chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: RSV
Symptoms: Premature delivery
Clinical narrative: No concerns during pregnancy. At 35 weeks and 4 days was dilated 1cm and 80% effaced. In 36 weeks and 2 days was dilated 3cm and amniotic fluid was low. For this reason a fetal stress test was done which was normal and 2 doses of betamethasone were given on 36+2 and 36+3. Preterm delivery. Delivered 36 weeks and 4 days. Baby weighed 5lb 15oz and was healthy although APGAR was 8/9 for coloring as it took longer for baby to pink up.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Muscle contractions involuntary, Muscle tightness, Myalgia, Neurological symptom, Paraesthesia
Clinical narrative: I have been having intermittent bilateral calf muscle pains and tightness, some intermittent muscle fasciculations in calf region and peroneal region L > R, and traveling paresthesias that can be in calf region, peroneal, quads. B hamstring tightness greater than normal. I had something similar two or three years ago and felt I needed to report it this year.  Albeit it isn't to the level of GBS, however, they are neurological type symptoms.   I have reported this to my PCP as well.   I have had no changes to physical routine or recreational routine since administration of vaccine
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Fatigue, Headache, Herpes zoster, Nausea
Clinical narrative: 1st symptom severe right sided headache and facial tingling, nov7  diagnosed with shingles to face, near eye, mouth and scalp. Nov 10th saw ophthalmologist no vision problem. Vessicels, rash, pain, itching,  fatigue, nausea, vomiting.  Nov 27 last day of antiviral. To date still dealing with headache, tingling and itching, and fatigue.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Pruritus, Rash, Vomiting
Clinical narrative: 1st symptom severe right sided headache and facial tingling, nov7  diagnosed with shingles to face, near eye, mouth and scalp. Nov 10th saw ophthalmologist no vision problem. Vessicels, rash, pain, itching,  fatigue, nausea, vomiting.  Nov 27 last day of antiviral. To date still dealing with headache, tingling and itching, and fatigue.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, COVID-19
Clinical narrative: hospitalized with COVID
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Dizziness, Gait inability, Hypersomnia
Clinical narrative: Patient received her first dose of Shingrix on 10/27/23 around 2pm.  She says that around 1am, she almost fell out of her bed and then could not see and could not walk.  She stated that she then laid back down and slept into the next afternoon in which she felt woozy.  Patient went to her regular check up a few days later.  Patient stated she completely recovered from this event about 1and 1/2 days after experiencing these symptoms.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Pt has had no adverse reactions at this time.  Pt was given two flu shots one month apart.  He was given the first vaccine on 11/6/23 and the second one on 12/11/23.  Pt indicated that he needed a flu shot on 12/11/23.  Flu shot was given and when this RN went to document the administration, discovered that he had already received a flu shot the previous month.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pruritus, Skin warm
Clinical narrative: Patient came into the pharmacy on 12/12/23 asking for someone to look at her arm. She had received Shingrix shot on 12/8/23. Patient's arm was really red, swollen, bruised, and warm to the touch.  The area affected was not where the shot was given in the arm. It was located on her lower arm near the elbow.  Patient proceeded to say that the redness and swelling keeps getting worse and very itching. Spoke to patient about contacting her primary physician to examine the area  and potentially taking Benadryl to help.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Occipital neuralgia, Pain of skin
Clinical narrative: pt developed Headache and shooting scalp pain the very next day after immunization- From physical exam determined to be occipital neuralgia
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: Shoulder pain and decreased ROM
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in ear
Age: 18.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Nausea, Pruritus, Urticaria, Vomiting
Clinical narrative: 12/04/23  1500   Received Varicella vax LPA, X017485, Exp 1/25/25 Received Heplisav vax LD. 0944609, Exp 01/29/26  LPA Arm started itching on the way home Spread down LT arm  12/07/23   Woke with pruritis, hives on neck, subsequently spread to back.  Self administered Benadryl.  12/07/23   Hives reoccurred. Self administered Benadryl.  12/08/23   Pruritis and hives spread to arms, torso, back, with nausea/vomiting.  Went to clinic.  Received steroid inj, and Rx for Pepcid and another ?allergy drug?.  12/12/2023  Reports no hives, but body is ?achy?
