chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site rash, Injection site swelling
Clinical narrative: Patient received vaccine in left arm IM, then a couple days later developed a rash on the fatty region of her left arm (upper and inner part of left arm). The rash was raised and red and about 4 inches in length. The emergency room diagnosed as cellulitis and prescribed Bactrim DS.
Age: 40.0
Sex: F
Vaccine: PNC21
Symptoms: Arthralgia, Pain in extremity, Pyrexia
Clinical narrative: "feel super feverish and having horrible arm/shoulder pain" reported by patient on 4/18/25
Age: 0.08
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Blood test normal, Magnetic resonance imaging normal, Nystagmus, Urine analysis normal
Clinical narrative: On morning of 11/13/2022 family sent video of patient with roving eye movements. This was worked up extensively and resulted in a diagnosis of nystagmus. The nystagmus has improved over the past year, but continues to be an issue.
Age: 17.0
Sex: F
Vaccine: MNP
Symptoms: Hot flush, Malaise, Nausea, Urticaria
Clinical narrative: pt mother stated  she was breaking out in hives, was having hot flashes, became nauseated, and was overall not feeling well. She was given Benadryl. She seemed to get better. She contacted doctors office and was offered an appt but mother stated the patient was getting better.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site warmth
Clinical narrative: Patients arm were red and warm to the injection site, patient did not have any other symptoms apart from those. After provider consulted patient, patient received  10 mL of Benadryl.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: On 4/17/2025 Resident received an expired Covid vaccine Lot# LM2222 expiration date 3/24/2025. Upon discovery today, 4/23/2025, resident is without adverse effects from receiving this vaccine.  Medical director aware. Pharmacy aware.
Age: 77.0
Sex: F
Vaccine: COVID19, PNC21
Symptoms: Injection site induration, Injection site reaction, Injection site vesicles
Clinical narrative: Resident came to clinic on 4/23/25 complaining of arm pain after receiving vaccines from Pharmacy on 4/18/25. Area was hard, red, induration present and large blister present (size of a quarter). No fever and pain only when area was palpated. She was prescribed antibiotics by the physician and is scheduled for a follow up on 4/28/25.
Age: 29.0
Sex: M
Vaccine: CHIK, RAB, TDAP, TYP, YF
Symptoms: Fatigue, Gastrointestinal disorder, Neck pain, Photophobia, Spinal pain
Clinical narrative: client stated "felt like his brain was swelling and eyes were bulging out of my head", neck and spinal pain, chills, sensitivity to light, extreme fatigue, and frequent GI issues, these last for 2-3 days and then he felt fine after that.
Age: 56.0
Sex: F
Vaccine: PNC21
Symptoms: Headache, Mass, Pyrexia, Rash erythematous
Clinical narrative: Patient stated fever and headache next day that has resolved but now has a red rash around area with a lump tthere
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: On 4/22/2025 Resident received an expired Covid vaccine Lot#LM2222 expiration 3/24/2025. Upon discovery today, 4/23/2025, resident is without adverse effects form receiving this vaccine. Medical director aware. Pharmacy aware.
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Swelling
Clinical narrative: Patient arrived 1 week later after receiving "Prevnar 20" with redness and swelling about the size and shape of a football. Patient denies having any redness, swelling, burning, or itching around her throat, mouth, or chest. Patient states swelling started as local redness and has since swollen to todays size.
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: Pt had no symptoms
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Blood culture negative, C-reactive protein increased, Haematocrit decreased, Haemoglobin normal, Infantile apnoea
Clinical narrative: Baby was stable on room air, ready for discharge, and a few hours after Prevnar 20, baby became apneic, turned gray and had to be placed on non-invasive mechanical ventilation. It took 2 days to fully recover and return to baseline. Of note, he received Pediarix the day prior., and ACTHIB the morning of the event (all vaccines spaced apart by 12 hours)
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Mechanical ventilation, Platelet count decreased, Skin discolouration, White blood cell count normal
Clinical narrative: Baby was stable on room air, ready for discharge, and a few hours after Prevnar 20, baby became apneic, turned gray and had to be placed on non-invasive mechanical ventilation. It took 2 days to fully recover and return to baseline. Of note, he received Pediarix the day prior., and ACTHIB the morning of the event (all vaccines spaced apart by 12 hours)
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Infantile apnoea
Clinical narrative: Baby received Pediatrix 12 hrs before HIB, and baby had a significant apneic event very shortly after HIB, requiring vigorous stimulation. Later that day at 5:14 PM (after Prevnar-20 given [Lot LJ5284 given IM in right thigh on 4/18/2025 @  11:47am]), baby had another significant even requiring vigorous stimulation, and placed on Nasal Cannula for breathing support. Baby was weaned back to room air the following day.
