chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: She got COVID after the vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 68-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Lot number: HH7595) at the age of 66 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Mar2021, when the patient was 64 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: Mar2021, when the patient was 64 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: Sep2021, when the patient was 64 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: Apr2022, when the patient was 65 years old, for COVID-19 Immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE), administration date: Sep2022, when the patient was 65 years old, for COVID-19 Immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 6 (BOOSTER), SINGLE), administration date: Apr2023, when the patient was 66 years old, for COVID-19 Immunization. The following information was reported: COVID-19 (non-serious) with onset 2025, outcome "unknown", described as "She got COVID after the vaccine".  Additional information:Other Products: No. The patient did not had prior vaccination within 4 weeks. She got COVID after the vaccine and was just prescribed Paxlovid and wanted to get some help with paying for Paxlovid.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: She got COVID after the vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 68-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Lot number: HH7595) at the age of 66 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Mar2021, when the patient was 64 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: Mar2021, when the patient was 64 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: Sep2021, when the patient was 64 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: Apr2022, when the patient was 65 years old, for COVID-19 Immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE), administration date: Sep2022, when the patient was 65 years old, for COVID-19 Immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 6 (BOOSTER), SINGLE), administration date: Apr2023, when the patient was 66 years old, for COVID-19 Immunization. The following information was reported: COVID-19 (non-serious) with onset 2025, outcome "unknown", described as "She got COVID after the vaccine".  Additional information:Other Products: No. The patient did not had prior vaccination within 4 weeks. She got COVID after the vaccine and was just prescribed Paxlovid and wanted to get some help with paying for Paxlovid.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: her last vaccination was Feb, and now she got COVID; her last vaccination was Feb, and now she got COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An 81-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Feb2025 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "her last vaccination was Feb, and now she got COVID". Therapeutic measures were taken as a result of covid-19.  Clinical course information: During an inbound call for financial assistance, the reporter stated that the patient was diagnosed with COVID and received a prescription for Paxlovid. The patient just got Pfizer vaccinated in Feb. When asked for confirmation regarding the patient vaccination in Feb the reporter started her last vaccination was Feb, and now she got COVID. It's unfortunate. The patient has been on Paxlovid before, and then had gotten COVID, have they changed the formula, is it what are the chances specifically of that happening again after you have been on it once.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: still to this day have a pain where the shot was administered; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 71-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Apr2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Primary immunization series complete), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2025, outcome "unknown", described as "still to this day have a pain where the shot was administered". The event "still to this day have a pain where the shot was administered" required physician office visit.  Additional information: The patient went to the Doctor and it could be two things, a reaction to drug or the pharmacist hit a nerve. The patient stated that all his/her COVID shots where Pfizer and until now have had no issues.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Angiogram cerebral, Atrial fibrillation, Atrial septal defect, Computerised tomogram
Clinical narrative: I had a hemorrhagic  stroke on 8/18/24 , with  craniotomy that same day. Since it was a cryptic stroke, I had further testing, which revealed AFib & PFO ( they don't think the PFO was the cause of the stroke). While I'm at the age where AFib can occur - I can't prove that the vaccines caused it - BUT you can't prove that the vaccine didn't cause it.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Craniotomy, Echocardiogram, Electrocardiogram, Haemorrhagic stroke, Magnetic resonance imaging
Clinical narrative: I had a hemorrhagic  stroke on 8/18/24 , with  craniotomy that same day. Since it was a cryptic stroke, I had further testing, which revealed AFib & PFO ( they don't think the PFO was the cause of the stroke). While I'm at the age where AFib can occur - I can't prove that the vaccines caused it - BUT you can't prove that the vaccine didn't cause it.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Developed redness, swelling, bruising about 48h after injection.  2.5cm area of redness and swelling. Seen in office 6/6/25 and symptoms were improving.  Low concern for ongoing infection.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Parent reported immunization reaction in arm Quadracel was administered. The arm was swollen, red, and hot to touch.
Age: 5.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There was no adverse reaction.   Pt. received vaccines on 4/22/2025 and then again on 5/30/2025 (father brought in child).    After the vaccines were given on  5/30/2025 the mother called the clinic wanted to know why more shots were given when she was told she was up to date with vaccines.  Our record showed these vaccines were due.   Mother was asked to bring in her vaccine record and when vaccines were entered into database patient was up to date after the 7/19/2024 vaccines.   Child received vaccines on 4/22/2025 that were not needed.   Mother did not report any adverse reaction and mother was informed that child was indeed up to date.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Parent reported immunization reaction in arm Quadracel was administered. The arm was swollen, red, and hot to touch.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Parent reported immunization reaction in arm Quadracel was administered. The arm was swollen, red, and hot to touch.
