chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.33
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: inadvertently administered adacel instead of daptacel to a 16-month-old patient with no reported adverse event; Initial information received on 13-Dec-2023 regarding an unsolicited valid non-serious case received via nurse.  This case involves, inadvertently administered diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] instead of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] to a 16-month-old patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB vaccine CONJ (TET TOX) (ACT HIB) for Immunisation; and hepatitis A vaccine INACT (VAQTA) for Immunisation.  On 12-Dec-2023, the patient received a 0.5 ml total dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection (strength, expiry date: unknown) (lot: U7928AA) via intramuscular route in the left deltoid for immunization and inadvertently administered adacel instead of daptacel to a 16-month-old patient with no reported adverse event (wrong product administered) (latency: same day)  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Blood pressure increased, Wheezing
Clinical narrative: PT EXPERIENCED WHEEZING ON THE RIGHT SIDE LATE OCTOBER/EARLY NOVEMBER, WENT ON ZPAK, GOT BETTER, BUT NOW BLOOD PRESSURE IS SPIKING 30PTS HIGHER THAN PREVIOUSLY. PT DOESN'T TAKE ANY MEDS FOR BP, AND IS CONCERNED THE VACCINE IS CAUSING THE BP SPIKE
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Loss of consciousness, Moaning, Seizure, Skin discolouration
Clinical narrative: about 1 minute after the vaccine was given to me, i passed out, my skin was grey, i was convulsing, and groaning, all uncontously
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Eye pruritus, Genital herpes, Paraesthesia, Pruritus
Clinical narrative: Nerve tingling and itching eyes, arms, body trunk. WORST is it seems to have awoken an OLD STD Herpes sore on vagina opening. Pain is fairly acute and very site specific to old location of herpes sore
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Vulvovaginal pain
Clinical narrative: Nerve tingling and itching eyes, arms, body trunk. WORST is it seems to have awoken an OLD STD Herpes sore on vagina opening. Pain is fairly acute and very site specific to old location of herpes sore
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Never had a reaction except maybe sore arm and tiredness; Never had a reaction except maybe sore arm and tiredness; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Never had a reaction except maybe sore arm and tiredness) and FATIGUE (Never had a reaction except maybe sore arm and tiredness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A, 045A21A, 039F21A and 002M21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hay fever.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Never had a reaction except maybe sore arm and tiredness) and FATIGUE (Never had a reaction except maybe sore arm and tiredness). At the time of the report, PAIN IN EXTREMITY (Never had a reaction except maybe sore arm and tiredness) and FATIGUE (Never had a reaction except maybe sore arm and tiredness) outcome was unknown.            No concomitant medication was reported.  Patient also never had COVID, no colds, or even the flu. No treatment information was reported.   This case was linked to MOD-2023-753900, MOD-2023-754021 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Eye abrasion
Clinical narrative: Minute residual vaccine somehow splashed in nurse's left eye causing a minor abrasion.; Child moved and a residual, a drop, splashed into my eye; This spontaneous case was reported by a nurse and describes the occurrence of EYE ABRASION (Minute residual vaccine somehow splashed in nurse's left eye causing a minor abrasion.) and ACCIDENTAL EXPOSURE TO PRODUCT (Child moved and a residual, a drop, splashed into my eye) in a 51-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU5551B) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19. Concurrent medical conditions included Penicillin allergy.    On 14-Nov-2023, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 14-Nov-2023, the patient experienced EYE ABRASION (Minute residual vaccine somehow splashed in nurse's left eye causing a minor abrasion.) and ACCIDENTAL EXPOSURE TO PRODUCT (Child moved and a residual, a drop, splashed into my eye). On 14-Nov-2023, ACCIDENTAL EXPOSURE TO PRODUCT (Child moved and a residual, a drop, splashed into my eye) outcome was unknown. At the time of the report, EYE ABRASION (Minute residual vaccine somehow splashed in nurse's left eye causing a minor abrasion.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter.  Patient height 64 inches.  It has been reported that while nurse was administering Moderna vaccine to patient, plunger was pushed and patient moved resulting in needles to come apart from syringe. Minute residual vaccine somehow splashed into the left eye causing a minor abrasion.  No treatment medications provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-751236 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2023: In follow-up non-significant information has been appended which included Quality Complaint number has been added. On 18-Dec-2023: Significant follow up received on 18 Dec 2023, Reporter details, patient details added. Patient history, event information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-751236:Same reporter
