chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Anaphylactic reaction, Anaphylaxis treatment
Clinical narrative: Onset of anaphylaxis within an hour of vaccine administration. Transferred to hospital ED via EMS from urgent care facility for ongoing treatment. Received medications for treatment of anaphylaxis (IM epinephrine, dexamethasone, racemic epinephrine neb). Discharged home after 8 hours of continued monitoring in the ED.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Anaphylactic reaction, Anaphylaxis treatment
Clinical narrative: Onset of anaphylaxis within 4 hours of immunization administration. Patient presented to hospital ED in anaphylaxis and required medications (IM epinephrine, diphenhydramine, famotidine, albuterol, fluid bolus, and corticosteroids) and extensive monitoring in the ED.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Pt woke up on 7-31-24 with a fever and rash on his left deltoid where vaccine was given. Man sent a photo of the rash to Dr. She advised cold compress, Benedryl. Report to Emergency department for SOB and continued rash.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Caller reported expired VARIVAX was administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 05-JUL-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter administered subcutaneously for prophylaxis (lot # W012164, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 12-APR-2024 [Expired product administered]; strength was not provided). On that day, the patient also received sterile diluent solution for injection/infusion (vial) 0.5 milliliter administered once subcutaneously as medication dilution (lot # W036927, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 18-AUG-2025; reported as concomitant therapy). No other information provided. No additional adverse events (AEs) or product quality complaint (PQC) were reported. At the time of reporting, the outcome of the events was unknown.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: no side effects; PROQUAD that was inadvertently reconstituted with PREVNAR; This spontaneous report was received from medical assistant professional referring to a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 26-JUL-2024, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 ml, intramuscular, lot # Y008789, expiration date: 30-OCT-2025 (strength, dose number, and anatomical location were not provided) for prophylaxis which was inadvertently reconstituted with pneumococcal vaccine conj 7v (crm197) (PREVNAR) (product preparation error). No side effects reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: chin numbness several times a day/intermittently; tingling in chin and it would come and go on several times in a day/intermittently; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 66-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Apr2024 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Blood Cholesterol Abnormal" (unspecified if ongoing); "Blood pressure abnormal" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for blood pressure abnormal; SIMVASTATIN taken for blood cholesterol abnormal. Vaccination history included: Covid-19 vaccine (dose 1), for COVID-19 immunisation; Covid-19 vaccine (dose 2), for COVID-19 immunisation; Covid-19 vaccine (dose 3), for COVID-19 immunisation; Covid-19 vaccine (dose 4), for COVID-19 immunisation; Covid-19 vaccine (dose 5), for COVID-19 immunisation; Covid-19 vaccine (dose 6), for COVID-19 immunisation; Covid-19 vaccine (dose 7), for COVID-19 immunisation. The following information was reported: HYPOAESTHESIA (non-serious) with onset Apr2024, 2 hrs after the suspect product(s) administration, outcome "unknown", described as "chin numbness several times a day/intermittently"; PARAESTHESIA (non-serious) with onset Apr2024, 2 hrs after the suspect product(s) administration, outcome "unknown", described as "tingling in chin and it would come and go on several times in a day/intermittently". Additional information: No other vaccine administered on the same date/4 weeks prior with Pfizer vaccine.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Dermatologic examination, Granulomatous dermatitis
Clinical narrative: severe allergy to vaccine booster; Granulomatous dermatitis; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 27Jul2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 55-year-old female patient received BNT162b2 (COMIRNATY), on 22Jan2022 as dose 3 (booster), single (Lot number: FJ5683) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "chronic health condition" (unspecified if ongoing). There were no concomitant medications. The following information was reported: GRANULOMATOUS DERMATITIS (non-serious) with onset 07Nov2023, outcome "not recovered"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "severe allergy to vaccine booster". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of granulomatous dermatitis.