Age: 3.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema multiforme, Urticaria
Clinical narrative: Patient developed a hive rash at night on the 31st. Received MMR/V 2 days prior (Given early for travel). However, she was also on Amoxicillin and that finished 2 days prior as well. The hives progressed to an erythema multiforme rash. She never developed a fever.
Age: 7.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Chest pain, Crying, Panic reaction
Clinical narrative: Patient described feeling chest pains after receiving the MMR and Varicella vaccines. She felt panicked and was crying and seeking comfort with her mother. Symptoms lasted for about an hour and then resolved.
Age: 5.0
Sex: F
Vaccine: DTAP, HEP
Symptoms: No adverse event, Vaccination error
Clinical narrative: There was NO adverse reaction to vaccinations administered. Doses that were not needed were administered due to incorrect immunization records that were entered into database by clerical staff.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Faeces discoloured, Fatigue, Rash, Rash erythematous
Clinical narrative: MOP states the child woke up and had a red, macular rash on her face, that progressed down her body through out the morning. Pt was not scratching. MOP also states pt is "not herself" and fatigued with yellow poop. Mother says the child has not exhibited this color before. There are 2 blisters on patient's fingers, but MOP suggests its probably from teething, since patient has been chewing on her fingers. no recent change in diet or activities.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash macular
Clinical narrative: MOP states the child woke up and had a red, macular rash on her face, that progressed down her body through out the morning. Pt was not scratching. MOP also states pt is "not herself" and fatigued with yellow poop. Mother says the child has not exhibited this color before. There are 2 blisters on patient's fingers, but MOP suggests its probably from teething, since patient has been chewing on her fingers. no recent change in diet or activities.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema
Clinical narrative: Hi, patient had 2 shots on Monday, one in each shoulder. His right shoulder is red and he said it feels like sunburn. His left is normal. He wasn't in the sun. I don't know which shot went into which arm. Other than that he's been behaving normally.
Age: 44.0
Sex: F
Vaccine: PNC20
Symptoms: Fatigue, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Fatigue/body aches at 24-48 hours, increasing injection site pain/swelling/heat for 3-4 days, hive like rash on injected shoulder at 60hrs post injection
Age: 44.0
Sex: F
Vaccine: PNC20
Symptoms: Pain
Clinical narrative: Fatigue/body aches at 24-48 hours, increasing injection site pain/swelling/heat for 3-4 days, hive like rash on injected shoulder at 60hrs post injection
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Incorrect route of product administration
Clinical narrative: Administered subcutaneously instead of intramuscularly
Age: 51.0
Sex: F
Vaccine: PNC21
Symptoms: Contusion, Erythema, Full blood count normal, Headache, Pain
Clinical narrative: Patient had headache and body aches the day after the vaccine. his arm then appeared red, swollen, warm, and itchy. When he came in for appt there was noticeable symptoms. Outlined the redness in skin marker. The next day it was out of the markings and a noticeable bruise has formed by the redness NOT by the injection site. Blood test was done to see if patient had an elevated WBC, he did not. This vaccine has been added to pts allergy list. Prednisone was given to help with symptoms.
