chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: 1/21-1/22/23 had redness/swelling/pain left arm, resolved by 1/23/23 1/27/23 had recurrence of redness, swelling, and now itchiness in same area of L arm. As of 1/30/23 swelling resolved, still has 3cm area of erythema and some itchiness.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Upper arm pain, increasing intensity first 2 days after shot, constant mild pain since
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Gait disturbance, Hypoaesthesia, Muscular weakness, Pain, Paraesthesia
Clinical narrative: Muscle weakness bilateral from waist down, numbness and tingling bilateral, bilateral pain. Inability to walk without holding on to someone or something. Bilateral loss of sensation.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Sensory loss
Clinical narrative: Muscle weakness bilateral from waist down, numbness and tingling bilateral, bilateral pain. Inability to walk without holding on to someone or something. Bilateral loss of sensation.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: This 3 year old patient was given a Pfizer 5-11 year old dose, 0.2 ml IM.
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: The adverse effect is unknown. The nurse is not able to get a hold of the patient. The nurse is advised to keep trying to get a hold of the patient.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation error, Single component of a two-component product administered
Clinical narrative: The vaccine was not mixed, only the adjuvant suspension component was administered to the patient. Patient did not experience any adverse symptoms. Patient was made aware.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Intense stomach pains for about an hour followed by vomiting
Age: 23.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pfizer COVID-19 Bivalent vaccine incorrectly administered as a primary series monovalent dose.  No signs or symptoms of ADRs
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Electroencephalogram abnormal, Eye disorder, Hypoacusis, Magnetic resonance imaging head normal, Muscle twitching
Clinical narrative: Started having seizures a few months after second shot.  Glazed eye look, did not hear anyone when talking to him,  stiff armed and legs and then shaking of arms and legs and quivering lips.  Episodes would last 30-60 seconds.   Was prescribed levetiracetam ER 500mg, 1 a day at bedtime for 30 days.  Did not help with seizures,  , increased to 1,000 and then to 1500 mg.  a day with no results.  Changed Doctors in October of 2022 and meds were changed to Oxcarbazepine 300 mg. , twice a day.  Had 2 seizures after that and none since.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Seizure, Tremor
Clinical narrative: Started having seizures a few months after second shot.  Glazed eye look, did not hear anyone when talking to him,  stiff armed and legs and then shaking of arms and legs and quivering lips.  Episodes would last 30-60 seconds.   Was prescribed levetiracetam ER 500mg, 1 a day at bedtime for 30 days.  Did not help with seizures,  , increased to 1,000 and then to 1500 mg.  a day with no results.  Changed Doctors in October of 2022 and meds were changed to Oxcarbazepine 300 mg. , twice a day.  Had 2 seizures after that and none since.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pruritus, Lymphadenopathy, Myalgia
Clinical narrative: Swollen lymph nodes in left armpit and collar bone. Muscle aches especially of upper body. Fatigue. Fever. Headache. Sore left arm. Itchiness at injection site.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Swollen lymph nodes in left armpit and collar bone. Muscle aches especially of upper body. Fatigue. Fever. Headache. Sore left arm. Itchiness at injection site.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Choking, Culture throat negative, Pharyngeal swelling, Streptococcus test negative
Clinical narrative: Four days after the second dose, my throat was swollen almost completely shut.  I choked repeatedly just trying to swallow saliva.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulation drug level below therapeutic, Arthralgia, Asthenia, Atelectasis, COVID-19
