chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of an expired dose of acthib with no reported adverse event; Initial information received on 01-Apr-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 2 months old male patient who was administered expired dose of HIB (PRP/T) Vaccine [ACT-HIB] 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 Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Daptacel) Polio Vaccine (Polio), Rotavirus Vaccine Live Oral 1V (Rotarix) and Pneumococcal Vaccine CONJ 7V (CRM197) (Prevnar) all for Prophylactic vaccination.  On 27-Mar-2024, the patient received 0.5 ml (dose 1)of expired suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) with no reported adverse event (expired product administered) (Latency: same day) (lot UJ834AA) (expiry:23-Feb-2024) (Frequency: once) (Strength: standard)  via intramuscular in left vastus lateralis for Immunization.   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: 18.0
Sex: M
Vaccine: MMR
Symptoms: Angiogram normal, Haematochezia, Haematocrit decreased, Haemoglobin decreased, Intensive care
Clinical narrative: Presented to ED on 4/2/2024 after having frank red blood stool.  No active bleed/obstruction seen on CT angio. Upper GI study pending.  CBC on presentation (4/2/2024): WBC 10.8, RBC 2.86, Hgb 7.9, Hct 24.2, plt 237. Required PRBC transfusion.  Infectious stool studies negative. No hemodynamic instability. Admitted to Pediatric ICU for hemodynamic monitoring. At the time of this report, patient is still admitted to the Pediatric ICU (hospital day 2) and will likely be transferred to his home GI center. Hematochezia has since resolved. He is able to PO clear liquids at this time.
Age: 18.0
Sex: M
Vaccine: MMR
Symptoms: Platelet count normal, Red blood cell count decreased, Red blood cell transfusion, Stool analysis normal, White blood cell count increased
Clinical narrative: Presented to ED on 4/2/2024 after having frank red blood stool.  No active bleed/obstruction seen on CT angio. Upper GI study pending.  CBC on presentation (4/2/2024): WBC 10.8, RBC 2.86, Hgb 7.9, Hct 24.2, plt 237. Required PRBC transfusion.  Infectious stool studies negative. No hemodynamic instability. Admitted to Pediatric ICU for hemodynamic monitoring. At the time of this report, patient is still admitted to the Pediatric ICU (hospital day 2) and will likely be transferred to his home GI center. Hematochezia has since resolved. He is able to PO clear liquids at this time.
Age: 94.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: The patient reported to the pharmacy with a large red area on the vaccinated arm, slightly larger than a silver dollar, with further spread above and below the area.  The patient was asked if the area was swollen, warm or tender to the touch.  The patient reported it had been swollen, but the swelling had resolved.  She denied warmth or tenderness on the area.  Her main complaint was the redness and some itching.  The patient stated she used "itching cream" on the area, which helped decrease the itching.
Age: 76.0
Sex: M
Vaccine: TDAP
Symptoms: Amnesia, Confusional state, Dementia, Fall
Clinical narrative: Patient experiences worsening of dementia symptoms including extreme confusion, falling, memory loss.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Doctor ordered the vaccine and medical assistant administered following doctors orders. Same vaccine was administered a month before. This vaccine is every 10 years.
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: Pt only reports having a sore arm. also received spikevax with the RSV vaccine.  Pt previously received a dose of Arexvy on 3/8/24 and was given an extra dose on 4/1/24 even though the vaccine is only approved for 1 dose
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Condition aggravated, Disability, Skin disorder
Clinical narrative: Patient states that 1-2 days after her vaccination she had "disabling" full body pain that aggravated her existing arthritis. She also developed sores on her face, chest, and shoulder that have since resolved.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient came in for a Wellness.  He was supposed to get HPV, FLU, MCV4 and Tdap vaccines.  The medical assistant grabbed HPV, FLU, MCV4, Tdap and DTAP.  She realized she had grabbed 5 vaccines instead of 4.  She grabbed one of the vaccines and put away.  She continued to prepare the vaccines and administer them to the patient.  When she was doing her paper work, she realized she had put away the wrong vaccine and had administered the wrong vaccine.  She had put away the FLU and instead of the  DTAP.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aortic dissection, Cardiac operation, Heart valve replacement
Clinical narrative: Aortic dissection, open heart surgery,  valve graft
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Sleep disorder
Clinical narrative: Patient states that it has been a month and a half since her vaccination and is still experiencing pain in the injection site. She states that it appears to be slightly swollen and she primarily experiences the discomfort/pain at night when she is trying to sleep. She states she does not have any limited motion and denies any redness or fever. Patient is following up with her primary provider to assess.