Age: 39.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient reported that she contracted COVID-19 in Dec2023; Patient reported that she contracted COVID-19 in Dec2023; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 40-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Sep2023 as dose 1, 0.3 ml single (Lot number: HH7595) at the age of 39 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 14Sep2023 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b4;BNT162b2;BNT162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), 0.3 ML SINGLE, Lot#:GH9702, via intramuscular in the right arm), administration date: 16Sep2022, when the patient was 39-year-old, for COVID-19 immunization; flu (inactivated) (DOSE NUMBER UNKNOWN, SINGLE), administration date: 26Sep2019, when the patient was 36-year-old, for Immunization; mmr (DOSE NUMBER UNKNOWN, SINGLE), administration date: 30Apr2019, when the patient was 36-year-old, for immunization; tdap (whooping cough) (DOSE NUMBER UNKNOWN, SINGLE), administration date: 26Oct2016, when the patient was 33-year-old, for Whooping Cough; flu (inactivated) (DOSE NUMBER UNKNOWN, SINGLE), administration date: 27Oct2015, when the patient was 32-year-old, for Immunization; tdap (whooping cough) (DOSE NUMBER UNKNOWN, SINGLE), administration date: 27Oct2015, when the patient was 32-year-old, for Whooping Cough; flu (DOSE NUMBER UNKNOWN, SINGLE), administration date: 11Oct2022, when the patient was 39-year-old, for Immunization; flu (DOSE NUMBER UNKNOWN, SINGLE), administration date: 12Oct2018, when the patient was 39-year-old, for Immunization; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" and all described as "Patient reported that she contracted COVID-19 in Dec2023". Additional information: At photo shoot on 29Jul2024, patient reported that she contracted COVID-19 in Dec2023.  No follow-up attempts are possible.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear inflammation, Erythema, Eye oedema, Eye pain, Eye pruritus
Clinical narrative: Beginning on the day of administration, I experienced headaches which have continued on a daily basis since that date. I also have had red inflamed auricles bilaterally as well as an eye issue of edema and pain and itching. I also have miosis.  In March of ?24 I had severe pain and itching along the nape of my neck.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Magnetic resonance imaging, Miosis, Neck pain, Pruritus
Clinical narrative: Beginning on the day of administration, I experienced headaches which have continued on a daily basis since that date. I also have had red inflamed auricles bilaterally as well as an eye issue of edema and pain and itching. I also have miosis.  In March of ?24 I had severe pain and itching along the nape of my neck.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Scan with contrast
Clinical narrative: Beginning on the day of administration, I experienced headaches which have continued on a daily basis since that date. I also have had red inflamed auricles bilaterally as well as an eye issue of edema and pain and itching. I also have miosis.  In March of ?24 I had severe pain and itching along the nape of my neck.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt. came in to the clinic for a school physical. After the school physical, she was due for one vaccine to update her record, HPV. It was to be her second dose. I administered the vaccine to the pt @ 3:57pm. Around 15-20 minutes later, as I was about to chart the procedure, I noticed on our EHR's vaccine record that the pt. had already received her second dose of HPV on 8/14/2023. It was not charted that she had received it. I missed it, and unfortunately, on the chart it was not noted that she had received it.  I notified the PA that saw the pt. for the physical, as well as the grandmother of the pt. I apologized to the grandmother about my error. The grandmother was upset about it, but was relieved to know that the pt. would be fine. No adverse reaction to the vaccine was noted from the pt.