Clinical narrative: Narrative:  1/18/23 - Pt presented to ED with fatigue x 3 days, mild sore throat, and productive cough since 1/17 after caregiver visited him. Per EMS, Pt 92% at room air upon arrival, then 98% on 2L O2. Pt reports pain to bilateral hips and legs x 1-2 months. No SOB, fever, or chest pain reported. Provider discussed EUA med. options with patient and Pt would like to take medication for COVID-19. Pharmacy consulted for med. options and paxlovid is not an viable option d/t Rx medications. PLAN: dc home (daughter is a nurse that will assist w/care) pcp f/u customary precautions d/w pt RX GUAIFENESIN RX INV-MOLNUPIRAVIR 200MG ORAL CAP TAKE FOUR CAPSULES BY MOUTH TWICE A DAY *SWALLOW CAPSULES WHOLE* 1/19/23 - Pt returned to ED 1/19 at 00:15 with SOB and states he has been feeling SOB x1 day after testing COVID positive. Pt stated he became so weak at home he could not even sit up in bed or go to bathroom. Pt to be admitted for inpatient care. Primary diagnosis = COVID-19; secondary diagnosis = weakness. **inpatient admission from 1/19/23 to 1/23/23** PRINCIPAL DIAGNOSIS (Reason for admission after study): covid infection, acute in extreme elder. ADDITIONAL DIAGNOSES: weakness due to covid headache due to covid HX of Pulmonary emboli on anticoagulation subtherapeutic INR in pt on warfarin for pulmonary embolism Hospital Course: Pt is a 85 yo male with pmhx of HTN, COPD, hx of PE 2019 on warfarin since then and hx of diverticular GI bleed 2019 who presented to agency ED on 01/18/2023 with cough, congestion and weakness. Pt was admitted to ward for COVID Infection, was afebrile, O2 sat 95% RA, was placed on and completed remdesvir x3d. given supportive care and melatonin to sleep. Pt c/o Weakness due to covid, so PT consulted, rec STR and OT consult 01/19: rec STR w DME , His slums score 17 = dementia; ppd negative 01/22/23,a nd daughter had agreed to STR, howver at time of dc pt decided he wanted to go home. Pt still w capacity this admission but has some memory issues Pt missed dose of warfarin while inpt on the medicaiton for PE, was given dvt coverage w lovenox while inpt, and INR did not reach therapeutic at time of dc ( 1.35). Discussed coverage at home w anticoag pharma, feel his INR will recover in a timely way at home. apparently warfarin was choosen in 2019 due to ease of reversibility with history of GI bleed hx, pt was placed on pantoprazole BID He is a full code, was taking po well, and afebrile, HDS at time of dc.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Computerised tomogram thorax abnormal, Dyspnoea, Fatigue, Lung opacity
Clinical narrative: Narrative:  1/18/23 - Pt presented to ED with fatigue x 3 days, mild sore throat, and productive cough since 1/17 after caregiver visited him. Per EMS, Pt 92% at room air upon arrival, then 98% on 2L O2. Pt reports pain to bilateral hips and legs x 1-2 months. No SOB, fever, or chest pain reported. Provider discussed EUA med. options with patient and Pt would like to take medication for COVID-19. Pharmacy consulted for med. options and paxlovid is not an viable option d/t Rx medications. PLAN: dc home (daughter is a nurse that will assist w/care) pcp f/u customary precautions d/w pt RX GUAIFENESIN RX INV-MOLNUPIRAVIR 200MG ORAL CAP TAKE FOUR CAPSULES BY MOUTH TWICE A DAY *SWALLOW CAPSULES WHOLE* 1/19/23 - Pt returned to ED 1/19 at 00:15 with SOB and states he has been feeling SOB x1 day after testing COVID positive. Pt stated he became so weak at home he could not even sit up in bed or go to bathroom. Pt to be admitted for inpatient care. Primary diagnosis = COVID-19; secondary diagnosis = weakness. **inpatient admission from 1/19/23 to 1/23/23** PRINCIPAL DIAGNOSIS (Reason for admission after study): covid infection, acute in extreme elder. ADDITIONAL DIAGNOSES: weakness due to covid headache due to covid HX of Pulmonary emboli on anticoagulation subtherapeutic INR in pt on warfarin for pulmonary embolism Hospital Course: Pt is a 85 yo male with pmhx of HTN, COPD, hx of PE 2019 on warfarin since then and hx of diverticular GI bleed 2019 who presented to agency ED on 01/18/2023 with cough, congestion and weakness. Pt was admitted to ward for COVID Infection, was afebrile, O2 sat 95% RA, was placed on and completed remdesvir x3d. given supportive care and melatonin to sleep. Pt c/o Weakness due to covid, so PT consulted, rec STR and OT consult 01/19: rec STR w DME , His slums score 17 = dementia; ppd negative 01/22/23,a nd daughter had agreed to STR, howver at time of dc pt decided he wanted to go home. Pt still w capacity this admission but has some memory issues Pt missed dose of warfarin while inpt on the medicaiton for PE, was given dvt coverage w lovenox while inpt, and INR did not reach therapeutic at time of dc ( 1.35). Discussed coverage at home w anticoag pharma, feel his INR will recover in a timely way at home. apparently warfarin was choosen in 2019 due to ease of reversibility with history of GI bleed hx, pt was placed on pantoprazole BID He is a full code, was taking po well, and afebrile, HDS at time of dc.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Mobility decreased, Oropharyngeal pain, Pain in extremity, Pleural thickening
