chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: vague neurological symptoms; This is a spontaneous report received from contactable reporter(s) (Physician).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization.  The following information was reported: NEUROLOGICAL SYMPTOM (non-serious), outcome "unknown", described as "vague neurological symptoms".  Additional information: Physician reported two cases of potential adverse events related to COVID vaccination. He had no specific details of either patient, though he was going to look into each for us. One case was a person who developed vague neurological symptoms weeks after the vaccination; and one who has a diagnosis of an underlying autoimmune disease who might have had an exacerbation post vaccination and post illness [actually had COVID as well] at an indistinct time period.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Dysphonia, Fatigue
Clinical narrative: still testing positive/ she had covid; still testing positive/ she had covid; still has problems with her voice; feels tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "still testing positive/ she had covid"; DYSPHONIA (non-serious), outcome "unknown", described as "still has problems with her voice"; FATIGUE (non-serious), outcome "unknown", described as "feels tired".  Clinical course: Caller said that she had covid, she still has problems with her voice and feels tired, but her throat is no longer hurting. She is still testing positive, and she would like to know how long she needs to wait before she goes out. She also asked about the new Pfizer covid vaccine release date. Caller has problems with her voice and feels tired due to covid and has taken four shots of Pfizer covid vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre; Initial information received on 29-Jun-2023 by health care professional regarding an unsolicited valid serious case issued from a literature article:   This case involves a female patient (age not reported; case 3) who experienced Guillain-Barre while receiving influenza vaccine (latency: unknown).  Her medical history was significant for osteoporosis, diabetes mellitus, chronic kidney disease, essential hypertension, multiple urinary tract infections, remission of squamous cell carcinoma.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed Guillain-Barre (Guillain-Barre syndrome) after influenza vaccination. At the time of reporting she was retired and lived alone, and she had recently become the main caregiver for her husband while he was in hospice.  Action taken: Not applicable Corrective treatment: Unknown Outcome: Unknown Seriousness criteria: Medically significant  Reporter causality: Related; Sender's Comments: Sanofi company comment dated 05-JUL-2023: This case involves an unknown age female patient (case 3) who experienced Guillain-Barre while receiving influenza vaccine. Based on information received the causal role of VACCINE cannot be excluded due to compatible temporal relationship of ADR to the VACCINE. Further information regarding time to onset, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: staff member administered an expired daptacel to a patient with no reorted adverse event; Initial information received on 06-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 31 months old female patient and staff member administered an expired diphtheria-15/tetanus/5 AC Pertussis Vaccine [Daptacel] to a patient with no reorted adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Jun-2023, the patient received a dose 4 at a dose of 0.5 ml of suspect diphtheria-15/tetanus/5 AC Pertussis Vaccine Suspension for injection (strength: standard, expiry date: 21-Jun-2023 and lot C5893AA) via intramuscular route in unknown administration site for immunization and staff member administered an expired daptacel to a patient with no reorted adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: nurse gave an expired pentacel to a patient with no reported adverse event; Initial information received on 07-Jul-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient and nurse gave an expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Suspension for injection (with an unknown expiry date, strength, lot number) via unknown route in unknown administration site for Prophylactic Vaccination (Immunisation).  On an unknown date, reporter reported nurse gave an expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] to a patient with no reported adverse event (expired product administered) (latency: same day).  It was reported, This situation is reported as a medication error due to administration of expired product to a patient.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event nurse gave an expired pentacel to a patient with no reported adverse 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 guidelines. 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: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: administration of tdap doses with the interval of less than a year with no reported adverse event; Initial information received on 07-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 12 years old female patient who was administered diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] dose with the interval of less than a year with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 06-Jul-2023, the patient received 0.5 mL dose 2 of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (batch number: U7666AA; expiry date: 08-Mar-2025) via intramuscular route in the right deltoid for immunization with the interval of less than a year with no reported adverse event (inappropriate schedule of product administration) (same day latency).  It was reported that, Adacel was given to patient that had Tdap 11 years and 9 months before that, getting a repeat dose a year later. They want to know what are the ramifications for the patient.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event administration of tdap doses with the interval of less than a year with no reported adverse 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 guidelines. 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.; Sender's Comments:  US-SA-2023SA210162:01683487
