chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUA4
Symptoms: Appendicectomy, Appendicitis perforated, Lithotripsy, Nephrolithiasis
Clinical narrative: Ruptured Appendix; This clinical trial case initially received on 14-Nov-2024, with additional information received on 15-Nov-2024, was reported by a health professional and concerns an elderly female subject.  Weight: 145.4 kg; Height: 63.5 cm  The subject was enrolled in the study  Past medical history included bilateral tubal ligation, appendectomy, multiple kidney stones. At the time of the event the subject had hypercholesterolemia, post menopausal, iron deficiency, osteopenia lumbar spine, herpes simplex virus type 1, seasonal allergies, drug allergies sulfa. Concomitant medication: refer to appropriate report section. The subject received Influenza vaccination within 3 previous season.The subject's historical vaccine included seasonal influenza vaccine (brand not specified) received on 27-Oct-2022 for unspecified indication.  Administration of company suspect drug: On 29-Nov-2023 15:05, the subject received aQIVc HD  vs QIVr vs aQIV for Prophylaxis of influenza, Dose regimen: 0.5 ml, Route of administration: Intravenous, Lot number: No batch number available. The vaccine was administered as per protocol.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 09-Sep-2024, the subject experienced Ruptured Appendix (Hospitalized, outcome: Recovered / Resolved, stop date: 09-Sep-2024). Intensity: Moderate.  Subject reported to site on 14-Nov-2024 at time of EOS visit that they were admitted from 09-Sep-2024 to 11-Sep-2024 for emergency appendectomy. Subject stated while being treated for ruptured appendix, they were also found to have multiple kidney stones. Kidney stones were treated the following month via outpatient lithotripsy. Subject denied illnesses or complications following the procedures.  aQIVc HD  vs QIVr vs aQIV action taken: Not Applicable Action taken in response to adverse event/; Healthcare encounter - medical advice/consultation, therapeutic procedure.  Reporter's assessment:  The investigator considered the event Ruptured Appendix as moderate and serious due to seriousness criteria of hospitalization and not related to the administration of the investigational drug. Alternative cause for the event included other.  The subject remained blinded in the study.; Reporter's Comments: Causality: Not related based on implausible temporal and biological relationship (9 months 10 days) after administration of study vaccine. Listedness was assessed using IB version 5.
Sex: U
Vaccine: FLUA4
Symptoms: Acute cholecystitis necrotic
Clinical narrative: Acute Gangrenous Cholecystitis; This clinical trial case, initially received on 14-Nov-2024, was reported by a health professional and concerns a subject of unknown age/gender.  The subject was enrolled in the study  Administration of company suspect drug(s): On an unknown date, the subject received aQIVc HD vs QIVr vs aQIV for Prophylaxis of influenza, Dose regimen: .5 ml, Route of administration: Intramuscular, Lot number: No batch number available. The study vaccine was administered as per the protocol.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 27-Aug-2024, the subject experienced Acute Gangrenous Cholecystitis (Medically Significant, outcome: Recovered / Resolved, stop date: 30-Aug-2024).   aQIVc HD vs QIVr vs aQIV action taken: Not Applicable  Reporter's assessment: The Investigator considered the event "Acute Gangrenous Cholecystitis" as severe and serious. The event was assessed as not related to study vaccine. The subject remains blinded in the study.; Reporter's Comments: Causality: Not related in line with investigator assessment due to implausible biological relationship.  Listedness was assessed using version.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy kidney, Blood albumin, Blood creatinine, Blood pressure measurement, Focal segmental glomerulosclerosis
Clinical narrative: Focal Segmental Glomerulosclerosis; This literature-non-study case was reported in a literature article and describes the occurrence of FOCAL SEGMENTAL GLOMERULOSCLEROSIS (Focal Segmental Glomerulosclerosis) in a 77-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.   LITERATURE REFERENCE:    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 FOCAL SEGMENTAL GLOMERULOSCLEROSIS (Focal Segmental Glomerulosclerosis) (seriousness criterion hospitalization). The patient was treated with Prednisone at an unspecified dose and frequency. At the time of the report, FOCAL SEGMENTAL GLOMERULOSCLEROSIS (Focal Segmental Glomerulosclerosis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy kidney: revealed complete effacement of podocytes and early-stage Focal Segmental Glomerulosclerosis (FSGS).. On an unknown date, Blood albumin: 2.3 g/dL. On an unknown date, Blood creatinine: 1.8 mg/dl elevated and Normal after treatment.. On an unknown date, Blood pressure measurement: high (150/86 mmHg). On an unknown date, Urine protein/creatinine ratio: 13.37 g/g (significant proteinuria).     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Patient with no personal or family history of kidney disease was admitted due to dizziness, anasarca, and acute kidney injury. Upon admission, his blood pressure was elevated at 150/86 mmHg. Laboratory tests revealed a serum creatinine level of 1.8 mg/dL (with a previously normal baseline), low albumin at 2.3 g/dL, and significant proteinuria with a urine-protein-to-creatinine ratio of 13.37 g/g. A kidney biopsy showed complete effacement of podocytes and early-stage focal segmental glomerulosclerosis (FSGS).  The patient's detailed history and workups were largely unremarkable, except for having received the Moderna COVID-19 vaccine approximately two months earlier. The patient was started on prednisone at a dose of 60 mg/day, which led to a complete resolution of proteinuria, normalization of serum creatinine levels, and overall improvement of symptoms.  This case underlined the importance of maintaining a high level of clinical suspicion for FSGS as a potential complication of COVID-19 vaccines. Further studies were suggested to establish a causal relationship.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Urine protein/creatinine ratio