Age: 56.0
Sex: M
Vaccine: HEPAB
Symptoms: Tinnitus
Clinical narrative: Tinnitus starting within a few hours, He notices  it mostly when it is quiet. The tinnitus does not impact his ability  to communicate or listing to TV. Not impacting sleep, but hears it when he wakes  up.  Will cancel the subsequent Twinrix doses, as repeat vaccine could make things  worse  Little is reported on Tinnitus and HBV vaccine, though it is listed as a side  effect.
Age: 66.0
Sex: F
Vaccine: HEPAB
Symptoms: Diarrhoea, Poor quality sleep, Vomiting
Clinical narrative: Patient got a vaccine for Twinrix yesterday. Patient's husband came today and told that she is having some side effects of the vaccine. Patient had diarrhea and was throwing up during night and was not able to sleep good. Told husband to watch out for any serious reaction and if any go to ER. He told he will keep a watch on her.
Age: 28.0
Sex: F
Vaccine: JEV1
Symptoms: Electrocardiogram normal, Heart rate increased, Inappropriate schedule of product administration, Lethargy, Palpitations
Clinical narrative: Patient received a second dose of the Ixiaro vaccine 5 years after receiving a single dose of this vaccine in 2020. She had no side effects after this first dose.  Patient felt lethargic the evening off and the day after receiving the second Ixiaro vaccine.  She stated that she developed an accelerated heart beat up to 106bpm and felt irregular heart palpitations that same day. ( day 1) I called the next day and patient had visited her PCP and her vitals were as follows: BP 122/74 and Pulse : 90BPM Patient reported a pulse of up to 120 bpm that day (day2) Her PCP scheduled an EKG for her. I called patient again 4/22/25. She stated that she felt heart palpitations for about 5 days and then not anymore. She still has an elevated heart beat as of 4/22/25. Pt states that her pulse is now between 70 and 90 bpm. She has no other symptoms.
Age: 59.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse even occurred. A pediatric dose was given instead of an adult dose. Patient will return tomorrow for Adult dose
Age: 40.0
Sex: F
Vaccine: HPV9
Symptoms: Tinnitus
Clinical narrative: PATIENT REPORTED TO NURSE ON 4/30/25 THAT SHE DEVELOPED RINGING IN BILATERAL EARS POST HPV INJECTION ON 4/30/24. PATIENT REPORTED SHE RECEIVED THE HPV INJECTION AGAIN ON 7/8/24 AND 2/5/25. PATIENT REPORTED SHE STILL HAS RINGING IN HER BILATERAL EARS. RINGING IN EARS WAS NOT REPORTED TO NURSING STAFF PRIOR TO DOSE 2 AND DOSE 3 . PATIENT REPORTED SHE HAS NOT FOLLOWED UP WITH A MEDICAL DOCTOR REGARDING THE RINGING IN HER EARS.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site about 4 inches by 4 inches, flat on edges
Age: 1.08
Sex: M
Vaccine: MMRV, PNC20, VARCEL
Symptoms: Neutropenia, Pyrexia, Rash
Clinical narrative: Patient developed post vaccine fever, rash and neutropenia
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received Covid Vaccine past the expiration date. Vaccine expired on 4/19/25. Vaccine was given on 4/21/25.  No adverse event has occurred at this time.