Age: 59.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt was administered Arexvy vaccine at the age of 59 yo.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac ablation, Supraventricular tachycardia
Clinical narrative: Supraventricular tachycardia with afib
Sex: M
Vaccine: HPV9
Symptoms: Off label use
Clinical narrative: off label use; This literature marketed report was received from the authors in a published literature article titled as stated below a male patient of unspecified age. Information regarding the patient's concomitant medications was not provided. The patient was heavy a tobacco smoker and drinker.  On unknown dates, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) as treatment for Recurrent respiratory papillomatosis (RRP) (Off label use) (strength, route of administration, lot # and expiration date were not reported).   Lot # is being requested and will be submitted if received.  This is one of two reports from the same literature article.   A copy of the published article is attached as further documentation of the patient's experience.   Literature Report: Sender's Comments:  US-009507513-2404USA001713:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC; HCP called to report inadvertent administration of VARIVAX on 29MAR2024 after a temperature excursion.; This spontaneous report was received from a Licensed Practical Nurse (L.P.N) and referred to a patient of unspecified age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 29-MAR-2024, the patient was vaccinated inadvertently with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (strength, dose quantity, dose number, vaccination scheme frequency, route of administration, and anatomical location of application were not reported; lot number X023717 that was verified to be valid with an expiration date reported and established as 26-SEP-2025) for prophylaxis. The administered vaccine suffered a temperature excursion of 70 degrees Fahrenheit (F) during a time frame reported as 16 hours, with no previous temperature excursion (product storage error).  No additional adverse event (AE) or product quality complain (PQC) were reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC.; HCP called to report inadvertent administration of expired PROQUAD to a patient. Product expired on 06MAR2024 and was administered to a patient on 01APR2024. No additional AE/PQC.; This spontaneous report was received from medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapy and drug reactions or allergies were provided.  On 01-APR-2024, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot number: W0285610 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date on 06-MAR-2024 (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis.  No adverse event reported.
Sex: M
Vaccine: COVID19
Symptoms: Renal transplant
Clinical narrative: A kidney transplant; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jun2023 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: RENAL TRANSPLANT (medically significant) with onset Aug2023, outcome "unknown", described as "A kidney transplant". Clinical course:Caller was calling about the Pfizer COVID vaccine, caller said caller's last COVID vaccine was in Jun2023, and caller mentioned caller had a kidney transplant after that in August. Upon transfer caller confirmed details provided by transfer agent. Confirmed kidney transplant was in Aug2023. He stated he did just fine, he was just concerned about taking the booster.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: Vaccine was giving without reconstitution. She will come back to the pharmacy and get another dose.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: bilateral tinnitus; This is a spontaneous report received from a Nurse from medical information team, Program ID.  A female patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1), administration date: 30Jan2021, for COVID-19 immunisation. The following information was reported: TINNITUS (non-serious) with onset 21Sep2021, outcome "unknown", described as "bilateral tinnitus". Additional information: Reporter was trying to complete an adverse reaction report, but she could not finish report because her last Covid vaccine was in 2021. On 21Sep2021, she developed bilateral tinnitus. She asked for the side effects of vaccine but did not receive the list of side effects.   Batch/lot number is not provided, and it cannot be obtained.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Computerised tomogram normal, Dyspnoea, Feeling abnormal, Injection site pain
Clinical narrative: After recieving the shingrix vaccine, the next day patient was in a lot of pain and when she would get shortness of breath. Patient was in lots of pain and saw her pulmonologist on 9/18/23.  He ordered methocarbamol (muscle relaxant).  Patient states she did not get any relief from the muscle relaxant. Patient had pain throughout her entire body. States she could barely stand up straight, took her about 30 minutes to straighten up.  Patient states her pain has gotten better, but still has pain in her arms and shoulders still.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Magnetic resonance imaging normal, Mobility decreased, Myalgia, Pain, Stomach scan normal