Clinical narrative: Focal Segmental Glomerulosclerosis; This literature-non-study case was reported in a literature article and describes the occurrence of FOCAL SEGMENTAL GLOMERULOSCLEROSIS (Focal Segmental Glomerulosclerosis) in a 77-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.   LITERATURE REFERENCE:    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 FOCAL SEGMENTAL GLOMERULOSCLEROSIS (Focal Segmental Glomerulosclerosis) (seriousness criterion hospitalization). The patient was treated with Prednisone at an unspecified dose and frequency. At the time of the report, FOCAL SEGMENTAL GLOMERULOSCLEROSIS (Focal Segmental Glomerulosclerosis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy kidney: revealed complete effacement of podocytes and early-stage Focal Segmental Glomerulosclerosis (FSGS).. On an unknown date, Blood albumin: 2.3 g/dL. On an unknown date, Blood creatinine: 1.8 mg/dl elevated and Normal after treatment.. On an unknown date, Blood pressure measurement: high (150/86 mmHg). On an unknown date, Urine protein/creatinine ratio: 13.37 g/g (significant proteinuria).     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Patient with no personal or family history of kidney disease was admitted due to dizziness, anasarca, and acute kidney injury. Upon admission, his blood pressure was elevated at 150/86 mmHg. Laboratory tests revealed a serum creatinine level of 1.8 mg/dL (with a previously normal baseline), low albumin at 2.3 g/dL, and significant proteinuria with a urine-protein-to-creatinine ratio of 13.37 g/g. A kidney biopsy showed complete effacement of podocytes and early-stage focal segmental glomerulosclerosis (FSGS).  The patient's detailed history and workups were largely unremarkable, except for having received the Moderna COVID-19 vaccine approximately two months earlier. The patient was started on prednisone at a dose of 60 mg/day, which led to a complete resolution of proteinuria, normalization of serum creatinine levels, and overall improvement of symptoms.  This case underlined the importance of maintaining a high level of clinical suspicion for FSGS as a potential complication of COVID-19 vaccines. Further studies were suggested to establish a causal relationship.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.
Sex: M
Vaccine: MEN, MENB, MMR, PNC13
Symptoms: Atonic seizures, Blood test, Electroencephalogram, Laboratory test, Meningitis
Clinical narrative: Meningitis; Atonic seizures; Pyrexia; Information was obtained on a request by The Company from the agency via a Public Case Detail (agency #AU-TGA-0000822209) concerning to a 1-year-old male patient.  This spontaneous report was received from a physician. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drugs reactions or allergies were not provided. The patient had no previous vaccine reactions (also reported as not applicable).  On 10-SEP-2024, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered as prophylaxis (strength, Lot number, expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency was not provided); also with a dose of meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO) (formulation, indication, strength, Lot number, expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency was not provided); also with a dose of meningococcal vaccine a/c/y/w conj (tet tox) (NIMENRIX) (formulation, indication, strength, Lot number, expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency was not provided); and with a dose of pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) (formulation, indication, strength, Lot number, expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency was not provided).  On an unknown date, an unspecified test was performed and showed screened for potential infectious source - blood tests, respiratory swab EEG completed.   On an unspecified date, the patient experienced meningitis. On 17-SEP-2024, the patient experienced atonic seizures and pyrexia.   Additionally, it was stated that the patient received treatment with IV antibiotics at observation in hospital to covered for potential meningitis.  At the time of reporting, the outcome of the event of meningitis was reported as unknown. The outcome of the events of atonic seizures and pyrexia was reported as recovered.  The causality assessment between the suspect vaccines with the events was related (also stated by the agency as possible).  Upon internal review, the event of meningitis was determined to be medically significant.  No follow-up should be scheduled for this report as no further information can be obtained from the local regulatory authority. Additional information is not expected.