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hyperhidrosis, Muscle spasms, Pyrexia
Clinical narrative: after receiving spikevax patient experienced fever, sweating, leg cramps...when she got up at around 4am she fainted and hit her head on the wall. her husband heard it and came to her aid. she was probably out for less than 1 minute. she called the doctor and doctor said to just monitor the  situation and report if there is any continuing or new symptoms (there were none)
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received Moderna bivalent covid vaccine on 9/6/2023 and received spikevax covid vaccine on 10/03/2023. This did not follow the vaccination schedule of waiting 2 months between vaccines.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Small intestinal obstruction, Vomiting
Clinical narrative: Nausea/vomiting. Patient inadvertently received COVID 19 vaccine on 11/21/23, even though she received one on 10/8/2023. Patient admitted for possible adverse reaction to vaccine but was also diagnosed with a partial small bowel obstruction.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Fluzone HD was given instead of Fluzone Quadrivalent.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: I have mild pain in my upper left arm. Slight redness and itching at the injection site.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Fluzone HD was given instead of Fluzone Quadrivalent.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Bedridden, Blood test abnormal, Epstein-Barr virus infection, Fatigue
Clinical narrative: Within 2 weeks of receiving the vaccine, I became incredibly ill with high fever, swollen glands, sore throat and severe fatigue. I was unable to care for my baby and was completely bed ridden. I was soon diagnosed with Epstein Bar Virus via bloodwork. From there, I developed a severe case of Shingles that ran along 4 nerve pathways. After months of being sick from these viruses that overtook my system because of the vaccine, I spent the next four years with severe muscular pain and debilitating chronic fatigue
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Loss of personal independence in daily activities, Lymphadenopathy, Malaise, Myalgia
Clinical narrative: Within 2 weeks of receiving the vaccine, I became incredibly ill with high fever, swollen glands, sore throat and severe fatigue. I was unable to care for my baby and was completely bed ridden. I was soon diagnosed with Epstein Bar Virus via bloodwork. From there, I developed a severe case of Shingles that ran along 4 nerve pathways. After months of being sick from these viruses that overtook my system because of the vaccine, I spent the next four years with severe muscular pain and debilitating chronic fatigue
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Within 2 weeks of receiving the vaccine, I became incredibly ill with high fever, swollen glands, sore throat and severe fatigue. I was unable to care for my baby and was completely bed ridden. I was soon diagnosed with Epstein Bar Virus via bloodwork. From there, I developed a severe case of Shingles that ran along 4 nerve pathways. After months of being sick from these viruses that overtook my system because of the vaccine, I spent the next four years with severe muscular pain and debilitating chronic fatigue
Age: 27.0
Sex: M
Vaccine: HEPAB, HPV9
Symptoms: Injection site bruising, Injection site mass, Injection site pain, Pain, Pain in extremity
Clinical narrative: Telemedicine visit on 12/6 with Dr describing his symptoms. Pain with abduction and elevation starting at about 15 degrees. Pain is located at injection site, with bruising and bumps around the injection site.  Pain in right arm began a few hours after injections and continued to get worse over time.   I called patient on 12/6 after his visit and asked that he come by health center so we could evaluate his right arm further. Patient stated he would come by later that day but never showed then said he would come by the next day or day after. He never returned and Dr sent a portal message to follow up with patient but no response.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Fluzone HD administered instead of Fluzone Quadrivalent
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Fluzone HD given instead of Fluzone Quadrivalent
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Fluzone HD given instead of Fluzone Quadrivalent
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had 12-month well child visit and was inadvertently given MMRV instead of Varicella vaccine. Patient received Hep A, MMR, and MMRV vaccine at that visit. Provider was notified when error was discovered and he had no concern for serious side effects. Informed parents of patient that error occurred. Father did not report any noticeable side effect from the error.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiocardiogram, Cardiac stress test, Echocardiogram, X-ray
Clinical narrative: Aortic root at the level of the sinus of Valsalva: 4.2 cm, Z score: 2.1 (based off provided height, weight, age and body surface area calculated using these parameters) Ascending aorta at the level of the main pulmonary artery: 3.2 cm, index value 1.5 cm/m\S\2, Within normal limits Descending aorta at the level of the main pulmonary artery: 2.4 cm, index value 1.1 cm/m\S\2, Within normal limits
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Fluzone HD given instead of Fluzone Quadrivalent.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Moderna Spikevax for 12 and older when he is 8 yrs old.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Pt was given Pfizer BioNTech  COVID-19 Vaccine for 5y to <12y dose of 0.3 ml
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Laboratory test normal, Malaise, Nausea
Clinical narrative: This RN was contacted by nurse which is employee's nurse. RN was told that client started feeling ill the evening of 12/1/23 with fatigue, headache, and nausea. Several days later on 12/6/23, client started with severe vertigo in which he went to local ER. Client was given IV infusion and labs were obtained and client was sent home. Client was seen by his eye doctor with no issues on unknown date. Client then was sent to ENT on either 12/7/23 or 12/8/23 with no issues found. Client returned back to work on 12/12/23 with continued vertigo.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: This RN was contacted by nurse which is employee's nurse. RN was told that client started feeling ill the evening of 12/1/23 with fatigue, headache, and nausea. Several days later on 12/6/23, client started with severe vertigo in which he went to local ER. Client was given IV infusion and labs were obtained and client was sent home. Client was seen by his eye doctor with no issues on unknown date. Client then was sent to ENT on either 12/7/23 or 12/8/23 with no issues found. Client returned back to work on 12/12/23 with continued vertigo.