Age: 0.5
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The HCP reported no adverse events/no additional AE; FBE calling to report that a dose of GARDASIL 9 was given to a 6 month old.; This spontaneous report was received from a physician via a company representative and referred to a 6-month-old patient with unknown gender. The patient's concurrent conditions, concomitant medications, historical drugs, pertinent medical history and drug reactions/allergies were not reported.  On 27-NOV-2023, the 6 months old patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, administered for prophylaxis (strength, exact dose, lot #, expiry date, anatomical site of administration and route of administration were not provided) (product administered to patient of inappropriate age). The child had been seen twice in the office since the date of administration and the health case professional (HCP) reported no adverse events (no AE). It was reported the HCP had reported this information to the Centers for Disease Control and Prevention (CDC). No additional information was reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Hypersensitivity, SARS-CoV-2 test
Clinical narrative: also previously taken Moderna vaccine and experienced allergy side effects; Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (also previously taken Moderna vaccine and experienced allergy side effects) and COVID-19 (Tested positive for COVID) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (also previously taken Moderna vaccine and experienced allergy side effects) and COVID-19 (Tested positive for COVID). At the time of the report, HYPERSENSITIVITY (also previously taken Moderna vaccine and experienced allergy side effects) and COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       The patient took unspecified Statin previously. It was reported that the patient was supposed to have a back surgery on the 27th (month unspecified). Treatment medications reported included unspecified steroids.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: headache; fever; Caller says they still can't touch their left arms because it is still painful at the injection site.; very very tired; could not even stand up; This spontaneous case was reported by a non-health professional and describes the occurrence of DYSSTASIA (could not even stand up), HEADACHE (headache), PYREXIA (fever), INJECTION SITE PAIN (Caller says they still can't touch their left arms because it is still painful at the injection site.) and FATIGUE (very very tired) in a 16-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058877) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu shot on 08-Nov-2023. Past adverse reactions to the above products included No adverse event with Flu shot.    On 15-Dec-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 15-Dec-2023, the patient experienced HEADACHE (headache), PYREXIA (fever) and INJECTION SITE PAIN (Caller says they still can't touch their left arms because it is still painful at the injection site.). In December 2023, the patient experienced DYSSTASIA (could not even stand up) and FATIGUE (very very tired). At the time of the report, DYSSTASIA (could not even stand up) and FATIGUE (very very tired) outcome was unknown and HEADACHE (headache), PYREXIA (fever) and INJECTION SITE PAIN (Caller says they still can't touch their left arms because it is still painful at the injection site.) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Caller reported about two daughters who received the vaccine on 15-Dec-2023, 6 to 7 pm. In the evening patient was okay, but they were supposed to go to school in the morning, but they could not go. They got sick, headache, fever, very tired, could not even stand up. They had plans to attend some activities and they could not do it. They would wake up and only could drink water and nothing else. Didn't eat anything and could barely drink water.   This case was linked to US-MODERNATX, INC.-MOD-2023-754036 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-754036:Patient 1
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13
Symptoms: Angioedema
Clinical narrative: developed acute allergic angioedema of the face ~12 hours after recieving vaccination. Recieved prednisolone, famotidine, diphenhydramine with resolution of symptoms.
Age: 18.0
Sex: F
Vaccine: FLU4, HPV9, MENB
Symptoms: Fall, Head injury, X-ray normal
Clinical narrative: after the administration of the vaccines, I asked the pt if she was ok; Pt said yes; she was left in observation. She stood up from the bed and she fell to the floor; she hit her forehead; she was evaluated by Dr We took her vitals: BP 110/55, (P?) 101. She was transported to ER for evaluation.
