chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Cominarty (NDC 00069-2362-10) past the BUD date of 10 weeks. The vaccine expired on 12/06/2023 but the patient received the vaccination on 12/13/2023. The manufacturer was contacted to determine stability of the vaccine and it was confirmed that there was no impact to vaccine quality attributes beyond 75 days. They also referred us to the CDC guidance on re-vaccination and CDC recommends "immediate re-vaccination without any interval". Patient  was informed and would like to get re-vaccinated.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Cominarty (NDC 00069-2362-10) past the BUD date of 10 weeks. The vaccine expired on 12/06/2023 but the patient received the vaccination on 12/13/2023. The manufacturer was contacted to determine stability of the vaccine and it was confirmed that there was no impact to vaccine quality attributes beyond 75 days. They also referred us to the CDC guidance on re-vaccination and CDC recommends "immediate re-vaccination without any interval". A message was left for the patient in this matter.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Cominarty (NDC 00069-2362-10) past the BUD date of 10 weeks. The vaccine expired on 12/06/2023 but the patient received the vaccination on 12/13/2023. The manufacturer was contacted to determine stability of the vaccine and it was confirmed that there was no impact to vaccine quality attributes beyond 75 days. They also referred us to the CDC guidance on re-vaccination and CDC recommends "immediate re-vaccination without any interval". A message was left for the patient
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered covid vaccine 16 days beyond use date on product.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Cominarty (NDC 00069-2362-10) past the BUD date of 10 weeks. The vaccine expired on 12/06/2023 but the patient received the vaccination on 12/13/2023. The manufacturer was contacted to determine stability of the vaccine and it was confirmed that there was no impact to vaccine quality attributes beyond 75 days. They also referred us to the CDC guidance on re-vaccination and CDC recommends "immediate re-vaccination without any interval". A message was left for the patient.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Cominarty (NDC 00069-2362-10) past the BUD date of 10 weeks. The vaccine expired on 12/06/2023 but the patient received the vaccination on 12/13/2023. The manufacturer was contacted to determine stability of the vaccine and it was confirmed that there was no impact to vaccine quality attributes beyond 75 days. They also referred us to the CDC guidance on re-vaccination and CDC recommends "immediate re-vaccination without any interval". Patient was informed and he would like to get re-vaccinated.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Localized swelling, warmth, redness, and pain
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Cominarty (NDC 00069-2362-10) past the BUD date of 10 weeks. The vaccine expired on 12/06/2023 but the patient received the vaccination on 01/03/2024. The manufacturer was contacted to determine stability of the vaccine and it was confirmed that there was no impact to vaccine quality attributes beyond 75 days. They also referred us to the CDC guidance on re-vaccination and CDC recommends "immediate re-vaccination without any interval". Patient was informed and he will discuss the need for re-vaccination with his physician.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Cominarty (NDC 00069-2362-10) past the BUD date of 10 weeks. The vaccine expired on 12/06/2023 but the patient received the vaccination on 12/08/2023. The manufacturer was contacted to determine stability of the vaccine and it was confirmed that there was no impact to vaccine quality attributes beyond 75 days. They also referred us to the CDC guidance on re-vaccination and CDC recommends "immediate re-vaccination without any interval". Patient was vaccinated on 12/08/2023 which fallas within the 75 day window specified by the manufacturer. He does not require re-vaccination.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Mom called office the morning of 01/12/24. She reported that patient had a "Swollen knot" the size of a baseball on her left thigh. The area is also erythematous, bruised, and itchy. Mom did not notice the reaction prior to the morning of 01/12, but she also notes that as it's been cold patient's legs have mostly been covered. No complaints from patient prior to 01/12 either. Picture was sent through patient's chart and consistent with vaccine site reaction. Recommended cool compress as needed to help reduce swelling as well as Zyrtec daily to help with itching. Mom to follow up one week after vaccination if not improved.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Cominarty (NDC 00069-2362-10) past the BUD date of 10 weeks. The vaccine expired on 12/06/2023 but the patient received the vaccination on 12/08/2023. The manufacturer was contacted to determine stability of the vaccine and it was confirmed that there was no impact to vaccine quality attributes beyond 75 days. They also referred us to the CDC guidance on re-vaccination and CDC recommends "immediate re-vaccination without any interval". Patient was vaccinated on 12/08/2023 which falls within the 75 day window specified by the manufacturer. She does not require re-vaccination.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received Covid-19 vaccine 16 days beyond product expiration date.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Lethargy, Nausea
Clinical narrative: Dizziness and terrible nausea, fatigue/ lethargy