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, UNK
Symptoms: Extra dose administered, Medication error, No adverse event, Wrong product administered
Clinical narrative: 2-month-old female patient was inadvertently administered both Pentacel and Pediarix instead of the ACTHIB and Pediarix with no reported adverse event; patient inadvertently received an extra dose of the DTaP and IPV antigens with no reported adverse event; Initial information received on 07-Jul-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (healthcare professional).  This case involves a 2 months old female patient who was inadvertently administered both pentacel and pediarix instead of the ACT-HIB and pediarix with no reported adverse event and patient inadvertently received an extra dose of the dtap and ipv antigens with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Jul-2023, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine via intramuscular route in the right thigh for prophylactic vaccination (strength, batch number, expiry date: unknown). Information on batch was requested. On 07-Jul-2023, the patient received a  dose of suspect Pediarix not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for prophylactic vaccination (strength, batch number, expiry date: unknown).  On 07-Jul-2023, 2-month-old female patient was inadvertently administered both pentacel and pediarix instead of the acthib and pediarix with no reported adverse event (wrong product administered) and received an extra dose of the dtap and ipv antigens with no reported adverse event (extra dose administered) (latency same day).  Action taken: not applicable  Outcome was Unknown for the events.  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 guidelines. 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Incorrect product formulation administered, Product administration error
Clinical narrative: 1. Patient was administered Pfizer monovalent vaccine after authorized use expired April 18, 2023. 2. Patient was prescribed Pfizer Bivalent covid vaccine and was administered Pfizer monovalent vaccine in error.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Blood culture positive, COVID-19, Culture urine positive, Escherichia test positive, Exposure to SARS-CoV-2
Clinical narrative: Assessment and Plan:   92-year-old female presented in the setting of UTI and positive blood cultures admitted for IV ceftriaxone.  Repeat cultures from 6/28 and 6/29 showing preliminary no growth, repeat blood cultures from 7/1 in process.  Had a smooth night into 7/2/2023 and was discharged in satisfactory condition to complete a course of p.o. cefadroxil.    COVID swab was checked day of discharge (per family request; apparently patient had been exposed to COVID prior to admission) and resulted positive.  Given that there were no measured hypoxemia, no new recommendations at this point other than to monitor symptoms and abide by home isolation and routine mask mask usage x5 days.    See also discharge summary that was pre-completed yesterday, reproduced below in italics.   ...she has a PMH of HTN, Afib on AC, diverticulosis, HLD, and stress urinary incontinence. She was recently seen in ED on 6/28 for left flank pain and UTI, and was discharged with cefadroxil. She was called back to the ED due to BCx positive for GNR and started on CTX. Blood and urine cultures grew E.coli (resistant to bactrim, otherwise pansusceptible). She was discharged on cefadroxil, plan for total of 2 week course.    Noted to have thrombocytopenia down to 80s. Likely in setting of infection. Improving at discharge, ordered for repeat labs as outpatient.        _________________ PPE Worn:   Mask: Isolation Eye Protection: no Patient Masked: no Hand Hygiene: yes        DO Hospitalist HBS      Note Details  Author (D.O.) File Time 7/2/2023 12:39 PM Author Type PHYSICIAN (D.O.) Status Addendum Last Editor (D.O.) Specialty Hospital Medicine Admit Date 6/29/2023  ED to Hosp-Admission (Discharged) on 6/29/2023  ED to Hosp-Admission (Discharged) on 6/29/2023   Revision History   Detailed Report  Note shared with patient Care Timeline  06/29   Admitted from ED 1817 07/02   Discharged 1352
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Flank pain, Gram stain positive, SARS-CoV-2 test positive, Thrombocytopenia, Urinary tract infection