Age: 88.0
Sex: F
Vaccine: RSV
Symptoms: Immunisation, Product preparation issue
Clinical narrative: Patient was accidently injected with adjuvant suspension only. Patient was notified of error. Patient was administered correctly mixed vaccine less than 5 minutes after first injection.  Pharmacist will call patient in 24 hours to inquire about any adverse affects.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient received wrong dose of vaccine. observed for 15 minutes. no known reactions
Age: 19.0
Sex: F
Vaccine: COVID19, HPV9
Symptoms: Dizziness, Electrocardiogram
Clinical narrative: Patient received HPV and covid vaccine at 1400. She received covid first then HPV. Then she expressed that she was feeling lightheaded. This MA laid the patient down and came and got other CMA. This MA abd other CMA laid an ice pack on the patients forehead. CMA advised this MA to go get Dr. Dr arrived in the room at 1403. Dr. advised to get an EKG and get another set of vital signs. MA proceeded to get the vital signs at 1405 BP was 108/72, pulse 90, pulse ox 97%. This MA proceeded to do the EKG. After EKG was performed this MA went and got Dr. to look at EKG results and assess the patient. Dr. gave permission for the patient to leave. Patient checked out at 1436.
Age: 48.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Redness, swelling, pain, heat at the site of vaccination
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Nausea, Retching
Clinical narrative: within 24 hours he started having nausea and retching that did not respond to Zofran
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient said he developed an itchy rash down his back starting a few hours after vaccination.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Member came to visit the OBGYN provider.  Patient agreed to receive the covid vaccine.  Covid vaccine signed by the physician.  CA administered the 5-11yo dose instead of the 12+ dose of the pfizer covid vaccine.  Member called to come back and recieve regular adult dose per CDC recommendations.
Age: 4.0
Sex: F
Vaccine: DTAP, HEP, VARCEL
Symptoms: Rash, Rash erythematous, Rash pruritic, Scab
Clinical narrative: Pt started geting rash on face aprox one month after vaccines were given. Individual red spots on face only. Pt reported spots itchy but not painful. Some appeared to be scabbing over. Mom stated she did not give any meds  or apply lotions or cream to the area.
Age: 87.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Balance disorder, Condition aggravated, Vertigo, Vestibular neuronitis
Clinical narrative: He go this vaccine, on Tuesday he had an episode of severe vertigo.  Then on Thursday he had similar reactions and again today.  He looses his balance and has the vertigo.  He took Meclizine which did not take, and he talked to his doctor and he put him on steroids again (prednisone).    He has a history of vestibular neuritis in August of this year, it started very suddenly, and was treated with Prednisone for 4-5 weeks, tapered off and then about 6-7 weeks he was back doing his normal activities.    He was fine until he took the vaccine, and feels that the vaccine exacerbated the vestibular neuritis.    He is a physician and he wants to  know if there is a combination of the vaccine and vestibular neuritis. He wants to know what exact neurological condition happens.   He had total remission for a long time and then got the vaccine and now it is back again.    He had all of his other vaccines, had COVID vaccines with no reactions at all.
Age: 87.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Condition aggravated, Vestibular neuronitis
Clinical narrative: He go this vaccine, on Tuesday he had an episode of severe vertigo.  Then on Thursday he had similar reactions and again today.  He looses his balance and has the vertigo.  He took Meclizine which did not take, and he talked to his doctor and he put him on steroids again (prednisone).    He has a history of vestibular neuritis in August of this year, it started very suddenly, and was treated with Prednisone for 4-5 weeks, tapered off and then about 6-7 weeks he was back doing his normal activities.    He was fine until he took the vaccine, and feels that the vaccine exacerbated the vestibular neuritis.    He is a physician and he wants to  know if there is a combination of the vaccine and vestibular neuritis. He wants to know what exact neurological condition happens.   He had total remission for a long time and then got the vaccine and now it is back again.    He had all of his other vaccines, had COVID vaccines with no reactions at all.
Age: 30.0
Sex: M
Vaccine: RAB
Symptoms: No adverse event, Product use issue
Clinical narrative: Patient did not experience any adverse events; however, the pharmacist realized after the vaccine was administered that we are not authorized to administer the rabies vaccine post-exposure.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Cough, Influenza like illness, Pain, Pyrexia
Clinical narrative: Having flulike symptoms, fever, body aches, chills.  Is able to eat and drink. Followed by persistent cough lasting 1 month later.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Thrombosis
Clinical narrative: BLOOD CLOTS IN LUNGS AND LEGS
Age: 51.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Injection site cellulitis, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: At the injection site, patient expierneced rash and erythema. Rash is warm to the touch and swollen.