Sex: U
Vaccine: FLUX
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Inoculated the wrong vaccine. They gave the flu shot instead of the RSV, which was scheduled. The patient had already had the previous flu shot on 10/17/2023 and never scheduled to have two of the same flu shot!   Medication administered to or used by the patient Yes  Where did the error occur Community pharmacy  When and how was error discovered Pharmacist notified patient  Level of staff who discovered the error Pharmacist  Who intervened  Pharmacist  Reporter's recommendations Give the correct vaccination as scheduled  Product involved Flu Vax Beyfortus  Type Vaccine related errors reported by consumers
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: Received the covid vaccines and later developed white patches on my skin that a dermatologist said was vitiligo. I believe differently as it has not spread and only showed up near my thyroid glands. Two patches on either side of my face. These are fading now they were visible a year after my vivid vaccines
Sex: U
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Pharmacy pharmacist administered a RSV vaccine that was not approved by the FDA for pregnant women 32-36 weeks. At the time of the vaccination I was 32 weeks. From the sheet given to me after the shot. MFG: Glaxosmith - RSV AREXVY INJ 1 VIAL (Directions: Administer 0.5 ml in the muscle as directed today). I had made an appt online with pharmacy. When I arrived on 10/27/2023 I was checked in and the pharmacist later (15-20min) came over and said that the RSV vaccine was only for people over 65 or pregnant between 32-36 weeks. I confirmed that I was pregnant 32 weeks and went back to waiting area. I was called in to get the shot after about 20-30min waiting. On Tuesday 10/31/2023 the pharmacy called and the pharmacist who administered the shot told me that I had been given the non-FDA approved for pregnant people RSV vaccine. They explained that on 10/27/2023 before they administered the vaccine they had checked the CDC website and another website for confirmation that the RSV vaccine I would be getting was appropriate for pregnant women. They continued to explain on 10/27 before administering the vaccine they had not seen anything indicating I could not receive the Glaxosmith RSV vaccine. I believe that on the CDC website and the other website there was adequate information for healthcare providers about which RSV vaccine was approved for pregnant women. I think that the pharmacist should have done a better job checking these websites. A simple web search would give a result that said Glaxosmith vaccine is not approved for pregnant people
Sex: U
Vaccine: FLUX, FLUX, FLUX
Symptoms: Wrong product administered
Clinical narrative: I came to the office for an "MA visit" to receive HBV and HPV vaccine afte rbeing previously screened by PCP and NP. Medical assistant administered Flu vaccine instead. I clearly stated at the begging of my appointment what the purpose of my visit is.  When and how was error discovered By patient and MA  Reporter's recommendations Medical assistant should verify my name and DOB and repeat loudly what vaccines she will be administer at today's visit.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT GIVEN AN EXPIRED DOSE OF THIS VACCINE.
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin discolouration, Skin warm
Clinical narrative: Within 2-3 days of vaccination, a dark red, discolored spot, the size of a half dollar appeared on the arm with pain. Typical vaccination side effects like heat and minor swelling were temporary. However, over the past 1.5 months, the arm continues to be discolored and the pain is continuing and excessive. Over the counter pain relievers are needed every day due to the continued pain.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT WAS GIVEN AN EXPIRED DOSE OF THE ABOVE VACCINE.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Chronic obstructive pulmonary disease, Condition aggravated, Dyslipidaemia
Clinical narrative: Admit date: 12/12/2023  Discharge date: 12/15/2023   Admitting Physician: DO   Attending Physician at the Time of Discharge: DO  Primary Care Physician: DO Reason for Admission: COPD exacerbation due to covid  Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) 72 YO female presented with dyspnea and wheezing, admitted with acute on chronic hypoxic respiratory failure due to covid, copd exacerbation.  Placed on steroid and remdesivir with improvement.  Will discharge home today on home O2 with brief prednisone course.  Problem list:Acute on chronic respiratory failure with hypoxia, resolved                -on home O2, mobilizing COVID infection               -remdesivir completed in hospital COPD with exacerbation               -Continue scheduled albuterol, LABA/ICS/LAMA               -prednisone prescribed on discharge  OSA on CPAP Pulmonary nodules, known to Pulm Hypothyroidism  Discharge Problem List     * (Principal) Acute on chronic respiratory failure with hypoxia (HCC)   Dyslipidemia   Hypothyroidism   Seasonal allergies   Acute exacerbation of chronic obstructive pulmonary disease (COPD) (HCC)   Severe protein-calorie malnutrition (HCC)   History of thyroid cancer   OSA (obstructive sleep apnea)   Chronic respiratory failure with hypoxia (HCC)   COVID-19 Discharged to home.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypothyroidism, Malnutrition, Obstructive sleep apnoea syndrome, Positive airway pressure therapy