Clinical narrative: Narrative:  1/18/23 - Pt presented to ED with fatigue x 3 days, mild sore throat, and productive cough since 1/17 after caregiver visited him. Per EMS, Pt 92% at room air upon arrival, then 98% on 2L O2. Pt reports pain to bilateral hips and legs x 1-2 months. No SOB, fever, or chest pain reported. Provider discussed EUA med. options with patient and Pt would like to take medication for COVID-19. Pharmacy consulted for med. options and paxlovid is not an viable option d/t Rx medications. PLAN: dc home (daughter is a nurse that will assist w/care) pcp f/u customary precautions d/w pt RX GUAIFENESIN RX INV-MOLNUPIRAVIR 200MG ORAL CAP TAKE FOUR CAPSULES BY MOUTH TWICE A DAY *SWALLOW CAPSULES WHOLE* 1/19/23 - Pt returned to ED 1/19 at 00:15 with SOB and states he has been feeling SOB x1 day after testing COVID positive. Pt stated he became so weak at home he could not even sit up in bed or go to bathroom. Pt to be admitted for inpatient care. Primary diagnosis = COVID-19; secondary diagnosis = weakness. **inpatient admission from 1/19/23 to 1/23/23** PRINCIPAL DIAGNOSIS (Reason for admission after study): covid infection, acute in extreme elder. ADDITIONAL DIAGNOSES: weakness due to covid headache due to covid HX of Pulmonary emboli on anticoagulation subtherapeutic INR in pt on warfarin for pulmonary embolism Hospital Course: Pt is a 85 yo male with pmhx of HTN, COPD, hx of PE 2019 on warfarin since then and hx of diverticular GI bleed 2019 who presented to agency ED on 01/18/2023 with cough, congestion and weakness. Pt was admitted to ward for COVID Infection, was afebrile, O2 sat 95% RA, was placed on and completed remdesvir x3d. given supportive care and melatonin to sleep. Pt c/o Weakness due to covid, so PT consulted, rec STR and OT consult 01/19: rec STR w DME , His slums score 17 = dementia; ppd negative 01/22/23,a nd daughter had agreed to STR, howver at time of dc pt decided he wanted to go home. Pt still w capacity this admission but has some memory issues Pt missed dose of warfarin while inpt on the medicaiton for PE, was given dvt coverage w lovenox while inpt, and INR did not reach therapeutic at time of dc ( 1.35). Discussed coverage at home w anticoag pharma, feel his INR will recover in a timely way at home. apparently warfarin was choosen in 2019 due to ease of reversibility with history of GI bleed hx, pt was placed on pantoprazole BID He is a full code, was taking po well, and afebrile, HDS at time of dc.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Productive cough, Pulmonary fibrosis, Pulmonary mass, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Narrative:  1/18/23 - Pt presented to ED with fatigue x 3 days, mild sore throat, and productive cough since 1/17 after caregiver visited him. Per EMS, Pt 92% at room air upon arrival, then 98% on 2L O2. Pt reports pain to bilateral hips and legs x 1-2 months. No SOB, fever, or chest pain reported. Provider discussed EUA med. options with patient and Pt would like to take medication for COVID-19. Pharmacy consulted for med. options and paxlovid is not an viable option d/t Rx medications. PLAN: dc home (daughter is a nurse that will assist w/care) pcp f/u customary precautions d/w pt RX GUAIFENESIN RX INV-MOLNUPIRAVIR 200MG ORAL CAP TAKE FOUR CAPSULES BY MOUTH TWICE A DAY *SWALLOW CAPSULES WHOLE* 1/19/23 - Pt returned to ED 1/19 at 00:15 with SOB and states he has been feeling SOB x1 day after testing COVID positive. Pt stated he became so weak at home he could not even sit up in bed or go to bathroom. Pt to be admitted for inpatient care. Primary diagnosis = COVID-19; secondary diagnosis = weakness. **inpatient admission from 1/19/23 to 1/23/23** PRINCIPAL DIAGNOSIS (Reason for admission after study): covid infection, acute in extreme elder. ADDITIONAL DIAGNOSES: weakness due to covid headache due to covid HX of Pulmonary emboli on anticoagulation subtherapeutic INR in pt on warfarin for pulmonary embolism Hospital Course: Pt is a 85 yo male with pmhx of HTN, COPD, hx of PE 2019 on warfarin since then and hx of diverticular GI bleed 2019 who presented to agency ED on 01/18/2023 with cough, congestion and weakness. Pt was admitted to ward for COVID Infection, was afebrile, O2 sat 95% RA, was placed on and completed remdesvir x3d. given supportive care and melatonin to sleep. Pt c/o Weakness due to covid, so PT consulted, rec STR and OT consult 01/19: rec STR w DME , His slums score 17 = dementia; ppd negative 01/22/23,a nd daughter had agreed to STR, howver at time of dc pt decided he wanted to go home. Pt still w capacity this admission but has some memory issues Pt missed dose of warfarin while inpt on the medicaiton for PE, was given dvt coverage w lovenox while inpt, and INR did not reach therapeutic at time of dc ( 1.35). Discussed coverage at home w anticoag pharma, feel his INR will recover in a timely way at home. apparently warfarin was choosen in 2019 due to ease of reversibility with history of GI bleed hx, pt was placed on pantoprazole BID He is a full code, was taking po well, and afebrile, HDS at time of dc.
