chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chills, Decreased appetite, Ear pain
Clinical narrative: Severe arthralgia ALL OVER, pain redness swelling of deltoid (L);102.8 temp; chills, nausea, loss of appetite ; insomnia; profound fatigue; flu like syndrome; SEVERE JOINT & tendon pain, sore throat, ears hurting
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Injection site erythema, Injection site swelling, Insomnia
Clinical narrative: Severe arthralgia ALL OVER, pain redness swelling of deltoid (L);102.8 temp; chills, nausea, loss of appetite ; insomnia; profound fatigue; flu like syndrome; SEVERE JOINT & tendon pain, sore throat, ears hurting
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Tendon pain
Clinical narrative: Severe arthralgia ALL OVER, pain redness swelling of deltoid (L);102.8 temp; chills, nausea, loss of appetite ; insomnia; profound fatigue; flu like syndrome; SEVERE JOINT & tendon pain, sore throat, ears hurting
Age: 66.0
Sex: M
Vaccine: TD
Symptoms: No adverse event
Clinical narrative: No adverse effect
Age: 35.0
Sex: F
Vaccine: RSV
Symptoms: Blood test abnormal, Crying, Dizziness, Exposure during pregnancy, Fatigue
Clinical narrative: Uncontrollably shaking, crying, dizziness, fatigue, vomiting, hot flashes, headache, extreme blurry vision, swelling of hands, feet and face
Age: 35.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Hot flush, Peripheral swelling, Swelling face, Tremor
Clinical narrative: Uncontrollably shaking, crying, dizziness, fatigue, vomiting, hot flashes, headache, extreme blurry vision, swelling of hands, feet and face
Age: 35.0
Sex: F
Vaccine: RSV
Symptoms: Vision blurred, Vomiting
Clinical narrative: Uncontrollably shaking, crying, dizziness, fatigue, vomiting, hot flashes, headache, extreme blurry vision, swelling of hands, feet and face
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Reporting an Adverse Event Following a Flu Vaccine: I received a flu shot (Fluzone High-Dose Trivalent 2024-2025, Manufacturer: Sanofi-Pasteur, Lot #U8524CA) on October 14, 2024, at the Pharmacy. I am reporting a persistent pain issue that I believe is related to the vaccine injection. Initially, I experienced what I would consider normal injection site pain. However, the pain did not subside as expected. After 30 days, I was still experiencing shoulder and arm pain at the injection site. The pain felt like a dull muscle ache along my upper left arm and radiated down to my wrist. Additionally, my arm felt mildly numb and weak. The pain interfered with my sleep, and I found some relief by taking two regular ibuprofen and one acetaminophen each night. On the 27th day after the injection, my wife noticed slight redness and swelling at or near the injection site. She described it as barely noticeable. The pain gradually decreased over the following weeks. By 45 to 60 days post-vaccination, I was able to sleep restfully without needing pain medication. However, I don't believe this prolonged pain is typical. Now, just over 60 days after the vaccination, the pain has mostly resolved, but I still experience stiffness in my shoulder when raising my arm overhead. This stiffness is not present in my other shoulder. Thank you for reviewing this report.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Sleep disorder
Clinical narrative: Reporting an Adverse Event Following a Flu Vaccine: I received a flu shot (Fluzone High-Dose Trivalent 2024-2025, Manufacturer: Sanofi-Pasteur, Lot #U8524CA) on October 14, 2024, at the Pharmacy. I am reporting a persistent pain issue that I believe is related to the vaccine injection. Initially, I experienced what I would consider normal injection site pain. However, the pain did not subside as expected. After 30 days, I was still experiencing shoulder and arm pain at the injection site. The pain felt like a dull muscle ache along my upper left arm and radiated down to my wrist. Additionally, my arm felt mildly numb and weak. The pain interfered with my sleep, and I found some relief by taking two regular ibuprofen and one acetaminophen each night. On the 27th day after the injection, my wife noticed slight redness and swelling at or near the injection site. She described it as barely noticeable. The pain gradually decreased over the following weeks. By 45 to 60 days post-vaccination, I was able to sleep restfully without needing pain medication. However, I don't believe this prolonged pain is typical. Now, just over 60 days after the vaccination, the pain has mostly resolved, but I still experience stiffness in my shoulder when raising my arm overhead. This stiffness is not present in my other shoulder. Thank you for reviewing this report.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pruritus, Rash macular
Clinical narrative: Day of the vaccination had chills, extreme fatigue, worsening body aches.  Lasted about 1 week then red blossoming splotches started.  Reddened areas would come and go, and itching was extreme.  Pt went to doctors office twice.  First time: OTC benadryl and hydrocortisone cream was recommended.  Second visit (12/19/24): a medrol dosepak was ordered. Issue has not resolved and it has been about 45 days
Age: 67.0
Sex: M
Vaccine: RSV, TDAP
Symptoms: Arrhythmia, Atrial fibrillation, Cardiac monitoring, Electrocardiogram abnormal
Clinical narrative: Arrhythmia twice on evening of 10/18/2024 and morning of 10/20/2024. Evaluated  at walk in clinic on 10/20/2024. Atrial fibrillation diagnosed. Seen in ER.  Atrial fibrillation stopped spontaneously on 10/20/2024 after two to four hours. No recurrence by symptoms or 30 day heart event monitor.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO SIGNS/SYMPTOMS AT TIME OF GIVEN VACCINE
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, HIBV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given Pentacel in error and the provider ordered Daptacel. No symptoms or side effects at this time.