Clinical narrative: After recieving the shingrix vaccine, the next day patient was in a lot of pain and when she would get shortness of breath. Patient was in lots of pain and saw her pulmonologist on 9/18/23.  He ordered methocarbamol (muscle relaxant).  Patient states she did not get any relief from the muscle relaxant. Patient had pain throughout her entire body. States she could barely stand up straight, took her about 30 minutes to straighten up.  Patient states her pain has gotten better, but still has pain in her arms and shoulders still.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Wrong technique in product usage process, X-ray normal
Clinical narrative: After recieving the shingrix vaccine, the next day patient was in a lot of pain and when she would get shortness of breath. Patient was in lots of pain and saw her pulmonologist on 9/18/23.  He ordered methocarbamol (muscle relaxant).  Patient states she did not get any relief from the muscle relaxant. Patient had pain throughout her entire body. States she could barely stand up straight, took her about 30 minutes to straighten up.  Patient states her pain has gotten better, but still has pain in her arms and shoulders still.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Computed tomographic gastrography, Computerised tomogram kidney normal, Computerised tomogram liver, Computerised tomogram normal
Clinical narrative: After recieving the shingrix vaccine, the next day patient was in a lot of pain and when she would get shortness of breath. Patient was in lots of pain and saw her pulmonologist on 9/18/23.  He ordered methocarbamol (muscle relaxant).  Patient states she did not get any relief from the muscle relaxant. Patient had pain throughout her entire body. States she could barely stand up straight, took her about 30 minutes to straighten up.  Patient states her pain has gotten better, but still has pain in her arms and shoulders still.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Dysstasia, Laboratory test, Magnetic resonance imaging hepatobiliary, Magnetic resonance imaging normal
Clinical narrative: After recieving the shingrix vaccine, the next day patient was in a lot of pain and when she would get shortness of breath. Patient was in lots of pain and saw her pulmonologist on 9/18/23.  He ordered methocarbamol (muscle relaxant).  Patient states she did not get any relief from the muscle relaxant. Patient had pain throughout her entire body. States she could barely stand up straight, took her about 30 minutes to straighten up.  Patient states her pain has gotten better, but still has pain in her arms and shoulders still.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Magnetic resonance imaging renal, Pain, Pain in extremity
Clinical narrative: After recieving the shingrix vaccine, the next day patient was in a lot of pain and when she would get shortness of breath. Patient was in lots of pain and saw her pulmonologist on 9/18/23.  He ordered methocarbamol (muscle relaxant).  Patient states she did not get any relief from the muscle relaxant. Patient had pain throughout her entire body. States she could barely stand up straight, took her about 30 minutes to straighten up.  Patient states her pain has gotten better, but still has pain in her arms and shoulders still.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported.; Nurse calling to report MMRII vaccine was inadvertently administered after expiration. Product did not undergo any temperature excursions and was supported per Post Expiry Memo. Permission to contact was granted. No additional information provided. N; This spontaneous report was received from a nurse regarding a patient of unspecified age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not reported.   On 26-FEB-2024, the patient was inadvertently vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) as prophylaxis (lot number W017556 and expiration date 07-JAN-2024 have been both confirmed as valid) (no more vaccination details were reported). It was stated that the product did not undergo any temperature excursions and was supported per Post Expiry Memo. No additional adverse event (AE) or product quality complaint (PQC) were reported.
Age: 11.0
Sex: F
Vaccine: COVID19, MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was 11 years 9 months at time of vaccine, and was incorrectly given the 12+ years COVID-19 vaccine. No adverse reactions.
Sex: U
Vaccine: RSV
Symptoms: Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Tenderness at the injection site; Terrible headache the day after; muscle achiness; tiredness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site tenderness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site tenderness (Verbatim: Tenderness at the injection site), headache (Verbatim: Terrible headache the day after), muscle pain (Verbatim: muscle achiness) and tiredness (Verbatim: tiredness). The outcome of the injection site tenderness, headache, muscle pain and tiredness were not reported.   It was unknown if the reporter considered the injection site tenderness, headache, muscle pain and tiredness to be related to Arexvy.     It was unknown if the company considered the injection site tenderness, headache, muscle pain and tiredness to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 This case was reported via interactive digital media.