Age: 90.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Eye irritation, Pruritus, Rash
Clinical narrative: Narrative:  Per Allergies/Adverse Reactions Item Detail "Patient reports rash after vaccine followed by blistering, burning, and itching. Patient states rash lasted about 3 weeks."
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Narrative: An error occurred while administering the Moderna Bivalent booster on 10/05/2022. Patient was given .25mL instead of the full dose of 0.5mL vaccine.Patient was retrn to facility for an addition.25mL dose on 10/06/2022
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Basophil percentage decreased, Blood calcium normal, Blood chloride increased, Blood creatinine increased, Blood gases abnormal
Clinical narrative: Narrative:  Pt is a long-term care resident in the nursing home. Two days after receiving a moderna bivalent booster, pt alerted nurse of shortness of breath. Patient required increased oxygen in the nursing home and rapid response was called when pt was unable to maintain SPO2 >85% with 100% NRB. Pt was transferred to MICU with admitting problems seen above in events 1 of 2. He was placed on IV abx, steroids, bronchodilators, and short term BiPAP. Conditioned improved after one day in MICU, was transferred to medical floor and stayed an additional 7 days, then transferred back to nursing home. Respiratory distress and hypoxemia thought to be due to aspiration PNA and COPD exacerbation.
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood glucose increased, Blood pH decreased, Blood potassium normal, Blood sodium normal, Blood urea increased
Clinical narrative: Narrative:  Pt is a long-term care resident in the nursing home. Two days after receiving a moderna bivalent booster, pt alerted nurse of shortness of breath. Patient required increased oxygen in the nursing home and rapid response was called when pt was unable to maintain SPO2 >85% with 100% NRB. Pt was transferred to MICU with admitting problems seen above in events 1 of 2. He was placed on IV abx, steroids, bronchodilators, and short term BiPAP. Conditioned improved after one day in MICU, was transferred to medical floor and stayed an additional 7 days, then transferred back to nursing home. Respiratory distress and hypoxemia thought to be due to aspiration PNA and COPD exacerbation.
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Carbon dioxide decreased, Chest X-ray abnormal, Chronic obstructive pulmonary disease, Condition aggravated, Differential white blood cell count
Clinical narrative: Narrative:  Pt is a long-term care resident in the nursing home. Two days after receiving a moderna bivalent booster, pt alerted nurse of shortness of breath. Patient required increased oxygen in the nursing home and rapid response was called when pt was unable to maintain SPO2 >85% with 100% NRB. Pt was transferred to MICU with admitting problems seen above in events 1 of 2. He was placed on IV abx, steroids, bronchodilators, and short term BiPAP. Conditioned improved after one day in MICU, was transferred to medical floor and stayed an additional 7 days, then transferred back to nursing home. Respiratory distress and hypoxemia thought to be due to aspiration PNA and COPD exacerbation.
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dyspnoea, Eosinophil percentage decreased, Fraction of inspired oxygen, Full blood count, Glomerular filtration rate decreased
Clinical narrative: Narrative:  Pt is a long-term care resident in the nursing home. Two days after receiving a moderna bivalent booster, pt alerted nurse of shortness of breath. Patient required increased oxygen in the nursing home and rapid response was called when pt was unable to maintain SPO2 >85% with 100% NRB. Pt was transferred to MICU with admitting problems seen above in events 1 of 2. He was placed on IV abx, steroids, bronchodilators, and short term BiPAP. Conditioned improved after one day in MICU, was transferred to medical floor and stayed an additional 7 days, then transferred back to nursing home. Respiratory distress and hypoxemia thought to be due to aspiration PNA and COPD exacerbation.