Age: 16.0
Sex: F
Vaccine: FLU3, MENB, MNQ
Symptoms: Blood glucose normal, Syncope
Clinical narrative: Patient received Meningococcal and MenB in right arm then flu in left arm.  After 3rd injection, patient had syncopal episode.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site pruritus
Clinical narrative: Constant pain and itchiness in entire area of injection. Difficulty lifting injected arm. Constant strong discomfort and pain every day for over three years now.
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events noted, however this vaccine was already given to the patient on 10/03/2023 and therefore is inappropriate to administer at this time.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, PNC20
Symptoms: Injection site swelling
Clinical narrative: Swelling in area where vaccinations were placed
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Patient was given a Moderna COVID 2024-2025 12 years and older dose and patient was 9 years old. No adverse reaction known.  Patient seen on 12/18 with just sore arm and headache. Patient had also recieved his flu shot the same day. No other reaction known
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction occur per patient. Patient received Arexvy vaccines twice on 9/20/23 and 12/18/24
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Pain, Rash
Clinical narrative: low-grade temp, body aches, fatigue, facial rash
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Injection site rash, Rash
Clinical narrative: Mom messaged at 10:25am with a picture of patient's abdominal area. In the picture, patient has a rash from her mid abdomen to the injection site on her left leg. No rash with slightly raised areas. Rash is not warm to touch, no fevers, and not bothering patient.
Age: 24.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blindness transient, Loss of consciousness, Seizure, Tremor
Clinical narrative: Patient received vaccine on 12/18 and called 12/19 to let the pharmacy know that she passed out the morning of 12/19 with her vision going out and it took her 20-30 seconds to recover and when she did, she was shaking / convulsing. She recovered since the incident and did not have another episode. She has no medical history of seizures. Patient informed her doctor's office about the same.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Lip pain, Lip swelling, Oral discomfort, Oral pain, Tongue discomfort
Clinical narrative: Swelling (monor) of lips, raw,sensitive, burning sensation on inside of lips,cheecks, roof of mouth and tongue . . Symptoms worsen after eating anything. Raw, sensitive, fingertips.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: PATIENT ASKED FOR FLU VACCINATION AND RECEIVED IT BUT CAME AFTER TO ASK FOR COVID VACCINATION. PATIENT HAD GOTTEN FLU VACCINATION AT DOCTORS OFFICE THAT MORNING. PATIENT RECEIVED TWO FLU VACCINATIONS IN ONE DAY
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was given Moderna 2024-2025 pediatric dose 5-11 years old dose instead of the adult dose 12 plus. No adverse reaction
Age: 1.08
Sex: M
Vaccine: FLU3, HEPA, MMRV, PNC20, VARCEL
Symptoms: Extra dose administered, Eye discharge, Iron deficiency, Pyrexia, Rhinorrhoea
Clinical narrative: Patient was ordered to have MMR, Varicella, Hep A, Flu, Prevnar 20. In place of original MMR vaccine this MA injected a Proquad vaccine. Patient was also given a Varicella vaccine, there for giving 2 doses of Varicella on the same date. Mistake was found on 12/18/2024. Rn clinical supervisor and supervising Physican were made aware.  Patients' mom was contacted after the mistake was found on 12/18/2024. Clinical supervisor who contacted patient's mom stated patient was doing fine, stated she didn't notice any adverse effects at injection sites. Patients' mom reported mild runny nose and eye discharge that has resolved, she also reported a mild fever only on 12/12/2024 evening. Patients' mom had no questions or concerns about patients' health. MA and Leadership working on this education, so it doesn't happen again.