Sex: U
Vaccine: MENB, MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Bexsero - Inappropriate age; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 84-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   Concurrent medical conditions included asplenia.   On an unknown date, the patient received the 2nd dose of Bexsero and the 1st dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero and Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Bexsero - Inappropriate age). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-MAR-2024 The pharmacist reported that the patient with Asplenia completed the two doses of Bexsero vaccine last year (2023). The patient was interested in getting a booster dose this year. The pharmacist asked the recommendation on this situation. The patient received the 2 doses of Bexsero vaccine in unapproved age which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: I got transverse mitis off your vaccine Moderna; This spontaneous case was reported by a patient and describes the occurrence of MYELITIS TRANSVERSE (I got transverse mitis off your vaccine Moderna) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYELITIS TRANSVERSE (I got transverse mitis off your vaccine Moderna) (seriousness criterion medically significant). At the time of the report, MYELITIS TRANSVERSE (I got transverse mitis off your vaccine Moderna) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No Concomitant medications provided by the reporter.  No treatment medications provided by the reporter.  Company Comment: This is a spontaneous case concerning a patient of an unknown age and gender, with no reported medical history, who experienced the serious (due to medically significant) unexpected, AESI event of MYELITIS TRANSVERSE, which occurred on an unknown date and with unknown latency after a dose of SPIKEVAX NOS (SPIKEVAX NOS) vaccine. No further information was disclosed. The benefit-risk relationship of SPIKEVAX NOS (SPIKEVAX NOS) vaccine is not affected by this report.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Red and warm to touch
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Nausea, Vomiting
Clinical narrative: Nauseous, could not stand up, vomited and could not eat or drink without vomiting for 3 days. Dizziness the entire time, continued for 3 weeks. After 2nd dose of Pfizer COVID-19 Vaccine.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Tinnitus
Clinical narrative: ear infection and subsequent tinnitus ever since
Age: 37.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Expired product administered
Clinical narrative: An expired insured MMR vaccine was inadvertently administered to a patient.  The CMA retrieved it from a box with other vials set to expire on April 6. However, this particular vial had expired on December 16, 2023, as it had been mistakenly placed in the wrong box.
Age: 37.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: An expired insured MMR vaccine was inadvertently administered to a patient.  The CMA retrieved it from a box with other vials set to expire on April 6. However, this particular vial had expired on December 16, 2023, as it had been mistakenly placed in the wrong box.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: NONE
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: pt received three shingrix shots instead of the recommended two
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling, Pruritus
Clinical narrative: Nerve tingling in arm ,across right chest, and right side of face. No rash or hives, only sore itchy swollen arm. Nerve tingling began almost immediately after leaving store and still have 2 days later.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Expired MMR Vaccine Administered
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Periarthritis, Tendon calcification, X-ray limb
Clinical narrative: Severe shoulder pain within hours after injection. Prescribed baclofen and meloxicam. Did not relieve symptoms. Shoulder pain, frozen shoulder, restricted movement. Xray taken 6 months after injection shows chronic calcification of the superspinatus tendon in left shoulder. Seeing orthopedic md on 4/17/24 for additional treatment options. MRI scheduled for 4/6/24
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: latest shot given 4/4/24, patient did not have card and didn't know previous date. went to enter into system and found out last shot was 2/12/24 less than 2 months ago.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pro Quad was expired. patient will need revaccination. Patient was properly notified of expired med and will reschedule at a later date to get that valid dose re-vacciinated. No adverse reaction that the patient's mother was aware of.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Mydriasis, Pallor, Vision blurred
Clinical narrative: Gave patient injection, after disposing of gloves and syringe patient became dizzy and blurred vision, patient because pale with white lips and pupils were completely dilated, was sitting with mother, got another nurse and helped patient to table to lay down, given water and a nutrigrain bar. Checked on patient after 5-10 mins, doing well.
Age: 19.0
Sex: F
Vaccine: MENB, MMR, TYP, YF
Symptoms: Expired product administered
Clinical narrative: Bexsero (Men B) vaccine was administered to Pt R. Delt by IM route. Expiration date of vaccine was 03/31/2024, Vx administration was 04/04/2024.
Age: 4.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Injection site erythema
Clinical narrative: MMRV given at 10:31 AM on left thigh.  While checking out at front desk, mom noticed redness to left thigh at injection site.   Was brought back to room at 10:48 AM, vitals HR = 98, R = 24, O2sat = 97%.  Ice applied to MMRV injection site and benadryl PO were given.  No anaphylaxis, no trouble breathing, no hives.  Per MA, site of redness was the MMRV injection site.  Patient observed for 35 minutes prior to leaving clinic by provider, APRN and clinic RN. Vitals at 11:10 AM - HR = 104, R = 24, O2sat = 98%.  Stable and sent home after monitoring.