Sex: U
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: AUTOIMMUNE PHENOMENOM; This spontaneous report received from a patient via social media. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose in series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced autoimmune phenomenom (Dose in series 1). The patient also reported that JJ Covid vaccine injured and had destroyed their entire life, career and health. They would never forgive or forget. Sorry for your devastating reaction also. They should be tried for their crimes against humanity and greed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of autoimmune phenomenom was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-Autoimmune disorder. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC20, RV5
Symptoms: Vaccination site erythema
Clinical narrative: 6 m.o. female with 1 in x 1.5 in area of erythema on left thigh at area of Pentacel vaccination about 24 hours ago. No fevers no fussiness
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash developed on hands and legs approximately 1 month after vaccination.   Treatment advised by provider: Aquaphor, 1/2 tsp of Benadryl for itchiness.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Full blood count normal, Laboratory test normal, Liver function test normal, Oral administration complication, Ultrasound scan normal
Clinical narrative: Baby started vomiting within 6 hours of vaccine administration. Intermittent daily vomiting  for a week following vaccination
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Vomiting
Clinical narrative: Baby started vomiting within 6 hours of vaccine administration. Intermittent daily vomiting  for a week following vaccination
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV
Symptoms: Pyrexia, Rash, Scab
Clinical narrative: Rash developed on face and extremities approximately 1 month following vaccination.  1 week later, rash worsened with the development of yellow crust around the nose.  The following week, fever developed with rash progressing to the patient's trunk area.  Treatment included bacitracin, Cephalexin (later d/c due to potential allergic reaction and changed to Clindamycin), Hydrocortisone, and Mupirocin.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Hormone level abnormal, Infertility, Menstrual disorder
Clinical narrative: Hormone imbalance, increased frequency of menstrual cycle, decreased fertility, anemia for the past 3 years.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Dizziness, Head injury, Investigation, Loss of consciousness
Clinical narrative: Menveo was administered and then Boostrix was administered. Patient got up and moved to another chair. After a few minutes, patient fell asleep, bumped their head on wall behind him, was snoring, and  body tight. Came to after 15 seconds or so. No allergic reaction. Patient said he felt weak and light headed, felt like he had been asleep much longer than that. EMS was called immediately. Patient given water and snack crackers. EMS arrived around 9:10AM.  EMS checked patient out and he left on his own accord.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Muscle tightness, Snoring
Clinical narrative: Menveo was administered and then Boostrix was administered. Patient got up and moved to another chair. After a few minutes, patient fell asleep, bumped their head on wall behind him, was snoring, and  body tight. Came to after 15 seconds or so. No allergic reaction. Patient said he felt weak and light headed, felt like he had been asleep much longer than that. EMS was called immediately. Patient given water and snack crackers. EMS arrived around 9:10AM.  EMS checked patient out and he left on his own accord.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Maternal exposure during breast feeding
Clinical narrative: Patient breastfeeding at the time of injection, vaccine given in error.  Per patient, they were advised by personal physicians to watch child for developmental milestones and any abnormal behaviors.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Syringe issue
Clinical narrative: HPV (Gardasil 9) vaccine was being administered to patient. As nurse was administering vaccine the liquid from the pre-filled syringe squirted out the side of the pre-filled syringe and the leur lock hub. Provider was notified and HPV vaccine was reordered and readministered with no additional issue.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Asthenia, COVID-19, Cough, Malaise