Age: 1.08
Sex: M
Vaccine: FLU3, HEPA, MMRV, PNC20, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Patient was ordered to have MMR, Varicella, Hep A, Flu, Prevnar 20. In place of original MMR vaccine this MA injected a Proquad vaccine. Patient was also given a Varicella vaccine, there for giving 2 doses of Varicella on the same date. Mistake was found on 12/18/2024. Rn clinical supervisor and supervising Physican were made aware.  Patients' mom was contacted after the mistake was found on 12/18/2024. Clinical supervisor who contacted patient's mom stated patient was doing fine, stated she didn't notice any adverse effects at injection sites. Patients' mom reported mild runny nose and eye discharge that has resolved, she also reported a mild fever only on 12/12/2024 evening. Patients' mom had no questions or concerns about patients' health. MA and Leadership working on this education, so it doesn't happen again.
Age: 37.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event
Clinical narrative: Patient received RSV-Abrysvo on 11/26/2024 and another dose on 12/06/2024   No adverse rea
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Injection site erythema, Injection site inflammation
Clinical narrative: Inflammation and redness at injections site and arm
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a repeat arexvy vaccine - previously got in September 2023. Reports no side effects
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received extra dose of Arexvy, first dose was 12/23/2023
Age: 1.33
Sex: F
Vaccine: DTPPVHBHPB, FLU3, PNC20
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was due for Dtap, flu, PCV20. Vaxelis was given in error instead of Dtap. No adverse event at time of administration.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient got a repeat Arexvy vaccine- initial dose was in September 2024
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling of body temperature change, Injection site erythema, Injection site pruritus
Clinical narrative: redness, warmth, induration, itching at  site of vaccine - onset same day, worsening over 3 days. Hot/cold/chills, faigute for 2 days.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site induration, Vaccination site warmth
Clinical narrative: redness, warmth, induration, itching at  site of vaccine - onset same day, worsening over 3 days. Hot/cold/chills, faigute for 2 days.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Chills, Myalgia, Pyrexia, Vomiting
Clinical narrative: Muscle pain throughout body, fever, chills and comiting.
Age: 1.0
Sex: F
Vaccine: HIBV, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was improperly stored, it was stored in the freezer and not the fridge. Dose was ineffective. No adverse reactions have been reported.
Age: 40.0
Sex: F
Vaccine: HEPAB
Symptoms: Dyspnoea, Nausea
Clinical narrative: Patient received vaccine at the pharmacy and felt fine. She walked out to her car when she started to have difficulty breathing and nausea. She was able to contact 911 and was helped by ambulance to the hospital. She was treated in the ER and sent home
Age: 1.5
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: A single-dose vial of Pfizer 5-11y was diluted with 1.1ml 0.9% sodium chloride and 0.3mL of this mixture was administered to the patient IM in the LVL site. In short, the Pfizer 5-11y vial was treated as if it were the Pfizer 6m-4y multi-dose vial in error.