Clinical narrative: Assessment and Plan:   92-year-old female presented in the setting of UTI and positive blood cultures admitted for IV ceftriaxone.  Repeat cultures from 6/28 and 6/29 showing preliminary no growth, repeat blood cultures from 7/1 in process.  Had a smooth night into 7/2/2023 and was discharged in satisfactory condition to complete a course of p.o. cefadroxil.    COVID swab was checked day of discharge (per family request; apparently patient had been exposed to COVID prior to admission) and resulted positive.  Given that there were no measured hypoxemia, no new recommendations at this point other than to monitor symptoms and abide by home isolation and routine mask mask usage x5 days.    See also discharge summary that was pre-completed yesterday, reproduced below in italics.   ...she has a PMH of HTN, Afib on AC, diverticulosis, HLD, and stress urinary incontinence. She was recently seen in ED on 6/28 for left flank pain and UTI, and was discharged with cefadroxil. She was called back to the ED due to BCx positive for GNR and started on CTX. Blood and urine cultures grew E.coli (resistant to bactrim, otherwise pansusceptible). She was discharged on cefadroxil, plan for total of 2 week course.    Noted to have thrombocytopenia down to 80s. Likely in setting of infection. Improving at discharge, ordered for repeat labs as outpatient.        _________________ PPE Worn:   Mask: Isolation Eye Protection: no Patient Masked: no Hand Hygiene: yes        DO Hospitalist HBS      Note Details  Author (D.O.) File Time 7/2/2023 12:39 PM Author Type PHYSICIAN (D.O.) Status Addendum Last Editor (D.O.) Specialty Hospital Medicine Admit Date 6/29/2023  ED to Hosp-Admission (Discharged) on 6/29/2023  ED to Hosp-Admission (Discharged) on 6/29/2023   Revision History   Detailed Report  Note shared with patient Care Timeline  06/29   Admitted from ED 1817 07/02   Discharged 1352
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Hyperhidrosis, Nausea, Pallor, Presyncope
Clinical narrative: Pt noted to have vasovagal response after injection of HPV vaccine. Pt given ice pack to base of neck and sip of water. Pt complaints of nausea and noted to be pale and have a bit of perspiration to her forehead. PCP informed and BP monitored. Pt given juice and crackers with mother in room while pt recovered. Pt reports feeling better and was able to ambulate out of the clinic on her own.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Walking aid user
Clinical narrative: Patient states she has been having vertigo since receiving the vaccine. She has to walk with a walker at times due to the vertigo. First vaccine received 1/24/2021
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Asthma exercise induced, Bronchitis, COVID-19, Chest X-ray abnormal
Clinical narrative: On 6/1/2022, I got my fourth dose of the Pfizer COVID-19 vaccine. On around 6/12/2022, I began to have significant asthma exacerbation, especially when I engaged in any physical activity, such as walking (especially when going uphill). I continued to feel run-down, and I would often have to nap. I saw a doctor in late June 2022, and I was given steroids and antibiotics. I was diagnosed with bronchitis. On 8/19/2022, I had to go back to the doctor, because I had excessive coughing, tightness in the chest, fever, and fatigue. I underwent a chest X-ray and was diagnosed with pneumonia. I was given 20 mg of prednisone, fluticasone, doxycycline monohydrate, albuterol nebulizer, and budesonide. On 8/30/2022, I tested positive for COVID-19. Fortunately, it was a mild case of COVID-19. I had some residual symptoms of pneumonia, which quickly faded. However, I had a fever for the first three or four days I had COVID-19. The fever alternated between 99 and 102 degrees. I had chest tightness in the chest that was not relieved by albuterol. I had a headache that lasted for about five days. I continue to have issues with asthma exacerbation. On 12/12/2022, I had bronchitis. I received a prednisone injection, which helped a great deal. I was also given doxycycline, which also helped. I haven't had bronchitis again since then, but the asthma exacerbation continues. It's now so severe that I can't work out or run. I use albuterol daily. I normally have to have two puffs in the morning, and I frequently have four puffs during the day. Since about June 2023, I've had use an albuterol nebulizer in the morning and before I go to bed. I also have to do cycles of budesonide.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Condition aggravated, Cough, Exercise tolerance decreased, Fatigue
Clinical narrative: On 6/1/2022, I got my fourth dose of the Pfizer COVID-19 vaccine. On around 6/12/2022, I began to have significant asthma exacerbation, especially when I engaged in any physical activity, such as walking (especially when going uphill). I continued to feel run-down, and I would often have to nap. I saw a doctor in late June 2022, and I was given steroids and antibiotics. I was diagnosed with bronchitis. On 8/19/2022, I had to go back to the doctor, because I had excessive coughing, tightness in the chest, fever, and fatigue. I underwent a chest X-ray and was diagnosed with pneumonia. I was given 20 mg of prednisone, fluticasone, doxycycline monohydrate, albuterol nebulizer, and budesonide. On 8/30/2022, I tested positive for COVID-19. Fortunately, it was a mild case of COVID-19. I had some residual symptoms of pneumonia, which quickly faded. However, I had a fever for the first three or four days I had COVID-19. The fever alternated between 99 and 102 degrees. I had chest tightness in the chest that was not relieved by albuterol. I had a headache that lasted for about five days. I continue to have issues with asthma exacerbation. On 12/12/2022, I had bronchitis. I received a prednisone injection, which helped a great deal. I was also given doxycycline, which also helped. I haven't had bronchitis again since then, but the asthma exacerbation continues. It's now so severe that I can't work out or run. I use albuterol daily. I normally have to have two puffs in the morning, and I frequently have four puffs during the day. Since about June 2023, I've had use an albuterol nebulizer in the morning and before I go to bed. I also have to do cycles of budesonide.