Clinical narrative: BRIEF OVERVIEW: Admission Date: 7/28/2024 Discharge Date: 07/29/2024  Discharge Disposition:  Home without services  Active Issues Requiring Follow-up: Follow up with PCP for myalgias and weakness due to COVID. Follow up potassium levels as outpatient since potassium chloride dose was lowered due to hyperkalemia.  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Generalized weakness [R53.1] Acute hypoxic respiratory failure [J96.01] COVID-19 [U07.1]  HOSPITAL COURSE: Elderly man with multiple chronic medical conditions who has received all of the recommendation COVID vaccinations presents with a one day history of severe myalgias, cough, malaise, and generalized weakness. Patient was evaluated and found COVID positive. Patient was Admitted for observation. The next day patient wa feeling much improved, he was using oxygen 3L as he uses at home. He was evaluated by PT which recommended discharge home. Will need follow up with PCP. Potassium was lowered from 20 meq to 10 meq due to hyperkalemia on admission. Will need monitoring of potassium levels as outpatient. NO need for steroid administration since patient oxygen usage at baseline and is vaccinated.  Discharged to Home.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, SARS-CoV-2 test positive
Clinical narrative: BRIEF OVERVIEW: Admission Date: 7/28/2024 Discharge Date: 07/29/2024  Discharge Disposition:  Home without services  Active Issues Requiring Follow-up: Follow up with PCP for myalgias and weakness due to COVID. Follow up potassium levels as outpatient since potassium chloride dose was lowered due to hyperkalemia.  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Generalized weakness [R53.1] Acute hypoxic respiratory failure [J96.01] COVID-19 [U07.1]  HOSPITAL COURSE: Elderly man with multiple chronic medical conditions who has received all of the recommendation COVID vaccinations presents with a one day history of severe myalgias, cough, malaise, and generalized weakness. Patient was evaluated and found COVID positive. Patient was Admitted for observation. The next day patient wa feeling much improved, he was using oxygen 3L as he uses at home. He was evaluated by PT which recommended discharge home. Will need follow up with PCP. Potassium was lowered from 20 meq to 10 meq due to hyperkalemia on admission. Will need monitoring of potassium levels as outpatient. NO need for steroid administration since patient oxygen usage at baseline and is vaccinated.  Discharged to Home.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Pain
Clinical narrative: Patient's arm is welted and raised up alot where he received the vaccine yesterday. It's so swollen that the skin is tight /red and pain to the touch. He's also having pain when raising arm. Family give Tylenol, icepack and Benadryl.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Skin tightness, Urticaria
Clinical narrative: Patient's arm is welted and raised up alot where he received the vaccine yesterday. It's so swollen that the skin is tight /red and pain to the touch. He's also having pain when raising arm. Family give Tylenol, icepack and Benadryl.
Age: 4.0
Sex: M
Vaccine: IPV, MNQ
Symptoms: Incorrect route of product administration, Wrong product administered
Clinical narrative: Patient was accidentally given Menveo instead of MMRV. This Menveo was also given subcutaneously.
Age: 65.0
Sex: M
Vaccine: HPV9
Symptoms: Wrong product administered
Clinical narrative: Patient was needing to get PCV 20. He did not Receive this. He mistakenly received Gardasil 9
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: Medical assistant administered a Hep B Engerix-B vaccine to the patient as the 2nd vaccine, instead of administering the 2nd Hep B HEPLISAV-B.
Age: 84.0
Sex: M
Vaccine: RSV
Symptoms: Wrong product administered
Clinical narrative: Patient had a prescription for the Shingles vaccine, and put shingles on the form. Pharmacist had been asked to do stock check for RSV vaccine and had verbally been asked to prepare RSV vaccine. At the time of injection, pharmacist had verbally confirmed that we are giving the RSV vaccine to which the patient had confirmed and not denied. There had been a prescription in the patient's file for Shingrix and patient had not yet received the RSV vaccine, and qualifies for it.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Presyncope
Clinical narrative: Vasovagal response lasting 20-30 minutes
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Within 3 minutes of receiving the vaccine, the patient fainted, and regained consiousness in less than a minute. No head injuries were sustained.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Decreased appetite, Dizziness, Headache, Insomnia
Clinical narrative: Pt called to report dizzyness, HA, insomnia, and loss appetite since 7/7/2024, concerned was d/t to receiving HeplisavB 6/26/2024.  Pt reports being evaluated twice in ER and once by PCP following onset.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Nausea
Clinical narrative: Vaccine administered. Patient Tolerated injection well.  Vaccine administered at 8:55am Left Deltoid, patient felt nauseous at 8:59am.  Patient was examined by Dr @9:00am and advised to stay 20-25min post vaccine admin.  BP was rechecked, Dr advised to provide water to patient and recheck BP after 10min @9:40am Per Dr it is ok for patient to drive home.
