection side hard and hot. Feel burning on the injection side. baseball size. No fever.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, COVID-19, Chest discomfort, Chills, Diarrhoea
Clinical narrative: Pt self reported receiving covid vaccine (no vaccine info available) and was admitted to inpatient facility for covid infection
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Dysuria, Fatigue, Headache
Clinical narrative: Pt self reported receiving covid vaccine (no vaccine info available) and was admitted to inpatient facility for covid infection
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Middle insomnia, Myalgia, Nausea, Oropharyngeal pain, Pollakiuria
Clinical narrative: Pt self reported receiving covid vaccine (no vaccine info available) and was admitted to inpatient facility for covid infection
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Productive cough, SARS-CoV-2 test positive, Stress, Thirst
Clinical narrative: Pt self reported receiving covid vaccine (no vaccine info available) and was admitted to inpatient facility for covid infection
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Wrong product administered
Clinical narrative: Order was written for IPV and HPV was given.  Md aware and patient is aware.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram head abnormal, Discharge, Exophthalmos, Eye pain
Clinical narrative: Pt self reported receiving covid vaccinations (no vaccine info available) and was admitted to inpatient facility with covid infection
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Facial bones fracture, Periorbital oedema, Sinusitis, Subperiosteal abscess
Clinical narrative: Pt self reported receiving covid vaccinations (no vaccine info available) and was admitted to inpatient facility with covid infection
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Pt self reported receiving covid vaccinations (no vaccine info available) and was admitted to inpatient facility with covid infection
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphocyte count normal, Monocyte count increased
Clinical narrative: lymphocyte count high 4.0 m 4/11/2022, 3.6 on 11/22/2022 monocyte count high 1.0 m 4/11/2022, 1.0 on 11/22/2022
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Oropharyngeal pain, Pain
Clinical narrative: I had a sore throat and took a COVID-19 test which was negative so I waited until the next next day and I tested again and the result was positive, that night I had a cough, runny nose, body aches, fever and headache. The symptoms lasted approximately three days and a headache that lasted three weeks and a cough that I still have at the time of my reporting.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: I had a sore throat and took a COVID-19 test which was negative so I waited until the next next day and I tested again and the result was positive, that night I had a cough, runny nose, body aches, fever and headache. The symptoms lasted approximately three days and a headache that lasted three weeks and a cough that I still have at the time of my reporting.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Decreased appetite, Gait disturbance, Headache, Insomnia
Clinical narrative: 2 migraine aura events 1 hour after booster; severe chills that night with teeth-chattering and sleeplessness; inability to walk upright (needed a walker) nausea. Threw up my breakfast in morning, severe headaches for at least 6 days following, loss of appetite.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine with aura, Nausea, Vomiting
Clinical narrative: 2 migraine aura events 1 hour after booster; severe chills that night with teeth-chattering and sleeplessness; inability to walk upright (needed a walker) nausea. Threw up my breakfast in morning, severe headaches for at least 6 days following, loss of appetite.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Gait inability, Insomnia
Clinical narrative: 2 migraine aura events 1 hour after booster; severe chills that night with teeth-chattering and sleeplessness; inability to walk upright (needed a walker) nausea. Threw up my breakfast in morning, severe headaches for at least 6 days following, loss of appetite.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine with aura, Sensory loss, Vomiting
Clinical narrative: 2 migraine aura events 1 hour after booster; severe chills that night with teeth-chattering and sleeplessness; inability to walk upright (needed a walker) nausea. Threw up my breakfast in morning, severe headaches for at least 6 days following, loss of appetite.
Age: 4.0
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Rash erythematous, Rash macular, Urinary incontinence, Vomiting
Clinical narrative: Patient immediately developed red blotchy diffuse rash;  Vomited.  Had urinary incontinence. No LOC.   VS remained normal.  Was given 25mg of po Benadryl.  No epi was given.  Patient was observed for over 30 minutes and symptoms resolved.  Phone follow-up later in day: patient was doing well with no symptoms.