Sex: M
Vaccine: MEN, MENB, MMR, PNC13
Symptoms: Pyrexia
Clinical narrative: Meningitis; Atonic seizures; Pyrexia; Information was obtained on a request by The Company from the agency via a Public Case Detail (agency #AU-TGA-0000822209) concerning to a 1-year-old male patient.  This spontaneous report was received from a physician. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drugs reactions or allergies were not provided. The patient had no previous vaccine reactions (also reported as not applicable).  On 10-SEP-2024, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered as prophylaxis (strength, Lot number, expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency was not provided); also with a dose of meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO) (formulation, indication, strength, Lot number, expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency was not provided); also with a dose of meningococcal vaccine a/c/y/w conj (tet tox) (NIMENRIX) (formulation, indication, strength, Lot number, expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency was not provided); and with a dose of pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) (formulation, indication, strength, Lot number, expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency was not provided).  On an unknown date, an unspecified test was performed and showed screened for potential infectious source - blood tests, respiratory swab EEG completed.   On an unspecified date, the patient experienced meningitis. On 17-SEP-2024, the patient experienced atonic seizures and pyrexia.   Additionally, it was stated that the patient received treatment with IV antibiotics at observation in hospital to covered for potential meningitis.  At the time of reporting, the outcome of the event of meningitis was reported as unknown. The outcome of the events of atonic seizures and pyrexia was reported as recovered.  The causality assessment between the suspect vaccines with the events was related (also stated by the agency as possible).  Upon internal review, the event of meningitis was determined to be medically significant.  No follow-up should be scheduled for this report as no further information can be obtained from the local regulatory authority. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hypoaesthesia, Hypoaesthesia oral, Lip swelling, Swelling face
Clinical narrative: same night as vaccine pt felt SOB that resolved overnight. Then had two days of generalized hives, took PO Benadryl for itching. 3 days after vaccine lips and right cheek swelling and numbness, given IV dexamethasone and Zyrtec. Given PO steroid taper and epi pen to take home from ED.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: same night as vaccine pt felt SOB that resolved overnight. Then had two days of generalized hives, took PO Benadryl for itching. 3 days after vaccine lips and right cheek swelling and numbness, given IV dexamethasone and Zyrtec. Given PO steroid taper and epi pen to take home from ED.
Age: 41.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Lymph node pain, Lymphadenopathy, Mobility decreased, Pain
Clinical narrative: EMP. REPORTED NEXT AM PAIN LEVEL 6 WITH NOTED SWELLING OF AXILLA LYMPH GLAND AND TENDERNESS. DIFFICULTY RAISING ARM  EMP STATES THIS "HAS HAPPENED IN THE PAST AFTER COVID SHOTS"  HER PCP IS AWARE OF HX
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC20, RV5
Symptoms: Erythema, Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: On 11/26/2024, father of client called clinic to report allergic reaction to last vaccines. Father stated client had no reaction to prior two series of vaccines. No new vaccines given during 6 month visit. Pentacel, Recombivax-B, Prevnar 20, and Rotateq all administered during 8 AM appointment on 11/22/2024. Father stated that at 10 AM mother noticed generalized red spots all over client's body while client was a mother's workplace. At 5:30pm that evening, client developed swelling, redness, and warmth around RVL injection site. Concerned, parents presented client to ER. ER reported to parents that client's airway clear, normal heart rate, and normal breathing; no signs of anaphylaxis, upper airway involvement, or palpitations. ER administered Benedryl, which parents stated resolved generalized red spots. Prior to receiving vaccines, father reported client was completing Amoxicillin regiment for ear infection that had been going on "for a couple weeks"; client received final dose of Amoxicillin on 11/22/2024. Father stated client will be seeing client's pediatrician Dr. on 11/26/2024 to follow-up from event and to consult how to proceed forward with immunizations.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Hypomenorrhoea
Clinical narrative: My first series of Covid vaccinations was while I was pregnant.  After giving birth my periods became very light and almost non-existent. I had fertility issues when trying for a second child and underwent surgery for scarring in my uterus.  Took supplements and was getting my periods back to normal.  Had to take a covid booster for a new job and by the end of the month my periods are almost non-existent again.  I am going back to see a fertility specialist but this is worrying that I would have this change so soon after.  I?ve had 2 menstrual cycles at this point and both have been very light and I?m worried this is effecting my fertility
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Varicella
Clinical narrative: Chickenpox---widespread rash and fever
Age: 43.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This patient received a second dose of the seasonal flu shot. Their first dose was administered at this same location on 09/05/2024. The patient stated they did not experience any adverse reactions after the second dose.