Clinical narrative: Admit date: 12/12/2023  Discharge date: 12/15/2023   Admitting Physician: DO   Attending Physician at the Time of Discharge: DO  Primary Care Physician: DO Reason for Admission: COPD exacerbation due to covid  Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) 72 YO female presented with dyspnea and wheezing, admitted with acute on chronic hypoxic respiratory failure due to covid, copd exacerbation.  Placed on steroid and remdesivir with improvement.  Will discharge home today on home O2 with brief prednisone course.  Problem list:Acute on chronic respiratory failure with hypoxia, resolved                -on home O2, mobilizing COVID infection               -remdesivir completed in hospital COPD with exacerbation               -Continue scheduled albuterol, LABA/ICS/LAMA               -prednisone prescribed on discharge  OSA on CPAP Pulmonary nodules, known to Pulm Hypothyroidism  Discharge Problem List     * (Principal) Acute on chronic respiratory failure with hypoxia (HCC)   Dyslipidemia   Hypothyroidism   Seasonal allergies   Acute exacerbation of chronic obstructive pulmonary disease (COPD) (HCC)   Severe protein-calorie malnutrition (HCC)   History of thyroid cancer   OSA (obstructive sleep apnea)   Chronic respiratory failure with hypoxia (HCC)   COVID-19 Discharged to home.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary mass, Respiratory failure, Wheezing
Clinical narrative: Admit date: 12/12/2023  Discharge date: 12/15/2023   Admitting Physician: DO   Attending Physician at the Time of Discharge: DO  Primary Care Physician: DO Reason for Admission: COPD exacerbation due to covid  Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) 72 YO female presented with dyspnea and wheezing, admitted with acute on chronic hypoxic respiratory failure due to covid, copd exacerbation.  Placed on steroid and remdesivir with improvement.  Will discharge home today on home O2 with brief prednisone course.  Problem list:Acute on chronic respiratory failure with hypoxia, resolved                -on home O2, mobilizing COVID infection               -remdesivir completed in hospital COPD with exacerbation               -Continue scheduled albuterol, LABA/ICS/LAMA               -prednisone prescribed on discharge  OSA on CPAP Pulmonary nodules, known to Pulm Hypothyroidism  Discharge Problem List     * (Principal) Acute on chronic respiratory failure with hypoxia (HCC)   Dyslipidemia   Hypothyroidism   Seasonal allergies   Acute exacerbation of chronic obstructive pulmonary disease (COPD) (HCC)   Severe protein-calorie malnutrition (HCC)   History of thyroid cancer   OSA (obstructive sleep apnea)   Chronic respiratory failure with hypoxia (HCC)   COVID-19 Discharged to home.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Confusional state, Metabolic encephalopathy, Urinary tract infection
Clinical narrative: Admit date: 12/5/2023  Discharge date: 12/15/2023   Admitting Physician: MD   Attending Physician at the Time of Discharge: DO  Primary Care Physician: MD Reason for Admission: acute metabolic encephalopathy  Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) 93 YO male sent to ED due to confusion and weakness.  Admitted with covid infection and UTI likely contributing.  Symptoms much improved.  Prolonged hospitalization awaiting release from isolation for subacute rehab, though doing well enough to go home today.  Discharged to Home Health Care Services
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Diarrhoea, Tremor
Clinical narrative: Diarrhea and severe shaking and chills that lasted a couple of hours
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Fatigue, Hypotension, Intensive care
Clinical narrative: Admit date: 12/9/2023  Discharge date: 12/17/2023    Admitting Physician: MD  Attending Physician at the Time of Discharge: MD  Primary Care Physician: NP Reason for Admission: COVID   Brief Summary of Hospital Stay: Patient presented to our ED for their complaint of weakness and fatigue. On initial workup in the ED, patient was evaluated for for these complaints and found to be notably hypotensive on admission requiring pressor support. Patient was subsequently transferred to the intensive care unit for appropriate medical care and treatment.  After continued care and workup in the intensive care unit, the patient was stable for transfer back to the general medical floor.  Our team assumed care and the patient continued to subjectively and objectively improve during this time.  With shared decision making, the optimal location for this patient to be discharged to was home with home therapy to follow. Patient was discharged to home via personal transport with appropriate follow ups scheduled.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, C-reactive protein increased, Joint swelling, Osteoarthritis, X-ray limb abnormal
Clinical narrative: Bilateral knee pain and swelling started day after and has persisted for more than 4 weeks. Has not responded to Prednisone
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Tinnitus
Clinical narrative: Ear pain(left ear), Ringing in the ears, Headaches
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bone pain, Chills, Fatigue, Nausea, Pain
Clinical narrative: 8-30-23 in the evening pt had pain in bones, chills, shivering 8-31-23 fever, aches, fatigue, nausea 9-1-23 hives started and lasted a couple of days prior to second shot- pt pre dosed with tylenol and after the shot she took tylenol every 6 hrs. 11-30-23 headache chills 12-1-23 aches, fatigue 12-2-23 Hives
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Urticaria
Clinical narrative: 8-30-23 in the evening pt had pain in bones, chills, shivering 8-31-23 fever, aches, fatigue, nausea 9-1-23 hives started and lasted a couple of days prior to second shot- pt pre dosed with tylenol and after the shot she took tylenol every 6 hrs. 11-30-23 headache chills 12-1-23 aches, fatigue 12-2-23 Hives
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Cough, Diarrhoea, Dyspnoea, Pain
Clinical narrative: Cough, dyspnea, body aches, diarrhea, fever, chills
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Cough, dyspnea, body aches, diarrhea, fever, chills
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED EXPIRED DOSE OF THE ABOVE VACCINE.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT WAS GIVEN AN EXPIRED DOSE OF THE ABOVE VACCINE.