Age: 1.25
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: The patient was seen to catch up on immunizations and based on the patient's vaccination card, it showed that he was missing his third hepatitis B vaccine so it was given on 12/04/22. However, when inputting vaccines into system, the patient's account was found which showed that he did received his third hepatitis B vaccine on 4/01/2022, it was just not added to his vaccination card so he received an extra dose.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose normal, Dizziness, Immediate post-injection reaction, Nausea, Taste disorder
Clinical narrative: Pt reported "medicine taste" in mouth within 1 minute of vaccine administration. Pt then reported nausea and dizziness within 3 minutes. Pt placed in sidelying position and allowed to rest with medical professionals immediately available. Blood glucose 184. Pt denied eating or drinking since waking. Pt reported improvement around 9:25am, orthostatics obtained - WNL. Geri-Lanta administered for nausea. Pt ambulated safely from clinic at 09:45.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Condition aggravated, Eye swelling, Flushing, Hypertension
Clinical narrative: h/o adverse reaction to J&J vaccine. Mast Cell specialist recommended mRNA vaccination in graded fashion in facility capable of treating anaphylaxis. Administered 0.1 mL increments of Pfizer monovalent vaccine with 30 minute interval X 2 doses. 20 minutes after second (of planned 3 doses), developed hypertension, flushing, itching, eye swelling & severe abdominal cramping. Procedure aborted. Treated with total of (2) doses epinephrine 0.3mg IM, Pepcid 40 mg PO, Diphenhydramine 50 mg IV. Transferred to emergency department for continued care. Admitted to ICU with epinephrine drip for recurrent symptoms.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Intensive care, Laboratory test, Pruritus
Clinical narrative: h/o adverse reaction to J&J vaccine. Mast Cell specialist recommended mRNA vaccination in graded fashion in facility capable of treating anaphylaxis. Administered 0.1 mL increments of Pfizer monovalent vaccine with 30 minute interval X 2 doses. 20 minutes after second (of planned 3 doses), developed hypertension, flushing, itching, eye swelling & severe abdominal cramping. Procedure aborted. Treated with total of (2) doses epinephrine 0.3mg IM, Pepcid 40 mg PO, Diphenhydramine 50 mg IV. Transferred to emergency department for continued care. Admitted to ICU with epinephrine drip for recurrent symptoms.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia
Clinical narrative: Patient called pharmacy to make aware about 6 months after vaccine administered to report intermittent arm numbness from shoulder to elbow in left arm that started a couple of weeks after receiving the vaccine
Age: 80.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Abdominal discomfort, COVID-19, Diarrhoea, Fatigue, Pyrexia
Clinical narrative: I had been traveling and on 11/26/22, and I started to experience stomach issues. I started running a low grade fever and felt fatigued. I attributed the fatigue to jet lag. On Monday, 11/28/2022, I did a rapid test at home and it was negative. I continued to have the stomach issues. In the next couple of days, I experienced diarrhea. I did a PCR and rapid test at home on 11/30/2022, and the rapid was negative, but the PCR was positive. I reached out to my doctor on 12/01/2022 and she prescribed PAXLOVID. I started taking it on 12/01/2022 and I just finished the medication on 12/05/2022. As of today, I feel fine.
Age: 80.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had been traveling and on 11/26/22, and I started to experience stomach issues. I started running a low grade fever and felt fatigued. I attributed the fatigue to jet lag. On Monday, 11/28/2022, I did a rapid test at home and it was negative. I continued to have the stomach issues. In the next couple of days, I experienced diarrhea. I did a PCR and rapid test at home on 11/30/2022, and the rapid was negative, but the PCR was positive. I reached out to my doctor on 12/01/2022 and she prescribed PAXLOVID. I started taking it on 12/01/2022 and I just finished the medication on 12/05/2022. As of today, I feel fine.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Bone pain, Gait disturbance, Headache, Inflammation
Clinical narrative: I experienced an extreme inflammatory response. I was hardly able to walk. I skipped showering the morning after as I was too stiff to raise my leg. I gingerly walked down the stairs when leaving for work. All joints and bones ached. I ran a fever at the 24 hour mark after injection. The fever lasted approximately five hours. As the soreness and stiffness wore off throughout the week. my joints were very sore. I have had persistent headaches. I had a perfect concentric red circle on my arm at the injection site x six days. The injection site was hot to touch for six days. At day three, I experienced soreness and swelling at the pectoralis muscle. No changes in color, no discharges from the breast. Overall a very unexpected inflammatory response. Tylenol was minimally helpful. I took 500 mg po q3H when symptoms would increase.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site warmth, Muscle swelling, Musculoskeletal stiffness, Myalgia