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Increased need for sleep, Pneumonia, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: On 6/1/2022, I got my fourth dose of the Pfizer COVID-19 vaccine. On around 6/12/2022, I began to have significant asthma exacerbation, especially when I engaged in any physical activity, such as walking (especially when going uphill). I continued to feel run-down, and I would often have to nap. I saw a doctor in late June 2022, and I was given steroids and antibiotics. I was diagnosed with bronchitis. On 8/19/2022, I had to go back to the doctor, because I had excessive coughing, tightness in the chest, fever, and fatigue. I underwent a chest X-ray and was diagnosed with pneumonia. I was given 20 mg of prednisone, fluticasone, doxycycline monohydrate, albuterol nebulizer, and budesonide. On 8/30/2022, I tested positive for COVID-19. Fortunately, it was a mild case of COVID-19. I had some residual symptoms of pneumonia, which quickly faded. However, I had a fever for the first three or four days I had COVID-19. The fever alternated between 99 and 102 degrees. I had chest tightness in the chest that was not relieved by albuterol. I had a headache that lasted for about five days. I continue to have issues with asthma exacerbation. On 12/12/2022, I had bronchitis. I received a prednisone injection, which helped a great deal. I was also given doxycycline, which also helped. I haven't had bronchitis again since then, but the asthma exacerbation continues. It's now so severe that I can't work out or run. I use albuterol daily. I normally have to have two puffs in the morning, and I frequently have four puffs during the day. Since about June 2023, I've had use an albuterol nebulizer in the morning and before I go to bed. I also have to do cycles of budesonide.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Lip swelling, Paraesthesia, Pharyngeal swelling
Clinical narrative: patient experienced potentially severe allergic reaction: face tingling, throat and lip swelling
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Allergy to vaccine, Hypoaesthesia, Oropharyngeal discomfort, Panic attack, Sensation of foreign body
Clinical narrative: patient experienced potentially severe allergic reaction: face tingling, throat and lip swelling
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Throat tightness
Clinical narrative: patient experienced potentially severe allergic reaction: face tingling, throat and lip swelling
Age: 77.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient received a Pfizer bivalent booster on 9/15/22, then mistakenly also received a Moderna bivalent booster on 10/18/22.
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Borrelia test positive, CSF white blood cell count negative, Coordination abnormal, Death, Dyspnoea
Clinical narrative: presented to ED June 9 complaining of numbness in hand 2 days prior to admission  He walked his dog for 1 mile day prior to admission, without difficulty On day of admission developed numbness in the feet and trouble walking .  His coordination was off, cut himself shaving.  Patient denies any headaches any vision changes.  No facial asymmetry no slurred speech.  On May 31, had returned from a  1-week fishing trip. He reported finding a tick on his right arm while on the trip.  He was feeling tired when he returned, no fever reported, no rash.  On June 6, had a Moderna COVID booster, 1 day prior to onset of symptoms.   Additional history obtained after discharge, was bitten by a garden snake, had taken a picture and confirmed the species. Admitted 6/9, LP done IVIG started on 6/10 Transferred to ICU overnight 6/10, dyspnea, decreased vital capacity, placed on bipap, and intubated on 6/11 On 6/14, no neurologic improvement noted, intubated and sedated, not moving extremities, was started on pheresis.No neurologic improvement with IVIG and PLEX for GBS Was made comfort measures and expired on 6/21
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Endotracheal intubation, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: presented to ED June 9 complaining of numbness in hand 2 days prior to admission  He walked his dog for 1 mile day prior to admission, without difficulty On day of admission developed numbness in the feet and trouble walking .  His coordination was off, cut himself shaving.  Patient denies any headaches any vision changes.  No facial asymmetry no slurred speech.  On May 31, had returned from a  1-week fishing trip. He reported finding a tick on his right arm while on the trip.  He was feeling tired when he returned, no fever reported, no rash.  On June 6, had a Moderna COVID booster, 1 day prior to onset of symptoms.   Additional history obtained after discharge, was bitten by a garden snake, had taken a picture and confirmed the species. Admitted 6/9, LP done IVIG started on 6/10 Transferred to ICU overnight 6/10, dyspnea, decreased vital capacity, placed on bipap, and intubated on 6/11 On 6/14, no neurologic improvement noted, intubated and sedated, not moving extremities, was started on pheresis.No neurologic improvement with IVIG and PLEX for GBS Was made comfort measures and expired on 6/21