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Haematocrit decreased, Haemoglobin decreased, Hypoxia, Intensive care, Lung opacity
Clinical narrative: Narrative:  Pt is a long-term care resident in the nursing home. Two days after receiving a moderna bivalent booster, pt alerted nurse of shortness of breath. Patient required increased oxygen in the nursing home and rapid response was called when pt was unable to maintain SPO2 >85% with 100% NRB. Pt was transferred to MICU with admitting problems seen above in events 1 of 2. He was placed on IV abx, steroids, bronchodilators, and short term BiPAP. Conditioned improved after one day in MICU, was transferred to medical floor and stayed an additional 7 days, then transferred back to nursing home. Respiratory distress and hypoxemia thought to be due to aspiration PNA and COPD exacerbation.
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume increased, Mean platelet volume decreased
Clinical narrative: Narrative:  Pt is a long-term care resident in the nursing home. Two days after receiving a moderna bivalent booster, pt alerted nurse of shortness of breath. Patient required increased oxygen in the nursing home and rapid response was called when pt was unable to maintain SPO2 >85% with 100% NRB. Pt was transferred to MICU with admitting problems seen above in events 1 of 2. He was placed on IV abx, steroids, bronchodilators, and short term BiPAP. Conditioned improved after one day in MICU, was transferred to medical floor and stayed an additional 7 days, then transferred back to nursing home. Respiratory distress and hypoxemia thought to be due to aspiration PNA and COPD exacerbation.
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Metabolic function test, Monocyte percentage, Neutrophil percentage increased, Platelet count normal, Pneumonia aspiration
Clinical narrative: Narrative:  Pt is a long-term care resident in the nursing home. Two days after receiving a moderna bivalent booster, pt alerted nurse of shortness of breath. Patient required increased oxygen in the nursing home and rapid response was called when pt was unable to maintain SPO2 >85% with 100% NRB. Pt was transferred to MICU with admitting problems seen above in events 1 of 2. He was placed on IV abx, steroids, bronchodilators, and short term BiPAP. Conditioned improved after one day in MICU, was transferred to medical floor and stayed an additional 7 days, then transferred back to nursing home. Respiratory distress and hypoxemia thought to be due to aspiration PNA and COPD exacerbation.
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Positive airway pressure therapy, Pulmonary mass, Red blood cell count decreased, Red cell distribution width increased, Respiratory distress
Clinical narrative: Narrative:  Pt is a long-term care resident in the nursing home. Two days after receiving a moderna bivalent booster, pt alerted nurse of shortness of breath. Patient required increased oxygen in the nursing home and rapid response was called when pt was unable to maintain SPO2 >85% with 100% NRB. Pt was transferred to MICU with admitting problems seen above in events 1 of 2. He was placed on IV abx, steroids, bronchodilators, and short term BiPAP. Conditioned improved after one day in MICU, was transferred to medical floor and stayed an additional 7 days, then transferred back to nursing home. Respiratory distress and hypoxemia thought to be due to aspiration PNA and COPD exacerbation.