Age: 51.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Cellulitis, Erythema, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: At the injection site, patient expierneced rash and erythema. Rash is warm to the touch and swollen.
Age: 51.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Skin warm
Clinical narrative: At the injection site, patient expierneced rash and erythema. Rash is warm to the touch and swollen.
Age: 10.0
Sex: F
Vaccine: COVID19-2, FLU4, HEP, HEPA, IPV, MMR, MNQ, VARCEL
Symptoms: Wrong product administered
Clinical narrative: This child came in for vaccines. I did not have my list I typically use in front of me & used a coworkers.  That one looked like menveo should have been given as well. Completely my fault, I know better. Wondered if something changed that I did not know about.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received Moderna Spikvax 0.5 ml instead of the recommended Moderna 6m-11yd dose of 0.25 ml.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was given pediatric dose of Covid vaccine in error. Mistake identified within 5 minutes of administration. Provider notified. Provider instructed to offer patient a second pediatric dose of Covid vaccine in order to equal a full adult dose. Error explained to patient.  Patient agreed with plan and second pediatric dose of Covid vaccine given 20 minutes after initial dose.  No adverse reactions noted. Instructed to call with any adverse effects or reactions. Also instructed on signs and symptoms that would warrant going to ER immediately. Patient verbalized understanding.
Age: 74.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: THE PATIENT WANTED TO RECEIVE A VACCINE FOR RSV, NOT FLU.  PT HAS NOT EXPERIENCED ANY SIDE EFFECTS FROM THE VACCINE, JUST A SORE ARM
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Asthenia, Dizziness, Feeling cold, Head discomfort
Clinical narrative: She got her vaccine, and after a couple of hours she was getting chilly, did not seem to be able to warm up.  Her joints started to hurt, and then she went to bed, woke up and had a horrific headache.  The pressure was all over and behind her eyes.  She still has the headache on the top of her head and it traveled down the back of her neck.  When she first got up she felt queasy and ate and that went away.  The headache has not gone away yet, and was a little woozy and weak this morning.  She has not been taking anything for the headache as she has not felt well enough to go up the stairs to get something.  She did send a message to her doctor that she had a reaction to the vaccine.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Nausea, Neck pain, Ocular discomfort
Clinical narrative: She got her vaccine, and after a couple of hours she was getting chilly, did not seem to be able to warm up.  Her joints started to hurt, and then she went to bed, woke up and had a horrific headache.  The pressure was all over and behind her eyes.  She still has the headache on the top of her head and it traveled down the back of her neck.  When she first got up she felt queasy and ate and that went away.  The headache has not gone away yet, and was a little woozy and weak this morning.  She has not been taking anything for the headache as she has not felt well enough to go up the stairs to get something.  She did send a message to her doctor that she had a reaction to the vaccine.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient incorrectly given high dose flu vaccine
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccination given past expiration date 10/31/2023. Patient notified and verbalized no adverse symptoms. Clinical director notified.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy, onset 12/7/23
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The patient received Pfizer 30mcg/0.3ml for their third COVID vaccine. Based on the schedule and their age, they should have received Pfizer 10 MCG/0.3 ML or Moderna 25 MCG/0.25 ML for patient age 5 - 11 yo with history of covid vaccination.  There were no known adverse events after vaccination.
Age: 88.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Gait disturbance
Clinical narrative: Persistent mild to moderate light headedness, not correlated with blood pressure, enough to limit use of stairs. Physician has been notified.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: THE CORRECT DOSE WAS ORDERED BY THE PROVIDER FOR THE PATIENT, HOWEVER, THE MEDICAL ASSISTANT PULLED AND ADMINISTERED THE INCORRECT DOSE. NO ADVERSE REACTION OCCURED OTHER THAN THE HIGHER DOSE BEING ADMINISTERED. PATIENT WAS COUNSELED ON POSSIBLE REACTIONS AND VERBALIZED UNDERSTANDING. THIS WAS ALSO REPORTED TO SANOFI.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient received Pfizer 30mcg/0.3ml on 10/16/23. Per the schedule and the patients age, they should have received Pfizer 10 MCG/0.3 ML or Moderna 25 MCG/0.25 ML for patient age 5 - 11 yo with history of covid vaccination.  No known adverse events from the vaccine.