Age: 11.0
Sex: F
Vaccine: HPV9, MNP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Client received injection Penbraya to Left Deltoid. No adverse events, treatments or outcomes reported at time of service or after injection. Client received Penbraya when she should have received Menactra. Nurse administered wrong injection due to confusing the 2 medications.   Nurse education completed to better understand the differences between the two vaccines, nurse will continue to orient with her preceptor until feeling more comfortable with immunizations.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Joint swelling, Peripheral swelling, Skin warm
Clinical narrative: per pt anaphylaxis reaction, swelling of arm/elbow, hot to the touch. pt went to hospital to receive treatment
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cardiac disorder
Clinical narrative: Heart problems
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Joint range of motion decreased, Pain, X-ray normal
Clinical narrative: Patient had bruising, pain, decrease range of motion, told to put hot and cold compresses, we ordered x-ray with no abnormalities, was told to get Physical Therapy.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: ABOUT 30 HOURS AFTER VACCINE WAS GIVEN IN THE OFFICE MOTHER NOTED SWELLING OF THE LEFT THIGH AND SOME ASSOCIATED REDNESS OF THE SKIN. THERE WAS A PALPABLE "KNOT" IN THE MUSCLE AND PATIENT DID NOT WANT THE AREA TOUCHED, COMPLAINED OF PAIN WITH ANY TOUCHING OF THAT AREA. WAS SEEN AND EVALUATED IN THE OFFICE 11AM 8/2 FOR THESE CONCERNS WITH EXAM FINDINGS OF A MUSCULAR KNOT IN THE LEFT THIGH, TENDERNESS ON PALPATION, REDNESS OVERLYING THE INJECTION SITE WITHOUT WARMTH, FLUCTUANCE OR DRAINAGE. PATIENT WAS ABLE TO BEAR WEIGHT AND WAS PLAYING AND WALKING/RUNNING WITHOUT ANY LIMITATIONS.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Injection site rash, Urticaria
Clinical narrative: Hives per parent report for 6 days.  Provider note states rash at injection site on both legs for 6 days.  Note is not completed, but skin care recommendations given.
Age: 73.0
Sex: M
Vaccine: CHOL, MNQ, YF
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Nurse administered Cholera vaccine to patient due to being recommended for itinerary for trip. Nurse did not realize that there was a maximum age for the Cholera vaccine which is 64 years old. Patient was notified of this by nurse that administered vaccine. Per patient, had not had any type of adverse reaction after taking vaccine. Denies any side effects after taking vaccine as well. Tolerated it without any difficulty.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Frequent bowel movements, Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: Fevers for 4 days from 102.5 to 105.4, decreased wet diapers and increased stooling.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Urine flow decreased
Clinical narrative: Fevers for 4 days from 102.5 to 105.4, decreased wet diapers and increased stooling.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Sleep disorder
Clinical narrative: I developed severe pain on the vaccine sight a few days after receiving the vaccine. Vaccine was administered on May 30th. The pain is worse at night in bed keeping me awake most of the night since.
Age: 79.0
Sex: F
Vaccine: CHOL, MNQ, YF
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Nurse administered Cholera vaccine to patient due to her itinerary during travel consult. Nurse was not aware that there is a maximum age for Cholera vaccine and administered vaccine to patient when she is over 64 years old. Patient was notified of this by nurse who administered the vaccine to her however patient states she has not experienced any side effects from the vaccine or any adverse events following it.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There was no adverse reaction that we were notified for.
Age: 18.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Syncope
Clinical narrative: Vasovagal syncope
Age: 63.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received ProQuad vaccine on 7/24/24 and again on 8/1/24 in error. No noted adverse side effects at this time. Manufacturer contacted, physician and family aware.