Age: 60.0
Sex: M
Vaccine: FLUC4, RSV
Symptoms: Arthralgia, Dizziness, Peripheral swelling
Clinical narrative: not sure if caused by this or the flu shot --my guess is this i have had flu shot before with no side effects ---- felt light headed for a few days but for the last 3 weeks my fingers have been swollen and joints are achy
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Asthenia, Diarrhoea, Mobility decreased, Nausea
Clinical narrative: Nurse administered the vaccine at 0900 in patient's home. Nurse received call from wife around 1100 that patient was weak and could not move his fingers on the right side, had increased pain in right shoulder down to elbow, also had nausea/diarrhea. Provider and Hospice nurse also contacted. Tylenol was administered and heating pad applied and had some relief. Ice pack x10 minutes was also recommended. No swelling, redness or tenderness at injection site.
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Nurse administered the vaccine at 0900 in patient's home. Nurse received call from wife around 1100 that patient was weak and could not move his fingers on the right side, had increased pain in right shoulder down to elbow, also had nausea/diarrhea. Provider and Hospice nurse also contacted. Tylenol was administered and heating pad applied and had some relief. Ice pack x10 minutes was also recommended. No swelling, redness or tenderness at injection site.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This patient was vaccinated at a mass preschool flu clinic on 12/19/2023 at approximately 11:00am. Consent form signed by parent, but parent was not present as prearranged by the preschool. During data entry of the flu vaccine into the Immunization Information System that afternoon, it was noted that the child had been vaccinated with the flu vaccine on 12/18/2023, at her pediatrician's office. The child's pediatrician was called on 12/19/2023, approximately 4pm and it was confirmed that the information of the child receiving the flu vaccine at their facility on 12/18/2023 was accurate. The child's mother, was than notified at approximately 4:30pm on 12/19/2023, by this organization that the child had received a flu vaccine at the mass preschool clinic. At this time there has been no adverse side effects reported by the pediatrician, parent, or preschool staff.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Lichen planopilaris
Clinical narrative: She got her vaccine, she has been getting Moderna vaccines since 2/27/21 and has had gradual hair loss, not knowing what it was from.  She has tried various vitamins and shampoos for hair loss with no affect.  She decided to go to the dermatologist and went there on 7/12/23.  He diagnosed her with Lichen Planopilaris frontal fibrosing alopecia, meaning that her hairline moved back.  She lost all the hair around her hairline and is 3/4" back and has no hair in the front like a receding hairline.  He started treating her with Doxycycline and chlorbetazol and gave intralesional cortisone injections of Kenalog which did not work.  On her next visit he kept her on Doxycycline and added hydroxychloroquine and did the steroid injections which did not help again.  She then erythema multiforme formed from the Hydroxychloroquine and it took 2-4 weeks to clear and got new skin after that, but felt like her body was burning and then had new skin.  She had some traveling to do, and then came back and saw her dermatologist in November and was put on  Avodart (dutasteride 0.5 mg).  She told them that they are squeamish as to her reaction and asked to be put on Methotrexate and they do not treat hair issues, but put her on Dutasteride for 4 months and if that does not work then they will put her on Accutane and hopefully they will get brave enough to be put on Methotrexate.  She is going to see a Trichologist who treats hair issues and they do treat people with different types of Shampoos but cannot prescribe medications.  They treat you to make your head look fuller but they do not treat the root of the problem which is treating the inflammation from the scalp.  The dermatologist in talking did tell her that he did see a lot of the issue now, but had only originally seen some off and on.  She has to be monitored closely monthly for her liver and kidneys due to the medication.    She did find an article where they are talking about alopecia in several women who have gotten the COVID vaccines.    She did not have any hair loss issues prior to the vaccine.  She does have pictures and a videos of the progression of her hair loss.  She has done some research and finding evidence on line of the issues with hair loss and that this has been reporting and putting the timeframes altogether and noticing that her hair was fine prior to the vaccines, and now she has profound hair loss.   She states that she will not get any  more COVID vaccines.  She feels that this information needs to be well publicized.   She is going to do probably the Novavax as it does not have the MRNA in it.   She is also using Ketoconazole shampoo as well.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Injection site pain, Mobility decreased