Age: 74.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Asthenia, Chills, Diarrhoea, Pain, Pyrexia
Clinical narrative: 11/22 - 11/23 - chills, slight fever, extremely achy and weak. Took several doses of Alka Seltzer Plus   Aches subsided and on 11/24 I had diarrhea and took Immidium
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Ear pain, Headache, Pain in jaw, Swelling
Clinical narrative: 3 days after receiving vaccine, my left side of my face and neck swelled. Pain experienced in jaw, left ear, left temple, and lower back teeth on the left. Symptoms steadily worsened. Saw doctor on Wednesday, Nov. 20. He diagnosed angioedema and prescribed prednisone and zyrtec. Took last dose of prednisone yesterday. Swelling and pain are gone.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Toothache
Clinical narrative: 3 days after receiving vaccine, my left side of my face and neck swelled. Pain experienced in jaw, left ear, left temple, and lower back teeth on the left. Symptoms steadily worsened. Saw doctor on Wednesday, Nov. 20. He diagnosed angioedema and prescribed prednisone and zyrtec. Took last dose of prednisone yesterday. Swelling and pain are gone.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient wanted to get a COVID vaccine but was given flu vaccine in error.  He had already gotten a flu vaccine at his physician's office. Patient not feeling any side effects.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, HIBV, PNC20, RV5
Symptoms: Extra dose administered
Clinical narrative: extra dose of Hib given in error
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Eye swelling, Muscular weakness
Clinical narrative: within half hour eye were slightly swollen, within 5 and half hours chest began to tighten and breathing became difficult, also muscle weakness in both legs
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Computerised tomogram, Fatigue, Gait inability
Clinical narrative: Moderate left arm pain but 12 hours later, lying in bed trying to sleep, I suddenly felt a strange movement through my whole body. Sat up and experienced extreme vertigo. Body was almost convulsive trying to stabilize itself. Could not walk but could crawl. Was nauseus and threw up. 911 ambulance took me to the hospital. Stroke signs (droopy mouth, numbness in extremities) were nil, but they conducted 2 cat scans (1 with contrast dye) and an MRI to rule out stroke. Was admitted as an inpatient for 1 day. Vertigo began to subside by next afternoon and I was able to walk with help. Vertigo continued to subside so that 3 days later I am able to walk normally. Extreme tiredness and feeling of weakness throughout my body continues.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Magnetic resonance imaging, Nausea, Pain in extremity, Scan with contrast, Sensory disturbance
Clinical narrative: Moderate left arm pain but 12 hours later, lying in bed trying to sleep, I suddenly felt a strange movement through my whole body. Sat up and experienced extreme vertigo. Body was almost convulsive trying to stabilize itself. Could not walk but could crawl. Was nauseus and threw up. 911 ambulance took me to the hospital. Stroke signs (droopy mouth, numbness in extremities) were nil, but they conducted 2 cat scans (1 with contrast dye) and an MRI to rule out stroke. Was admitted as an inpatient for 1 day. Vertigo began to subside by next afternoon and I was able to walk with help. Vertigo continued to subside so that 3 days later I am able to walk normally. Extreme tiredness and feeling of weakness throughout my body continues.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder, Urine analysis, Vertigo, Vomiting
Clinical narrative: Moderate left arm pain but 12 hours later, lying in bed trying to sleep, I suddenly felt a strange movement through my whole body. Sat up and experienced extreme vertigo. Body was almost convulsive trying to stabilize itself. Could not walk but could crawl. Was nauseus and threw up. 911 ambulance took me to the hospital. Stroke signs (droopy mouth, numbness in extremities) were nil, but they conducted 2 cat scans (1 with contrast dye) and an MRI to rule out stroke. Was admitted as an inpatient for 1 day. Vertigo began to subside by next afternoon and I was able to walk with help. Vertigo continued to subside so that 3 days later I am able to walk normally. Extreme tiredness and feeling of weakness throughout my body continues.
Age: 51.0
Sex: F
Vaccine: YF
Symptoms: Chills, Fatigue, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Started the next day. 11/19/24 Fever. chills. fatigue. injection site reaction was red and swollen. Patient felt the need to go to urgent care . lasted for a few days.