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Cominarty (NDC 00069-2362-10) past the BUD date of 10 weeks. The vaccine expired on 12/06/2023 but the patient received the vaccination on 12/15/2023. The manufacturer was contacted to determine stability of the vaccine and it was confirmed that there was no impact to vaccine quality attributes beyond 75 days. They also referred us to the CDC guidance on re-vaccination and CDC recommends "immediate re-vaccination without any interval". Patient was contacted and she declined re-vaccination.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Cominarty (NDC 00069-2362-10) past the BUD date of 10 weeks. The vaccine expired on 12/06/2023 but the patient received the vaccination on 01/03/2024. The manufacturer was contacted to determine stability of the vaccine and it was confirmed that there was no impact to vaccine quality attributes beyond 75 days. They also referred us to the CDC guidance on re-vaccination and CDC recommends "immediate re-vaccination without any interval". Patient was contacted and at his request his prescriber was contacted to determine if he is eligible to receive re-vaccination as he was on Methotrexate. Prescriber did not recommend re-vaccination and this was communicated to the patient.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient Expired
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Dizziness, Heart rate increased, Neutrophil count increased, Postural orthostatic tachycardia syndrome
Clinical narrative: tachycardia, tremors, lightheadedness, dysautonomia, Postural Orthostatic Tachycardia Syndrome
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Tremor, White blood cell count increased
Clinical narrative: tachycardia, tremors, lightheadedness, dysautonomia, Postural Orthostatic Tachycardia Syndrome
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: MMR/V (Proquad) was given with Varicella instead of MMR and Varicella given as individual vaccinations. There was no adverse signs or symptoms yesterday or today.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Sleep disorder
Clinical narrative: Patient received in right arm,  later in the day, patient experienced pain level of 9 while trying to sleep at the time intermittently. Currently when only opening doors at a level 6.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: High dose Fluzone (for 65 yrs of age and older) given to a 2 year old by mistake) No symptoms at this time.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Expired product administered
Clinical narrative: Patient received Covid-19 vaccine 16 days beyond use date on product.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Rash, Rash erythematous, Urticaria
Clinical narrative: Within less than 12 hours, I broke out with severe hives and red dot rash covering my whole body.  I contacted advise nurse and primary doctor. Advised to take Benedryl. I took for 3 days with no help. I continued to flush with lots of fluids as water and green tea. Continued to update facility So doctor.  Seen doctor also. This painful and uncomfortable side effect continued for 6 weeks. As of today, the remaining hives and red dot rash remain on the large part of my back painfully, inner arms and head.
Age: 17.0
Sex: F
Vaccine: FLUN4
Symptoms: Dizziness, Headache
Clinical narrative: headaches, feel dizzy
Age: 53.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events reported. Injection was given to him at the age of 53 even though he is not yet the age that the Arexvy shot is approved for (60). Patient was informed afterwards that he was not at the approved age upon recognition of his age.  He was informed not to be concerned and that he would likely be okay. He was informed I might contact him at a later date.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Chills, Confusional state, Differential white blood cell count normal, Full blood count
Clinical narrative: Patient is very sick, seemingly a reaction from having the covid booster vaccine yesterday. She presents with fever, confusion, lethargy, chills, elevated pulse, RRs and  decrease O2 sats. 2L NC applied, IV inserted L AC, NS running at 50cc/hr, STAT prednisone 40mg and benadryl ordered, but upon administration resident began to vomit and never got any pills in. CBC with diff and CMP obtained, GFR is 15. WBC is WNL, however absolute neutrophils are elevated, indicating infection. CXR = R airspace disease. PA made aware, requesting to give STAT 30mg of prednisone. Doctor to advise.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Glomerular filtration rate increased, Heart rate increased, Lethargy, Malaise, Neutrophil count increased
Clinical narrative: Patient is very sick, seemingly a reaction from having the covid booster vaccine yesterday. She presents with fever, confusion, lethargy, chills, elevated pulse, RRs and  decrease O2 sats. 2L NC applied, IV inserted L AC, NS running at 50cc/hr, STAT prednisone 40mg and benadryl ordered, but upon administration resident began to vomit and never got any pills in. CBC with diff and CMP obtained, GFR is 15. WBC is WNL, however absolute neutrophils are elevated, indicating infection. CXR = R airspace disease. PA made aware, requesting to give STAT 30mg of prednisone. Doctor to advise.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient is very sick, seemingly a reaction from having the covid booster vaccine yesterday. She presents with fever, confusion, lethargy, chills, elevated pulse, RRs and  decrease O2 sats. 2L NC applied, IV inserted L AC, NS running at 50cc/hr, STAT prednisone 40mg and benadryl ordered, but upon administration resident began to vomit and never got any pills in. CBC with diff and CMP obtained, GFR is 15. WBC is WNL, however absolute neutrophils are elevated, indicating infection. CXR = R airspace disease. PA made aware, requesting to give STAT 30mg of prednisone. Doctor to advise.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Child aged 4 was given 0.25ml/25mcg dose pulled from a vial labeled for 12years and older.  Child was monitored in the clinic. Child did not develop any adverse symptoms while monitored in the clinic post-vaccination.