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Intensive care, Lumbar puncture abnormal, Mobility decreased, Plasmapheresis, Positive airway pressure therapy
Clinical narrative: presented to ED June 9 complaining of numbness in hand 2 days prior to admission  He walked his dog for 1 mile day prior to admission, without difficulty On day of admission developed numbness in the feet and trouble walking .  His coordination was off, cut himself shaving.  Patient denies any headaches any vision changes.  No facial asymmetry no slurred speech.  On May 31, had returned from a  1-week fishing trip. He reported finding a tick on his right arm while on the trip.  He was feeling tired when he returned, no fever reported, no rash.  On June 6, had a Moderna COVID booster, 1 day prior to onset of symptoms.   Additional history obtained after discharge, was bitten by a garden snake, had taken a picture and confirmed the species. Admitted 6/9, LP done IVIG started on 6/10 Transferred to ICU overnight 6/10, dyspnea, decreased vital capacity, placed on bipap, and intubated on 6/11 On 6/14, no neurologic improvement noted, intubated and sedated, not moving extremities, was started on pheresis.No neurologic improvement with IVIG and PLEX for GBS Was made comfort measures and expired on 6/21
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Skin laceration, Treponema test negative, Vital capacity decreased, West Nile virus test negative
Clinical narrative: presented to ED June 9 complaining of numbness in hand 2 days prior to admission  He walked his dog for 1 mile day prior to admission, without difficulty On day of admission developed numbness in the feet and trouble walking .  His coordination was off, cut himself shaving.  Patient denies any headaches any vision changes.  No facial asymmetry no slurred speech.  On May 31, had returned from a  1-week fishing trip. He reported finding a tick on his right arm while on the trip.  He was feeling tired when he returned, no fever reported, no rash.  On June 6, had a Moderna COVID booster, 1 day prior to onset of symptoms.   Additional history obtained after discharge, was bitten by a garden snake, had taken a picture and confirmed the species. Admitted 6/9, LP done IVIG started on 6/10 Transferred to ICU overnight 6/10, dyspnea, decreased vital capacity, placed on bipap, and intubated on 6/11 On 6/14, no neurologic improvement noted, intubated and sedated, not moving extremities, was started on pheresis.No neurologic improvement with IVIG and PLEX for GBS Was made comfort measures and expired on 6/21
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Rash erythematous
Clinical narrative: Patient developed a small, bumpy, red rash on her upper abdominal area,  and left neck/collar bone.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Inflammation, Joint range of motion decreased, Swelling, Tendonitis
Clinical narrative: Pain in posterior shoulder and limiting AROM of the shoulder.  Mild swelling no erythema.  Tendonitis suspected
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness
Clinical narrative: After receiving 2 vaccines in the office, the patient walked outside with her father. As they approached their parked vehicle, the patient's father stated the patient stated she felt dizzy and her eyes closed for a few seconds. The patient's father assisted her to lie down on the parking lot. The patient's father stated that the patient did not hit her head or any other body parts. The patient was helped into a wheelchair by office staff and brought back into the office where the patient was assisted to lie down on an exam table with her feet elevated as per Dr.'s instruction. Within a few minutes the patient drank apple juice and ate crackers and stated she felt better. The patient walked out of
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Eye movement disorder, Feeling hot
Clinical narrative: PfizER vAccine wAs Administered to patient At ApproximAtely 2:30 pm. At Approx. 2:41 p pt wAs Asked by nurse "Are you oK AND how Are you feeling?" Pt stAteD "Im feeliNg oK" AND per Nurse pt eyes rolleD to the bAck of her heAD Nurse immediately Approached patient, vitAls AssessEd, Safety mAintAineD, Nurse asked mon question, mom stated pt hAD Not eAteN prior to vaccinatioN, pt felt wAs WaRm to touch. Pt wAs giveN fluids AND crAckers, ice pAck plAced underneath left ARM. SAfety meAsures mAintAinED. VitAls reAssEssED AND wIthiN NorMAL LImITs. Pt was moNitored for 30 miNutes. Nurse Asked pt how she wAs feeling, pt stAtes she feels fine AND wAs Able to Ambulate without difficulty; pt AccompAnied with mom AND AdditioNAl family
Age: 53.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Peripheral swelling, Rash
Clinical narrative: On June 2 or 3  2023, my left arm including the injection site became red and swollen with pain that couldn't be controlled. by the morning of June 4, 2023, my arm was double in size, very hot and red and painful. That afternoon, I went to Urgent Care where I was given a steroid injection to stop the swelling and given a 4 day prescription of prednisone to be taken. The swelling stoped but did not reduce so I went back to Urgent Care where they referred me to Sports medicine and was given a steroid taper for 7 days and did x rays in that area, Most of the swelling has gone but the pain is still there and nothing makes it go away.