Age: 0.58
Sex: M
Vaccine: FLU3
Symptoms: Oral mucosal eruption
Clinical narrative: After the patient was vaccinated with fluzone at 1:53pm. By 2:00pm the patient presented with a red rash around his mouth. Patient did not have a local reaction at the injection site, and no rash elsewhere on the body. I examined the patients tongue, and it was of normal size. Patient was not in any distress. Lung sounds and heart sounds were within normal limits. I educated parents on dosage of diphenhydramine. I stated they could give diphenhydramine if the rash persisted. I observed the patient until 2:30 pm and the patient's rash did not spread. Spoke with the patient's parents at 3:00pm, they stated the rash was still there but it had not spread and there were no other symptoms. Spoke with patient's parents 11/26/24 at 10:00 AM and parent states that the rash was gone by 5pm on 11/25/24. States patient is completely back to baseline.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient had no reactions to vaccine given. i am just documenting wrong pfizer age group vaccine was given to the child.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Swelling
Clinical narrative: sharp pain beginning 3 days after immunization. slight swelling.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Swelling
Clinical narrative: sharp pain and slight swelling beginning 3 days after immunization
Age: 9.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient and family came in for both FLU and COVID injections. Patient has Medicaid insurance and flu vaccine pulled  and prepared and injection labeled. Vaccine of 5-11 year old for COVID injection was expired on 11/15/2024, so writer should have borrowed from regular stock for patients injection. Mistakenly writer prepared the 12+ vaccine covid shot for patient instead of the 5-11 year old dose. Writer did not notice the mistake until charting the injections. Vaccine representative contacted through email by RN Lead to see regarding any contraindications or side effects. Writer also called Covid Providers Line for DH and left a message to have a call back and called the CDC hotline and spoke to employee. Per employee CDC guidelines for a patient receiving a higher than authorized dose it is still ok for patient to receive the COVID injection again next year. Employee discussed side effects to look for including fever, fatigue, HA, chills, diarrhea, irritibility, sleepiness, and loss of appetite. Redness, pain, and swelling at the injection site. LM on patients mom's secure voicemail regarding the error and will follow up today to speak directly with mom to get an update on how patient is feeling.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Atrial fibrillation, Cardioversion, Echocardiogram, Electrocardiogram
Clinical narrative: MODERNA #1 1/12/2021 MODERNA #2 2/9/2021  DEVELOPED VACCINE INDUCED MYOPERICARDITIS AND PAROXYSMAL ATRIAL FIBRILLATION.  TREATED WITH METOPROLOL ELIQUIS COLCHICINE AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Myopericarditis
Clinical narrative: MODERNA #1 1/12/2021 MODERNA #2 2/9/2021  DEVELOPED VACCINE INDUCED MYOPERICARDITIS AND PAROXYSMAL ATRIAL FIBRILLATION.  TREATED WITH METOPROLOL ELIQUIS COLCHICINE AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Cough, Lower respiratory tract infection
Clinical narrative: Developed Chest cold, and cough from drug #00069246510 LN5496 EXP Sept 30, 2025 Abrysvo
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: "It started about an hour and a half after receiving the vaccination so about 4:45 or 5 pm that day.  The adverse event is ringing in the ear and loss of hearing in the left ear.  I did go to my primary physician's office and saw the nurse practitioner there.  They started me on zyrtec and flonase, "
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Exercise tolerance decreased, Loss of personal independence in daily activities, Mobility decreased, Pain
Clinical narrative: The patient is a 53-year-old female who presents for evaluation of left shoulder pain.   She received her influenza vaccine in her left arm during her last visit. Initially, she experienced mild soreness, which was not a cause for concern. However, over time, the pain intensified, preventing her from sleeping on her left side and making it difficult to wear a bra. The pain, which she describes as radiating down her arm, has been exacerbated by recent physical activity, including walking her dog. The pain has been interfering with her daily activities and she has been unable to make sudden movements. Applying ice to the area provided some relief.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: The patient is a 53-year-old female who presents for evaluation of left shoulder pain.   She received her influenza vaccine in her left arm during her last visit. Initially, she experienced mild soreness, which was not a cause for concern. However, over time, the pain intensified, preventing her from sleeping on her left side and making it difficult to wear a bra. The pain, which she describes as radiating down her arm, has been exacerbated by recent physical activity, including walking her dog. The pain has been interfering with her daily activities and she has been unable to make sudden movements. Applying ice to the area provided some relief.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Laboratory test, Myocarditis, Pericarditis, Ultrasound scan
Clinical narrative: Diagnosed as with Myocarditis and Pericarditis
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No adverse side effects when followed up in November 2024.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient should have received flu shot
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3
Symptoms: Injection site swelling, Injection site urticaria, Rash
Clinical narrative: Swelling hives covered most of the patient's anterior left upper thigh area on 11/23/24, then developed the rash all over his body ( except the face ) on 11/24/24.
Age: 63.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Arthralgia
Clinical narrative: Patient reports severe pain in the right shoulder that occurs every evening after having received Prevnar20. Pt states pain only occurs in the evening hours and is not present upon awakening.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Blister rupture, Peripheral swelling, Rash, Wound
Clinical narrative: pt. had swelling and rash to right arm then extended down to right hand. Then developed rash to left dorsal foot which resulted in large blister with surrounding small vesicles. Have since popped and has open sore.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram, Hypoaesthesia, Magnetic resonance imaging head, Sinoscopy, Tinnitus
Clinical narrative: facial numbness initially then severe tinnitus
Age: 26.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Malaise, Pallor, Syncope
Clinical narrative: Patient started feeling unwell after getting the two shots. Looked pale. She was about to get an HPV vaccine in the other arm, but since she looked unwell, I paused. Then she fainted shortly after. After less than a minute, she awakened with jerking movement. She looked pale but she stated she was ok. She laid on the floor for a few minutes and sat up when she felt better. The color returned to her face and after another 15 minutes, she was back to normal.