Age: 51.0
Sex: F
Vaccine: PNC21
Symptoms: Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient had headache and body aches the day after the vaccine. his arm then appeared red, swollen, warm, and itchy. When he came in for appt there was noticeable symptoms. Outlined the redness in skin marker. The next day it was out of the markings and a noticeable bruise has formed by the redness NOT by the injection site. Blood test was done to see if patient had an elevated WBC, he did not. This vaccine has been added to pts allergy list. Prednisone was given to help with symptoms.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV, PNC20
Symptoms: Erythema, Rash
Clinical narrative: Woke up with bright red blotch on left cheek and left earlobe. Arms and back covered in rash.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal, Palpitations, Ventricular extrasystoles
Clinical narrative: Chest pain with palpitations
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Arrhythmia, Bradycardia, Echocardiogram, Electrocardiogram
Clinical narrative: Heart arrhythmia, PVC?s, PAC?s, tachycardia, bradycardia
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram ambulatory, Implantable cardiac monitor insertion, Supraventricular extrasystoles, Tachycardia, Ultrasound scan
Clinical narrative: Heart arrhythmia, PVC?s, PAC?s, tachycardia, bradycardia
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: Heart arrhythmia, PVC?s, PAC?s, tachycardia, bradycardia
Age: 57.0
Sex: F
Vaccine: TYP, UNK, UNK
Symptoms: Arthralgia, C-reactive protein, Mobility decreased, Neck pain, Polymyalgia rheumatica
Clinical narrative: Dec 13th day of injections; mild joint pain began on Dec 17th; Typhoid fever pills completed on Dec 20; Dec 26th moderate joint pain of knees and hips after riding in car for 2 hours; Jan 14, 2024 neck and shoulder pain began (moderate); knee, hip, neck and shoulder pain continue to worsen throughout Jan and early Feb 2024; Feb 10th, woke up and could not get out of bed without assistance; diagnosed with PMR March 18, 2024
Age: 57.0
Sex: F
Vaccine: TYP, UNK, UNK
Symptoms: Red blood cell sedimentation rate
Clinical narrative: Dec 13th day of injections; mild joint pain began on Dec 17th; Typhoid fever pills completed on Dec 20; Dec 26th moderate joint pain of knees and hips after riding in car for 2 hours; Jan 14, 2024 neck and shoulder pain began (moderate); knee, hip, neck and shoulder pain continue to worsen throughout Jan and early Feb 2024; Feb 10th, woke up and could not get out of bed without assistance; diagnosed with PMR March 18, 2024
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Hyperhidrosis, Hypotension, Syncope
Clinical narrative: Pt. initially tolerated injection well but had a syncopal episode around 11:08 am. Pt. sat in a chair right before episode and mother kept him in the chair. No fall occurred. Pt. was initially sweaty, and BP was low, but it increased within a few minutes. Instructed parent and child to report episode to healthcare facility when future vaccines are received, so they can make accommodations in case this was a vagal episode.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Photopsia, Retinal detachment, Vitreous detachment
Clinical narrative: On April 9, 2021, the vitreous in my left eye detached at approximately 9:30 PM CST. This event was very obvious to me as I was sitting in a dark room at the time it happened. I saw a series of bright, white flashes in the corner of my eye, which subsided within a couple of minutes.
Age: 31.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Hypoaesthesia, Malaise, Nausea, Syncope, Tinnitus
Clinical narrative: Hep B administered IM in right deltoid; pt tolerated well. TDaP administered IM in left deltoid; after administration complete, pt states, "I don't feel well", and had syncope episode. Patient regained consciousness and reports ringing in her ears, numb hands, and nausea. Facility code blue arrived and took pt blood pressure and O2 sats and transferred by wheel chair to same day clinic for observation.
Age: 31.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: No adverse event
Clinical narrative: There have been no adverse reactions
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site induration, Pain in extremity
Clinical narrative: Left arm is hard from the shoulder down to the elbow. Painful to lift arm.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Had to stick pt twice. Pt flinched on first stick. Removed needle and replaced with new needle and stuck patient again approximately 1 inch away then pushed vaccine in.
Age: 17.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Cough, Dyspnoea, Throat clearing, Throat tightness, Urticaria
Clinical narrative: Patient's father brought him back to the office about 30 minutes after he left. He had hives on bilateral arms, face, neck, chest, and  back. Patient was coughing and trying to clear his throat. He stated his throat felt tight and he was SOB. Patient was sent straight to the ED. Patient was given Zyrtec, Epi, Famotidine, and Solu-Medrol.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient was given Hep V vaccine and the vaccine was expired.
Age: 61.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site cellulitis, Injection site rash, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: Patient reports that a rash appeared on left arm the day after the vaccine (located directly below the site of the injection on her left arm)  but that she wasn't immediately concerned. Reports the rash was flat and seem to improve until yesterday when it got larger, hot to touch, and much more swollen.  Exam demonstrated erythematous rash 3" x 5," hot to touch, and swollen, without abscess. Patient treated for cellulitis at site. Rx provided for Cephalexin 500mg every 6 hours for 10 days. Patient picked up the medication today (6/6/2025)
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity, Rash erythematous, Skin warm
Clinical narrative: RED RASH LARGER THAN 2 INCHES. PAIN IN ARM. SKIN HOT TO TOUCH. LASTED FOR AT LEAST 5 DAYS.