Age: 53.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: On June 2 or 3  2023, my left arm including the injection site became red and swollen with pain that couldn't be controlled. by the morning of June 4, 2023, my arm was double in size, very hot and red and painful. That afternoon, I went to Urgent Care where I was given a steroid injection to stop the swelling and given a 4 day prescription of prednisone to be taken. The swelling stoped but did not reduce so I went back to Urgent Care where they referred me to Sports medicine and was given a steroid taper for 7 days and did x rays in that area, Most of the swelling has gone but the pain is still there and nothing makes it go away.
Age: 53.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Pain in extremity, Peripheral swelling, X-ray
Clinical narrative: On June 2 or 3  2023, my left arm including the injection site became red and swollen with pain that couldn't be controlled. by the morning of June 4, 2023, my arm was double in size, very hot and red and painful. That afternoon, I went to Urgent Care where I was given a steroid injection to stop the swelling and given a 4 day prescription of prednisone to be taken. The swelling stoped but did not reduce so I went back to Urgent Care where they referred me to Sports medicine and was given a steroid taper for 7 days and did x rays in that area, Most of the swelling has gone but the pain is still there and nothing makes it go away.
Sex: U
Vaccine: MMRV
Symptoms: Interchange of vaccine products, No adverse event, Product storage error
Clinical narrative: PROQUAD also suffered from a non supported temperature excursion; No Additional AE; HCP called to report that the patient was given PROQUAD instead of MMR II; This spontaneous report was received from a pharmacist concerning to a patient of unspecified age and gender.  The patient's pertinent medical history, concurrent conditions, concomitant therapies and frug reactions/allergies were not reported.  On an unspecified date, doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) lot #W029552, expiration date: 14-MAR-2024 underwent a non-supported temperature excursion of 8 degrees Celsius (C) for 1344 hours without previous temperature excursions (product storage error).  On 18-MAY-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) lot #W029552, expiration date: 14-MAR-2024 (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis, instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (interchange of vaccine products).  No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: COVID19
Symptoms: Embolism venous
Clinical narrative: Venous thromboembolism; This literature-non-study case was reported in a literature article and describes the occurrence of EMBOLISM VENOUS (Venous thromboembolism) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.        No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EMBOLISM VENOUS (Venous thromboembolism) (seriousness criterion medically significant). At the time of the report, EMBOLISM VENOUS (Venous thromboembolism) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported. This case refers to a patient of unknown age and gender who experienced the Venous thromboembolism after first dose of mRNA-1273 vaccine.   This study described simultaneous vaccination (SV) with primary series COVID-19 vaccines and assess 23 pre-specified health outcomes following SV among persons aged greater than or equal to 5 years in the Vaccine Safety Datalink (VSD). from December 11, 2020-May 21, 2022. Analyses assessed frequency of SV.   Rate ratios (RRs) were estimated by Poisson regression when the number of outcomes was greater than or equal to 5 across both doses, comparing outcome rates between COVID-19 vaccinees receiving SV and COVID-19 vaccinees receiving no SV in the 1-21 days following COVID-19 vaccine dose 1 and 1-42 days following dose 2 by SV type received.  The most frequent simultaneous vaccines were influenza, HPV, Tdap, and meningococcal. Outcomes following SV with COVID-19 vaccines were rare (total of 56 outcomes observed after dose 1 and dose 2). Overall rate of outcomes among COVID-19 vaccinees who received SV was not statistically significantly different than the rate among those who did not receive SV.  The most frequent simultaneous vaccines were influenza, HPV, Tdap, and meningococcal. Outcomes following SV with COVID-19 vaccines were rare (total of 56 outcomes observed after dose 1 and dose 2). Overall rate of outcomes among COVID-19 vaccines who received SV was not statistically significantly different than the rate among those who did not receive SV.   This case was linked to US-MODERNATX, INC.-MOD-2023-731103 (Linked Report).  Company Comment: This is a literature non-study case concerning a patient of unknown age and gender, with no reported medical history, who experienced the serious (due to medically significant) unexpected, event of embolism venous. The event on an unknown date after a dose of mRNA-1273 vaccine (dose number and date of administration were not provided). Clinical course, supportive diagnostic procedures, vaccine received in the context of simultaneous vaccination, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731103:Master case