Age: 25.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Arthralgia, Injection site pain, Pain
Clinical narrative: On 07/23/2024, patient got MMR and Varicella vaccination IM to the right upper arm. Right after patient had aching pain to the right upper arm radiating to the right elbow. Today, 08/02/2024, patient continues to have the aching pain to the right shoulder radiating to the elbow.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Exposure via skin contact, Needle issue
Clinical narrative: Patient was being administered vaccination when needle broke and vaccine ran down patient leg. Another vaccination was administered to patient with success.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Dyskinesia, Eye movement disorder, Fatigue, Injection site haemorrhage, Loss of consciousness
Clinical narrative: At 10:00 AM nurse administered HPV vaccine to patient in the left deltoid muscle. Patient at time of administration was seated next to mom on a couch in the exam room. There was bleeding at the injection site following vaccine administration. Nurse held pressure on site for approximately 60 seconds and placed a bandage on the site after cleaning it. After bandage was placed, the patient's head started drooping forward and nurse asked him if he was okay. He responded stating that he was just tired but immediately after this response his eyes rolled back into his head and he started to fall forward from his seated position. Nurse and mom guided him to a safe position lying on his back with his feet elevated. He also displayed 2 seconds of jerking motions with his head, arms, and legs which resolved quickly. Patient was unconscious for approximately 8-10 seconds. Another nurse obtained vitals and MD was notified. MD assessed patient and he was given apple juice and crackers once he was fully alert, oriented, and deemed appropriate by MD.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Posture abnormal
Clinical narrative: At 10:00 AM nurse administered HPV vaccine to patient in the left deltoid muscle. Patient at time of administration was seated next to mom on a couch in the exam room. There was bleeding at the injection site following vaccine administration. Nurse held pressure on site for approximately 60 seconds and placed a bandage on the site after cleaning it. After bandage was placed, the patient's head started drooping forward and nurse asked him if he was okay. He responded stating that he was just tired but immediately after this response his eyes rolled back into his head and he started to fall forward from his seated position. Nurse and mom guided him to a safe position lying on his back with his feet elevated. He also displayed 2 seconds of jerking motions with his head, arms, and legs which resolved quickly. Patient was unconscious for approximately 8-10 seconds. Another nurse obtained vitals and MD was notified. MD assessed patient and he was given apple juice and crackers once he was fully alert, oriented, and deemed appropriate by MD.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: The parent noticed pink wheals on the patient's legs around 6:00pm on 8/1 following receiving vaccines around 2:00PM that day. No fever, no other symptoms.
Age: 42.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 81.0
Sex: M
Vaccine: PNC20
Symptoms: Paraesthesia
Clinical narrative: Patient felt tingling sensation in extremities around 15 minutes after vaccine.
Age: 36.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 76.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Condition aggravated, Fatigue, Influenza like illness, Migraine, Pain
Clinical narrative: Patient reports migraine starting about an hour after vaccines administered. She is experiencing mild-flu like symptoms the next day (feels feverish, body aches, fatigue)
Age: 76.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient reports migraine starting about an hour after vaccines administered. She is experiencing mild-flu like symptoms the next day (feels feverish, body aches, fatigue)
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Activated partial thromboplastin time, Amylase, Blood creatine phosphokinase MB, Blood ethanol, Blood lactic acid
Clinical narrative: 7/30/2024 0945 Sitting in chair when had syncope episode in Radiology waiting room. Syncope episode lasted approximately 10 seconds.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Blood magnesium, Blood pH, Blood thyroid stimulating hormone, C-reactive protein, Chest X-ray
Clinical narrative: 7/30/2024 0945 Sitting in chair when had syncope episode in Radiology waiting room. Syncope episode lasted approximately 10 seconds.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Computerised tomogram head, Differential white blood cell count, Electrocardiogram, Fibrin D dimer, Full blood count
Clinical narrative: 7/30/2024 0945 Sitting in chair when had syncope episode in Radiology waiting room. Syncope episode lasted approximately 10 seconds.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Glycosylated haemoglobin, International normalised ratio, Lipase, Metabolic function test, Mononucleosis heterophile test
Clinical narrative: 7/30/2024 0945 Sitting in chair when had syncope episode in Radiology waiting room. Syncope episode lasted approximately 10 seconds.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Red blood cell sedimentation rate, Syncope, Troponin
Clinical narrative: 7/30/2024 0945 Sitting in chair when had syncope episode in Radiology waiting room. Syncope episode lasted approximately 10 seconds.
Age: 1.17
Sex: F
Vaccine: MMRV
Symptoms: Cough, Dysphagia, Febrile convulsion, Rash
Clinical narrative: Febriles seizures x 2 days. Difficulty swallowing x 7 days. Cough x 7 days. Severe rash.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: Patient reported radiating pain and stiffness in left arm through shoulder and neck. Patient reported experiencing symptoms within days of receiving vaccines and is still experiencing symptoms around 3 weeks after event.