Clinical narrative: I experienced an extreme inflammatory response. I was hardly able to walk. I skipped showering the morning after as I was too stiff to raise my leg. I gingerly walked down the stairs when leaving for work. All joints and bones ached. I ran a fever at the 24 hour mark after injection. The fever lasted approximately five hours. As the soreness and stiffness wore off throughout the week. my joints were very sore. I have had persistent headaches. I had a perfect concentric red circle on my arm at the injection site x six days. The injection site was hot to touch for six days. At day three, I experienced soreness and swelling at the pectoralis muscle. No changes in color, no discharges from the breast. Overall a very unexpected inflammatory response. Tylenol was minimally helpful. I took 500 mg po q3H when symptoms would increase.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: I experienced an extreme inflammatory response. I was hardly able to walk. I skipped showering the morning after as I was too stiff to raise my leg. I gingerly walked down the stairs when leaving for work. All joints and bones ached. I ran a fever at the 24 hour mark after injection. The fever lasted approximately five hours. As the soreness and stiffness wore off throughout the week. my joints were very sore. I have had persistent headaches. I had a perfect concentric red circle on my arm at the injection site x six days. The injection site was hot to touch for six days. At day three, I experienced soreness and swelling at the pectoralis muscle. No changes in color, no discharges from the breast. Overall a very unexpected inflammatory response. Tylenol was minimally helpful. I took 500 mg po q3H when symptoms would increase.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Central venous catheterisation, Chest X-ray abnormal, Constipation
Clinical narrative: Pt brought to ED via EMS with weakness, chronic inability to walk, SOB, wheezing, decubitus ulcer, constipation; was sent to hospital by home health nurse to assess possible infection of decubitus; pt requesting SNF for rehab; pt has a feeding tube; recent hospitalization for pneumonia and sepsis; was on ABX through PICC line; has completed ABX and home health nurse removed PICC line; now CXR shows severe emphysematous changes bilaterally with right pleuroparenchymal disease; DNR/DNI; evaluation of decubitus, no surgical intervention needed; wound care ordered; pt found to be positive for COVID during hospitalization; started on ABX and Decadron; no acute respiratory issues;  dc'd for PT and continued care; pt passed away
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Decubitus ulcer, Dyspnoea, Emphysema, Gait inability
Clinical narrative: Pt brought to ED via EMS with weakness, chronic inability to walk, SOB, wheezing, decubitus ulcer, constipation; was sent to hospital by home health nurse to assess possible infection of decubitus; pt requesting SNF for rehab; pt has a feeding tube; recent hospitalization for pneumonia and sepsis; was on ABX through PICC line; has completed ABX and home health nurse removed PICC line; now CXR shows severe emphysematous changes bilaterally with right pleuroparenchymal disease; DNR/DNI; evaluation of decubitus, no surgical intervention needed; wound care ordered; pt found to be positive for COVID during hospitalization; started on ABX and Decadron; no acute respiratory issues;  dc'd for PT and continued care; pt passed away
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pleural disorder, Pneumonia, SARS-CoV-2 test positive, Sepsis, Wheezing
Clinical narrative: Pt brought to ED via EMS with weakness, chronic inability to walk, SOB, wheezing, decubitus ulcer, constipation; was sent to hospital by home health nurse to assess possible infection of decubitus; pt requesting SNF for rehab; pt has a feeding tube; recent hospitalization for pneumonia and sepsis; was on ABX through PICC line; has completed ABX and home health nurse removed PICC line; now CXR shows severe emphysematous changes bilaterally with right pleuroparenchymal disease; DNR/DNI; evaluation of decubitus, no surgical intervention needed; wound care ordered; pt found to be positive for COVID during hospitalization; started on ABX and Decadron; no acute respiratory issues;  dc'd for PT and continued care; pt passed away
Age: 10.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: None. Dose was invalidated due to 10-minute excursion.
Age: 1.58
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: None-vaccine was given too soon. Only 22 days after dose #1.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Abdominal pain upper, Diarrhoea, Malaise
Clinical narrative: On Monday November 28th I had several episodes of a loose stool and mild malaise including stomach pain, on Tuesday the 29th of November the stomach pain and malaise was severe. On Wednesday the thirteenth of November this continued with moderate abdominal pain and malaise. I saw my doctor and Appendicitis was ruled out a diet recommendation was given, this lasted for a week with no clarity as to cause.