Age: 57.0
Sex: F
Vaccine: PNC21, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: LOCAL REDNESS, SWOLLEN EVEN (4/23) 3RD DAY FROM SUNDAY 4/20;
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, MMRV, PNC20
Symptoms: Irritability, Productive cough, Pyrexia, Rash, Respiratory tract congestion
Clinical narrative: Fever on and off for 1-2 weeks, vomiting, fussiness, congestion, wet cough, rash outbreak on neck and groin area
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, MMRV, PNC20
Symptoms: Vomiting
Clinical narrative: Fever on and off for 1-2 weeks, vomiting, fussiness, congestion, wet cough, rash outbreak on neck and groin area
Age: 15.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: 15 years old, Female patient came with her mom to get vaccinated yesterday at 5:30pm. Patient was administered covid Moderna 12+up and Fluarix - influenza vaccine. Prior to vaccine administration patient was screen for severe allergies to food, medications and vaccines. Mom stated that her daughter does not have any prior history of severe allergies reactions to food, medications and vaccines. Influenza - fluarix - Lot number PG52S - Given IM - Right deltoid - 5:30 pm and Covid - Moderna - Lot number 8080433 - Given IM - Right deltoid - 5:31 pm. During patient observation at 5:35 pm = Patient complained feeling nauseas and then vomit. Patient was alert and orientated x3. at 5:40 pm Vital signs reading was: BP: 85/63 - HR: 105 '  SAT: 95%. at 5:44 pm : BP: 88/69 - HR: 89' - SAT: 95%. At 6:00 pm : BP: 92/76 - HR: 104 - SAT: 99%. At 6:05 pm: 93/75 - HR: 86' - SAT: 98%. after patient last vital signs. Patient stated, she was feeling better and had no further symptoms. Mom declined ambulance transport. Patient was recommended to wait 15 more minutes for further observation. After these 15 minutes, Patient stated that she felt and had no more symptoms. Mom was recommended to go to urgent care in case if she has worsened symptoms. Mom reported that patient had her last meal at 12:00 pm and had no anything else after that.  Patient left the scene walking with no complications in company with her mother and sister.  Follow up call will be done today. Made follow up call to patient's mom at 1:40 pm - 04/23/2025 - Mom reported that patient didn't have any more symptoms and she went to school today in the morning. Mom also reported that she didn't have to take her to urgent care. Provider was notified.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, MMRV, PNC20
Symptoms: Cough, Pyrexia, Respiratory tract congestion
Clinical narrative: Patient experienced 1-2 weeks of fever on and off, congestion, and cough.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Blood glucose increased, Blood lactic acid, Blood pH decreased, Haematochezia, Hyporesponsive to stimuli
Clinical narrative: Had cold symptoms and seen in two clinics. Then had large emesis, pallor, decreased responsiveness. Called EMS and taken to ED where he had large bloody stool.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Intestinal dilatation, Nasopharyngitis, Pallor, Ultrasound abdomen normal, Urinary system X-ray
Clinical narrative: Had cold symptoms and seen in two clinics. Then had large emesis, pallor, decreased responsiveness. Called EMS and taken to ED where he had large bloody stool.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Vomiting, White blood cell count increased, X-ray abnormal
Clinical narrative: Had cold symptoms and seen in two clinics. Then had large emesis, pallor, decreased responsiveness. Called EMS and taken to ED where he had large bloody stool.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: large red, raised and firm area just below injection site that is tender to the touch that measures about 3cm by 3cm.
Age: 54.0
Sex: F
Vaccine: FLU3, FLUC4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: The site of the injection has been sore basically since I got the shot.  The muscle now hurts when I move my arm in certain ways.  I can feel a knot in my arm/muscle where the shot was given.  I have an appointment with my primary doctor but I can't get in to see her until June.  At my annual ob/gyn appointment, I showed it to my doctor and she advised me to report it and get into see my primary doctor since some much time has gone by since I had the shot.
Age: 54.0
Sex: F
Vaccine: FLU3, FLUC4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: The site of the injection has been sore basically since I got the shot.  The muscle now hurts when I move my arm in certain ways.  I can feel a knot in my arm/muscle where the shot was given.  I have an appointment with my primary doctor but I can't get in to see her until June.  At my annual ob/gyn appointment, I showed it to my doctor and she advised me to report it and get into see my primary doctor since some much time has gone by since I had the shot.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: A third dose of Shingrix vaccination was given at an off site clinic. Vaccinator checked and there were no Shingrix doses reported for the patient. Vaccinator also asked patient if he had ever received a shingles vaccination and he stated it had been over 10 years since he received a shingles vaccination.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 30.0
Sex: F
Vaccine: FLU3, HEP, HPV9, MMR, TDAP, VARCEL
Symptoms: Dizziness
Clinical narrative: Patient began sweating a lot and felt dizzy. She put her head down. After staff started fanning the patient and putting alcohol under her nose, she felt better. She was able to leave after waiting in the pharmacy for a couple of minutes and drinking water.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Ankle brachial index abnormal, Arthralgia, Atrial fibrillation, Back pain, Balance disorder
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Benign prostatic hyperplasia, Bladder outlet obstruction, Blood loss anaemia, COVID-19, Foot deformity
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Gastrooesophageal reflux disease, Glucose tolerance impaired, Hypertension, Hyponatraemia
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Lower urinary tract symptoms, Memory impairment, Mobility decreased, Muscular weakness, Neuropathy peripheral
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Obesity, Orthostatic hypotension, Osteoarthritis, Peripheral arterial occlusive disease, Peripheral vascular disorder
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral venous disease, SARS-CoV-2 test positive, Urinary retention
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 70.0
Sex: F
Vaccine: PNC21, RSV
Symptoms: Injection site erythema, Injection site warmth, Peripheral swelling
Clinical narrative: Patient experienced swelling and redness on right arm. Arm was hot to the touch for 3 days. Patient presented to the pharmacy Tuesday 4/22. Arm was still hot to the touch, erythema size of a hand. Patient went to the doctor on 4/23 and patient states the redness was spreading
Age: 57.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient sent picture of what looks like her left arm via mychart, area looks red. " It seems I m having a little reaction to the pneumonia vaccine. It s just hot and swollen on the site . I ve put a ice on it a little bit." Pt denies any other symptoms. 4/23/25, @ 14:18. Pt was vaccinated at a pharmacy.