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Musculoskeletal discomfort
Clinical narrative: Patient reported that he immediately felt pain on the injection site and he is having ongoing pain and trouble lifting his left arm. He denies any tingling sensations. According to the patient, the needle might have went into the joint and his pain in the left arm is affecting his shoulder as well.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received a second influenza vaccine with the same flu season.  Pt requested to get their flu vaccine during an office visit with their pcp on 01/11/2024. The vaccine was administered with no complications or adverse reactions, the error did not become apparent until documenting the administration, supervisor was informed soon after.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: I immediately lost my smell and taste.  Reported it to Primary Doctor
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: PATIENT CAME TO THE PHARMACY ON 1/11/24 AND REPORTED THAT EVER SINCE SHE RECEIVED THE RSV AND FLU VACCINE ON 10/21/23 SHE HER ARM HAS BEEN STIFF AND HAS LOSS RANGE OF MOTION. SHE STATES SHE HAS NEVER HAD ANY ISSUES WITH THE FLU VACCINE AND BELIEVES ITS FROM THE AREXY VACCINE. SHE REPORTED THAT AFTER ADMINISTRATION SHE HAD NORMAL SORENESS FOR A FEW DAYS, BUT THAT RESOLVED AND THEN HER ARM BECAME STIFF.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated
Age: 32.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 34 weeks pregnant, received vaccination and needle did not initially break skin on left (non-dominant) arm, vaccine was attempted again in right arm more forcefully.  Injection site is warm, swollen, red, and extremely sore for 48 hours.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Pfizer vaccine expiration date on vial is 12/2024; however expiration date from date vial was removed from frozen state by pharmacy is 1/8/24.  Vaccine given 4 days post expiration date.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malaise, SARS-CoV-2 test, Urticaria
Clinical narrative: HIVES ON NECK AND CENTER OF CHEST COVERING over 8" of skin.  Appeared day after and still very bad 4 days later.   Tired and not feeling well for 48 hours after. Dizzy for 48 hours.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Laboratory test abnormal, Seizure
Clinical narrative: Pt initially admitted to acute care hospital for sz activities. Further work up showed PE. Full dose Lovenox started and pt was transitioned to PO Eliquis.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pfizer vaccine expiration date on the vial is 12/2024; however the expiration date from the date the vial was removed from frozen state by pharmacy is 1/8/24.  Vaccine given 4 days post expiration date.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Injection site erythema, Injection site rash, Injection site reaction, Rash pruritic
Clinical narrative: Red welt 2 1/2 inch diameter at injection site became itchy rash for days 2-4 Increase in resting heart rate of 1 bpm for each of the next 4 days, finally coming day 2 bpm on the 5th day post-injection. (According to smart watch tracker) During normal training runs, average heart rate is usually 147-152 BPM with heart rate varying +/- 5 bpm from the average.  On a run 4 days after the injection, the avg heart rate was 167 bpm with the heart rate varying from 137 to 203 bpm. After the very 1st Moderna vaccine that I received on 12/3/2020, I did develop the Moderna arm. But, I do not recall the very scary increase in heart rate during a run.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Red welt 2 1/2 inch diameter at injection site became itchy rash for days 2-4 Increase in resting heart rate of 1 bpm for each of the next 4 days, finally coming day 2 bpm on the 5th day post-injection. (According to smart watch tracker) During normal training runs, average heart rate is usually 147-152 BPM with heart rate varying +/- 5 bpm from the average.  On a run 4 days after the injection, the avg heart rate was 167 bpm with the heart rate varying from 137 to 203 bpm. After the very 1st Moderna vaccine that I received on 12/3/2020, I did develop the Moderna arm. But, I do not recall the very scary increase in heart rate during a run.