Age: 55.0
Sex: M
Vaccine: COVID19, FLU4, PNC20
Symptoms: Brain stem infarction, Dysarthria, Facial paralysis, Hemiparesis, Hypoaesthesia
Clinical narrative: The patient noticed left sided weakness and left facial numbness around 8:30a the morning after receiving vaccines.  The patient called his wife around 10:30a  and she noticed he was slurring his speech and had facial drooping on the left side.  The patient's wife took him to the emergency room and he was admitted to the hospital.  A MRI of the brain showed an acute anterior right paramedian pontine infarction.  A thrombolytic was not indicated due to outside of tPA window.  Thrombectomy not indicated.  The patient stayed 2 days in the hospital.  The patient was discharged 10/26/2023 in stable condition with symptoms improving.
Age: 55.0
Sex: M
Vaccine: COVID19, FLU4, PNC20
Symptoms: Magnetic resonance imaging head abnormal
Clinical narrative: The patient noticed left sided weakness and left facial numbness around 8:30a the morning after receiving vaccines.  The patient called his wife around 10:30a  and she noticed he was slurring his speech and had facial drooping on the left side.  The patient's wife took him to the emergency room and he was admitted to the hospital.  A MRI of the brain showed an acute anterior right paramedian pontine infarction.  A thrombolytic was not indicated due to outside of tPA window.  Thrombectomy not indicated.  The patient stayed 2 days in the hospital.  The patient was discharged 10/26/2023 in stable condition with symptoms improving.
Age: 79.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: pt came in and requested a flu shot. It was discovered after that they had already gotten the flu shot in august. No adverse events have occurred.
Age: 82.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: PATIENT WAS ADAMENT THAT THEY HAD NOT RECEIVED THE FLU VACCINE, HOWEVER, AFTER FURTHER INVESTIGATION, THEY HAD IN FACT GOT IT FOUR MONTHS AGO. THEREFORE, PATIENT GOT TWO FLU VACCINES.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Bell's palsy
Clinical narrative: She developed Bell's palsy 2-3 days after the COVID vaccine. She thinks it was Pfizer but isn't sure.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Albumin globulin ratio normal, Aspartate aminotransferase normal, Basophil count, Basophil percentage, Biopsy skin
Clinical narrative: 10/25/23: developed BLE rash described as no itching and no pain but spots that started spreading significantly within 24 hrs. 10/26/23: same description from patient during telemed visit. BLE petechiae and purpura. No other signs of infection, bleeding, ROS unremarkable save for her history of vaccination and history of skin cancers in past (nothing active). stat cbc, cmp. and she had a same-day urgent appt with dermatology who did a punch bx and UA. Derm prescribed clobetasol ointment which the patient applied to BLE daily. 11/1/23: patient's rash improving BLE. still no other signs of bleeding, infection, no itching. 11/14/23: patient's rash nearly gone. she continued using the clobetasol until rash had resolved.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin increased, Blood calcium normal, Blood chloride normal
Clinical narrative: 10/25/23: developed BLE rash described as no itching and no pain but spots that started spreading significantly within 24 hrs. 10/26/23: same description from patient during telemed visit. BLE petechiae and purpura. No other signs of infection, bleeding, ROS unremarkable save for her history of vaccination and history of skin cancers in past (nothing active). stat cbc, cmp. and she had a same-day urgent appt with dermatology who did a punch bx and UA. Derm prescribed clobetasol ointment which the patient applied to BLE daily. 11/1/23: patient's rash improving BLE. still no other signs of bleeding, infection, no itching. 11/14/23: patient's rash nearly gone. she continued using the clobetasol until rash had resolved.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine normal, Blood glucose normal, Blood sodium normal, Blood urea nitrogen/creatinine ratio increased, Blood urea normal
Clinical narrative: 10/25/23: developed BLE rash described as no itching and no pain but spots that started spreading significantly within 24 hrs. 10/26/23: same description from patient during telemed visit. BLE petechiae and purpura. No other signs of infection, bleeding, ROS unremarkable save for her history of vaccination and history of skin cancers in past (nothing active). stat cbc, cmp. and she had a same-day urgent appt with dermatology who did a punch bx and UA. Derm prescribed clobetasol ointment which the patient applied to BLE daily. 11/1/23: patient's rash improving BLE. still no other signs of bleeding, infection, no itching. 11/14/23: patient's rash nearly gone. she continued using the clobetasol until rash had resolved.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Carbon dioxide, Eosinophil count, Eosinophil percentage, Full blood count normal, Globulins increased
Clinical narrative: 10/25/23: developed BLE rash described as no itching and no pain but spots that started spreading significantly within 24 hrs. 10/26/23: same description from patient during telemed visit. BLE petechiae and purpura. No other signs of infection, bleeding, ROS unremarkable save for her history of vaccination and history of skin cancers in past (nothing active). stat cbc, cmp. and she had a same-day urgent appt with dermatology who did a punch bx and UA. Derm prescribed clobetasol ointment which the patient applied to BLE daily. 11/1/23: patient's rash improving BLE. still no other signs of bleeding, infection, no itching. 11/14/23: patient's rash nearly gone. she continued using the clobetasol until rash had resolved.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Glomerular filtration rate decreased, Haematocrit normal, Haemoglobin normal, Immature granulocyte count, Lymphocyte count