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: White blood cell count increased
Clinical narrative: Narrative:  Pt is a long-term care resident in the nursing home. Two days after receiving a moderna bivalent booster, pt alerted nurse of shortness of breath. Patient required increased oxygen in the nursing home and rapid response was called when pt was unable to maintain SPO2 >85% with 100% NRB. Pt was transferred to MICU with admitting problems seen above in events 1 of 2. He was placed on IV abx, steroids, bronchodilators, and short term BiPAP. Conditioned improved after one day in MICU, was transferred to medical floor and stayed an additional 7 days, then transferred back to nursing home. Respiratory distress and hypoxemia thought to be due to aspiration PNA and COPD exacerbation.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product administration error, Underdose
Clinical narrative: Narrative: An error occurred while administering the Moderna bivalent booster 10/5/22 at the facility, he was given half a dose of the vaccine which is 0.25 ml instead of 0.5 ml. Another COVID 19 Moderna Bivalent Booster 0.25 ml given 10/6/22 Left deltoid. Lot AS7146B Exp. 10/6/22
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose, Vaccination error
Clinical narrative: Narrative:  An error occured while administering the Moderna Bivalent booster on 10/05/2022. Patient was given .25mL instead of the full dose of 0.5mL vaccine. Patient was to return to campus for addition.25mL dose on 10/06/2022.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 76.0
Sex: M
Vaccine: FLUA4
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Narrative: Patient reported the day after receiving the influenza (Fluad) vaccine he experienced body aches, headache, nausea and fever. Symptoms went away within 48 hours, no treatment necessary.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022) and NO ADVERSE EVENT (No Adverse event) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A and 5/6/6979) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022).    No concomitant product reported by reporter. Pharmacy staff reported that they inadvertently administered 51 doses of the monovalent vaccines. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master case
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022) and NO ADVERSE EVENT (No Adverse event) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 069H21A, 021C21A and 047B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022).    No concomitant product reported by reporter. Pharmacy staff reported that they inadvertently administered 51 doses of the monovalent vaccines. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:master case
Age: 74.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 19-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medication was provided by reporter. No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live Significant follow up ; Patient information updated, vaccinations details updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master Case
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Flank pain, Livedo reticularis, Neck pain
Clinical narrative: PAIN IN NECK; PAIN IN HIPS, BACK AND ELBOWS IT'S TYPICALLY RIGHT FLANK PAIN; ALMOST LIKE IT SWELLED; LITTLE DISCOMFORT; PAIN IN RIGHT HAND/PAIN IN LEFT ARM/PAIN IN PALM HAND; PAIN IN RIGHT KNUCKLE/PAIN IN RIGHT SHOULDER; ARM FROM THE WRIST TO MID BICEPS JUST MOTTLED  IT IS LIKE IN TWO JOINTS, LIKE RIGHT IN THE KNUCKLE/GOT A SPOT IN HAND TO THAT'S WHERE IT HURTS; This spontaneous report received from a health care professional concerned a 60 year old male. The patient's weight was 210 pounds, and height was 74 inches. The patient's pre-existing medical conditions included: The patient had been healthy and had no conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 19-SEP-2021) dose was not reported, administered on 16-SEP-2021 for covid-19 prophylaxis. Age at time of vaccination 60 years old. Concomitant medications included acetylsalicylic acid for prevent blood clots. On 16-SEP-2021, the patient experienced arm from the wrist to mid biceps just mottled it is like in two joints, like right in the knuckle/got a spot in hand to that's where it hurts. On 16-SEP-2021, the patient experienced pain in right hand/pain in left arm/pain in palm hand. On 16-SEP-2021, the patient experienced pain in right knuckle/pain in right shoulder. On an unspecified date, the patient experienced pain in neck, pain in hips, back and elbows it's typically right flank pain, almost like it swelled, and little discomfort. Treatment medications (dates unspecified) included: ibuprofen, betula lenta, curcuma longa, and chondroitin sulfate/glucosamine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in right hand/pain in left arm/pain in palm hand, pain in right knuckle/pain in right shoulder, pain in neck, and pain in hips, back and elbows it's typically right flank pain, had not recovered from little discomfort, and the outcome of arm from the wrist to mid biceps just mottled it is like in two joints, like right in the knuckle/got a spot in hand to that's where it hurts and almost like it swelled was not reported. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: PAIN IN NECK; PAIN IN HIPS, BACK AND ELBOWS IT'S TYPICALLY RIGHT FLANK PAIN; ALMOST LIKE IT SWELLED; LITTLE DISCOMFORT; PAIN IN RIGHT HAND/PAIN IN LEFT ARM/PAIN IN PALM HAND; PAIN IN RIGHT KNUCKLE/PAIN IN RIGHT SHOULDER; ARM FROM THE WRIST TO MID BICEPS JUST MOTTLED  IT IS LIKE IN TWO JOINTS, LIKE RIGHT IN THE KNUCKLE/GOT A SPOT IN HAND TO THAT'S WHERE IT HURTS; This spontaneous report received from a health care professional concerned a 60 year old male. The patient's weight was 210 pounds, and height was 74 inches. The patient's pre-existing medical conditions included: The patient had been healthy and had no conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 19-SEP-2021) dose was not reported, administered on 16-SEP-2021 for covid-19 prophylaxis. Age at time of vaccination 60 years old. Concomitant medications included acetylsalicylic acid for prevent blood clots. On 16-SEP-2021, the patient experienced arm from the wrist to mid biceps just mottled it is like in two joints, like right in the knuckle/got a spot in hand to that's where it hurts. On 16-SEP-2021, the patient experienced pain in right hand/pain in left arm/pain in palm hand. On 16-SEP-2021, the patient experienced pain in right knuckle/pain in right shoulder. On an unspecified date, the patient experienced pain in neck, pain in hips, back and elbows it's typically right flank pain, almost like it swelled, and little discomfort. Treatment medications (dates unspecified) included: ibuprofen, betula lenta, curcuma longa, and chondroitin sulfate/glucosamine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in right hand/pain in left arm/pain in palm hand, pain in right knuckle/pain in right shoulder, pain in neck, and pain in hips, back and elbows it's typically right flank pain, had not recovered from little discomfort, and the outcome of arm from the wrist to mid biceps just mottled it is like in two joints, like right in the knuckle/got a spot in hand to that's where it hurts and almost like it swelled was not reported. This report was non-serious.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: On 11/11/2021, the Patient received a Pfizer vaccine for 12+ and it should have been 5-11. The patient's MD, the MA who administered the vaccine, and the patient's guardian were contacted. Follow-up was done with teaching following the rights of medication administration.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: On 12/06/the 2021-Patient received Covid Pfizer vaccine. The dose was for 12+. She should have received the 5-11 dose as she was 11. No adverse effects
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19, Chest X-ray normal, Condition aggravated, Death
Clinical narrative: 3rd DOSE PFIZER COVID VACCINE GIVEN 11/18/21, LOT #FH8028 to ED from SNF for AMS and poor oral intake over past few days; found to be positive for COVID although oxygenating well on RA and CXR showed no acute findings; in Atrial Fibrillation; positive for UTI; multiple decubitus ulcers on sacrum, hip, back; DNR/DNI; transferred to ICU; ABX and vasopressors; severe sepsis; critical; pt's condition worsened and she passed away in the hospital
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Decubitus ulcer, General physical health deterioration, Hypophagia, Intensive care, Mental status changes
Clinical narrative: 3rd DOSE PFIZER COVID VACCINE GIVEN 11/18/21, LOT #FH8028 to ED from SNF for AMS and poor oral intake over past few days; found to be positive for COVID although oxygenating well on RA and CXR showed no acute findings; in Atrial Fibrillation; positive for UTI; multiple decubitus ulcers on sacrum, hip, back; DNR/DNI; transferred to ICU; ABX and vasopressors; severe sepsis; critical; pt's condition worsened and she passed away in the hospital
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sepsis, Urinary tract infection, Urine analysis abnormal
Clinical narrative: 3rd DOSE PFIZER COVID VACCINE GIVEN 11/18/21, LOT #FH8028 to ED from SNF for AMS and poor oral intake over past few days; found to be positive for COVID although oxygenating well on RA and CXR showed no acute findings; in Atrial Fibrillation; positive for UTI; multiple decubitus ulcers on sacrum, hip, back; DNR/DNI; transferred to ICU; ABX and vasopressors; severe sepsis; critical; pt's condition worsened and she passed away in the hospital
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Inappropriate schedule of product administration
Clinical narrative: And after 1 month she got facial paralysis; 1st dose received 10May2021/2nd dose received 24May2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 24May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, Expiry: Unknown), administration date: 10May2021, when the patient was 54-year-old, for COVID-19 Immunization, reaction(s): "And after 1 month she got facial paralysis". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 24May2021, outcome "unknown", described as "1st dose received 10May2021/2nd dose received 24May2021"; FACIAL PARALYSIS (medically significant) with onset 28Jul2021, outcome "recovering", described as "And after 1 month she got facial paralysis". The event "and after 1 month she got facial paralysis" required physician office visit. Therapeutic measures were taken as a result of facial paralysis.  Clinical information: Patient had facial paralysis and has been seeing doctors, and they said it wasn't from the vaccine, but patient believes that it is due to the vaccine. Patient got the vaccines last year, and after 1 month patient got facial paralysis. Patient read about all this and a normal facial paralysis only lasts 6-8 weeks, but she has had this problem for 2 years. Patient was told that the vaccines had absolutely nothing to do with it, but patient talked to Pfizer 2 months ago and they told her that the vaccines did have a lot of contraindications and side effects and among all the side effects was facial paralysis. When patient called 2 months ago, they gave her a webpage but she lost it. Patient doesn't know if Pfizer made a report when she called 2 months ago, but this is the 2nd time patient had talked to someone. Patient had seen many doctors for the facial paralysis and they told her they couldn't do anything for the side effect of the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Loss of personal independence in daily activities, Pain, Pain in extremity, Skin mass, Skin warm
Clinical narrative: Patient sent message" The injection site is swollen with a lump under my skin and it?s hot to the touch. Also above approx 2-3 inches above Injection site is a swollen lump."