Age: 49.0
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Underdose
Clinical narrative: I was a vaccinator at clinic.  I requested Hep A, MCV4, and Monkeypox for an adult patient.  I was given a prefilled syringe of Hep A, a vial of MCV4, and MPX by the vaccine manager.  I was unaware I was given state vaccines and administered vaccine to patient.  It was later discovered the vaccine were state and the patient was under vaccinated.  Corrective Actions is being taken.
Age: 8.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event. DTap instead of Tdap given to a 7 year old.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Blood oestrogen normal, Blood testosterone decreased, Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: I began menstruating twice a month. Not just spotting, they are full and heavy periods. My periods, prior to the vaccine, were typically every four weeks with light to moderate flow. I?ve never had complaints of irregular or heavy periods, or ever had to see a medical provider for treatment concerning my periods until after the vaccine. My periods changed to moderate to heavy flow, twice a month.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rocky mountain spotted fever, Spotted fever rickettsia test positive, Ultrasound pelvis normal
Clinical narrative: I began menstruating twice a month. Not just spotting, they are full and heavy periods. My periods, prior to the vaccine, were typically every four weeks with light to moderate flow. I?ve never had complaints of irregular or heavy periods, or ever had to see a medical provider for treatment concerning my periods until after the vaccine. My periods changed to moderate to heavy flow, twice a month.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure diastolic increased, Blood pressure increased, Blood pressure systolic increased
Clinical narrative: Elevated blood pressure, increase of a minimum of 15 points both sys/dia
Age: 3.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: patient age three  should have received Dtap (daptacel), not Tdap (Adacel) Event entered as medication error.  Counter measures include leveraging electronic health record for a hard stop.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, COVID-19, Dizziness, Fall, Syncope
Clinical narrative: Reported Symptoms:  10013573:DIZZINESS;  10016178:FALLING DOWN;  10042772:SYNCOPE;  10047862:WEAKNESS;  10084268: COVID-19;      NARRATIVE: Patient received three doses of Pfizer COVID 19 vaccine in Jan/Oct 21. The patient presented to the ED on 31 Dec 22 with severe weakness that caused the patient to fall.   The patient was admitted for COVID-19 observation.   The patient was discharged in stable condition on 3 Jan 2023.   Reported per EUA. Other Relevant HX:   Other: COVID 19, severe weakness and fall
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Symptom recurrence
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/14/2022  &  2/8/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angina pectoris
Clinical narrative: STABLE ANGINA
Age: 45.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chronic respiratory failure, Symptom recurrence
Clinical narrative: CHRONIC RESPIRATORY FAILURE 12/18/2022  &   1/31/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neuropathy peripheral
Clinical narrative: NEUROPATHY
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypotension, Shock
Clinical narrative: HYPOTENSION SHOCK, UNSPECIFIED
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Diarrhoea, Febrile convulsion, Pyrexia, Vomiting
Clinical narrative: Mother reports vomiting, diarrhea, fever, and febrile seizure
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Neuropathy peripheral
Clinical narrative: NEUROPATHY
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: injection site redness, swelling, itching
Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Hypoxia
Clinical narrative: ACUTE ST ELEVATION MI, UNSPECIFIED ACUTE NON ST ELEVATION MI HYPOXIA