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reactions have been reported. Patient was given a kinrix instead of dtap and polio separately. No revaccination is needed.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Bacterial test negative, Blood glucose increased, Blood test normal, Brain fog, CSF protein increased
Clinical narrative: Within weeks of the vaccination, he experienced severe headaches, neck pain, and confusion, which are hallmark symptoms of aseptic meningitis or central nervous system inflammation. This was followed by a rapid decline in motor function, including loss of mobility, speech impairments, and swallowing difficulties, which are characteristic of neurological autoimmune conditions such as atypical Guillain-Barré Syndrome (GBS) or Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).  His CSF findings, which show elevated protein (150 mg/dL), high WBC count, and high glucose (considering diabetes), strongly indicate systemic inflammation and immune dysregulation rather than a purely infectious process. Despite the resolution of some virus-like symptoms (e.g., fever, brain fog) after discontinuation of antibiotics, there are persistent neurological deficits. Lack of a positive PCR or infectious markers.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Confusional state, Diplegia, Dysphagia, Gait inability
Clinical narrative: Within weeks of the vaccination, he experienced severe headaches, neck pain, and confusion, which are hallmark symptoms of aseptic meningitis or central nervous system inflammation. This was followed by a rapid decline in motor function, including loss of mobility, speech impairments, and swallowing difficulties, which are characteristic of neurological autoimmune conditions such as atypical Guillain-Barré Syndrome (GBS) or Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).  His CSF findings, which show elevated protein (150 mg/dL), high WBC count, and high glucose (considering diabetes), strongly indicate systemic inflammation and immune dysregulation rather than a purely infectious process. Despite the resolution of some virus-like symptoms (e.g., fever, brain fog) after discontinuation of antibiotics, there are persistent neurological deficits. Lack of a positive PCR or infectious markers.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Headache, Loss of consciousness, Magnetic resonance imaging normal, Meningitis aseptic
Clinical narrative: Within weeks of the vaccination, he experienced severe headaches, neck pain, and confusion, which are hallmark symptoms of aseptic meningitis or central nervous system inflammation. This was followed by a rapid decline in motor function, including loss of mobility, speech impairments, and swallowing difficulties, which are characteristic of neurological autoimmune conditions such as atypical Guillain-Barré Syndrome (GBS) or Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).  His CSF findings, which show elevated protein (150 mg/dL), high WBC count, and high glucose (considering diabetes), strongly indicate systemic inflammation and immune dysregulation rather than a purely infectious process. Despite the resolution of some virus-like symptoms (e.g., fever, brain fog) after discontinuation of antibiotics, there are persistent neurological deficits. Lack of a positive PCR or infectious markers.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Motor dysfunction, Myopathy, Neck pain, Nervous system disorder
Clinical narrative: Within weeks of the vaccination, he experienced severe headaches, neck pain, and confusion, which are hallmark symptoms of aseptic meningitis or central nervous system inflammation. This was followed by a rapid decline in motor function, including loss of mobility, speech impairments, and swallowing difficulties, which are characteristic of neurological autoimmune conditions such as atypical Guillain-Barré Syndrome (GBS) or Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).  His CSF findings, which show elevated protein (150 mg/dL), high WBC count, and high glucose (considering diabetes), strongly indicate systemic inflammation and immune dysregulation rather than a purely infectious process. Despite the resolution of some virus-like symptoms (e.g., fever, brain fog) after discontinuation of antibiotics, there are persistent neurological deficits. Lack of a positive PCR or infectious markers.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Neurological decompensation, Pyrexia, Speech disorder, Tremor, Viral test negative
Clinical narrative: Within weeks of the vaccination, he experienced severe headaches, neck pain, and confusion, which are hallmark symptoms of aseptic meningitis or central nervous system inflammation. This was followed by a rapid decline in motor function, including loss of mobility, speech impairments, and swallowing difficulties, which are characteristic of neurological autoimmune conditions such as atypical Guillain-Barré Syndrome (GBS) or Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).  His CSF findings, which show elevated protein (150 mg/dL), high WBC count, and high glucose (considering diabetes), strongly indicate systemic inflammation and immune dysregulation rather than a purely infectious process. Despite the resolution of some virus-like symptoms (e.g., fever, brain fog) after discontinuation of antibiotics, there are persistent neurological deficits. Lack of a positive PCR or infectious markers.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: Within weeks of the vaccination, he experienced severe headaches, neck pain, and confusion, which are hallmark symptoms of aseptic meningitis or central nervous system inflammation. This was followed by a rapid decline in motor function, including loss of mobility, speech impairments, and swallowing difficulties, which are characteristic of neurological autoimmune conditions such as atypical Guillain-Barré Syndrome (GBS) or Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).  His CSF findings, which show elevated protein (150 mg/dL), high WBC count, and high glucose (considering diabetes), strongly indicate systemic inflammation and immune dysregulation rather than a purely infectious process. Despite the resolution of some virus-like symptoms (e.g., fever, brain fog) after discontinuation of antibiotics, there are persistent neurological deficits. Lack of a positive PCR or infectious markers.