Age: 2.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: AThe child was inadvertently administered the entire vial of the vaccine instead of the 0.25 ml dose. No adverse effects noted.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Gait disturbance, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Severe swelling of leg. Hot to the touch. Red. Pain. Limping when walking.  Antibiotics started on 04/04/2024.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Upon vaccination around 9:30am 4/5/2024, the patient stood up so the next family member could be vaccinated, she responded well to the vaccine initially. After vaccinating the next patient roughly five minutes later, Piper fainted and was on the floor.  We sat her up right into a chair as she regained consciousness, we got her a bottle of water, and an ice pack for the back of her head where a bump began to form. The patient was taken care of by her father & sister who walked her out to her car. We asked several questions asking how she felt, other than pain in her head she said she felt fine. Her father said there was no history of fainting but believed it was just not taking vaccinations well.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient is experiencing redness, swelling, itching, and site is hot to the touch.
Age: 92.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute kidney injury, Acute myocardial infarction, Arthralgia, COVID-19, Chest X-ray abnormal
Clinical narrative: Admit date: 3/28/2024  Discharge date: 4/4/2024  Admitting Physician: DO   Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD,   Reason for Admission: Weakness  Brief Summary of Hospital Stay: Patient is a 93 year old female who presented to ED with weakness. She has history of CP and has chronic left sided weakness but given the generalized weakness with her underlying disability was unable to care for herself and walk. Was seen at an outside ED and was provided tizanidine for symptoms. She was discharged home and symptoms worsened thus she came in. She admitted to a sore throat and some congestion and was found to be positive for COVID. She experienced a sudden episode of hypoxia and chest x ray revealed findings consistent with viral pna. She was started on a 5 day course of Remdesivir and steroids.   She was found to have an acute kidney injury which resolved with IVF. She was found to have elevated troponin which was considered to be a type II NSTEMI related to COVID, the cardiology team was consulted and she was started aspirin therapy. She experienced two episodes of a fib with RVR which was controlled by increasing her beta blocker and giving IV digoxin. She completed her course of remdesivir and steroid therapy and her clinical condition improved. She noted some left sided hip pain, and an xray revealed a slight abnormality in the left femoral head which was evaluated with a CT which was inconclusive. She was discharged in stable condition on 4/4/2024. Discharged to Home.
Age: 92.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram normal, Hypoxia, Oropharyngeal pain, Pneumonia viral, Respiratory tract congestion
Clinical narrative: Admit date: 3/28/2024  Discharge date: 4/4/2024  Admitting Physician: DO   Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD,   Reason for Admission: Weakness  Brief Summary of Hospital Stay: Patient is a 93 year old female who presented to ED with weakness. She has history of CP and has chronic left sided weakness but given the generalized weakness with her underlying disability was unable to care for herself and walk. Was seen at an outside ED and was provided tizanidine for symptoms. She was discharged home and symptoms worsened thus she came in. She admitted to a sore throat and some congestion and was found to be positive for COVID. She experienced a sudden episode of hypoxia and chest x ray revealed findings consistent with viral pna. She was started on a 5 day course of Remdesivir and steroids.   She was found to have an acute kidney injury which resolved with IVF. She was found to have elevated troponin which was considered to be a type II NSTEMI related to COVID, the cardiology team was consulted and she was started aspirin therapy. She experienced two episodes of a fib with RVR which was controlled by increasing her beta blocker and giving IV digoxin. She completed her course of remdesivir and steroid therapy and her clinical condition improved. She noted some left sided hip pain, and an xray revealed a slight abnormality in the left femoral head which was evaluated with a CT which was inconclusive. She was discharged in stable condition on 4/4/2024. Discharged to Home.
Age: 92.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Troponin increased, X-ray of pelvis and hip abnormal
Clinical narrative: Admit date: 3/28/2024  Discharge date: 4/4/2024  Admitting Physician: DO   Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD,   Reason for Admission: Weakness  Brief Summary of Hospital Stay: Patient is a 93 year old female who presented to ED with weakness. She has history of CP and has chronic left sided weakness but given the generalized weakness with her underlying disability was unable to care for herself and walk. Was seen at an outside ED and was provided tizanidine for symptoms. She was discharged home and symptoms worsened thus she came in. She admitted to a sore throat and some congestion and was found to be positive for COVID. She experienced a sudden episode of hypoxia and chest x ray revealed findings consistent with viral pna. She was started on a 5 day course of Remdesivir and steroids.   She was found to have an acute kidney injury which resolved with IVF. She was found to have elevated troponin which was considered to be a type II NSTEMI related to COVID, the cardiology team was consulted and she was started aspirin therapy. She experienced two episodes of a fib with RVR which was controlled by increasing her beta blocker and giving IV digoxin. She completed her course of remdesivir and steroid therapy and her clinical condition improved. She noted some left sided hip pain, and an xray revealed a slight abnormality in the left femoral head which was evaluated with a CT which was inconclusive. She was discharged in stable condition on 4/4/2024. Discharged to Home.