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: 5-10 minutes after administering the vaccine, patient started to gets swelling, hives on right shoulder around the site of the injection. No breathing problems. No other site on the body had hives or swelling. The attending Physician was alerted, by the medical assist. Dr. and the patient's mother discussed options on how to address the reaction. The patient's mother elected to have the patient take liquid diphenhydramine and to put ice on the shoulder as well. Patient was given 12.5 ml of liquid diphenhydramine orally and ice in a bag was applied to the site with ease. After 25-30 minutes the swelling and hives went down. Advised to call the clinic if hives or swelling returned OR to go to the Emergency Room if after clinic hours. Patient and mother voiced understanding. Questions were encouraged and answered. Patient and mother left office. N
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Agitation, Crying, Pyrexia, Screaming, Ultrasound scan normal
Clinical narrative: 7/1/2023 @ 2;25 AM  Mom contacted Nurse Triage Call Line for concerns of fever up to 102.0 F, vomiting x 5, increasing crying, fretfulness.  Nurse advised: If no improvement to call back. In the meantime monitor, give Tylenol. 7/1/2023 @ 6:51 PM  Mom called Nurse Triage Call Line reporting pt. continues to have fever, (unmeasured), vomited 5 more times and is "screaming bloody murder." Kicking and pulling legs up. Advised to Hospital. Ultra Sound results: non obstructive bowel gas pattern. Due to severe symptoms of intussusception , sent to Hospital. for further eval. U/S repreated. and was negative for intussusception. Sent home on observance.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: 7/1/2023 @ 2;25 AM  Mom contacted Nurse Triage Call Line for concerns of fever up to 102.0 F, vomiting x 5, increasing crying, fretfulness.  Nurse advised: If no improvement to call back. In the meantime monitor, give Tylenol. 7/1/2023 @ 6:51 PM  Mom called Nurse Triage Call Line reporting pt. continues to have fever, (unmeasured), vomited 5 more times and is "screaming bloody murder." Kicking and pulling legs up. Advised to Hospital. Ultra Sound results: non obstructive bowel gas pattern. Due to severe symptoms of intussusception , sent to Hospital. for further eval. U/S repreated. and was negative for intussusception. Sent home on observance.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Respiratory failure
Clinical narrative: HYPERCAPNIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: I have developed an itchy red spot where I received my vaccinations, one on each arm
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Transient ischaemic attack
Clinical narrative: TRANSIENT CEREBRAL ISCHEMIA ACUTE NON ST ELEVATION MI
Age: 2.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: PATIENT WAS GIVEN TDAP NOT DTAP.  THIS IS NUMBER 4 IN SERIES. NO S/S OF ADVERSE REACTION. MD AWARE. MEDICAL DIRECTOR AWARE. NO HARM OR INJURY TO PATIENT.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Chest X-ray, Dyspnoea, Muscular weakness
Clinical narrative: migratory arthralgias Intermittent muscle weakness in bilateral lower extremities shortness of breath
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Ocular hyperaemia
Clinical narrative: 1st. dose pain in left eye with blood red in left half of eye. 2nd vaccine eye pain slighty red. Called my eye doctor office. Tech recommended eye drops and to calle back if it worsened. symptoms lased about 3 days.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Chronic respiratory failure, Hypoxia, Respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: The provider ordered  varicella and an MMR vaccines to be given separately and the RN drew up a Proquad and an MMR and that was given to the child
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cerebellar ataxia, Muscular weakness, Wheelchair user
Clinical narrative: Pt stated that with in about a week she started having muscle weakness and that it has progressively gotten worse.  She was walking with a walker quite a bit prior to vaccination but no uses a motorized WC.   Provider requested a VAERS report to be submitted.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired COVID Moderna bivalent vaccine. Patient was stable and no treatment was necessary. I contact Moderna to determine the viability of the vaccine.  They said "The vaccine administered on June 29, 2023 from lot number 042H22A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration." No other doses were given to this patient.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Injection site erythema, Nausea, Pain
Clinical narrative: Unknown if Bexsero or Trumenba. Patient was seen at another clinic for sports physical and MenB vaccination on 7/10/23. Developed localized soreness and dizziness/nausea that evening lasting through 7/12/23. Called PCP and was advised to be checked at this clinic. Localized swelling and mild erythema at injection site.  No systemic swelling, no difficulty breathing, no wheezes, no fever.