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest pain, Deep vein thrombosis, Laboratory test abnormal, Pain in extremity
Clinical narrative: PT presented to a hospital with complaint of chest pain and leg pain. Workup showed bilateral PE and L popiteal non-occlusive DVT. Eliquis added.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pfizer vaccine expiration date on the vial is 12/2024; however the expiration date from the date the vial was removed from frozen state by pharmacy is 1/8/24.  Vaccine given 4 days post expiration date.
Age: 35.0
Sex: M
Vaccine: VARCEL
Symptoms: Decreased appetite, Injection site rash, Syncope
Clinical narrative: The patient received two subcutaneous vaccines. These were MMR and Varivax (varicella). The patient received the first vaccine (MMR) in the left arm seemingly without trouble. The second vaccine in the left arm caused the patient to slowly slip down to the ground (faint). Also, a small rash appeared at the site of the injection a few minutes after the vaccine and the fainting occurred. The patient reported not eating the entire day leading up to the vaccine at 2:30 pm. He also reported not drinking too much water that day either. He stayed at the pharmacy under observation for about an hour. He claimed to feel fine about 15 minutes after the vaccine. His blood pressure was relatively normal when checked. He was given a few glucose tablets and some water to sip on.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Pts mother reports severe abdominal pain and diarrhea for several weeks.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Patient only received lyophilized MenA reconstituted with sterile water, not with MenCYW-135 Liquid Conjugate.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: no adverse event. state requested to report because the vaccine was taken off of authorized use at time of injection.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: no adverse event. state requested to report because the vaccine was taken off of authorized use at time of injection.
Age: 0.5
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age for vaccine given - no known adverse reactions at this time. Reporting error in administration
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: no adverse event. state requested to report because the vaccine was taken off of authorized use at time of injection.
Age: 13.0
Sex: F
Vaccine: COVID19, FLU4, HPV9, TDAP
Symptoms: Blindness, Dizziness
Clinical narrative: Patient presented to clinic requesting vaccines HPV #1, Tdap #1, Flu, and Covid 19.  Health history form completed by patient, reviewed by RN, discussed with patient and parent.  VIS given to, and reviewed with, patient and parent.  All patient and parent questions answered by RN.  Vaccines administered.  Patient sat in clinic room x 10 mins then proceeded to waiting room. Patient began to feel "lightheaded" and "vision went dark".  Clinic staff assisted patient to clinic room in order to recline.  RN assessed patient, asked questions about onset of symptoms, monitored alertness, monitored pulse, gave fluids and sugar.  RN monitored patient for another 10 mins until patient reported feeling better.  No other concerns were reported.  RN discussed with parent fainting after vaccination and advised parent to monitor patient, and seek medical care if patient's level of consciousness changes.
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: no adverse event. state requested to report because the vaccine was taken off of authorized use at time of injection.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine 23 days beyond use date on product.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: no adverse event. state requested to report because the vaccine was taken off of authorized use at time of injection.
Age: 0.92
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received the 2nd dose too early.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine 21 DAYS beyond use date on product.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine 23 days beyond use date on product.
Age: 12.0
Sex: M
Vaccine: IPV
Symptoms: Circumstance or information capable of leading to medication error, Wrong product administered
Clinical narrative: Pt to clinic for immunizations. Pt was entered incorrectly. Before correction of report, pt needed polio vaccine. Once report was corrected, Pt did not need IPV vaccine. Pt came to clinic with sibling who also needed vaccines and required a IPV vaccine. Nurse accidently gave a IPV immunization when the pt did not require that dose.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction, Neuralgia, Pain in extremity
Clinical narrative: Severe Pain in both feet 7/10 (soles, heels, toes, arch); took one 12-hr Aleve before bed time. Slept well, but the next morning the pain was reduced to 4/10; took one more Aleve in morning before calling GP. Pain reduced by end of day.  I was concerned that I might have a serious fall. Please note, I have never had this issue with any of the previous 6 Covid-19 vaccines/boosters or any other vaccine in my life.   However, 5 months earlier I caught Covid-19 on a bike ride.  Initially a tingle in throat, but by the 2nd day overnight very severe foot pain (8/10), coupled with rhinitis; absolutely no sleep possible.  By 2 am took a Flexeril muscle relaxant which had absolutely no beneficial effect. At 8 am I made appointments with my with both my Podiatrist & GP.  Podiatrist described symptom as "Covid Feet" with nerve pain.  Same day I took the Covid test which was positive and saw the GP who prescribed Paxlovid.  Within a few hours after taking the Paxlovid, the neurological pain was completely gone. Regrettably, the OTC "am/pm" cold remedies were worthless over two weeks for the rhinitis & sore throat.  FDA had then reported publicly this was true. I got my GP to prescribe Levofloxacin 100mg which cured the respiratory symptoms overnight!