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient started to experience swelling , redness and warmth in the arm one week after the vaccine.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Abdominal X-ray, Lethargy, Pallor, Ultrasound abdomen, Vomiting projectile
Clinical narrative: Projectile vomiting, pale, and lethargic
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Vaccine was administered and there were no adverse events.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash
Clinical narrative: Rashes  on arms & legs and itchiness started 2 days after vaccination,  its been 3 wks and still have rashes & itchiness
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Patient came in for Well Child and was due for her Varivax. The Medical Assistant got the vaccine ready and had the second verifer check the vaccine. Both clinical staff signed off on the form. Medical Assistant noticed when she went to input vaccine into computer that the vaccine expired on 4/11/2025. This was a VFC vaccine and I will also report to them. Medical Assistant reached out to mom of patient and let her know what happened and notified the provider that patient was seeing that day. Medical Assistant did advise mom that patient will have to come back to get another Varivax, however there should be no negative effects of getting the expired vaccine.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blood test, COVID-19, Dyspnoea
Clinical narrative: I experienced the usual side effects of the vaccine, which eventually subsided. However, several days after my initial reaction, I felt as if I had a severe case of COVID. My lungs burned, and breathing became difficult. I felt utterly drained, as if my body were aflame. My joints ached intensely. For two to three months after I began to improve, I needed to perform breathing treatments. I continued to feel fatigued for approximately six months.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pulmonary pain
Clinical narrative: I experienced the usual side effects of the vaccine, which eventually subsided. However, several days after my initial reaction, I felt as if I had a severe case of COVID. My lungs burned, and breathing became difficult. I felt utterly drained, as if my body were aflame. My joints ached intensely. For two to three months after I began to improve, I needed to perform breathing treatments. I continued to feel fatigued for approximately six months.
Age: 74.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Gait disturbance, Nausea, Skin laceration, Vertigo
Clinical narrative: Patient woke up at 4am this morning.  She stood up from bed and had severe nausea & vertigo, stumbling into a wall mirror.  Mirror didn't break, but she received a minor cut from the edging.  The  high severity of the nausea and dizziness stayed from about 4 am until 8:30 am.   She did not vomit.  Between that time and reporting to this pharmacist (around noon today), patient states she is still having intermittent nausea and dizziness but at a quarter of the severity.   I recommended meclizine over the counter to aid with the nausea and dizziness or reaching out to prescriber for a prescription anti-nausea med.  Patient seemed content to rest the remainder of the day and take it easy.