Age: 12.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 11 years old dose given to a 12 years old patient. Called parents and they declined to get the additional dose needed.
Age: 58.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Wrong vaccination given; should not have been given at all
Age: 21.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Abdominal pain lower, Diarrhoea, Dizziness, Loss of consciousness, Mydriasis
Clinical narrative: Administration of 3 vaccines Hep A, Hep B, and Tdap. During explanation of VIS sheets patient states " I'm feeling dizzy" had patient sit in chair. Patient's eyes became dilated and patient passed out for 30 sec. Patient became responsive and after about 30 seconds after patient had a seizure  for about 5 seconds, loss of bladder control, and slid off chair ( did not hit her head ). I called provider in room once patient was safely back in chair to request water and something to eat. Patient relays last time she had anything to eat was 6 pm 4/2/2024 and it was not much as she went to bed still a bit hungry. Patient states she had half of a coffee prior to appt. Patient then had a 2 second seizure 8 min after the first. Patient expressed pain in lower abdomin. Asked if she can go to the bathroom. Provider and myself assisted patient to the bathroom. For patient's safety I did stay in the bathroom with patient, patient agreed to this. Patient did has loose stools, was still complaining of abdominal pain 8 out of 10. Patient's father was called for transportation to the ER via car.   4/3/2024 (2 hours) Emergency Medical Decision Making Patient with no medical history presents for episode of loss of consciousness with shaking and loss of bladder.  Differential diagnosis includes not limited to acute allergic reaction, acute syncope due to injections, seizure or intracranial pathology such as tumor mass.   Patient will have labs, EKG and CT imaging.  I discussed workup at the bedside with the patient including the parents at the bedside.  Did use shared decision model, while possibly related to shots and simple syncope, it is noted the patient had tonic-clonic shaking as well as loss of bladder.  Due to this will plan for CT imaging of the brain as patient has never had this before to rule out intracranial abnormality.  Patient is overall well-appearing alert, able tolerate oral intake here in the emergency department.   After on-call neurology conversation, we will plan for outpatient follow-up given this atypical presentation of syncope and/or seizure.  I have lower suspicion for seizure given the description and patient's history, however I would appreciate outpatient neurology follow-up in interim as well as primary care follow-up.
Age: 21.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Seizure, Tremor, Urinary incontinence
Clinical narrative: Administration of 3 vaccines Hep A, Hep B, and Tdap. During explanation of VIS sheets patient states " I'm feeling dizzy" had patient sit in chair. Patient's eyes became dilated and patient passed out for 30 sec. Patient became responsive and after about 30 seconds after patient had a seizure  for about 5 seconds, loss of bladder control, and slid off chair ( did not hit her head ). I called provider in room once patient was safely back in chair to request water and something to eat. Patient relays last time she had anything to eat was 6 pm 4/2/2024 and it was not much as she went to bed still a bit hungry. Patient states she had half of a coffee prior to appt. Patient then had a 2 second seizure 8 min after the first. Patient expressed pain in lower abdomin. Asked if she can go to the bathroom. Provider and myself assisted patient to the bathroom. For patient's safety I did stay in the bathroom with patient, patient agreed to this. Patient did has loose stools, was still complaining of abdominal pain 8 out of 10. Patient's father was called for transportation to the ER via car.   4/3/2024 (2 hours) Emergency Medical Decision Making Patient with no medical history presents for episode of loss of consciousness with shaking and loss of bladder.  Differential diagnosis includes not limited to acute allergic reaction, acute syncope due to injections, seizure or intracranial pathology such as tumor mass.   Patient will have labs, EKG and CT imaging.  I discussed workup at the bedside with the patient including the parents at the bedside.  Did use shared decision model, while possibly related to shots and simple syncope, it is noted the patient had tonic-clonic shaking as well as loss of bladder.  Due to this will plan for CT imaging of the brain as patient has never had this before to rule out intracranial abnormality.  Patient is overall well-appearing alert, able tolerate oral intake here in the emergency department.   After on-call neurology conversation, we will plan for outpatient follow-up given this atypical presentation of syncope and/or seizure.  I have lower suspicion for seizure given the description and patient's history, however I would appreciate outpatient neurology follow-up in interim as well as primary care follow-up.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Gingival pain, Inflammation, Oral herpes, Pyrexia