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Adverse event, COVID-19, Insomnia, Pain, Pain assessment
Clinical narrative: Severe Pain in both feet 7/10 (soles, heels, toes, arch); took one 12-hr Aleve before bed time. Slept well, but the next morning the pain was reduced to 4/10; took one more Aleve in morning before calling GP. Pain reduced by end of day.  I was concerned that I might have a serious fall. Please note, I have never had this issue with any of the previous 6 Covid-19 vaccines/boosters or any other vaccine in my life.   However, 5 months earlier I caught Covid-19 on a bike ride.  Initially a tingle in throat, but by the 2nd day overnight very severe foot pain (8/10), coupled with rhinitis; absolutely no sleep possible.  By 2 am took a Flexeril muscle relaxant which had absolutely no beneficial effect. At 8 am I made appointments with my with both my Podiatrist & GP.  Podiatrist described symptom as "Covid Feet" with nerve pain.  Same day I took the Covid test which was positive and saw the GP who prescribed Paxlovid.  Within a few hours after taking the Paxlovid, the neurological pain was completely gone. Regrettably, the OTC "am/pm" cold remedies were worthless over two weeks for the rhinitis & sore throat.  FDA had then reported publicly this was true. I got my GP to prescribe Levofloxacin 100mg which cured the respiratory symptoms overnight!
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine 23 days beyond use date on product.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV1
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event. Client provided vaccination prior to notation of temperature excursion below - 0 Celsius. Excursion was not noted with daily checks, but with download of temperature data logger. Notification of recommendation for repeat of 2 vaccines (PCV,Pentacel)  was made.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test normal, Chest discomfort, Coagulation time, Electrocardiogram normal, Hypertension
Clinical narrative: I woke up a few days after receiving the vaccine to an insane amount of pressure in my chest. I believed I was having a heart attack. Paramedics were called and they advised me that they believed I was having a panic attack. I have never had a panic attack and they informed me that I should go to the hospital if I did not notice a change within the next day or two. They advised me that everything looked normal but that my blood pressure was a little high.  A few days later I went to the emergency room because things were staying the same.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Panic attack
Clinical narrative: I woke up a few days after receiving the vaccine to an insane amount of pressure in my chest. I believed I was having a heart attack. Paramedics were called and they advised me that they believed I was having a panic attack. I have never had a panic attack and they informed me that I should go to the hospital if I did not notice a change within the next day or two. They advised me that everything looked normal but that my blood pressure was a little high.  A few days later I went to the emergency room because things were staying the same.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Patient fainted after having vaccines administered in the office. As patient was exiting office, PT fainted and injured his right frontal head causing bump on skin. Oxygen levels taken (see vitals), not requiring oxygen. Patient was reevaluated after the fall. He was lucid, no n/v, and otherwise normal. Patient walked out after a 15 minute wait. After the patient left, mother called the clinic to notify us of vomiting. He was told to go directly to the ER.
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event
Clinical narrative: Pt was given a dose of Abrysvo on 12/15/2023 at 32 weeks gestation and then in clinic again at 36 weeks gestation was given another dose on 1/12/2024. Pt was counseled by physician prior to administration and never verbalized she was already given vaccination on 12/15/2023. Physician made aware of medication error when nurse when to chart in state registry.  Pt has due date of 02/09/2024. Contacted Immunization rep, Pfizer manufacturer, and CDC.  Pt was called and updated on findings per CDC as getting an extra dose of vaccination is not likely to cause an adverse reaction but could increase risk for minor local reaction of injection site pain, headache, and or nausea. Pt verbalized understanding and voiced she knew she had received vaccinations on appt in December but did not remember which ones. Pt advised to return to clinic if increase minor reaction occurs or report immediately to ED if after hours. Pt verbalized understanding.  Pt has not had any reaction to receiving a second dose of vaccination at this time.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine beyond 23 days use date on product.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 32.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Product storage error
Clinical narrative: Patient was administered COVID vaccine 23 days beyond use date on product.