Age: 0.58
Sex: M
Vaccine: FLU3
Symptoms: Dyskinesia, Electroencephalogram normal, Movement disorder
Clinical narrative: unvoluntary head, neck, and eye movements.   Appear as seizures.   Please note the flu vaccine he received was Influenz Trivalent PF.5 ml.  That was not listed as a choice.
Age: 60.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Neck pain
Clinical narrative: Extreme neck pain 3 hours after receiving injections. I'm not sure which flu shot I got.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Injection site reaction - firm palpable nodule 1.5", tender, redness, warmth. Lasted 4 weeks until starting to get smaller and less painful
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Disorientation, Dizziness, Dysstasia, Fall
Clinical narrative: pt says she went to bed after getting her vaccine but she had trouble getting out of bed the next day. She felt she was sedated. When she tried to get up she staggered. She tried to make a phone call but she was diorented and gave the caller the wrong name and phone number. After a few hours that seemed to wear off. By the following day she was still light headed and loosing her balance. She had to use her cane to get around. She was having trouble getting around, not able to take a walk. She had to cancel appointments. On 10/29/24. Still being light headed, she was trying to open the fridgerator door but was unable to do so, she fell down and hit the floor. This caused aknot on her left shin. Her left leg and foot turned purple. She applied iced to help with the swelling that helped. By the 10/31 all of the symptoms were gone. She went to Urgent Care. because she still had swelling of the left leg. She had X-rays that were negative. She was told to continue applying ice to help with the swelling.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Limb injury, Loss of personal independence in daily activities, Mobility decreased, Peripheral swelling
Clinical narrative: pt says she went to bed after getting her vaccine but she had trouble getting out of bed the next day. She felt she was sedated. When she tried to get up she staggered. She tried to make a phone call but she was diorented and gave the caller the wrong name and phone number. After a few hours that seemed to wear off. By the following day she was still light headed and loosing her balance. She had to use her cane to get around. She was having trouble getting around, not able to take a walk. She had to cancel appointments. On 10/29/24. Still being light headed, she was trying to open the fridgerator door but was unable to do so, she fell down and hit the floor. This caused aknot on her left shin. Her left leg and foot turned purple. She applied iced to help with the swelling that helped. By the 10/31 all of the symptoms were gone. She went to Urgent Care. because she still had swelling of the left leg. She had X-rays that were negative. She was told to continue applying ice to help with the swelling.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Somnolence, Walking aid user, X-ray normal
Clinical narrative: pt says she went to bed after getting her vaccine but she had trouble getting out of bed the next day. She felt she was sedated. When she tried to get up she staggered. She tried to make a phone call but she was diorented and gave the caller the wrong name and phone number. After a few hours that seemed to wear off. By the following day she was still light headed and loosing her balance. She had to use her cane to get around. She was having trouble getting around, not able to take a walk. She had to cancel appointments. On 10/29/24. Still being light headed, she was trying to open the fridgerator door but was unable to do so, she fell down and hit the floor. This caused aknot on her left shin. Her left leg and foot turned purple. She applied iced to help with the swelling that helped. By the 10/31 all of the symptoms were gone. She went to Urgent Care. because she still had swelling of the left leg. She had X-rays that were negative. She was told to continue applying ice to help with the swelling.
Age: 0.5
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There was confusion about the vaccine being given to a 6 mos. old.  It said on the box that it is to be used for individuals 18 years of age and older.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immediate post-injection reaction, Injection site pain, Malaise
Clinical narrative: I had recovered from the sore arm at the injection site and the 2 to 3 days of headache, fatigue, aches, and malaise immediately after the vaccine,  when the sore throat started on Day 4.  The sore throat got worse each day, so on Day 7 I went to my primary care clinic and got a throat culture. The culture was positive for strep, so I started a 10 day course of amoxicillin that evening. It is now Day 14 and I'm feeling fine as I finish out the course of antibiotics.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Streptococcus test positive
Clinical narrative: I had recovered from the sore arm at the injection site and the 2 to 3 days of headache, fatigue, aches, and malaise immediately after the vaccine,  when the sore throat started on Day 4.  The sore throat got worse each day, so on Day 7 I went to my primary care clinic and got a throat culture. The culture was positive for strep, so I started a 10 day course of amoxicillin that evening. It is now Day 14 and I'm feeling fine as I finish out the course of antibiotics.