Age: 29.0
Sex: F
Vaccine: RAB, TYP
Symptoms: Choking sensation, Dyspnoea
Clinical narrative: -Patient received vaccines for typhoid and rabies at 11:08am on 4/21/25; patient returned at 245pm on 4/21/25 complaining of SOB: stating that she felt like she was breathing through a straw and someone was choking her; medications ordered  by doctor and patient given: EpiPen 0.3mg, Cetirizine 10mg tab, and methylprednisolone acetate 40mg injection; patient's symptoms resolved within 90 minutes and back to baseline; patient discharged home with Rx for EpiPen 0.3mg and strict instructions to follow up with the ER if symptoms return; patient called by facility next day 4/22  to check on patient's status; and patient stated she is feeling better; facility scheduled appt for patient to return for in-person follow up at 330p, 4/23/25.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain
Clinical narrative: Patient felt like he had a "crick" in his neck the next morning with occasional shooting pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV
Symptoms: Cyanosis, Dyskinesia, Electrocardiogram normal, Fall, Pyrexia
Clinical narrative: Patient left the office after receiving her vaccines.  Of note, she received 2 combination vaccines but had received indidual components of the vaccine previously per her immunization record that was brought to the office.  About an hour after receiving her vaccines, pt. was with mom at mom's doctor's appointment when pt. reportedly fell to the floor, and started having jerking movements.  Mom stated that her face turned blue/purple and her lips turned black.  Patient's vitals were obtained and she was taken to the ER via ambulance.  Mom stated that the episode lasted about 1-2 minutes and by the time the ambulance arrived 20 minutes later she had returned to her baseline.  Pt. was examined in the ER and an EKG was reportedly normal.  Pt. was discharged home and mom states that she was sleepy and slept for about 2 hours.  Pt. then woke up because she was hungry and ate.  Mom noted at that time that pt. had a fever as she was hot to touch but she wanted a blanket on her.  Patient followed up in the office on 04/23/2025 and was playing, eating and acting normal.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV
Symptoms: Skin discolouration, Skin warm, Somnolence
Clinical narrative: Patient left the office after receiving her vaccines.  Of note, she received 2 combination vaccines but had received indidual components of the vaccine previously per her immunization record that was brought to the office.  About an hour after receiving her vaccines, pt. was with mom at mom's doctor's appointment when pt. reportedly fell to the floor, and started having jerking movements.  Mom stated that her face turned blue/purple and her lips turned black.  Patient's vitals were obtained and she was taken to the ER via ambulance.  Mom stated that the episode lasted about 1-2 minutes and by the time the ambulance arrived 20 minutes later she had returned to her baseline.  Pt. was examined in the ER and an EKG was reportedly normal.  Pt. was discharged home and mom states that she was sleepy and slept for about 2 hours.  Pt. then woke up because she was hungry and ate.  Mom noted at that time that pt. had a fever as she was hot to touch but she wanted a blanket on her.  Patient followed up in the office on 04/23/2025 and was playing, eating and acting normal.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased, Loss of personal independence in daily activities
Clinical narrative: Pt reports higher than normal heart rate when exercising.  Usually experiences elevated heart rate when walking and when weight training.  Last walking session, he experienced heart higher than normal elevation.  For last weight training session, he also experienced a higher than normal heart rate.  He skipped weight  training today and will attempt tomorrow (4/24/25).
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Chills, Crying, Facial pain, Headache
Clinical narrative: Adverse Events: Fever of 101.1, Body aches, Chills, Headache, Jaw & Face pain, sharp stomach pain, high heart rate and involuntary crying.  Treatment: 2 Advil, and 2 Tylenol about four to six hours apart. Outcomes: patient felt a bit better after Advil but is currently declining again.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Heart rate increased, Pain, Pain in jaw, Pyrexia
Clinical narrative: Adverse Events: Fever of 101.1, Body aches, Chills, Headache, Jaw & Face pain, sharp stomach pain, high heart rate and involuntary crying.  Treatment: 2 Advil, and 2 Tylenol about four to six hours apart. Outcomes: patient felt a bit better after Advil but is currently declining again.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient put in for an appointment for RSV vaccine and came in and received vaccine, but later corporate office notified pharmacy that patient already received vaccine 12/7/2023.
Age: 27.0
Sex: M
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: exposed to HPV following their first  dose of GARDASIL 9; a patient who missed their second dose of GARDASIL 9; This spontaneous report was received from a pharmacist and refers to a 27-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   In October 2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (0.5ml/dose), administered by Intramuscular route (strength, lot # and expiration date were not reported) for prevention of human papillomavirus (HPV)-related disease.  On an unknown date, the patient missed his  second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (Vaccine dose omission) and was exposed to HPV following his first dose of suspect vaccine. The reporter could not confirm if patient has contracted HPV following exposure. No symptoms reported. At the reporting time, the outcome of exposed to HPV was unknown.   The action taken with suspect vaccine was not applicable (conflicting information: also reported as dose not changed).   The causal relationship between the event of exposed to HPV and suspect vaccine was not provided.   Lot# is being requested and will be submitted if received.