Clinical narrative: Fever blisters on lower lip Irritation/inflammation of palate Sore gums; painful flossing and brushing Persistent low-grade fever
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Urticaria
Clinical narrative: Mild urticarial rash, which started within one hour of vaccination, resolved with diphenhydramine.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Ankle fracture, Asthenia, Central venous catheterisation, Chest X-ray abnormal
Clinical narrative: immediate diarrhea, 90x days on end, hospitalized with diverticulitis, turned sepsis - 2 holes in my colon for 4 months. Went home with IV treatment and a pic line for 6 weeks. Eventually had two blood transfusions, sigmoid colon removed; still having chronic diarrhea or constipation, immediately after eating. Stomach swelling, dizziness, shortness of breath, swollen ankles, chest xrays with sinus tachycardia, currently added verbizi and omepeazole; cannot go shopping or working due to immediate urgency to go to the bathroom or stomach pains,
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Colectomy, Colitis, Computerised tomogram, Constipation, Crohn's disease
Clinical narrative: immediate diarrhea, 90x days on end, hospitalized with diverticulitis, turned sepsis - 2 holes in my colon for 4 months. Went home with IV treatment and a pic line for 6 weeks. Eventually had two blood transfusions, sigmoid colon removed; still having chronic diarrhea or constipation, immediately after eating. Stomach swelling, dizziness, shortness of breath, swollen ankles, chest xrays with sinus tachycardia, currently added verbizi and omepeazole; cannot go shopping or working due to immediate urgency to go to the bathroom or stomach pains,
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Defaecation urgency, Diarrhoea, Diverticulitis, Dizziness, Dyspnoea
Clinical narrative: immediate diarrhea, 90x days on end, hospitalized with diverticulitis, turned sepsis - 2 holes in my colon for 4 months. Went home with IV treatment and a pic line for 6 weeks. Eventually had two blood transfusions, sigmoid colon removed; still having chronic diarrhea or constipation, immediately after eating. Stomach swelling, dizziness, shortness of breath, swollen ankles, chest xrays with sinus tachycardia, currently added verbizi and omepeazole; cannot go shopping or working due to immediate urgency to go to the bathroom or stomach pains,
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gastrointestinal oedema, Immediate post-injection reaction, Impaired work ability, Irritable bowel syndrome, Joint swelling
Clinical narrative: immediate diarrhea, 90x days on end, hospitalized with diverticulitis, turned sepsis - 2 holes in my colon for 4 months. Went home with IV treatment and a pic line for 6 weeks. Eventually had two blood transfusions, sigmoid colon removed; still having chronic diarrhea or constipation, immediately after eating. Stomach swelling, dizziness, shortness of breath, swollen ankles, chest xrays with sinus tachycardia, currently added verbizi and omepeazole; cannot go shopping or working due to immediate urgency to go to the bathroom or stomach pains,
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Large intestine perforation, Loss of personal independence in daily activities, Magnetic resonance imaging, Nausea, Sepsis
Clinical narrative: immediate diarrhea, 90x days on end, hospitalized with diverticulitis, turned sepsis - 2 holes in my colon for 4 months. Went home with IV treatment and a pic line for 6 weeks. Eventually had two blood transfusions, sigmoid colon removed; still having chronic diarrhea or constipation, immediately after eating. Stomach swelling, dizziness, shortness of breath, swollen ankles, chest xrays with sinus tachycardia, currently added verbizi and omepeazole; cannot go shopping or working due to immediate urgency to go to the bathroom or stomach pains,
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sinus tachycardia, Transfusion, Wrist fracture
Clinical narrative: immediate diarrhea, 90x days on end, hospitalized with diverticulitis, turned sepsis - 2 holes in my colon for 4 months. Went home with IV treatment and a pic line for 6 weeks. Eventually had two blood transfusions, sigmoid colon removed; still having chronic diarrhea or constipation, immediately after eating. Stomach swelling, dizziness, shortness of breath, swollen ankles, chest xrays with sinus tachycardia, currently added verbizi and omepeazole; cannot go shopping or working due to immediate urgency to go to the bathroom or stomach pains,
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness transient, Blindness unilateral, Blood glucose normal, Blood pressure increased, Chills