Age: 8.0
Sex: M
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse reaction reported yet.  Immunization was administered unintentionally into intramuscular route.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Fall
Clinical narrative: Patient fell upon trying to stand after receiving HPV vaccine
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Pain, Pericarditis
Clinical narrative: Pericarditis, repeated hospitalization, steroid myopathy in legs, chronic pain, disability from work
Age: 56.0
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered
Clinical narrative: Varicella was administered in error. Colleague came to clinic for administration of MMR dose #2. Colleague has a history of Varicella positive titer and reports no allergy to Varicella. Colleague was educated on potential adverse reaction and at this time denies any adverse reactions. Colleague was administered MMR #2 on opposite arm within the hour of receiving Varicella.
Age: 11.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt did not have an adverse reaction that we know of, however vaccine was given before the age it is indicated.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Feeling abnormal, Formication, Paraesthesia, Sensory disturbance
Clinical narrative: On April 12, I was given the Tdap injection at pharmacy.  After receiving it, I felt a strange sensation on the left arms.  I felt something crawling moving inside as if the medicine started working giving me small popping sensations.  I thought this was normal and that the injection was working for me.  But these crawling popping feelings continued to move day by day to different areas and I thought it was the medicine still doing the job.   On June 1,  during the night these sensations continue stronger from the mid section down.  So the lower body started shaking uncontrollably for 5 to 10  seconds and I thought nothing of it the next day as I didn't feel it.  I have been with little energy pushing myself day in and day out.  On the night of 6/5/25 I didn't feel my left leg but then the sensation left quickly while the right had lots of tingling.  I am not sleeping well either as these little popping feelings continue waking me up.  Some days I feel great and some days I feel terrible.  I just want to get better.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Sleep disorder, Tremor
Clinical narrative: On April 12, I was given the Tdap injection at pharmacy.  After receiving it, I felt a strange sensation on the left arms.  I felt something crawling moving inside as if the medicine started working giving me small popping sensations.  I thought this was normal and that the injection was working for me.  But these crawling popping feelings continued to move day by day to different areas and I thought it was the medicine still doing the job.   On June 1,  during the night these sensations continue stronger from the mid section down.  So the lower body started shaking uncontrollably for 5 to 10  seconds and I thought nothing of it the next day as I didn't feel it.  I have been with little energy pushing myself day in and day out.  On the night of 6/5/25 I didn't feel my left leg but then the sensation left quickly while the right had lots of tingling.  I am not sleeping well either as these little popping feelings continue waking me up.  Some days I feel great and some days I feel terrible.  I just want to get better.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: 24 HRS POST VACCINATION, LOW GRADE FEVER, PAIN, REDNESS AND SWELLING AT INJECTION SITE.  PAIN AND REDNESS CONTINUED FOR 3 DAYS.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic fatigue syndrome, Impaired work ability, Loss of personal independence in daily activities, Postural orthostatic tachycardia syndrome
Clinical narrative: Started with POTS symptoms and ME/CFS between 12/1/23 and 12/4/23 that escalated to having to be out of work, inability to work full time, and marked functional decline.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema
Clinical narrative: Small red fluid filled blisters on L wrist and R thigh
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Pt received the diluent only, the powder was not reconstituted.