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC. No additional information; HCP called to report inadvertent administration of VARIVAX after a temperature excursion. Vaccine was administered on 27FEB2025 to a patient.; This spontaneous report was received from a nurse (registered nurse [RN]) and refers to a patient of an unknown age and gender.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 27-Feb-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), injection (valid lot #Y011019, with provided and established expiration date: 18-Jun-2026) for prophylaxis (exact dose, dose number, anatomical location, and route of administration were not provided) reconstituted with sterile diluent (MERCK STERILE DILUENT) solution for injection (expiration date, and lot # were not reported).   Administered dose of suspect vaccine was exposed to the temperature excursion on an unknown date: -12.13 Celsius degrees (C) for 0 hours 39 minutes 0 seconds (product storage error, onset date: 27-Feb-2025). Previous temperature excursion was reported as yes: -14.19 C for 9 minutes and -14.25 C for 16 minutes. There was no additional adverse event (AE) reported (no adverse event).
Vaccine: MMRV
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: HCP called to report that during administration of PROQUAD the patient "moved". The HCP is unable to confirm if the patient received the full dose.; No additional adverse event; This spontaneous report was received from a 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 an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), 0.5 mL, lot #Y011209; which has been verified to be valid to be valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, expiration date reported and upon internal review establish as 18-DEC-2025, administered for prophylaxis and with sterile diluent (BAXTER STERILE DILUENT) (indication, expiration date, and lot # were not reported). It was reported that during the administration of the vaccine the patient moved so the nurse was unable to confirm if the patient received the full dose (Accidental underdose). No additional adverse event (No adverse event).
Age: 1.0
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AEs  reported; PROQUAD and VARIVAX inadvertently administered at the same office visit.ion provided.  No additional AEs or PQC reported.; This spontaneous report has been received from a nurse practitioner and refers to a 1-year-old patient of unknown gender.  There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 13-MAR-2025, the patient was inadvertently vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) solution for injection, 0.5 ml, subcutaneously in left thigh, lot # Y015557, expiration date 16-SEP-2026 (dose number was not provided) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) solution for injection, 0.5 ml, subcutaneously in left thigh, lot # Y016874, expiration date 07-APR-2026 (dose number not provided), at the same office visit, for prophylaxis (Accidental overdose). Both vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date not provided). No symptoms and no additional adverse events were reported.
Sex: M
Vaccine: COVID19, MMR, MMR
Symptoms: Fatigue
Clinical narrative: Felt tired; This spontaneous report was received from a consumer and refers to a 66-year-old male patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported. He also stated that he is unsure if he received the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) as a child.  On 16-Mar-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Solution for injection administered as prophylaxis by unknown route (lot # and expiration date were not reported) which was diluted with a sterile diluent, solution for injection administered by unknown route (expiration date and lot # were not reported) along with a Covid vaccine (unspecified) administered by unknown route (indication, expiration date, and lot # were not reported).  On 16-Mar-2025 (also reported as after the vaccinations), the patient experienced felt tired. The patient recovered/resolved from the event on an unspecified day in March 2025.   The causal relationship between the event and the suspect vaccines/sterile diluent was not provided.   Lot # is being requested and will be submitted if received.
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B surface antibody negative, Vaccination failure
Clinical narrative: non-responder;   This literature marketed report has been received from the authors of a published literature article concerning a patient of unknown age and gender with human immunodeficiency virus infection. Concomitant medications included cabotegravir;rilpivirine.  On an unknown dates, the patient was vaccinated with 3 doses of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) at 0, 1 or 2, and 6 months administered intramuscularly for prophylaxis (dose, vaccination site, lot number and expiration date were not reported).  On an unknown date, the patient's hepatitis B antibody surface was negative, it was considered that patient was a non-responder (vaccination failure). Subsequently, the patient was re-vaccinated. The outcome of the event was not provided.  Per internal guidelines the event was determined to be related to Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB).  This case was classified as non-valid due to the lack of patient's identifiers.  Lot # is being requested and will be submitted if received.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; TE for GARDASIL 9 that occurred on02/13/2025 and then was inadvertently administered to apati ent on 02/19/2025.; This spontaneous report was received from a medical assistant and refers to a 16-year-old male patient. The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On 19-FEB-2025, the patient was vaccinated with an improperly stored dose of  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9 SYRINGE (DEVICE)) (involved lot # was X020725, expiration date: 16-APR-2026 [verified to be valid]); 0.5 ml/once, administered for prophylaxis (strength, and route of administration were not provided). Temperature excursion was 1.2 C for 0 hours 30 minutes 0 seconds (On 13-FEB-2025). There was no previous temperature excursion nor report of adverse event or product quality complaint involved.