Clinical narrative: 10/25/23: developed BLE rash described as no itching and no pain but spots that started spreading significantly within 24 hrs. 10/26/23: same description from patient during telemed visit. BLE petechiae and purpura. No other signs of infection, bleeding, ROS unremarkable save for her history of vaccination and history of skin cancers in past (nothing active). stat cbc, cmp. and she had a same-day urgent appt with dermatology who did a punch bx and UA. Derm prescribed clobetasol ointment which the patient applied to BLE daily. 11/1/23: patient's rash improving BLE. still no other signs of bleeding, infection, no itching. 11/14/23: patient's rash nearly gone. she continued using the clobetasol until rash had resolved.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Monocyte count
Clinical narrative: 10/25/23: developed BLE rash described as no itching and no pain but spots that started spreading significantly within 24 hrs. 10/26/23: same description from patient during telemed visit. BLE petechiae and purpura. No other signs of infection, bleeding, ROS unremarkable save for her history of vaccination and history of skin cancers in past (nothing active). stat cbc, cmp. and she had a same-day urgent appt with dermatology who did a punch bx and UA. Derm prescribed clobetasol ointment which the patient applied to BLE daily. 11/1/23: patient's rash improving BLE. still no other signs of bleeding, infection, no itching. 11/14/23: patient's rash nearly gone. she continued using the clobetasol until rash had resolved.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Monocyte percentage increased, Neutrophil count, Neutrophil percentage, Rash, Red blood cell count
Clinical narrative: 10/25/23: developed BLE rash described as no itching and no pain but spots that started spreading significantly within 24 hrs. 10/26/23: same description from patient during telemed visit. BLE petechiae and purpura. No other signs of infection, bleeding, ROS unremarkable save for her history of vaccination and history of skin cancers in past (nothing active). stat cbc, cmp. and she had a same-day urgent appt with dermatology who did a punch bx and UA. Derm prescribed clobetasol ointment which the patient applied to BLE daily. 11/1/23: patient's rash improving BLE. still no other signs of bleeding, infection, no itching. 11/14/23: patient's rash nearly gone. she continued using the clobetasol until rash had resolved.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Red cell distribution width normal, White blood cell count
Clinical narrative: 10/25/23: developed BLE rash described as no itching and no pain but spots that started spreading significantly within 24 hrs. 10/26/23: same description from patient during telemed visit. BLE petechiae and purpura. No other signs of infection, bleeding, ROS unremarkable save for her history of vaccination and history of skin cancers in past (nothing active). stat cbc, cmp. and she had a same-day urgent appt with dermatology who did a punch bx and UA. Derm prescribed clobetasol ointment which the patient applied to BLE daily. 11/1/23: patient's rash improving BLE. still no other signs of bleeding, infection, no itching. 11/14/23: patient's rash nearly gone. she continued using the clobetasol until rash had resolved.
Age: 9.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Patient given DTAP instead of TDAP
Age: 1.08
Sex: M
Vaccine: FLUC4, HEPA, MMR
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient was being seen for a WCC and needed vaccines.  The unit we have has a bi-directional interface with our EHR system so that orders placed in our EHR system go to our unit to tell it which vaccines to pull. The order placed was for MMR, Hep A and Varicella. According to the staff member who gathered the vaccines, what dispensed from the order was MMR, Hep A and Flulaval. The Flulaval was given to the patient (patient's 3rd dose this season) instead of the Varciella.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Antinuclear antibody positive, Arthralgia, Biopsy site unspecified normal, C-reactive protein increased, Chills
Clinical narrative: 53 yo F with reported history of anxiety, insomnia, bulimia nervosa, eating disorder, hypothyroidism, H/o Hashimoto's disease, asthma, dyslipidemia, and impaired fasting glucose.  Had started increasing her activity level with more walking. While at first visit with PCP to establish care, pt received Shingrix vaccine in her left arm at 1634 3/13/23 (lot # K2B5N).   Patient reported afterward she experienced body aches, shaking and chills, needing a hot water bath that night to stay warm. Also started a new medication "Beberbine 500mg po daily" for cholesterol and blood sugar metabolism.  The next day, she developed pain in hips and buttocks and had significant morning stiffness.  She started to feel better but then increased her physical activity from "sedentary" to "megawalks" which consist of 20,000 steps at a time.  Developed worsening pain noted bilateral knee pain and effusions and developed bilateral shoulder pain, started in left and then right, she thought due to overusing them.   Treated with ketorolac and baclofen.  Then tried cyclobenzaprine.  Tried multiple supportive care measures at home such as physical therapy, massage, Epsom salt soaks.  Arthralgias with myalgias seem to respond significantly to prednisone.  Initial CRP was 0.49 4/29/23 and rose to 0.9 8/2/23 and then 1.40 8/29/23.  ANA positive.  EBV antibody positive (immune).  Diagnosed with polymyalgia rheumatica August 2023 and Giant Cell arteritis (biopsy negative).  Patient concerned that Shringix is responsible for onset of autoimmune disease.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Epstein-Barr virus antibody positive, Feeling cold, Giant cell arteritis, Injection site pain, Joint effusion