Age: 65.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Aptyalism, Dry mouth, Mouth ulceration
Clinical narrative: Extreme dry mouth, complete loss of saliva, mouth ulcers
Age: 65.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Dry mouth, Mouth ulceration, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Extreme dry mouth, complete loss of saliva, mouth ulcers
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Headache, Nasal congestion, Pyrexia
Clinical narrative: I received my COVID-19 5th dose on 10/23/2022. My adverse event started on 11/26/2022 in the morning around 8:00AM. I had a scratchy throat, nasal congestions, headaches, fatigue and low grade fever. On 12/05/2022 I called my doctor and she prescribed me PAXLOVID for 5-6 days. I am also taking over the counter medications such as ibuprofen  and cough syrup as per needed.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Throat irritation
Clinical narrative: I received my COVID-19 5th dose on 10/23/2022. My adverse event started on 11/26/2022 in the morning around 8:00AM. I had a scratchy throat, nasal congestions, headaches, fatigue and low grade fever. On 12/05/2022 I called my doctor and she prescribed me PAXLOVID for 5-6 days. I am also taking over the counter medications such as ibuprofen  and cough syrup as per needed.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: At 10-minute mark of post vaccine waiting period patient felt dizzy. patient was instructed to wait additional time to see if symptoms resolved. patient still felt dizzy, and provider notified for Evalution. patient advised to wait additional time frame prior to releasing.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Expired product administered
Clinical narrative: First dose of Rotarix vaccine was administered past 15 weeks of age. Infant is not having any problems per Mom via phone conversation on 12-6-22. This was infants first immunizations outside of Birth Hepatitis B in hospital.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Hypertension, Malaise, Migraine
Clinical narrative: After receiving the vaccine, I had a migraine headache, and this happened after each COVID-19 vaccine. On 07/04/2022 I started not feeling well with a sore throat. On 07/06/2022 I tested positive with a home test for COVID-19. I contacted my doctor and was prescribed PAXLOVID. I rebound after taking the full prescription and was sick for a week. I also experienced a racing heart, high blood pressure, heart palpitations and fatigue.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Palpitations, SARS-CoV-2 test positive
Clinical narrative: After receiving the vaccine, I had a migraine headache, and this happened after each COVID-19 vaccine. On 07/04/2022 I started not feeling well with a sore throat. On 07/06/2022 I tested positive with a home test for COVID-19. I contacted my doctor and was prescribed PAXLOVID. I rebound after taking the full prescription and was sick for a week. I also experienced a racing heart, high blood pressure, heart palpitations and fatigue.
Age: 9.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: The vaccination given was expired by 2 days. Given on 12/2/2022 and expired on 11/30/2022. No adverse reaction occurred. Reported to Pfizer and waiting to hear back if vaccination needs to be repeated.
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Death, Pupil fixed, Seizure, Unresponsive to stimuli
Clinical narrative: About 5 days after getting her Moderna Bivalent booster she had a seizer which started around 05:49am and lasted about an hour.  Lorazepam 2mg/ml gave 1ml initially. 0632 Dr. called for update on resident, notified that resident still seizing and that family declines wanting resident sent out to ER. Verbal order received to give repeat dose of lorazepam in 5 minutes if still seizing. 0637 second dose given. 0730 Family still declines wanting resident sent to ER; pupils fixed: BP 182/90, RR 26, AP 102, temp. 97.0. Right side of face drawn Dr. and ICP called. Morphine ordered. She was unresponsive from then on. She passed away on 12/02/2022 at 12:26pm.
Age: 7.0
Sex: M
Vaccine: COVID19, FLU4, VARCEL
Symptoms: Expired product administered
Clinical narrative: Vaccination given on 12/2/2022 but it expired on 11/30/2022. Waiting on response from Pfizer if dose needs to be repeated.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Paranoia
Clinical narrative: Paranoia new onset overnight
Age: 5.0
Sex: M
Vaccine: COVID19, FLU4, VARCEL
Symptoms: Expired product administered
Clinical narrative: Vaccination given on 12/2/2022 but it expired on 11/30/2022. Waiting on response from Pfizer if dose needs to be repeated.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient has given Pneumovax 23 Vaccine on 08/17/2021 and given again on 11/26/2022. the pneumovax 23 vaccine was given 15 month apart.  No adverse event reported .