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; MMR II was administered after a temperature excursion.; This spontaneous report was received from a medical assistant and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 17-Mar-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), once, lot #X022135, expiration date: 01-Jun-2025, administered for prophylaxis (strength, dose, route of administration and anatomical location were not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The products were administered after a temperature excursion (Product storage error). The excursion temperature was 52.5 Fahrenheit with time frame of 1 hour. There was no previous temperature excursion. No additional adverse event (AE) was reported (No adverse event).  This is one of four reports received from the same reporter.
Age: 4.0
Vaccine: MMRV
Symptoms: No adverse event, Product preparation error
Clinical narrative: no adverse event; Physician reported an AE for PROQUAD. The caller said a dose was reconstituted with normal saline and administered to a patient on 3/20/2025. Confirmed with caller no other AE occurred. Caller provided consent for follow up. No other AE. No PQC.; This spontaneous report was received from a physician and refers to a 4-year-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 20-MAR-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y006771, expiration date: 24-Sep-2025) (1 dose), for prophylaxis. The reporter stated that a dose was reconstituted with normal saline (lot #HN2235, expiration date: 01-Oct-2025) and administered to the patient (product preparation error). The physician confirmed that no other adverse event occurred (no adverse event).
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: experienced diffuse redness around and below the injection site; the site was red and felt hot for about 3 days; This spontaneous report was received from a consumer referring to a female patient, age was not provided.  Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On an unknown date, the patient was vaccinated with pneumococcal 21-valent conjugate (CAPVAXIVE) injection, administered intramuscularly as a dose of 0.5 ml for prophylaxis (anatomical location, lot number and expiration date were not reported).   On an unknown date, reported as 1 day after vaccination, the patient experienced diffuse redness around and below the injection site (Redness), the site was red and felt hot (Vaccination site warmth) for about 3 days and then subsided without intervention or medication. At the time of the reporting, the outcome of the event was recovered. The causal relationship between the events and the suspect therapy was not provided.; Reporter's Comments:
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Medical assistant reported that a patient missed second dose of RECOMBIVAX today.  The patient received the first dose on 1/11/2025.  No additional AEs were reported, no further information provided. No PQC.; No additional AE; This spontaneous report was received from a medical assistant and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 11-Jan-2025, the patient received the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), lot #Y006602, expiration date: 05-Feb-2026, administered for prophylaxis (strength, dose and rout e of administration were not provided).  It was reported that the patient missed second dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) today (Inappropriate schedule of vaccine administered). No additional adverse events (AEs) were reported, no further information provided (No adverse event). This is a non-valid case due to lack of patient's identifiers.
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms reported.; administration of PROQUAD on 3/26/2025 and product expired on 3/24/2025; This spontaneous report was received from a 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 26-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Solution for injection (lot #X023598, expiration date: 24-Mar-2025) 0.5 mL administered as prophylaxis (Expired product administered) which was diluted with a sterile diluent (lot #1950614, expiration date: 10-Dec-2025) both administered by unknown route. In addition, it was confirmed that the product did not experience a temperature excursion. No symptoms were reported (No adverse event).
Vaccine: VARCEL, HIBV
Symptoms: Product storage error
Clinical narrative: No additional AEs were reported; The nurse is reporting that a patient received improperly stored vaccine; This spontaneous report was received from a 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 24-Mar-2025, the patient was vaccinated with 1 dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX UPGRADE) lot# Y013350 and expiration date reported as and upon internal review confirmed as 02-Aug-2026 (exact dose, route of administration and vaccination site were not reported) administered for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). The nurse was reporting that the patient received improperly stored vaccine (temperature: 14.92F; time frame: 1 hour 40 minutes; previous temperature excursion: no) (product storage error).
Vaccine: VARCEL, HIBV
Symptoms: Product storage error
Clinical narrative: PEDVAX HIB was administered after a temperature excursion; This spontaneous report was received from an Other health professional referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.   On 24-Mar-2025, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), Injection (lot #X022981, expiration date: 21-May-2026) 0.5 mL administered by Intramuscular route for prophylaxis.  It was reported that the suspect vaccine was underwent temperature excursions of 54.19 degree Fahrenheit (F) (the time frame was 2 hours 45 minutes) (product storage error). There were no previous temperature excursions.