Age: 0.5
Sex: F
Vaccine: DTAPIPV, DTPPVHBHPB, PNC20, RV5
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Instead of receiving a flu vaccine, patient received a Kinrix vaccine in addition to Vaxelis in the same day. Parents informed after reaching out to poison control and the parents reported back that there has been no reaction or change in patient. Patient later rescheduled for flu vaccine on 11/26.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, FLU3, PNC20
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Influenza vaccine (FluLaval) given at the incorrect age. Patient had not yet turned 6 months old at the time of vaccination. Patient was 4 months old on 10/22/2024 which was the date of dose 1.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Death
Clinical narrative: Reporting patient passed away recently.  Death date unknown at this time.   First Vaxelis vaccine given on 12/06/2024.   Patient was to return to HD on 12/20/2024 for additional other vaccines; recently passed away.  Funeral was on 12/19/2024.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site cellulitis, Injection site swelling, Injection site warmth
Clinical narrative: Patient was seen for swelling and warmth of right thigh on 12/19/24.  No other symptoms.  Provider prescribed cefdinir for treatment of right thigh cellulitis.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Throwing up and fever
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Patient's daughter said she had pain since immunization, given OTC pain relief and not getting better. They were in urgent care 12/19 and was referred to ER when daughter inform us of issue about an hour ago.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cough, SARS-CoV-2 test
Clinical narrative: Acute cough
Age: 12.0
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Hypoaesthesia, Oropharyngeal pain, Rash, Rash erythematous, Swollen tongue
Clinical narrative: patient c/o arms feeling numb, throat pain, face and neck redness with rash, tongue swelling
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Duplicate Vaccine given, dose outside of CDC guideline. Patient previously received vaccine 12/22/2023. Patient did not report accurate vaccine history at time of interaction and state immunization database did not show history of RSV vaccine when checked prior to administration.
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: patient received two doses of arexvy 12/02/2023  and 12/17/2024
Age: 6.0
Sex: M
Vaccine: UNK
Symptoms: Injection site reaction
Clinical narrative: Patient is a 6 year old male with no pertinent past medical history who presents with reaction to R arm after getting a flu shot 12/4/24. No fevers. Erythema seemed to be spreading so he went to urgent care. Started abx,  q6h was given cephalexin. Not itchy and not painful.   No other bug bites or other rashes.  Patient remains very active and is otherwise well, no fever, vomiting, diarrhea. No similar reactions in the past.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient does not meet the age requirements for this vaccine.  This vaccine is only for patients 65 y/o and older.  As of today, no adverse symptoms have been reported by the patient since vaccination.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: COVID-19, Myalgia, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: Mild sore throat for 1day and myalgias for 2 days.
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Blood pressure increased, Chills, Decreased appetite, Fatigue
Clinical narrative: Elevated BP 180/100. Fatigue. Low grade fever. Achy muscles and joints.  Chills  loss of appetite
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Myalgia, Pyrexia
Clinical narrative: Elevated BP 180/100. Fatigue. Low grade fever. Achy muscles and joints.  Chills  loss of appetite
Age: 0.75
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Patient was given the Spikevax Moderna COVID-19 vaccine meant for children 12+ years instead of the COVID-19 vaccine for his age range. Patient's mother was made aware the next day and reported low-grade fever, typical reaction after vaccination in a child his age.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pain in extremity, Peripheral coldness
Clinical narrative: woke up with pain to left arm.  Went to ER same day felt ice cold arms, no swelling and pain with movement.
Age: 15.0
Sex: M
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Was Given to early No Side effects
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bursa disorder, Myalgia, Shoulder injury related to vaccine administration, Ultrasound joint abnormal
Clinical narrative: According to the opinion of ARNP,  the patient is more than likely having a shoulder injury related to vaccine administration as a result of vaccine provided on 09/10/24. She was not experiencing any pain in her shoulder prior to receiving her COVID-19 vaccine on 09/10/24. She felt like injection was given higher in the shoulder than it should have been. She has been having pain in the shoulder and bicep area ever since. Called office about this on 10/15/24, seen in office for same on 11/15/24 and on 12/2/24.
Age: 62.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: pt report sore arm beginning after vaccination. has had other medications changing in the mean time but this soreness has remained constant. can only lift to shoulder height, painful when reaching across. pt will discuss with their medical provider
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Nodule, Rash, Skin warm, Swelling
Clinical narrative: 2 inch (width) by 3 inch (height) rash, very hot with swelling and  a knot inside lasting one week.