Clinical narrative: Shoulder pain & restricted movement. Pain at injection site.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site discomfort, Injection site pain, Muscular weakness, Myalgia
Clinical narrative: On 10/20/2023, patient began with sore deltoid muscle area. As days went by, patient still was experiencing pain and discomfort in the area. Denies tingling, but experiences occasional numbness in left arm. To this day, patient experiences intermittent pain and has weakness of left arm. He has been in contact with his primary care provider who advised him this may be a vaccine adverse reaction.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: On 10/20/2023, patient began with sore deltoid muscle area. As days went by, patient still was experiencing pain and discomfort in the area. Denies tingling, but experiences occasional numbness in left arm. To this day, patient experiences intermittent pain and has weakness of left arm. He has been in contact with his primary care provider who advised him this may be a vaccine adverse reaction.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Injection site pain
Clinical narrative: chills, soreness at injection site
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: Resident died.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Joint lock
Clinical narrative: Pt reports no previous adverse reaction to covid vaccinations. Pt reports that the day after her vaccination, she felt joint pain and as if her joints "Locked up." Reports this is improving slowly.  This reaction was to the current 2023-2024 vaccine she received at the pharmacy
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling, Skin burning sensation
Clinical narrative: She got her vaccine, and was OK, and then at 4:00 AM her arm started to hurt and her hand swelled.  Then the rest of her body just hurt.   This continued and then within a couple of days her face got red, and the days went on it got redder and redder and felt that her face was on fire, swollen.  Now her skin is just peeling, and it's just awful.  She mentioned her reaction during her husbands doctor visit and he dismissed it and that some people have reactions to it.  She saw a dermatologist yesterday, and he is prescribing a cream for her face.   Her new prescription will be ready tomorrow.    She did not have any skin issues prior to her vaccine, but is photosensitive and has had problems in the past with antibiotics and cannot be out in the sun when she takes those.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation, Swelling face
Clinical narrative: She got her vaccine, and was OK, and then at 4:00 AM her arm started to hurt and her hand swelled.  Then the rest of her body just hurt.   This continued and then within a couple of days her face got red, and the days went on it got redder and redder and felt that her face was on fire, swollen.  Now her skin is just peeling, and it's just awful.  She mentioned her reaction during her husbands doctor visit and he dismissed it and that some people have reactions to it.  She saw a dermatologist yesterday, and he is prescribing a cream for her face.   Her new prescription will be ready tomorrow.    She did not have any skin issues prior to her vaccine, but is photosensitive and has had problems in the past with antibiotics and cannot be out in the sun when she takes those.
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED AN EXPIRED DOSE OF THE ABOVE VACCINE.
Age: 1.0
Sex: M
Vaccine: FLUA4, HIBV, HPV9
Symptoms: Wrong product administered
Clinical narrative: DR ORDERED PCV 15 BUT HPV WAS ADMINTERED ON ACCIDENT.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT WAS GIVEN AN EXPIRED DOSE OF THE ABOVE VACCINE.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: no adverse events known
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Pfizer MDV was not diluted
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Neuralgia, Pain
Clinical narrative: patient had shooting nerve pain in face and side the vaccine was given on
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Headache, Injection site induration, Injection site swelling, Local reaction
Clinical narrative: hard and swelling of area of injection site, headache, chills, severe local reaction
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: No adverse effects occurred.  Pt was given Pfizer Covid-19 vaccine , 2023-2024 formula and when diluting vial the amount used was incorrect. Provider on site was notified and per provider since pt has previously received 2 doses, it was not necessary to repeat a dose. Parent was notified of situation, no concerns expressed from parent.
Age: 29.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: 29-year-old patient came into clinic to receive Abrysvo (RSV vaccine) as ordered but was accidentally given Arexvy (RSV vaccine) instead.  Patient is 35 weeks. EDD: January 20, 2024.  Mishaps has been reported to all involved parties. Patient has been informed of error.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC15, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: ProQuad given in addition to Varicella vaccine. No problems noted after administration of vaccines.