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Patient sent message" The injection site is swollen with a lump under my skin and it?s hot to the touch. Also above approx 2-3 inches above Injection site is a swollen lump."
Age: 71.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Cerebrovascular accident, Hemiparesis
Clinical narrative: STROKE/ right side paralyses; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (STROKE/ right side paralyses) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027E22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Oct-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-2022, the patient experienced CEREBROVASCULAR ACCIDENT (STROKE/ right side paralyses) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (STROKE/ right side paralyses) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Company comment: This is a spontaneous case concerning 71 years old male patient, with no medical history, who experienced the unexpected serious (medically significant) AESI event of cerebrovascular accident, which occurred one month after the fourth dose of mRNA-1273. At the time of reporting event is not recovered. No further information on clinical course, lab data, treatment received. Patient elderly age could be risk factor for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 71.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE/ right side paralyses; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (STROKE/ right side paralyses) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027E22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Oct-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-2022, the patient experienced CEREBROVASCULAR ACCIDENT (STROKE/ right side paralyses) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (STROKE/ right side paralyses) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Company comment: This is a spontaneous case concerning 71 years old male patient, with no medical history, who experienced the unexpected serious (medically significant) AESI event of cerebrovascular accident, which occurred one month after the fourth dose of mRNA-1273. At the time of reporting event is not recovered. No further information on clinical course, lab data, treatment received. Patient elderly age could be risk factor for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 64.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Burning sensation, Injected limb mobility decreased, Injection site haemorrhage, Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient reported both arms being sore, that he could not lift them. Doctor, his PCP, prescribed lidocaine 5% patches that he picked up from us. They told him if things did not improve in the next few weeks, he should reach out to them for an MRI.
Age: 64.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Syringe issue
Clinical narrative: Patient reported both arms being sore, that he could not lift them. Doctor, his PCP, prescribed lidocaine 5% patches that he picked up from us. They told him if things did not improve in the next few weeks, he should reach out to them for an MRI.
Age: 64.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient reported both arms being sore, that he could not lift them. Doctor, his PCP, prescribed lidocaine 5% patches that he picked up from us. They told him if things did not improve in the next few weeks, he should reach out to them for an MRI.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac stress test, Chest X-ray, Echocardiogram, Investigation, Myocarditis
Clinical narrative: Got Covid on 31Dec2022.; got Covid on 31Dec2022.; she got the J and J as dose 1/Pfizer COVID booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 20Nov2021 as dose 2 (booster), single (Lot number: EW0186) at the age of 65 years, in arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "she got the J and J as dose 1/Pfizer COVID booster"; DRUG INEFFECTIVE (medically significant) with onset 31Dec2022, outcome "unknown", described as "Got Covid on 31Dec2022."; COVID-19 (medically significant) with onset 31Dec2022, outcome "unknown", described as "got Covid on 31Dec2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2022) Positive, notes: got COVID virus on 31Dec2022. Therapeutic measures were not taken as a result of drug ineffective, covid-19, interchange of vaccine products.The patient had no other medical conditions. Indication for the Pfizer booster was also mentioned as general health guidelines as a good citizen. Reporter stated that she wanted to alert that she had an adverse reaction to the booster shot. In 2021, when she was 64 as soon as she was eligible in Mar2021, she got the J and J and had a good night's sleep and was fine. In Nov2021, 7-8 months later the J and J was not available so she got the Pfizer booster vaccine. Patient mentioned that she would like to get another booster but does not know if there has been any research done on individuals who suffered from myocarditis after the Pfizer shot and asked if ther was a vaccine recommended for that demographic. There may be clinical research done and they may share that with her. She mentioned that she did get Covid three weeks ago because she did not know which vaccine to take. She did not go to a physician. She did not know if she still has it and she will be tested for Covid tomorrow. She still has some effects. It was further specified that patient received Pfizer COVID booster on 20Nov2021 and got COVID virus on 31Dec2022.; Sender's Comments: Linked Report(s) : PFIZER INC-202300036615 same reporter, product and patient, different event.;