Age: 34.0
Sex: M
Vaccine: ANTH, IPV
Symptoms: Chills, Headache, Hyperhidrosis, Tremor
Clinical narrative: Service member received the polio and anthrax vaccines at 1 pm in the afternoon 9/7/2019 in his left arm, went to urgent care on 9/9/2019 for a headache, shaking, chills, and sweating. No fever was present, vital signs normal on intake.  Member was treated with a shot of toradol, which he reported did not help. Member went home.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Pyrexia, Urinary tract infection
Clinical narrative: Resident died following a physical therapy session
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Nerve conduction studies abnormal
Clinical narrative: Patient stated two days after her covid shot she began experiencing pain in her left arm that felt like she was being shocked, radiating from her fingertips to her elbow. It was the same arm she received the vaccine. It became more constant being triggered by movement, so she went to her PCP who ordered a nerve conduction test. She received the results 11/25/24 and stated her results were abnormal and her PCP was referring her to a neurologist.
Age: 14.0
Sex: M
Vaccine: CHOL
Symptoms: Lip dry, Rash, Rash erythematous, Rash pruritic, Sleep disorder
Clinical narrative: Onset 11/18/24 in afternoon Thinks 2/2 covid vax in am same day No change in diet, soap, cosmetics Face, ears, and b/l arms red, itchy, dry, little bumps No lip/tongue swelling, no SOB, no CP Itchy, difficulty sleeping at night   Self tx: ice to lipids, helped with itchiness but now skin on lips dry and irritated Tx administered in in clinic: loratadine 10 mg x 1 Tx prescribed: steroid taper Under care with allergy for similar reaction over summer not related to vaccine, allergist has recommended genetic testing Has Epipen
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Hyperhidrosis, Hypopnoea, Loss of consciousness, Posture abnormal
Clinical narrative: Approximately 5-10 minutes following receiving COVID vaccine, patient found sitting in exam room chair with head back and eyes staring. Patient had shallow breathing, diaphoretic, and had a positive carotid pulse but negative response to sternal rub. Exam chair flattened and legs lifted, BP rose to 117/77 and ppt became alert. Patient stated "everything went black." Upon sitting up, ppt BP dropped to 96/70 then 90/65. EMS called and ppt brought to The  Hospital.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Staring, Unresponsive to stimuli
Clinical narrative: Approximately 5-10 minutes following receiving COVID vaccine, patient found sitting in exam room chair with head back and eyes staring. Patient had shallow breathing, diaphoretic, and had a positive carotid pulse but negative response to sternal rub. Exam chair flattened and legs lifted, BP rose to 117/77 and ppt became alert. Patient stated "everything went black." Upon sitting up, ppt BP dropped to 96/70 then 90/65. EMS called and ppt brought to The  Hospital.
Age: 0.17
Sex: M
Vaccine: PNC20, RV5, VARCEL
Symptoms: Wrong product administered
Clinical narrative: VARICELLA GIVEN BY MISTAKE. STATE NOTIFIED. PARENTS NOTIFIED. STAFF RE-TRAINING
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient isn't having any adverse event. Patient received a flu shot on 11/20 and then came back on 11/25 and asked to receive a flu shot. As she was leaving after receiving the flu shot, she then came back and said I didn't mean to say or get a flu shot I wanted an RSV. So basically, the patient received two flu shot in 5 days.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Gave Heplisav to a 17 year old.  Contraindication for under 18 years of age.  No signs or symptoms. No adverse reaction.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Anti-ganglioside antibody positive, Immunoglobulin therapy, Muscular weakness, Urticaria
Clinical narrative: patient was administered flu vaccine 10/23/24 patient returned to clinic 11/4/24 for 4 day hx of urticaria and was given oral prednisone course and cetrizine for management patient presented to ED 11/7/24 with 4 days history of progressing ascending weakness to b/l extremities, started on IVIG x 5 days, +ganglioside antibodies confirmed dx, improving but weakness persists esp with grip strength
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache
Clinical narrative: After the vaccine the patient complained that she felt light headache and needed to lie down on the floor. She claimed that she has the same situation 2-3 years ago when she got a flu vaccine. she lay down for about 20 minutes, water and cold pack were provided to the patient.
Sex: F
Vaccine: UNK
Symptoms: Wrong product administered
Clinical narrative: Wrong vaccine given
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: vaccine needed diluent was needed and .3ml was improperly administration, 5 times dosage recommendation given. provider notified, supervisor notified parents . vaers notified working on call out to parents for details how to manage miss dosage of vaccine protocols -
Age: 84.0
Sex: F
Vaccine: UNK
Symptoms: Biopsy artery, Blood test, Gait disturbance, Headache, Injected limb mobility decreased
Clinical narrative: SEVERE HEADACHES, SEVERE MUSCLE INFLAMMATION (RIGHT ARM), SHOULDERS, NECK, INNER THIGHS, LEGS,  LEFT ARM, EXTREME DIFFICULTY GETTING OUT OF BED, WALKING, COULD NOT LIFT LEFT ARM  I BEGAN DOCTOR CARE 09/16/24.  I HAVE BEEN DIAGNOSED WITH POLYMYALGI RHEUMATICA.  I BEGAN TAKING 50 MG OF PREDNISONE DAILY AND I AM NOW DOWN TO 10 MG DAILY.