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; patient received fi rst doseof GARDASIL 9 on July 19th 2021, second dose on March 18th 2025 and would like to complete the series; This spontaneous report has been received from a healthcare student (Also reported as Nurse, conflicting information) referring to a 27-year-old patient of unspecified gender.  The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not provided.  On 19-JUL-2021, the patient was vaccinated as prophylaxis with the first dose of HPV rL1 6 11 16 18 31 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route of administration, lot #, and expiration date were not provided); and on 18-MAR-2025, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route of administration, lot #, and expiration date were not provided) (Inappropriate schedule of vaccine administered). No additional adverse event (AE).
Age: 16.0
Sex: M
Vaccine: UNK
Symptoms: Abdominal pain upper, Anxiety, Arthralgia, Balance disorder, Confusional state
Clinical narrative: Fainted; He did not feel well; Chronic fatigue; anxiety; irritability; confusion; his body temperature was hot all the time; floaters; cramping; pain in his joints; stomach aches; double vision; He would sleep 15-17 hours a day but never felt rested.; dizzy; difficulty with his balance; Information has been received from a lawyer and refers to a 16-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with the first and only dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, dose, frequency, lot#, and expiry date was not reported) for prophylaxis. Patient's mother was exposed that vaccine was safe, prevented cancer, and teenagers must got it. Immediately after the Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccination, patient fainted and when he came to, he did not feel well. Also experienced complete exhaustion and developed chronic fatigue. He would sleep 15-17 hours a day but never felt rested. He could not stay awake. He developed pain in his joints and generally felt unwell. He complained of stomach aches and cramping, which caused him to use the bathroom often at school, and at home. He started drinking one and a half to three gallons of water daily. Everyday tasks became difficult, including picking out clothes, taking a shower, choosing foods to eat, and brushing his teeth. He started experiencing confusion, anxiety, and irritability. His body temperature was hot all the time. Upon standing, he got dizzy, he had difficulty with his balance, and his heart would race. His vision was affected, and he experienced floaters and double vision. Patient was evaluated and treated by numerous specialists, including gastroenterologists, internal medicine doctors, dermatologists, psychologists, psychiatrists, cardiologists, sleep medicine doctors, neurologists, chiropractors, acupuncturists, immunologists, and Ear Nose and Throat doctors. He also received brain scans to determine the cause of his symptoms. At the reporting time, the outcome of the events was not reported. Causality assessment was related.  Upon internal review, the event of fainted was determined to be medically significant.
Age: 16.0
Sex: M
Vaccine: UNK
Symptoms: Diplopia, Dizziness postural, Fatigue, Feeling hot, Hypersomnia
Clinical narrative: Fainted; He did not feel well; Chronic fatigue; anxiety; irritability; confusion; his body temperature was hot all the time; floaters; cramping; pain in his joints; stomach aches; double vision; He would sleep 15-17 hours a day but never felt rested.; dizzy; difficulty with his balance; Information has been received from a lawyer and refers to a 16-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with the first and only dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, dose, frequency, lot#, and expiry date was not reported) for prophylaxis. Patient's mother was exposed that vaccine was safe, prevented cancer, and teenagers must got it. Immediately after the Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccination, patient fainted and when he came to, he did not feel well. Also experienced complete exhaustion and developed chronic fatigue. He would sleep 15-17 hours a day but never felt rested. He could not stay awake. He developed pain in his joints and generally felt unwell. He complained of stomach aches and cramping, which caused him to use the bathroom often at school, and at home. He started drinking one and a half to three gallons of water daily. Everyday tasks became difficult, including picking out clothes, taking a shower, choosing foods to eat, and brushing his teeth. He started experiencing confusion, anxiety, and irritability. His body temperature was hot all the time. Upon standing, he got dizzy, he had difficulty with his balance, and his heart would race. His vision was affected, and he experienced floaters and double vision. Patient was evaluated and treated by numerous specialists, including gastroenterologists, internal medicine doctors, dermatologists, psychologists, psychiatrists, cardiologists, sleep medicine doctors, neurologists, chiropractors, acupuncturists, immunologists, and Ear Nose and Throat doctors. He also received brain scans to determine the cause of his symptoms. At the reporting time, the outcome of the events was not reported. Causality assessment was related.  Upon internal review, the event of fainted was determined to be medically significant.