Age: 16.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Extra dose administered
Clinical narrative: These 2 vaccines were given in error to patient.  They were meant to be given to her sister and were incorrectly administered to her.   She did not need these vaccines.  She completed the 2 vaccines for HPV (dose 1 : 11/8/22, dose 2: 11/10/23) prior to age 15 which means she did not need a 3rd dose.  She completed her TDAP series 6/5/19 and did not need this extra TDAP vaccine.  We are concerned about adverse long term or short term effects of being given the wrong vaccines. Also, the doctor's office needs to be reported due to their gross errors in administering the wrong vaccines to our children.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient expired 6/5/2025.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Wrong patient
Clinical narrative: This vaccine was given in error to patient.  Her 16 year old sister was supposed to receive this vaccine and the medical assistant made a gross error in administering this vaccine to the wrong child.  This vaccine should not have been administered to a healthy 11 year old with no pre-existing health concerns or need for Men B vaccine.  Another form was filled out for her sister, since she received the vaccines meant for patient.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered past beyond use date of 5/13/25.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Pityriasis rosea-like rash on front and back torso, not painful or itchy. Started with small outbreak and progressed to entire area as described.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patients mom called to mention that the site of the injection was hard and red and that she was complaining of it hurting. She noticed it the Thursday after the vaccine and called Friday 6/6/25 to ask us about it. She drew a circle around it on Wednesday to see if it kept spreading and it did so she called. We informed her that it is a normal reaction, and to use tyelenol, ice it, to not let her touch the area and to watch her fever. If she were to spke a fever or it was to get worse over the weekend to go to urgent care as our clinic is not open on the weekend.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered past beyond use date of 5/13/25. No known adverse event reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysstasia, Headache, Mobility decreased, Pain in extremity
Clinical narrative: Extreme pain in both hips, middle to lower back along spine, pain down both legs. Have never had it this bad, not due to exercise or housework. On a pain scale, it was a 9 out of 10.  Extreme difficulty moving, needed help getting out of chair. Also headaches started about the same time, 1 and a half to 2 days after shot. Took acetaminophen around the clock, and medical marijuana at evening. Neither helped to relieve the pain. It lasted a good 48 hours, finally felt some relief. Still sore but manageable. Different from arthritis and over worked joint pains I've had. Didn't see a physician.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal pain
Clinical narrative: Extreme pain in both hips, middle to lower back along spine, pain down both legs. Have never had it this bad, not due to exercise or housework. On a pain scale, it was a 9 out of 10.  Extreme difficulty moving, needed help getting out of chair. Also headaches started about the same time, 1 and a half to 2 days after shot. Took acetaminophen around the clock, and medical marijuana at evening. Neither helped to relieve the pain. It lasted a good 48 hours, finally felt some relief. Still sore but manageable. Different from arthritis and over worked joint pains I've had. Didn't see a physician.
Age: 57.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Fatigue, Headache, Induration, Injection site pain
Clinical narrative: Pt messaged in stating:  It hurt quite a bit at the time of vaccination, but didn?t think anything of it. Approximately 24 hours after I developed chills, severe fatigue and headache which I didn?t think too much of. My arm has continued to hurt since, is swollen and hard and is red 1/4 down my arm now. Advised to be seen for potential cellulitis. Had office visit at walk-in clinic on 6/5/25 for cellulitis, and ER visit 6/6/25 for concerns this is worsening. Placed on antibiotics.
Age: 57.0
Sex: F
Vaccine: PNC21
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Pt messaged in stating:  It hurt quite a bit at the time of vaccination, but didn?t think anything of it. Approximately 24 hours after I developed chills, severe fatigue and headache which I didn?t think too much of. My arm has continued to hurt since, is swollen and hard and is red 1/4 down my arm now. Advised to be seen for potential cellulitis. Had office visit at walk-in clinic on 6/5/25 for cellulitis, and ER visit 6/6/25 for concerns this is worsening. Placed on antibiotics.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Condition aggravated, Seizure
Clinical narrative: seizures, pt was brought to ER, treatment unknown, pt was discharged home unmedicated
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Cough, Influenza like illness, Neck pain, Productive cough, Respiratory tract congestion
Clinical narrative: Flu like symptoms: chest and sinus congestion, phlegm, cough, neck pain
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Sinus congestion
Clinical narrative: Flu like symptoms: chest and sinus congestion, phlegm, cough, neck pain
Age: 13.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Adjustment disorder with mixed anxiety and depressed mood, Blood thyroid stimulating hormone, Computerised tomogram head, Drug screen, Full blood count
Clinical narrative: Approximately 3-4 weeks after receiving these vaccines, the patient developed selective mutism and started to her voices in her head. 2 weeks later she developed suicidal ideations and was hospitalized for 4 days for adjustment disorder with mixed anxiety/depression with psychotic features
Age: 13.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Hallucination, auditory, Metabolic function test, Pregnancy test urine, Psychotic disorder, Selective mutism
Clinical narrative: Approximately 3-4 weeks after receiving these vaccines, the patient developed selective mutism and started to her voices in her head. 2 weeks later she developed suicidal ideations and was hospitalized for 4 days for adjustment disorder with mixed anxiety/depression with psychotic features
Age: 13.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Suicidal ideation, Syphilis test, Urine analysis, Vitamin B12
Clinical narrative: Approximately 3-4 weeks after receiving these vaccines, the patient developed selective mutism and started to her voices in her head. 2 weeks later she developed suicidal ideations and was hospitalized for 4 days for adjustment disorder with mixed anxiety/depression with psychotic features
Age: 0.92
Sex: M
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Patient had rash and fever that presented on 6/5. Did visit today on 6/6 - rash is currently present.