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Blister, Blood fibrinogen abnormal, Blood smear test abnormal, C-reactive protein abnormal, Crying
Clinical narrative: Days after vaccine, child became fussy and not sleeping. Started amoxicillin for 10 days due to diagnosed ear infection. Child continued to be fussy, not sleeping and then 21 days from the shot, a raised bumpy rash started on child's cheeks and upper arms. Rash continued to worsen each day with fever, snotty nose, irritability, crying in pain and not sleeping. Rash spread to every inch of his body from the top of his head to the bottom of his feet. Rash started as raised red bumps and began to collide into one giant rash. Rash appears as measles rash. As the rash flattened to skin level, it turned dark red/purple. Child sent to ER for vasculitis. PTT/PT levels were elevated and treated with Vit K.  ER swabs child's mouth for measles and canceled lab without attempting to get approved from the health department or notifying the mother. Today is day 21 of the rash and it still has not completely healed. Rash is raised blister looking bumps that are now skin colored that appear on cheeks, arms and legs.
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Ear infection, Full blood count abnormal, Insomnia, Irritability, Metabolic function test abnormal
Clinical narrative: Days after vaccine, child became fussy and not sleeping. Started amoxicillin for 10 days due to diagnosed ear infection. Child continued to be fussy, not sleeping and then 21 days from the shot, a raised bumpy rash started on child's cheeks and upper arms. Rash continued to worsen each day with fever, snotty nose, irritability, crying in pain and not sleeping. Rash spread to every inch of his body from the top of his head to the bottom of his feet. Rash started as raised red bumps and began to collide into one giant rash. Rash appears as measles rash. As the rash flattened to skin level, it turned dark red/purple. Child sent to ER for vasculitis. PTT/PT levels were elevated and treated with Vit K.  ER swabs child's mouth for measles and canceled lab without attempting to get approved from the health department or notifying the mother. Today is day 21 of the rash and it still has not completely healed. Rash is raised blister looking bumps that are now skin colored that appear on cheeks, arms and legs.
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Prothrombin time prolonged, Pyrexia, Rash, Rash erythematous, Rash papular
Clinical narrative: Days after vaccine, child became fussy and not sleeping. Started amoxicillin for 10 days due to diagnosed ear infection. Child continued to be fussy, not sleeping and then 21 days from the shot, a raised bumpy rash started on child's cheeks and upper arms. Rash continued to worsen each day with fever, snotty nose, irritability, crying in pain and not sleeping. Rash spread to every inch of his body from the top of his head to the bottom of his feet. Rash started as raised red bumps and began to collide into one giant rash. Rash appears as measles rash. As the rash flattened to skin level, it turned dark red/purple. Child sent to ER for vasculitis. PTT/PT levels were elevated and treated with Vit K.  ER swabs child's mouth for measles and canceled lab without attempting to get approved from the health department or notifying the mother. Today is day 21 of the rash and it still has not completely healed. Rash is raised blister looking bumps that are now skin colored that appear on cheeks, arms and legs.
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Red blood cell sedimentation rate abnormal, Rhinorrhoea, Urine analysis normal
Clinical narrative: Days after vaccine, child became fussy and not sleeping. Started amoxicillin for 10 days due to diagnosed ear infection. Child continued to be fussy, not sleeping and then 21 days from the shot, a raised bumpy rash started on child's cheeks and upper arms. Rash continued to worsen each day with fever, snotty nose, irritability, crying in pain and not sleeping. Rash spread to every inch of his body from the top of his head to the bottom of his feet. Rash started as raised red bumps and began to collide into one giant rash. Rash appears as measles rash. As the rash flattened to skin level, it turned dark red/purple. Child sent to ER for vasculitis. PTT/PT levels were elevated and treated with Vit K.  ER swabs child's mouth for measles and canceled lab without attempting to get approved from the health department or notifying the mother. Today is day 21 of the rash and it still has not completely healed. Rash is raised blister looking bumps that are now skin colored that appear on cheeks, arms and legs.