Age: 32.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Expired product administered
Clinical narrative: Patient was administered COVID vaccine 23 days beyond use date on product.
Age: 32.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine 17 days beyond use date on product.
Age: 32.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 17 days beyond use date on product.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine beyond 23 days use date on product.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 13 DAYS
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10 days beyond use.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine 23 days beyond use date on product.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine 23 days beyond use date on product.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 23 days beyond use date on product.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event, Pain in extremity
Clinical narrative: No adverse event, patient had already had the Abrysvo vaccine. Administration of Arexvy represents a duplicate immunization.  Patient did report she believes she had a sore arm.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Patient report that the vaccine has caused such severe stiffness in her arm that she cannot move it at all. This started immediately after the vaccination and has continued until it was reported to me today.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine 21 DAYS beyond use date on product.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: VACCINE FAILURE - USER WITH A COMPLETE VACCINATION SCHEDULE FOR >2 WEEKS HAD COVID-19; This spontaneous report received from a physician by a Regulatory Authority (Vaccines, PT-INFARMED-T202108-2462) on 11-JAN-2024 was received on 11-JAN-2024 and concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: covid-19 immunisation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393) dose was not reported,(dose series 1) administered on 16-JUL-2021 for covid-19 immunisation. Age at time of vaccination 3 decade old. No concomitant medications were reported. On 14-AUG-2021, the patient experienced vaccine failure - user with a complete vaccination schedule for >2 weeks had covid-19. Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine failure - user with a complete vaccination schedule for >2 weeks had covid-19 was not reported. This report was serious (Other Medically Important Condition).; Reporter's Comments: Other information-Symptoms starting on 14-08-2021Test performed on 14-08-2021 (laboratory)
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: VACCINE FAILURE - USER WITH A COMPLETE VACCINATION SCHEDULE FOR >2 WEEKS HAD COVID-19; This spontaneous report received from a physician by a Regulatory Authority (Vaccines, PT-INFARMED-T202108-2463) on 11-JAN-2024 was received on 11-JAN-2024 and concerned a 24 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: covid-19 immunisation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393) dose was not reported, (dose series 1) administered on 20-JUL-2021 for covid-19 immunisation. Age at time of vaccination 3 decade old. No concomitant medications were reported. On 12-AUG-2021, the patient experienced vaccine failure - user with a complete vaccination schedule for >2 weeks had covid-19. On 14-AUG-2021, Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine failure - user with a complete vaccination schedule for >2 weeks had covid-19 was not reported. This report was serious (Other Medically Important Condition).; Reporter's Comments: Other information-Symptoms starting on 12-08-2021Test performed on 14-08-2021 (laboratory)
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; HCP called to report inadvertent administration of expired MMR-II to a patient. Product expired on 18OCT2023 and was administered to a patient on 14DEC2023. No additional AE/PQC.; This spontaneous report was received from nurse referred to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 14-DEC-2023, the patient was vaccinated inadvertent administration of expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (rHA) (M-M-R II) injection, lot #W034714, expiration date: 18-OCT-2023, as prophylaxis (dose, strength, and route of administration were not provided) (Expired product administered). There was no additional adverse event (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP called to report ROTATEQ inadvertently administered to patient on 12/14/2023 which had expired on 11/17/2023; 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 14-DEC-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1908328, expiration date: 17-NOV-2023, administered orally for prophylaxis (strength, dose not provided) (Expired product administered). The reporter called to report this expired dose of vaccine that was inadvertently administered to the patient. No additional adverse event was reported (No adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE; HCP calling to report a patient inadvertently received an expired dose of GARDASIL 9. No side effects reported. No previous temperature excursions. No additional information/clarification provided. No additional AE/no PQC.; This spontaneous report was received from a pharmacist and referred to a 43-year-old of unknown gender patient. The patient's concurrent conditions, pertinent medical history, and drug reactions/allergies were not reported.  On 15-DEC-2023, the patient was inadvertently vaccinated an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml (lot number: 1780878, expiration date: 02-DEC-2023) (strength and route of administration were not reported) for prophylaxis (expired product administered). No side effects reported. No previous temperature excursions. No additional information/clarification provided. No additional adverse event (no adverse event).