Age: 60.0
Sex: F
Vaccine: DTAP
Symptoms: Cough, Dizziness, Nausea
Clinical narrative: I went into my car and got really dizzy. I got nausea and been coughing a lot ever since. I could test it in my mouth.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was not scheduled. Came in with another patient. . While running tests, Patient came out of the room and approached the nurse and asked for her covid and flu shot. Consent form was brought to the room. Nurse did not check to and misunderstood patient and believed she was  asking for a Covid Booster. Nurse then gave the patient both the Covid Bivalent and a Flu vaccine. She realized her mistake the next day when she was uploading the information to that the patient had not had any Covid vaccines prior to this visit. She immediately notified provider and Nurse supervisor. Clinic Manager was then notified. Patient contacted. No at this time.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product label issue
Clinical narrative: Verified pt by name/DOB. Patient was administered a Pfizer Orange Pedi( 5-11 yrs) vaccine IM in left arm. After the vaccine was administered the nurse was unable to document the correct vaccine lot number. The nurse called supervisor to discuss why lot number was not in the system. Nurse was told the lot number was from an expired vaccine. The nurse looked at the label on the vial which had a expiration date of 12/6/2022 and inventory dispersion paperwork with the exact lot number with expiration date of 12/6/2022, which all came from immunization clerk from main office. Nurse was told vaccine was mislabeled. Nurse supervisor contacted Pfizer and medical director for direction and treatment of patient. After speaking with Pfizer and medical director it was determined patient needed to return for another covid vaccine injection as soon as possible. Parents were contacted and brought patient  into clinic the same day for another covid vaccine without any complications or adverse reactions
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient already received a dose of Pfizer Bivalent in Sept 2022 but was unaware when she came in to get a dose today. She did not have her vaccine card with her. It was realized after she left through system that patient had already completed the Pfizer series. So today she received an extra dose of Pfizer Bivalent.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: This was the patient's 2nd flu shot of the 2022 season.  The patient already received 1 flu shot on 10/17/2022.  The patient signed up for appointments for both shots.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient previously received vaccine series with COVID-19 Moderna vaccine (3/17/2021, 4/14/2021, 12/5/2021) and additional booster with Pfizer-BioNTech monovalent 5/23/2022.  Patient requested additional booster which should have been with the bivalent formulation. However instead the physician ordered for the patient to receive Pfizer-BioNTech monovalent vaccine on 10/4/2022. Dose administered and no harm occurred to patient. Ordering physician notified of error.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered, No adverse event
Clinical narrative: Verified pt by name/DOB. Patient was administered a Pfizer Orange Pedi( 5-11 yrs) vaccine IM in left arm. After the vaccine was administered the nurse was unable to document the correct vaccine lot number. The nurse called supervisor to discuss why lot number was not in the system. Nurse was told the lot number was from an expired vaccine. The nurse looked at the label on the vial which had a expiration date of 12/6/2022 and inventory dispersion paperwork with the exact lot number with expiration date of 12/6/2022, which all came from immunization clerk from main office at County. Nurse was told vaccine was mislabeled. Nurse supervisor contacted Pfizer and medical director for direction and treatment of patient. After speaking with Pfizer and medical director it was determined patient needed to return for another covid vaccine injection as soon as possible. Parents were contacted and brought patient  into clinic the same day for another covid vaccine without any complications or adverse reactions
Age: 82.0
Sex: M
Vaccine: FLUA4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This was the patient's 2nd flu shot of the 2022 season.  The patient received his first flu shot on 10/17/2022.  The patient made an appointment for both shots.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Oropharyngeal pain, Pain
Clinical narrative: I had soring at the injection site which was expected. I also had chills, sore throat, body aches and a very bad headache that lasted about 5 days. In April of 2022, I had a bump that appear at the crown of my head about the size of a nickel. It did itch along with some other spots that appeared on my head as well.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: I had soring at the injection site which was expected. I also had chills, sore throat, body aches and a very bad headache that lasted about 5 days. In April of 2022, I had a bump that appear at the crown of my head about the size of a nickel. It did itch along with some other spots that appeared on my head as well.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: NP placed HepB immunization order for 25 yo patient in EMR. MA administered 10 mcg/0.5 mL dose to patient. MA did not scan medication prior to administration and when during documentation was wondering why EMR was not accepting the NDC that was administered to patient. Appropriate HepB dose/product for a 25 yo is 20 mcg/1 mL, thus the 10 mcg/0.5 mL did not match the order placed. Patient was able to be returned back to clinic to receive full dose.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Inflammation, Malaise
Clinical narrative: I did not have a reaction to the vaccine. On 09/26/2022, I started not feeling well with a stuffy nose and fever. I tested positive with a home test for COVID-19. The fever lasted for three days and on the second day I lost my sense of taste and smell. After COVID-19 I have had a lot of inflammation in my knees and my hands swell. I never had those symptoms before.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Peripheral swelling, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I did not have a reaction to the vaccine. On 09/26/2022, I started not feeling well with a stuffy nose and fever. I tested positive with a home test for COVID-19. The fever lasted for three days and on the second day I lost my sense of taste and smell. After COVID-19 I have had a lot of inflammation in my knees and my hands swell. I never had those symptoms before.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient presented for and received a Bivalent Moderna vaccine however had already received a Bivalent Moderna on 09/20/2022.  This was discovered when entering the injection into the system.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient received Novavax in error.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast abnormal, Breast cancer female
Clinical narrative: Oct 2022 developed breast cancer
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Pain, SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid twice had bad cough and severe aches and pains.