Age: 76.0
Sex: F
Vaccine: PNC20
Symptoms: Contusion
Clinical narrative: patient came back on 6/6/25 AM presenting bruising in the left forearm region only. She reported that it happened the next morning 5/31/25 after she was given Prevnar20 on 5/30/25. She reported no other symptoms besides the bruise in the middle of her left forearm with a bump. She reported the bruise was bigger but going away over time. not too much pain. Injection site had no sings of bruising or swelling and no fever. Patient was on warfarin.  No previous reaction like this reported per patient. Advice to monitor and checked with PCP
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: brief syncope within 5 minutes of vaccine adminstration. Per mom, patient has history of syncope. Occurred once before without patient getting a vaccine
Age: 72.0
Sex: F
Vaccine: HEPAB
Symptoms: Hypoaesthesia, Lip swelling, Paraesthesia, Tongue erythema
Clinical narrative: Patient reported mouth tingling/numbness, swelling of the lips, and red spots on the tongue
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Fatigue
Clinical narrative: Patient received the Prevnar 20 vaccine twice.  Patient feels tired.
Age: 0.67
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: 8 months old baby was here for a well child check for vaccines. Pt due for Dtap, IPV and PCV. Pt received Tdap instead of Dtap. Informed provider, provider talked to parents. " Patient inadvertently received Tdap in place of Dtap and WCC today, as noted in visit.  After visit, reviewed CDC guidance more fully and found the following:  Persons aged 2 months?6 years. If Tdap is administered inadvertently instead of DTaP as any one of the first 3 doses of the tetanus-diphtheria-pertussis vaccination series, the Tdap dose should not be counted as valid, and a replacement dose of DTaP should be administered. The replacement dose of DTaP can be administered as soon as feasible at any interval after the inadvertent Tdap dose. (Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP)  Recommendations and Reports / April 27, 2018 / 67(2);1?44)  Timing of Tdap not specific. Agency recommends Dtap within 72 hours or delay 4 weeks.  D/w MA who called parents to schedule for Tdap as soon as possible within 72 hours.  If parents prefer to wait, can receive at next WCC, but would recommend sooner."?
Age: 65.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: patient presented today (eod) with delayed injection site reaction which she says began today (6 days after receiving the vaccine). She presented with redness around the site about 3 inches in diameter, itchiness and warm to the touch, as well as skin being inflammed and hard only around the area. She did not have the symptoms anywhere else. No fever reported. Advised patient to get benadryl (either cream or tablets ) and to place an ice pack on it. If she gets worse to go to an urgent care clinic or visit her doctor. I told her I would call her tomorrow to check in on her.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac, Chest pain, Echocardiogram, Electrocardiogram, Myocarditis
Clinical narrative: Intense chest pain,. Went to ED at Hospital. Testing indicated troponin levels of 12.6. Diagnosed with myocarditis.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: Intense chest pain,. Went to ED at Hospital. Testing indicated troponin levels of 12.6. Diagnosed with myocarditis.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Cancer surgery, Chemotherapy, Computerised tomogram, Joint noise, Magnetic resonance imaging spinal abnormal
Clinical narrative: Patient previously healthy.  Started with back pain in SI joint in 2023. Then in April '25, had a snap in back.  MRI showed large Lumbar sarcoma tumor.  Requiring chemo and major surgery.  These vaccines are causing cancer and no one is studying it because they don't believe it is from the vaccines but it is
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Sacral pain, Sarcoma
Clinical narrative: Patient previously healthy.  Started with back pain in SI joint in 2023. Then in April '25, had a snap in back.  MRI showed large Lumbar sarcoma tumor.  Requiring chemo and major surgery.  These vaccines are causing cancer and no one is studying it because they don't believe it is from the vaccines but it is
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient came in looking for second dose of Shingrix, misread date of first dose and administered second dose, then after patient got shot the frame time between two doses was only 16 days.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient developed redness, itching and mild swelling on left deltoid, site of T-dap vaccine vaccination administration. Patient was prescribed Hydrocortisone cream and Benadryl
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: patients had injection site reaction that was red; injection site reaction that was swollen; injection site reaction that was hot to touch; Initial information received on 05-Jun-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old female patient who had injection site reaction that was red, swollen and was hot to touch after receiving Diphtheria-15/Tetanus/5 HYBRID AC pertussis/IPV (VERO) vaccine [Quadracel (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles vaccine live (ENDERS-EDMONSTON), Mumps vaccine live (JERYL LYNN), rubella vaccine live (WISTAR RA 27/3), varicella zoster vaccine live (OKA/MERCK) (Proquad) for Immunisation.  On an unknown date, the patient received an unknown dose of suspect Diphtheria-15/Tetanus/5 HYBRID AC pertussis/IPV (VERO) vaccine Suspension for injection (lot U7838AA and expiry date- 25-Jul-2027) strength-unknown via intramuscular route in the left deltoid for Immunization.  On an unknown date the patient developed injection site reaction that was red, swollen, and hot to touch (vaccination site erythema), (vaccination site swelling) and (vaccination site warmth) (latency: unknown).  Reportedly- 3 separate patients that had reaction with specific lot number.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.