Age: 81.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Erythema, Mass, Tenderness
Clinical narrative: Pt states redness the size of a quarter, painful to touch, hard lump under the skin.....seems to be a bit better today, but still painful
Age: 0.67
Sex: M
Vaccine: PNC20
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 3rd dose was given too early in series while following medical/management standing orders. No adverse events noted at this time.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Ear congestion, Erythema, Flushing, Peripheral swelling
Clinical narrative: within 6 hours congestion in left ear, felt heartbeat in ear, swelling and redness of arm, flushing of the face, flushing was intermittent for 2 days, and still has ear congestion currently
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Emotional distress, Guillain-Barre syndrome
Clinical narrative: This is a vaccine error. Patient has had  gullain barre in 10/23/2019. She received influenza vaccine  10/23/2019. Influenza thought to be  the culprit. She inadvertently receive high dose influenza vaccine on 12/11/2024  and understandably very upset and worried. No symptoms  currently  . I am reporting this as a vaccine error and would like advice as to what to do next. Ivig? Can she still receive flu vaccines?  This is less than a week out so we have not yet checked for antibodies. She will see a neurologist tomorrow.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling, Tenderness, Urticaria
Clinical narrative: Hives this AM - has a picture and def looks like hives 3cmx2cm. Now hives resolved. But still with swelling and tenderness.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Myalgia, Pulmonary function test
Clinical narrative: Weakness, shortness of breath, muscle aches
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: second flu vaccine given for 2024 flu season, no reactions, no complications
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis, Hypersensitivity, Injection site reaction
Clinical narrative: Patient came into the pharmacy to pick up an antibiotic and steroid as a result of the pneumonia vaccine she received on 12/12/24.  She said her doctor wasn't sure if it was cellulitis, an allergic reaction, or injection site reaction.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure diastolic increased, Palpitations
Clinical narrative: Heart palpitations and increase diastolic bp lasting 9 days so far.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC20, RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: child was inadvertently given the influenza vaccine prior to 6 months of age
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: large swelling to left deltoid ~2" that has persisted 6 weeks later. Swelling less visible but tender to touch and feels harder than right deltoid.
Age: 5.0
Sex: M
Vaccine: COVID19, DTAP, FLU3, MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Client had received the 1st dose of COVID19 (Moderna) vaccine on 09/20/2024 at the age of 5 years 11 days. On 10/25/2024 client came in for a follow up visit to catch up on vaccines. Client received another dose of COVID19 (Moderna) vaccine at age 5 years, 1 month.  Client presented no adverse reactions within the 15 minute waiting period after administration.   Notified mom of the vaccine error on 12/19 at 3:58 pm. Informed mom that at last appointment, client recevied a dose of COVID19 vaccine that was not needed. When asked, mom stated that client did not have any serious or non-serious reactions after vaccine administration. Mom stated that she did not have any follow up questions regarding the error.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis
Age: 1.08
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: PT WAS GIVEN PROQUAD INSTEAD OF MMR AND VARICELLA SEPERATE. PT HAS HAD NO PHYSICAL RECTIONS AT THIS TIME.
Age: 39.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: Vaccines administered 0817, itching reported 0831, RN observed red welts on face, neck, back, monitored for resolution with reduction in symptoms ~0851 and free of symptoms and released around 0930.  Verified full resolution of symptoms via phone call at 1440 the same day.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, Fatigue, Injection site pain
Clinical narrative: Patient came to pharmacy yesterday for the RSV vaccine and received it. However, patient received an RSV vaccine last year and she forgot. Spoke to patient today and she reports injection site soreness and fatigue. No other issues reported.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pharmacist called and reported that patient has received an "extra dose" of pneumococcal vaccine. Caller stated the patient has had 3 doses of PNEUMOVAX 23 and 1 dose of PREVNAR 13.; Caller stated no patient symptoms were reported.; This spontaneous report was received from pharmacist and refers to a 74-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown dates, the patient was vaccinated with all three doses of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (exact doses, lot #, expiration dates, routes of administration and anatomical locations were not provided); and one dose of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), (1 dose, exact dose, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis (Extra dose administered). No patient symptoms were reported (No adverse event). No additional information provided. No additional AE/no PQC reported.  This is one of two reports from the same reporter.  Lot # is being requested and will be submitted if received.; Sender's Comments:  US-009507513-2412USA006125:MSD
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Medical assistant reported that a patient received an expired PNEUMVAX on 12/16/2024.; This spontaneous report has been received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.  On 16-DEC-2024, the patient was vaccinated with an expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, as a first dose, administered for prophylaxis (lot number reported as X018278, which has been verified as valid, expiration date reported and validated as 24-NOV-2024) (strength, dose, route of administration, and anatomical site of injection were not provided) (Expired product administered).  No additional adverse events were reported in the patient.