Clinical narrative: 53 yo F with reported history of anxiety, insomnia, bulimia nervosa, eating disorder, hypothyroidism, H/o Hashimoto's disease, asthma, dyslipidemia, and impaired fasting glucose.  Had started increasing her activity level with more walking. While at first visit with PCP to establish care, pt received Shingrix vaccine in her left arm at 1634 3/13/23 (lot # K2B5N).   Patient reported afterward she experienced body aches, shaking and chills, needing a hot water bath that night to stay warm. Also started a new medication "Beberbine 500mg po daily" for cholesterol and blood sugar metabolism.  The next day, she developed pain in hips and buttocks and had significant morning stiffness.  She started to feel better but then increased her physical activity from "sedentary" to "megawalks" which consist of 20,000 steps at a time.  Developed worsening pain noted bilateral knee pain and effusions and developed bilateral shoulder pain, started in left and then right, she thought due to overusing them.   Treated with ketorolac and baclofen.  Then tried cyclobenzaprine.  Tried multiple supportive care measures at home such as physical therapy, massage, Epsom salt soaks.  Arthralgias with myalgias seem to respond significantly to prednisone.  Initial CRP was 0.49 4/29/23 and rose to 0.9 8/2/23 and then 1.40 8/29/23.  ANA positive.  EBV antibody positive (immune).  Diagnosed with polymyalgia rheumatica August 2023 and Giant Cell arteritis (biopsy negative).  Patient concerned that Shringix is responsible for onset of autoimmune disease.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Myalgia, Pain, Polymyalgia rheumatica
Clinical narrative: 53 yo F with reported history of anxiety, insomnia, bulimia nervosa, eating disorder, hypothyroidism, H/o Hashimoto's disease, asthma, dyslipidemia, and impaired fasting glucose.  Had started increasing her activity level with more walking. While at first visit with PCP to establish care, pt received Shingrix vaccine in her left arm at 1634 3/13/23 (lot # K2B5N).   Patient reported afterward she experienced body aches, shaking and chills, needing a hot water bath that night to stay warm. Also started a new medication "Beberbine 500mg po daily" for cholesterol and blood sugar metabolism.  The next day, she developed pain in hips and buttocks and had significant morning stiffness.  She started to feel better but then increased her physical activity from "sedentary" to "megawalks" which consist of 20,000 steps at a time.  Developed worsening pain noted bilateral knee pain and effusions and developed bilateral shoulder pain, started in left and then right, she thought due to overusing them.   Treated with ketorolac and baclofen.  Then tried cyclobenzaprine.  Tried multiple supportive care measures at home such as physical therapy, massage, Epsom salt soaks.  Arthralgias with myalgias seem to respond significantly to prednisone.  Initial CRP was 0.49 4/29/23 and rose to 0.9 8/2/23 and then 1.40 8/29/23.  ANA positive.  EBV antibody positive (immune).  Diagnosed with polymyalgia rheumatica August 2023 and Giant Cell arteritis (biopsy negative).  Patient concerned that Shringix is responsible for onset of autoimmune disease.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: 53 yo F with reported history of anxiety, insomnia, bulimia nervosa, eating disorder, hypothyroidism, H/o Hashimoto's disease, asthma, dyslipidemia, and impaired fasting glucose.  Had started increasing her activity level with more walking. While at first visit with PCP to establish care, pt received Shingrix vaccine in her left arm at 1634 3/13/23 (lot # K2B5N).   Patient reported afterward she experienced body aches, shaking and chills, needing a hot water bath that night to stay warm. Also started a new medication "Beberbine 500mg po daily" for cholesterol and blood sugar metabolism.  The next day, she developed pain in hips and buttocks and had significant morning stiffness.  She started to feel better but then increased her physical activity from "sedentary" to "megawalks" which consist of 20,000 steps at a time.  Developed worsening pain noted bilateral knee pain and effusions and developed bilateral shoulder pain, started in left and then right, she thought due to overusing them.   Treated with ketorolac and baclofen.  Then tried cyclobenzaprine.  Tried multiple supportive care measures at home such as physical therapy, massage, Epsom salt soaks.  Arthralgias with myalgias seem to respond significantly to prednisone.  Initial CRP was 0.49 4/29/23 and rose to 0.9 8/2/23 and then 1.40 8/29/23.  ANA positive.  EBV antibody positive (immune).  Diagnosed with polymyalgia rheumatica August 2023 and Giant Cell arteritis (biopsy negative).  Patient concerned that Shringix is responsible for onset of autoimmune disease.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: administering nurse gave expired covid vaccine, no adverse effect
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Gait disturbance, Mobility decreased, Pain in extremity
Clinical narrative: pt came in today  12/12/23:reporting s/s: sore arm, joint pain (difficulty walking), and limited ROM
Age: 0.17
Sex: M
Vaccine: UNK
Symptoms: No adverse event
Clinical narrative: told pt to wait 15 min after vaccine, saw no reaction after vaccine
Age: 37.0
Sex: F
Vaccine: COVID19, FLUC4, COVID19, FLUC4
Symptoms: Ear inflammation, Headache, Tinnitus
Clinical narrative: 24 hours after the vaccines I started experiencing ringing and inflammation in both ear, particularly worst on my right ear. My inner ear feels inflamed and pounding when I'm walking and I'm constantly hearing a ring as if I had been to a super loud concert, which I haven't. It's been more that 3 days now and the ringing is not stopping. I reached out to my PC and waiting to hear back on whether I need to be seen or not.