Age: 0.33
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: administered vaccine that had temperature excursion Max/low temperature reached: Maximum 10 C, duration between 15 minutes to 2 hours and staff noticed it at around 4:00 m in the morning with no reported adverse event; Initial information received on 05-Jun-2025 regarding an unsolicited valid non-serious case received from  a pharmacist.  This case involves 4 months old male patient who administered IPV (VERO) [IPOL] that had temperature excursion max/low temperature reached: maximum 10 celsius, duration between 15 minutes to 2 hours and staff noticed it at around 4:00 m in the morning with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Jun-2025, the patient received an unknown dose of suspect IPV (VERO), Suspension for injection (lot W1C831M, expiry date: 21-Nov-2025, strength: standard and frequency: once) via unknown route in unknown administration site for immunization and had temperature excursion max/low temperature reached: maximum 10 celsius, duration between 15 minutes to 2 hours and staff noticed it at around 4:00 m in the morning  with no reported adverse event (poor quality product administered) (Latency: same day).  Reportedly, Human error was No. Reason: Fridge just gave out and they had to replace it. Product was administered post excursion. Extended stability data did not cover the excursion.   Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: imovax was told to take her booster shot on Day 7 and 21 but she took it on Day 9 with no reported adverse event; Initial information received on 05-Jun-2025 regarding an unsolicited valid non-serious case received from a patient.  This case involves an unknown age female patient who was on RABIES (HDC) VACCINE [IMOVAX RABIES] was told to take her booster shot on day 7 and 21 but she took it on day 9 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a Booster dose of suspect RABIES (HDC) VACCINE Powder and solvent for suspension for injection (strength, dose, batch and expiry date unknown) via unknown route in unknown administration site for Immunization was told to take her booster shot on day 7 and 21 but she took it on day 9 with no reported adverse event (inappropriate schedule of product administration) (same day latency). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  Action taken: not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Gastrooesophageal reflux disease, Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Developed significant redness and swelling of right upper arm following vaccination, has had recurrent urticaria localized to vaccine site on right upper arm as often as daily to weekly since October 2024.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Coronary arterial stent insertion, Coronary artery thrombosis, Laboratory test, Myocardial infarction
Clinical narrative: February 14th 2025 had a blood clot heart attack had to have a stent put in
Age: 50.0
Sex: M
Vaccine: PNC21
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site pain, Muscular weakness, Shoulder injury related to vaccine administration
Clinical narrative: routine wellness visit with vaccinations with simultaneous vaccine administration by two  people: one in left arm without difficulty but right upper arm vaccination administration with immediate pain and burning from shoulder into top of hand. Within 3 hours the right arm pain progressed to a 10 on a scale of 0-10 including weakness and overall disability.