Age: 84.0
Sex: F
Vaccine: UNK
Symptoms: Mobility decreased, Myositis, Polymyalgia rheumatica
Clinical narrative: SEVERE HEADACHES, SEVERE MUSCLE INFLAMMATION (RIGHT ARM), SHOULDERS, NECK, INNER THIGHS, LEGS,  LEFT ARM, EXTREME DIFFICULTY GETTING OUT OF BED, WALKING, COULD NOT LIFT LEFT ARM  I BEGAN DOCTOR CARE 09/16/24.  I HAVE BEEN DIAGNOSED WITH POLYMYALGI RHEUMATICA.  I BEGAN TAKING 50 MG OF PREDNISONE DAILY AND I AM NOW DOWN TO 10 MG DAILY.
Age: 0.67
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Notified parents, supervisor, vaers
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a second dose of the flu vaccine.  She had the first one through the peer-to-peer vaccine clinic.  I did not see the vaccine in her list when the second dose was given 11/19/24.  She did not have any adverse effects from the vaccine.
Age: 1.17
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Irritability
Clinical narrative: 14-month-old patient got an adult dose of Hep A vaccine.  I called mom and explained to watch for typical symptoms.  Mom reported that child was fussy, so she gave her Tylenol and was fine the next day.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: PCV 20 was given 10 days earlier than should be given. last dose was 10/29/2024 since it was a catch up dose, next one should have been given 11/29/24.  No adverse reaction observed. f/u with parent and pt did not have syptoms after vaccination.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia
Clinical narrative: Patient called the pharmacy reporting a metallic taste in her mouth starting a few hours after vaccine administration. She reports she had a similar reaction after receiving a COVID vaccine. Patient stated metallic taste usually resolves in the following day or so. Patient will update pharmacy if reaction continues.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Shot was administered in the morning, and by late afternoon child vocalized pain in the area. Upon inspection, the injection site (and surrounding area) was hard, tender, and very swollen. A fever of over 102.4 spiked that night, and Ibuprofen was administered. The fever did not return, but arm remained swollen for 2 more days (until the following Sunday). This child had never received this combo vaccine, but had received the IPV and dTap vaccines separately with no reaction. This is the first vaccine this child has ever reacted to.
Age: 66.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received a Flu Vaccine on 08/28/24 and 11/25/24
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Patient called with c/o left arm redness, itchiness and hives for 8 days after receiving the vaccine.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Patient was given a vaccination that had previously gone out of the temperature range.  I discovered this today, 11/26/24, and called Merck and based on the temperature data, they verified that the vaccine was safe to give, and the patient did not need to get re-vaccinated.  The patient has not had any adverse effects.
Age: 79.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: SEVERE SHOULDER PAIN; INABILITY TO RAISE ARM
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: possible duplicate flu vaccination according to the pharmacy record, pt can't recall getting it previously during the same season, pt is feeling well however, no adverse symptoms reported so far
Age: 1.42
Sex: F
Vaccine: DTAPIPVHIB, FLU3, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Irritability
Clinical narrative: On 11/19/24 patient was here in our office received vaccines listed above. Approximately 36 hours after injections patient's left thigh was red and itchy. On 11/21/24 mother scheduled appointment here and stated patient was fussy and temp was 100. Left thigh red and swollen. No limp. Walks and runs well. Macular minimally tender oval of 6x7cm on left lateral thigh with central hole (likely vaccine site). No discharge or fluctuance. Moves leg normally. Cetirizine was prescribed for itch. Outcome unknown
Age: 53.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Facial pain, Neck pain, Occipital neuralgia, Skin burning sensation, Trigeminal neuralgia
Clinical narrative: Neck pain, Faicla pain / burning - Trigeminal neuralgia / Occipital Neuralgia - ongoing
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic reaction
Clinical narrative: Patient did not wait the 15 mins and left the pharmacy. Patient said she went to the hospital to be treated for anaphylaxis.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Pt had itchy bumps mainly on the arms and other part of the body
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: covid vaccine was given after expiration date on the sticker on the box, which was dated 11/14/2024, even though the vial itself has a date of 12/2025
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Dizziness, Headache, Tremor, Urticaria
Clinical narrative: Severe tremors and shaking on Thursday . Woke up Sunday morning with blisters and hives all over my body . Dizziness and headache
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiocardiogram, COVID-19, Echocardiogram, Electrocardiogram, Laboratory test
Clinical narrative: PFIZER #1 4/8/2021 PFIZER #2 4/29/2021 PFIZER #3 UNKNOWN DATE  DEVELOPED VACCINE INDUCED MYOPERICARDITIS  POTS AND RECURRENT SARS-COV-2 INFECTION TREATED WITH COLCHICINE PROPRANOLOL AND PROTOCOL BASE SPIKE DETOXIFICATION.