Age: 62.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Cerebrovascular accident, Vertebrobasilar artery dissection
Clinical narrative: vertebral artery dissection and stroke the following day. Hospitalization for the same.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Device connection issue, Exposure via skin contact
Clinical narrative: Needle was not fully tightened on syringe, the contents of the syringe spilled out onto his arm
Age: 15.0
Sex: M
Vaccine: HPV9, IPV, MNQ, VARCEL
Symptoms: Dizziness, Feeling hot, Feeling jittery, Pallor, Syncope
Clinical narrative: After vaccines were given, patient was sitting upright on exam table, patient got dizzy, lightheaded, and hot and started leaning backwards, patient laid down on exam table(fainted). Patient's skin was pale. Parent states child had not eaten anything today and has fainted before in the past but not when vaccines were given. Jitteriness in hands noted. Patient given juice and a snack. BP- 110/62, O2-99. Color began to return and patient stated he felt better after a few minutes. Patient sat up-right, dangled feet, and stood up without any problems. Patient remained in clinic x 30 minutes. Patient denies any problems, ambulated without any assistance. Educated parent on taking patient to ER/Pediatrician to be evaluated since he has fainted before as well for further testing/bloodwork.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: No adverse event, Wrong patient received product
Clinical narrative: Patient was due for second dose of HPV vaccine, in the same room was the brother of patient who was also due for HPV and two other vaccines including Tdap and Men ACWY. medical assistant administered the vaccines intended for the brother of the patient. Patient was monitored after administration of vaccines; no adverse reaction was observed during monitoring patient. mom at bedside was given ER precautions and monitor for any anaphylactic reactions.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Patient states that she began feeling unwell and running fever the evening of the vaccine and is continuing to feel badly. She has redness, swelling and pain at the site
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness
Clinical narrative: LE weakness and mild UE hand weakness, suspected Guillain Barre Syndrome. Patient treated with 5 days of IVIG (Privigen)
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Rash
Clinical narrative: Rash on both forearms, slightly less on both lower legs.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Immediate post-injection reaction, Inflammation, Pain, Pain in extremity
Clinical narrative: On 10.5.2023, Pt mother called doctor office to report that patient had soreness and pain since the vaccine. no redness, warmth or swelling but had significant pain in shoulder. Took ibuprofen and seen in office on 10.6.2023.  Pt reported immediate pain at time of injection, could not move arm without pain, throbbing, pain spread to right back, down arm to above elbow. difficulty lifting and bending arm without significant pain. difficulty sleeping.  Dx with SIRVA (shoulder injury related to vaccine adminstration).  Prescribed methylprednisolone pack x6 days. cyclobenzaprine 5mg 3 times day for muscle pain. ibuprofen around the clock. Referal to ortho doctor.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Shoulder injury related to vaccine administration, Ultrasound scan abnormal, X-ray limb
Clinical narrative: On 10.5.2023, Pt mother called doctor office to report that patient had soreness and pain since the vaccine. no redness, warmth or swelling but had significant pain in shoulder. Took ibuprofen and seen in office on 10.6.2023.  Pt reported immediate pain at time of injection, could not move arm without pain, throbbing, pain spread to right back, down arm to above elbow. difficulty lifting and bending arm without significant pain. difficulty sleeping.  Dx with SIRVA (shoulder injury related to vaccine adminstration).  Prescribed methylprednisolone pack x6 days. cyclobenzaprine 5mg 3 times day for muscle pain. ibuprofen around the clock. Referal to ortho doctor.
Age: 1.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Physician ordered and inadvertent vaccine for patient. Physician ordered a quadracel and was given by medical assistant. 18 month old given an inadvertent vaccine (Quadracel), per -nurse states no side effects for patient. No adverse effect reported by patient.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient was too young to receive the high-dose flu vaccine.  There were no adverse events.  This was a medical error.
Age: 67.0
Sex: F
Vaccine: FLU4, RSV, VARZOS
Symptoms: Pain in extremity
Clinical narrative: patient experienced longer than normal pain in arm of injection, patient went to doctor to rule out infection.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received the Spikevax 12+ when the patient is 6 years old.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chills, Discomfort, Feeling cold, Gastrooesophageal reflux disease
Clinical narrative: 13 hours later (2 a.m.)  had extreme chills,  constant urinary pressure, worst joint pain and headache I have ever experienced, nausea, reflux.   Our bedroom is 64 degrees and I was wearing flannel nightgown and pants, heavy robe, hat, comforter, and three blankets.  I was still cold.  Chills and urinary pressure began subsiding 5 hours later, completely subsiding an hour after that.  I am at 47 hours and still have a bad headache, joint pain, and some nausea.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Nausea
Clinical narrative: 13 hours later (2 a.m.)  had extreme chills,  constant urinary pressure, worst joint pain and headache I have ever experienced, nausea, reflux.   Our bedroom is 64 degrees and I was wearing flannel nightgown and pants, heavy robe, hat, comforter, and three blankets.  I was still cold.  Chills and urinary pressure began subsiding 5 hours later, completely subsiding an hour after that.  I am at 47 hours and still have a bad headache, joint pain, and some nausea.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Already received a dose of Flu this year, should not have received this dose.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Spikevax 12+ and patient was 4 years old
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Biopsy skin abnormal, Exfoliative rash, Psoriasis, Rash, Rash pruritic
Clinical narrative: Both shoulders and then upper chest broke out in bumps I've never had before. They itched and then broke open, leaving behind itchy, crusty skin. The one on my chest continue to grow from pencil eraser size to and inch across. It continued to crust and scale. I went to see my dermotologist on Dec 13, 2023 after it didn't clear up. She suspected early psorasis and performed a biopsy which confirmed her visual dx.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Scab, Wound
Clinical narrative: Both shoulders and then upper chest broke out in bumps I've never had before. They itched and then broke open, leaving behind itchy, crusty skin. The one on my chest continue to grow from pencil eraser size to and inch across. It continued to crust and scale. I went to see my dermotologist on Dec 13, 2023 after it didn't clear up. She suspected early psorasis and performed a biopsy which confirmed her visual dx.