Age: 50.0
Sex: M
Vaccine: PNC21
Symptoms: X-ray abnormal
Clinical narrative: routine wellness visit with vaccinations with simultaneous vaccine administration by two  people: one in left arm without difficulty but right upper arm vaccination administration with immediate pain and burning from shoulder into top of hand. Within 3 hours the right arm pain progressed to a 10 on a scale of 0-10 including weakness and overall disability.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Culture, Hypophagia, Oropharyngeal pain, Streptococcus test negative, Urticaria
Clinical narrative: + hives on lower back and upper buttocks and L posterior shoulder, decreased po intake ? sore throat. Rapid strep in office negative. RVP 7 pending. No hx of prior hives. Mom with chronic urticaria following covid 19 vaccination and very hesitant to give child vaccines. Mom's urticaria progressed to anaphylaxis symptoms and required ER visit and she subsequently carries an Epipen.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Ear swelling, Erythema, Peripheral swelling, Swelling face
Clinical narrative: Facial swelling, ear lob swelling, and erythema to the lateral aspect of the right arm. 2" x 2" erythematous firm swelling on the left arm at the sight of the immunization. Diphenhydramine and Prednisolone administered in the clinic. Facial swelling and erythema significantly improved. Patient discharged home and advised to follow up with PCP in 2 days. Advised to call 911 or seek care at the ER for worsening symptoms.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash macular
Clinical narrative: BLOTCHY NECK RASH PER PT
Age: 5.0
Sex: M
Vaccine: PPV
Symptoms: Nasal congestion, Swelling of eyelid
Clinical narrative: Patient presented to the walk-in clinic with bilateral eye swelling (eyes swollen shut) and nasal congestion. Keeping his head covered in a blanket and reluctant to talk to parents. Oral Prednisolone and Diphenhydramine was administered in the clinic. Nasal congestion improved and he was able to start opening his eyes. Patient was discharged home on Prednisolone and Benadryl and advised to follow up with PCP in 2 days. Parents where advised to call 911 or take the child straight to the ER for worsening symptoms.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Hypopnoea, Loss of consciousness, Malaise
Clinical narrative: Patient was administered the vaccine and as soon as she got the shot she complained of not feeling well. Shortly, she complained feeling dizzy and could not breath. Emergency services were alerted 911 was called. Pharmacist checked the patient and she was breathing very shallow with no sign of consciousness. Pharmacist determined that Epinephrine was warranted and administered Epinephrine. Patient gained consciousness within few minutes and the EMS arrived and checked her. We followed up with the patient the next day and she said she was doing fine. She had to go back to ER on Friday night and they observed her for 3 hours, her BP was high and they did not find anything significant to hospitalize her.
Age: 38.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Received vaccine after expiration. Expired 5/24/25
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: PATIENT REPORTED THAT SHE HAD SEVERE PAIN AT THE SITE AND HAD COMPROMISED RANGE OF MOTION, SWELLING AT SITE WITH PIMP-LIKE CHARACTERISTICS
Age: 52.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Pain, Swelling
Clinical narrative: local reaction: redness swelling ( size of a tangerine) and pain. treated symptomatically ( over the counter pain meds, ice, monitoring)
Age: 73.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site pain, Pyrexia, Rash, Swelling
Clinical narrative: Swelling, Rash, Fever and soreness injection site
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Quadracel (Dtap-IPV combination) was given in Left upper Thigh to patient on 6/5/25. This is the patients 5th dose of Dtap and  4th dose of IPV. Patient went home with no complaints of swelling, redness a=immediately after vaccine was given. Mom noticed Redness and swelling spreading toward the inner thigh on 6/6/25 around 10 AM and drew a mark around the area to keep track of the swelling and redness. Mom reports that when patient woke up this morning 6/7/25 at 7:30 AM there was a much larger amount of swelling than the morning before on 6/6 which prompted her to call the officeand request an appointment. Mom came into the office at 10:30 to be seen with physicians assistant who saw the patient and asked for a consult with another in house provider. Both physicians decided that it did not look like typical cellulitis as the redness was not spreading bilaterally from the vaccine administration sight and was instead spreading toward her inner thigh from the vaccine administration sight. Patient was given a 10ml dose of cetirizine in clinic to see if that would help the redness and swelling to go down. Patient was monitored for an hour after dose was given and there was no change in the reaction sight. Providers decided to prescribe patient cephalexin 2 times daily for 7 days to be on the safe side in the case that it is cellulitis.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspepsia, Endoscopy upper gastrointestinal tract abnormal, Eructation, Gastritis, Malaise
Clinical narrative: Developed inflammation in the stomach and esophagus in October 2023 after being sick. Still believe to have it to this day due to daily indigestion and burping. I also believe to have inflammation in my muscles,  especially in the neck and shoulder area.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myositis, Oesophagitis
Clinical narrative: Developed inflammation in the stomach and esophagus in October 2023 after being sick. Still believe to have it to this day due to daily indigestion and burping. I also believe to have inflammation in my muscles,  especially in the neck and shoulder area.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got shingles