Age: 37.0
Sex: F
Vaccine: COVID19, FLUC4, COVID19, FLUC4
Symptoms: Inner ear inflammation, Tinnitus
Clinical narrative: 24 hours after the vaccines I started experiencing ringing and inflammation in both ear, particularly worst on my right ear. My inner ear feels inflamed and pounding when I'm walking and I'm constantly hearing a ring as if I had been to a super loud concert, which I haven't. It's been more that 3 days now and the ringing is not stopping. I reached out to my PC and waiting to hear back on whether I need to be seen or not.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC15, RV1
Symptoms: No adverse event
Clinical narrative: ask pt to wait 15 min after vaccine saw no reaction after 15 min given vaccine
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: administering nurse gave expired covid vaccine, no adverse effect
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: the patient has no side effects; the 3rd dose was given at 7 months 5 days of age, on 11/20/2023 at 3:30PM; second dose of PEDVAX HIB was given at 3 months post the first vaccination instead of the PI recommended 2 months; This spontaneous report was received from a medical assistant referring to a 5-month-old infant with unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-JUN-2023, when the patient was 2.5 months, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (0.5ml/once; strength, lot #, expiry date, and route of administration were not provided) for prophylaxis. The second dose was given on 25-SEP-2023, when patient was 5 months and 10 days of age (0.5ml; strength, lot #, expiry date, and route of administration were not provided), it was given at 3 months post the first vaccination instead of the recommended 2 months (inappropriate schedule of product administration). The patient's third dose was given on 20-NOV-2023 at 15:30, when the patient was 7 months 5 days of age (0.5ml, lot#: X005171 with expire date 13-NOV-2025), however the 3rd/booster dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) should not be administered prior to 12 months of age (product administered to patient of inappropriate age). The patient had no side effects.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The nurse is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VARIVAX (x006983   3/7/2025) Temperature: 6.2F  Time frame: 5; This spontaneous report was received from an nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-NOV-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #x006983, expiration date: 07-MAR-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion in 6.2 Farenheit for 5 minutes wih no previous temperature excursion (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: No additional AE/PQC; HCP called to report that an adult patient was accidentally given a pediatric dose of RECOMBIVAX HB. No symptomatic events were reported. No additional information provided. No additional AE/PQC. Operator of device= HCP; This spontaneous report was received from a medical assistant and refers to an adult patient of unspecified age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 05-DEC-2023, the patient was vaccinated by health care professional (HCP) with pediatric dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 0,5 milliliter (also reported as series), lot # w025817, expiration date 21-MAY-2025 (route of administration and anatomical location were not provided) for prophylaxis (adult use of a child product). No additional adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP calling to report an AE regarding PNEUMOVAX 23. HCP reported that a patient was administered an expired dose of the PNEUMOVAX 23 vaccine. Patient was administered the vaccine on 12/07/2023. HCP had no further clarifications. Permission was provid; This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 07-DEC-2023 the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # W021636 and expiration date 01-OCT-2023, for prophylaxis (exact dose, dose number, route and site of administration were not provided) (expired product administered and no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects reported; HCP calling to report an expired GARDASIL 9 immunization was inadvertently administered to a patient. No side effects reported. No additional AE/no PQC.; This spontaneous report was received from a pharmacist and refers to a 11-year-old patient. No information on patient's medical history, current conditions, and concomitant medications.  On 07-DEC-2023 the patient was vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1780878 and expiration date 02-DEC-2023, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided) (expired product administered and no adverse event).