Age: 22.0
Sex: F
Vaccine: PNC20
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given PCV-20 vaccine accidentally instead of HPV Vaccine that was due.  Pt was informed by PA-C about the mistake during the appointment.  Pt did not experience adverse reaction to getting the PCV-20 vaccine per conversation with PA-C.
Age: 18.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypotonia, Loss of consciousness
Clinical narrative: Vaccine was administered to patient, while the pharmacist was talking to patient she asked if he was ok. He responded that he was not. Pharmacist retrieved some juice for patient to drink, when she returned patient was slumped over in seat appearing to be unconscious, unsure if full loss of consciousness. Pharmacist asked patients father if he would like her to call 911 and he responded that this has happened before and patient should be ok with juice. Pharmacist provided a cookie as well and sat with patient and patients father. After consuming cookie and juice patient recovered and left without further incident.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: hand paresthesia/numbness
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This patient received their 2 month vaccinations at their 1 month well child check. They did not have any symptoms or adverse outcomes because of this. Patient's parent was notified by clinic management to notify.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Paraesthesia, Rash, Rash erythematous
Clinical narrative: Red, painful rash to LUE and tingling/numbness of fingers.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Biopsy, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Soreness in right arm; lifting arm issues
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, IPV, TDAP
Symptoms: Erythema, Pruritus, Rash macular
Clinical narrative: Patient developed areas of  red blotchy areas and itching to L hand, L arm, L shoulder,  and L side of face. within 5 minutes of administering all the vaccinations.  Patient had greatest itchiness to L hand and L arm.  Patient given Benadryl 2 tabs at 1130.  Patient monitored for 30 minutes with resolution of redness to L hand and arm, decrease in redness to face and L shoulder, and no itchiness.  Advised to go to ER if symptoms return, breathing difficulties, or other concerning  issues.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Bone pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: Very sore arm, difficulty in ROM, bone pain that has continued 4 weeks after vaccine.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Multiple use of single-use product, Wrong product administered
Clinical narrative: I am a pharmacist I accidently gave a patient little or no drop of sterile diluent of measles, mumps, Rubella vaccine to a patient instead of a Flu shot. However the needle is a new needle that was not used on anybody it was only use to mix mmr vaccine. So Inject an empty or little sterile water of the diluent on the patient.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; -1.1c for 1 hour 24 min/PROQUAD was administered to one patient; This spontaneous report was received from a healthcare professional and referred to a 4-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5ml, lot #y005461, expiration date: 02-SEP-2025, administered for prophylaxis (strength, and route of administration were not provided).  On 27-JUN-2024, the temperature was -1.1 c for hour 24 minutes (Product storage error), -8.7c for 33 minutes, -14.1c for 8 min. There was no adverse event.
Sex: F
Vaccine: HPV9
Symptoms: Adnexa uteri pain
Clinical narrative: pain in her ovaries; This spontaneous report was received from Consumer and refers to a female patient of an unknown date. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in June 2024 (reported as about 3.5 weeks ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in June 2024 (reported as about 36 hours after administration), the patient experienced pain in her ovaries. The customer refused to answer any further questions and stated her overall goal was to get her daughter better first. No additional information was provided. At the time of reporting, the outcome of the event of pain in her ovaries was not reported. The action taken with the suspect vaccine regarding pain in her ovaries was not applicable.   The causal relationship between pain in her ovaries and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported. No additional adverse event (AE) was reported.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; exposed to multiple temperature excursions; This spontaneous report was received from a medical assistant and refers to a 5-year-old male patient.   The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. Concomitant medications included sterile diluent (BAXTER STERILE DILUENT)  On 14-JUN-2024, the patient  was vaccinated with improper storage second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered in the left thigh, lot #X015939, expiration date: 05-DEC-2024; first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection, administered in the right thigh, lot #W028734, expiration date: 08-SEP-2024; first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X018954, expiration date: 13-JUL-2025, administered in the right thigh; and first dose of diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX), administered in the left thigh, lot # 34MF9, expiration date: 13-FEB-2026; all administered for prophylaxis (strengths, doses, and routes of administration were not provided) at the private doctor's office/hospital (product storage error). The temperature excursion occurred because of a reading from a Digital Data Logger. No prior temperature excursions but multiple current temperature excursions. It was reported that 16 different excursions began on 22-APR-2024 but were identified "last week" between 10-JUN-2024 to 14-JUN-2024. No additional adverse event (AE) was reported.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2406USA005882:
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; Nurse calling to report that her son received 2 doses of MMRII today; This spontaneous report was received from a nurse and refers to a 4-year-old male. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-JUL-2024, the patient was vaccinated with 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided) (overdose). It was reported that the patient had not experienced any side effects or adverse events at this time (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Expired vaccine administered; This spontaneous report was received from pharmacist and refers to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 23-JUL-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 ml, valid lot #X012185, expiration date: 03-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered) administered concomitantly with sterile diluent.  No additional adverse event (AE) was reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP calling to report PROQUAD was administered after experiencing a temperature excursion. No side effects reported. No additional information/clarification provided. No additional AE/no PQC.         ?    Names of vaccines involved (including lot/e; This spontaneous report was received from a nurse practitioner, referring to a 4-year-old patient of unknown gender.  The patient's medical history and concurrent conditions were not provided. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On 12-JUL-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live ((therapy type: recombinant Human albumin/ rHA) (PROQUAD) injection, 0.5 milliliter, lot #Y005000 has been verified to be a valid lot number, expiration date was reported and validated as 26-AUG-2025, administered for prophylaxis after experiencing a temperature excursion (strength, and route of administration were not provided) (product storage error). Details of temperature excursion was as follow: temperature at -6.8 degree Celsius for 1 hour and 44 minutes. There was no previous temperature excursion. No side effects reported. No additional adverse (AE)/no product concern (PQC) was reported (no adverse event).
Age: 39.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No additional AE; HCP called to report VAQTA and RECOMBIVAX HB pediatric doses were given to a 39-year-old patient. Caller stated no symptoms have been reported and these were the first doses of these products given to this patient. No further information provided. No; This spontaneous report was received from a medical assistant referring to a 39-year-old male patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 05-JUL-2024, the patient was vaccinated with pediatric doses of hepatitis a vaccine, inactivated(VAQTA) lot # x023975, expiration date 18-APR-2025, 0.5 milliliter (route of administration not reported) and hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # x021477, expiration date 18-MAY-2026, 0.5 milliliter (route of administration not reported) both for prophylaxis (underdose). No adverse event was reported.
Sex: M
Vaccine: CHOL
Symptoms: Product storage error
Clinical narrative: Patient reconstituted vaccine after it was kept at room temperature for 48 hours and took it; Patient reconstituted vaccine after it was kept at room temperature for 48 hours and took it; Case reference number US-BN-2024-001935 is a spontaneous case report initially received from a health professional via Communication (reference number: USBAV24-1087) on 21-May-2024 and concerns a male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient took a dose of Vaxchora (batch number: unknown) at an unknown dose, via an unknown route and site of administration for unknown indication. As reported, Vaxchora vaccine was left out for 48 hours and the patient reconstituted 48 hours later after it has been left at room temperature and the patient took it because the package insert says it's viable up to five days (explicitly coded as 'product storage error' and 'product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vaxchora.  Additional information received from a pharmacist via Communication (USBAV24-1091) on 21-May-2024: included additional reference number (USBAV24-1091), patient gender and confirmation that vaccine was reconstituted 48 hours later after room temperature.; Reporter's Comments: A male patient of unknown age took a dose of Vaxchora for unknown indication. As reported, Vaxchora vaccine was left out for 48 hours and the patient reconstituted 48 hours later after it has been left at room temperature and the patient took it because the package insert says it's viable up to five days, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vaxchora. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age took a dose of Vaxchora for unknown indication. As reported, Vaxchora vaccine was left out for 48 hours and the patient reconstituted 48 hours later after it has been left at room temperature and the patient took it because the package insert says it's viable up to five days, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vaxchora. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.