Clinical narrative: At 8:45 am, was lightheaded, had raised blood pressure and heartbeat, severe complex migraine on left side, numbness/tingling and pain on the left side of head, neck, and arm, chills, and temporary blindness in left eye. Took CHLORPROMAZINE HCL 10MG TAB and 2 ACETAMINOPHEN 250/ASA 250/CAFF 65MG TAB. Vitals at 9:00 am were BP 166/102, HR 76,  TEMP 97.6, O2 100, RR 16. Was taken to ER by wheelchair. Was administered ATIVAN by 9:34 am. Some symptoms improved (mainly blood pressure, heart rate, and numbness/tingling of the arm, neck, and left side of face). By 11:00 am, experienced a severe complex migraine on right side, with numbness of the right side of the face and temporary blindness in right eye. Was administered TORADOL IM via right deltoid injection at 11:40 am. Symptoms were reduced to a 5/10. Discharged at 12:18 pm via wheelchair to spouse for transport home. Continued to experience migraine symptoms on both the left and right side for almost two weeks. The right side complex migraines, which never occurred until the 2nd PFIZER COVID19 injection, still occur monthly to this day.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Electrocardiogram, Headache, Heart rate increased
Clinical narrative: At 8:45 am, was lightheaded, had raised blood pressure and heartbeat, severe complex migraine on left side, numbness/tingling and pain on the left side of head, neck, and arm, chills, and temporary blindness in left eye. Took CHLORPROMAZINE HCL 10MG TAB and 2 ACETAMINOPHEN 250/ASA 250/CAFF 65MG TAB. Vitals at 9:00 am were BP 166/102, HR 76,  TEMP 97.6, O2 100, RR 16. Was taken to ER by wheelchair. Was administered ATIVAN by 9:34 am. Some symptoms improved (mainly blood pressure, heart rate, and numbness/tingling of the arm, neck, and left side of face). By 11:00 am, experienced a severe complex migraine on right side, with numbness of the right side of the face and temporary blindness in right eye. Was administered TORADOL IM via right deltoid injection at 11:40 am. Symptoms were reduced to a 5/10. Discharged at 12:18 pm via wheelchair to spouse for transport home. Continued to experience migraine symptoms on both the left and right side for almost two weeks. The right side complex migraines, which never occurred until the 2nd PFIZER COVID19 injection, still occur monthly to this day.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Migraine, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: At 8:45 am, was lightheaded, had raised blood pressure and heartbeat, severe complex migraine on left side, numbness/tingling and pain on the left side of head, neck, and arm, chills, and temporary blindness in left eye. Took CHLORPROMAZINE HCL 10MG TAB and 2 ACETAMINOPHEN 250/ASA 250/CAFF 65MG TAB. Vitals at 9:00 am were BP 166/102, HR 76,  TEMP 97.6, O2 100, RR 16. Was taken to ER by wheelchair. Was administered ATIVAN by 9:34 am. Some symptoms improved (mainly blood pressure, heart rate, and numbness/tingling of the arm, neck, and left side of face). By 11:00 am, experienced a severe complex migraine on right side, with numbness of the right side of the face and temporary blindness in right eye. Was administered TORADOL IM via right deltoid injection at 11:40 am. Symptoms were reduced to a 5/10. Discharged at 12:18 pm via wheelchair to spouse for transport home. Continued to experience migraine symptoms on both the left and right side for almost two weeks. The right side complex migraines, which never occurred until the 2nd PFIZER COVID19 injection, still occur monthly to this day.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Chills, Dairy intolerance, Feeding disorder, Food intolerance
Clinical narrative: First 3 days- 103 fever, vomitting, severe chills and shaking- next 30 days were severe nausea, could not eat.  when I went back to eating, I started slowly and carefully.  Discovered I can no longer tolerate the following:  any fatty foods, no roughage (fruits and veggies) no acidic foods, very little sugar tolerated, very limited dairy and only if I take Lactaid with it.  These dietary problems and limitations have continued to this day.  If anything, my system is becoming less tolerant than ever as time goes on.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Tremor, Vomiting
Clinical narrative: First 3 days- 103 fever, vomitting, severe chills and shaking- next 30 days were severe nausea, could not eat.  when I went back to eating, I started slowly and carefully.  Discovered I can no longer tolerate the following:  any fatty foods, no roughage (fruits and veggies) no acidic foods, very little sugar tolerated, very limited dairy and only if I take Lactaid with it.  These dietary problems and limitations have continued to this day.  If anything, my system is becoming less tolerant than ever as time goes on.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Seizure
Clinical narrative: on 4/2 patient called to ask about shingles vacine, and on that call he reported to have had seizure episode/s the night after he got TDap vaccine on 2/28/24.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Administration error-wrong vaccination given