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; patient received 1 dose of GARDASIL 9 after the product was involved in a temperature excursion.; This spontaneous report was received from a registered nurse (R.N.), concerning a 15-year-old patient (gender not reported). The patient's medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On 26-DEC-2023, 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) pre-filled syringe injection, 1 dose,  lot# X019863, expiration date: 14-FEB-2025, administered for prophylaxis (dose, route of administration, and anatomical location were not provided) following a temperature excursion of 13.08 degree Celsius for 1 hour 15 minutes (product storage error). It was stated that no previous temperature excursion was reported. No patient symptoms have been reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2312USA010648: US-009507513-2312USA010597: US-009507513-2312USA010641: US-009507513-2312USA010804:MSD
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The nurse is reporting that a patient received improperly stored vaccine.; This spontaneous report was received from a licensed practical nurse and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 27-DEC-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dosage form, lot #x017489, expiration date: 25-JUN-2025, (strength, exact dose, dose#, route of administration, and anatomical site of vaccination were not provided) for prophylaxis (product storage error). The suspect vaccine was stored at 17.2 Fahrenheit (F) degrees for 50 minutes. No previous temperature excursions were reported. No additional adverse events (AEs) were reported (no adverse event).
Age: 1.08
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse issues or side effects; inadvertently administered PROQUAD and VARIVAX at the same time; This spontaneous report has been received from a physician and an office manager and referred to a 13-month-old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown) and pneumococcal vaccine conj 7v (crm197) (PREVNAR).    On 03-JAN-2024, the patient was inadvertently vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (0.5 milliliter once; lot # W011625 verified to be a lot valid number, expiration date was 06-APR-2024; route and strength unknown), the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) (0.5 milliliter once; lot # X009129 verified to be a valid lot number, expiration date reported as 26-SEP-2024 and September 2024, but upon internal validation established as 24-SEP-2024; route and strength unknown) both for prophylaxis and pneumococcal vaccine conj 7v (crm197) (PREVNAR) at the same time (Accidental overdose) by a nurse (also reported as medical assistant), reconstituted with sterile diluent (manufacturer unknown). The patient was only supposed to get measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) and pneumococcal vaccine conj 7v (crm197) (PREVNAR). There were no adverse issues or side effects like febrile seizures reported in relation to the administration of the vaccines by the patient (No adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs or PQC reported; Caller reported expired dose of MMR II was administered.; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-JAN-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, recombinant human albumin (rHA), 0.5 milliliter, administered for prophylaxis lot number U039907 has been verified to be a valid lot number, expiration date reported and validated as 16-DEC-2023) (expired product administered), frequency reported as "SQ" (strength, vaccination scheme, anatomical location and route of administration were not provided). There was no additional adverse event.
Age: 44.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HCP reporting that a patient received their first dose of MMRII at approximately 44 years of age; No side effects reported; This spontaneous report was received from a pharmacist referring to a 44 year old male patient. No information regarding the patient's pertinent medical history, concomitant therapy and drug reactions or allergies were provided.  On an unknown date, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 0.5 milliliter (strength, route, lot number, expiration date and anatomical location were not provided) for prophylaxis (product administered to patient of inappropriate age). No side effects reported.
Sex: U
Vaccine: RV5
Symptoms: Infantile spitting up, No adverse event, Underdose
Clinical narrative: No additional AEs were reported; Physician reported that an infant received less than half of the recommended dose of ROTATEQ because the infant spitted out during the administration of the vaccine; This spontaneous report was received from a physician and refers to a n infant 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 the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot number X015246 that was verified to be valid with expiration date: 15-DEC-2024, administered orally for prophylaxis (strength, specific dosage, vaccination scheme and anatomical site of application were not provided) and on 08-JAN-2024, the patient was administered with the second dose in the series, administered orally for prophylaxis (strength, specific dosage, vaccination scheme, lot number, expiration date and anatomical site of application were not provided), but received less than half of the recommended dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) because the infant spitted out during the administration (accidental underdose). The physician did not report any issues with the first dose. No additional AEs were reported. No further information provided. No PQC.