Age: 49.0
Sex: F
Vaccine: HEPA, TD
Symptoms: Arthropathy, Bone marrow oedema, Discomfort, Immediate post-injection reaction, Loss of personal independence in daily activities
Clinical narrative: Td given in left upper deltoid, Hep A given left lower deltoid.  "Uncomfortableness immediately after injection" Arm sore for the remainder of the day. Following day, the pain was "horrible." Difficulty lifting arm, unable to exercise d/t the discomfort, sleep issues,  MRI ordered and completed. Orthopedic consult pending
Age: 49.0
Sex: F
Vaccine: HEPA, TD
Symptoms: Magnetic resonance imaging abnormal, Mobility decreased, Pain, Sleep disorder, Tendon disorder
Clinical narrative: Td given in left upper deltoid, Hep A given left lower deltoid.  "Uncomfortableness immediately after injection" Arm sore for the remainder of the day. Following day, the pain was "horrible." Difficulty lifting arm, unable to exercise d/t the discomfort, sleep issues,  MRI ordered and completed. Orthopedic consult pending
Age: 49.0
Sex: F
Vaccine: HEPA, TD
Symptoms: Tendon rupture
Clinical narrative: Td given in left upper deltoid, Hep A given left lower deltoid.  "Uncomfortableness immediately after injection" Arm sore for the remainder of the day. Following day, the pain was "horrible." Difficulty lifting arm, unable to exercise d/t the discomfort, sleep issues,  MRI ordered and completed. Orthopedic consult pending
Age: 86.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea, Dizziness, Gait disturbance, Myalgia
Clinical narrative: very lightheaded, muscle pains, difficulty walking, loose bowels
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Medication was given at wrong time.  Patient was not due for vaccine. Vaccine was given 3months early.   There were no adverse reactions. Informed patient he would still need to retake the 3rd vaccine in 3months. He was seen by provider in the office and outcome was good.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinitis
Clinical narrative: Symptoms:Rhinitis
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Bursitis, Injected limb mobility decreased, Loss of personal independence in daily activities, Musculoskeletal stiffness
Clinical narrative: On 10.31.23, Pt returned to dr office for routine follow up. At that time she stated left shoulder pain since flu shot. trouble elevating shoulder and rotating internally. Dx shoulder bursisits since flu shot. ortho referral for cortisone injection. can not take NSAID's due to kidney disease.  On 11.01.23, seen for left shoulder pain, limited range of motion, stiffness after flu shot. Pain reaching overhead, interfers with ADL, no hx of similar problem before flu shot. hx of right rotator cuff tear with repair. Exam documented, Xrays show mildly high riding humerus, mild degenerative changes of AC joint. positive impingement test and restrictions overhead. Inject rosuvastatin.   Injection may have pecked the bone or entered the subacromials space, bursa.  Cortisone injection givenin subacromial space. Physical therapy ordered, tylenol 3 times day, ice/heat, elevation prn. 12.12.2023, ortho visit for left shoulder aching, sharp pain with limited ROM. Pain did not improve with cortisone injection and PT, only temporary relief.  MRI ordered to rule out supraspinatus tear. MRI scheduled for 12/21/23.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Rotator cuff syndrome, X-ray limb abnormal
Clinical narrative: On 10.31.23, Pt returned to dr office for routine follow up. At that time she stated left shoulder pain since flu shot. trouble elevating shoulder and rotating internally. Dx shoulder bursisits since flu shot. ortho referral for cortisone injection. can not take NSAID's due to kidney disease.  On 11.01.23, seen for left shoulder pain, limited range of motion, stiffness after flu shot. Pain reaching overhead, interfers with ADL, no hx of similar problem before flu shot. hx of right rotator cuff tear with repair. Exam documented, Xrays show mildly high riding humerus, mild degenerative changes of AC joint. positive impingement test and restrictions overhead. Inject rosuvastatin.   Injection may have pecked the bone or entered the subacromials space, bursa.  Cortisone injection givenin subacromial space. Physical therapy ordered, tylenol 3 times day, ice/heat, elevation prn. 12.12.2023, ortho visit for left shoulder aching, sharp pain with limited ROM. Pain did not improve with cortisone injection and PT, only temporary relief.  MRI ordered to rule out supraspinatus tear. MRI scheduled for 12/21/23.