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cough, Paranasal sinus hypersecretion, Respiratory syncytial virus test positive, SARS-CoV-2 test negative, Sleep disorder
Clinical narrative: On 11/27/2022 in the morning around 8:00AM. I woke up with a Sinus drainage and cough. I couldn't sleep because of the cough. So on 11/30/2022 I called my doctor and she prescribed me with cough medication which didn't help. On 12/05/2022 I called my doctor again since the cough medication wasn't helping at all. She then prescribed me an antibiotics called amoxicillin. I just started taking it from yesterday. I have to take it for at least 10 days.
Age: 1.08
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rash maculo-papular, Urticaria
Clinical narrative: Per mom, rash on forehead and face; no swelling around lips or eyes began one day after vaccination. Diffuse rash across abdomen, chest, and upper/lower extremities began two days after vaccination.   Upon examination, diffuse rash across the body, scattered maculopapular bumps mainly across face and forehead, some rash along the abdomen appears more urticarial. Pt has had no signs of anaphylaxis, breathing normal, no swelling around face or mouth, no changes to PO intake. Benadryl 5 mL every 8 hours needed for symptoms and Tylenol 5.5 mL every 8 hour as needed for pain. Pt to follow-up as needed.
Age: 65.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site haematoma, Injection site pain, Pain, Pruritus, Quality of life decreased
Clinical narrative: Medical resident injected approximately 9CMs below acromion process. Did not check for landmark. Stated when offered by NP in clinic to give the injection said she had given before and before I could say anything  she gave the injection. No pain but approximately three days later noticed a hematoma at site and itching. Over time have developed pain with various movements of arm and with extension developed moderate to severe cramping at site. Negative impact on quality of life at this point.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Death on 11/21/2022
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Pfizer vaccine was placed in Freezer instead of Refrigerator for storage.  Was thawed and administered.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Gave Pfizer vaccine rather than the Bivalent booster dose. vial is same color. No harm to patient.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Dysphonia, Headache, Lymphadenopathy, Myalgia
Clinical narrative: Right after vaccine I started getting a headache; coughing with nasal congestion; body aches; muscle aches; swollen glands and lymph nodes and a sore throat. Two weeks later I had a change in symptoms; major congestion; puffy face; lingering cough, hoarseness. I was prescribed amoxicillin which I have been taking for 6 days. However I still have nasal mucus; chest congestion and hoarseness.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nasal congestion, Oropharyngeal pain, Pain, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Right after vaccine I started getting a headache; coughing with nasal congestion; body aches; muscle aches; swollen glands and lymph nodes and a sore throat. Two weeks later I had a change in symptoms; major congestion; puffy face; lingering cough, hoarseness. I was prescribed amoxicillin which I have been taking for 6 days. However I still have nasal mucus; chest congestion and hoarseness.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test negative, Swelling face
Clinical narrative: Right after vaccine I started getting a headache; coughing with nasal congestion; body aches; muscle aches; swollen glands and lymph nodes and a sore throat. Two weeks later I had a change in symptoms; major congestion; puffy face; lingering cough, hoarseness. I was prescribed amoxicillin which I have been taking for 6 days. However I still have nasal mucus; chest congestion and hoarseness.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema
Clinical narrative: Patient presents redness in chest area after 20 minutes of administration of TDAP BOOSTRIX Vaccine.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site mass, Mass
Clinical narrative: Patient says has a lump that goes from site of injection up and across her shoulder to her clavicle.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: NO ADVERSE EVENT REPORTED