Age: 0.17
Sex: U
Vaccine: HEP, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; HCP calling to report that 2 month old inadvertently received both VAXELIS and RECOMBIVAX.  No Adverse effects reported. No other information provided. No additional AE. Confirmed with caller no PQC.; This spontaneous report was received from a medical assistant and refers to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-OCT-2024, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, single dose, lot# W035402 is not valid for  the vaccine, expiration date: 07-MAR-2025, administered for prophylaxis (strength, and route of administration were not provided) and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (manufacturer unknown) (V419) injection, single dose, lot #2CA52C1, expiration date: 24-FEB-2026, administered for prophylaxis (strength, and route of administration were not provided) inadvertently (accidental overdose). No Adverse effects reported (no adverse event). No other information provided. No additional AE.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; PROQUAD was stored in the refrigerator and administered to multiple patients/unsupported PROQUAD was administered; This spontaneous report was received from a Medical Assistant and refers to a 4-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 17-OCT-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (recombinant Human albumin), dose description "not reported", lot #Y002099, expiration date: 09-JUL-2025, administered for prophylaxis (anatomical location, strength, and route of administration were not provided), after vaccine being stored in refrigerator (Product storage error). No reported signs/symptoms of adverse effects. No additional adverse event.  This is one of the several reports from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Caller reports product that experienced temperature excursion beginning 12/7/2024 was administered 12/9/2024. Product had both below and above excursion.  Names of vaccines involved (including lot/expiration) GARDASIL 9 Y007197 8/18/2026 Temperature; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 09-DEC-2024, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, lot # Y007197 with expiration date 18-AUG-2026, for prophylaxis (strength, dose, route of administration and anatomical location were not reported). It was stated that the temperature excursion started on 07-DEC-2024 with a temperature below 36 F° (31.2 F) for 144 hours and above 47 F° (48.3) for 144 hours (discrepant information, as the date of administration was reported as 09-DEC-2024). There were not previous temperature excursions reported. No additional adverse event (AE) was reported.
Sex: U
Vaccine: HIBV, PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms/side effects reported.; Caller reports product that experienced temperature excursion beginning 12/7/2024 was administered 12/9/2024; This spontaneous report was received from a medical assistant concerning to a patient of unspecified age and gender.  The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  Beginning on 07-DEC-2024, doses of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) underwent below and above temperature excursion at temperature below 36 degrees Fahrenheit (F) (31.2 F) for 144 hours, 0 minutes and 0 seconds, and above 47 F (48.3 F) during a timeframe of 144 hours, 0 minutes, and 0 seconds with no previous temperature excursion.  On 09-DEC-2024, the patient was vaccinated with improperly stored doses of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection pre-filled syringe, lot #X026480, expiration date: 12-JAN-2026 (exact dose, dosage regimen, anatomical location and route of administration were not provided); and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #X021053, expiration date: 15-MAY-2026 (exact dose, dosage regimen, anatomical location and route of administration were not provided) (product storage error). Both vaccines were administered as prophylaxis.  No symptoms or side effects were reported (no adverse event.)
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Caller reports product that experienced temperature excursion beginning 12/7/2024 was administered 12/9/2024.; This spontaneous report was received from a other health professional referring to a unknown age and gender patient.   Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On 09-DEC-2024, the patient was vaccinated with an improperly stored dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection, for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location not provided, lot number X026480 and expiration date on 12-JAN-2026). The administered dose of the vaccine experienced a temperature excursion 31.2 degrees Fahrenheit for 144 hours and 48.3-degrees Fahrenheit for 144 hours. It was not reported if the information was recorded by a data logger or not. No previous temperature excursion reported. There was no adverse effect reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a child was given PROQUAD and VARIVAX the same day on unknown date; No symptoms or side effects reported. No additional AE; This spontaneous report has been received from a Physician and referring a child patient of an unknown age and gender.  The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.  On an unknown date, the same day, patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, and varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, dose administered, vaccination schedule, indication, route and anatomical location, lot #, and expiration date were not provided regarding any of the vaccines) (overdose). No symptoms or side effects reported. No additional adverse event (AE) (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; product that experienced temperature excursion beginning 12/7/2024 was administered 12/9/2024; This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 09-DEC-2024, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #Y007197, expiration date: 18-AUG-2026, administered for prophylaxis (strength, and route of administration were not provided) after temperature excursion (beginning 07-DEC-2024) with temperature below 36 degrees F (31.2F) for 144 hours 0 minutes and 0 seconds; and above 47 degrees F (48.3F) for 144 hours 0 minutes and 0 seconds (Product storage error). No symptoms/ side effects reported.