chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: I, give a Varicella vaccine to Pt 07/25/2023, instead of a Vaxelis vaccine on 09/26/2023. I just realized that on 12/07/2023 when she came back to clinic. She is behind one dose of vaxelis. I talked to Dr. on 12/07/2023, and she said that I have to let mother of child know that patient needs to come back in 4 more weeks to get cut up and apologize for the wrong vaccine given to patient. I called MOC and she agreed to come back on 01/23/2023. I explained to mother that if patient didn't have any side effects back on 09/26/2023, she will not have any at this moment.  I let MOC know that patient will be fine. I also talked to coordinator and we will fill out the VAERS Form. Also my supervisor is aware of this event.  Patient didn't have any adverse event
Age: 84.0
Sex: M
Vaccine: RSV, RSV, RSV
Symptoms: Balance disorder, Gait disturbance, Pain
Clinical narrative: About two days after I took the RSV vaccine I started to get pain (day and night) in my limbs and torso: the pains  still pesrsist to the point that I have difficulty going up/down the stairs (one step at a time and always holding to the hanrail), and I also have difficulty walking due to unsteadiness. I have been taking tylenol ( 4000 mg/day, or ibuprofen 400 mg/day), but the pain persists. I saw a neurologist, who prescribed Gabapentin 2 wks ago  (100 mg/day first week, 200 mg/day 2nd and 3rd weeks, and 300mg/day after) which seems to be helping at night. I also saw my PCP: both of them stated that the pain may be due to RSV vaccine.
Age: 84.0
Sex: M
Vaccine: RSV, RSV, RSV
Symptoms: Bone pain, Myalgia
Clinical narrative: About two days after I took the RSV vaccine I started to get pain (day and night) in my limbs and torso: the pains  still pesrsist to the point that I have difficulty going up/down the stairs (one step at a time and always holding to the hanrail), and I also have difficulty walking due to unsteadiness. I have been taking tylenol ( 4000 mg/day, or ibuprofen 400 mg/day), but the pain persists. I saw a neurologist, who prescribed Gabapentin 2 wks ago  (100 mg/day first week, 200 mg/day 2nd and 3rd weeks, and 300mg/day after) which seems to be helping at night. I also saw my PCP: both of them stated that the pain may be due to RSV vaccine.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Hyperhidrosis, SARS-CoV-2 test, Sinus congestion
Clinical narrative: Sinus Congestion, sweating
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Client was given pregnancy  test by Phlebotomist and test result was verified by second Phlebotomist and found to be negative after 3 minutes of waiting.  After a few additional minutes passed by, Phlebotomist noticed that pregnancy test had second line indicating a positive pregnancy result.  Urine test was tested again x 2  and came back positive.  Client was called and asked to return to clinic for retest, but client declined and stated that she could return tomorrow.  Client doesn't believe that she could be pregnant given her history of Polycystic Ovarian Disease.
Age: 79.0
Sex: M
Vaccine: PNC20
Symptoms: Aplastic anaemia, Dyspnoea, Red blood cell count decreased, Transfusion
Clinical narrative: Patient came into the pharmacy today (12/11/23) and states that after 1 week after getting Prevnar 20 vaccine on  9/26/23 that he started experiencing  shortness of breath and went to ER. After getting lab work done, he was telling me that he ended up having a low red blood cell count. He was also stating that he got blood transfusions  between the time he felt the shortness of breath and now. He explained to me that he does not know if its from the vaccine and the physicians also told him that they are unaware of the source. He said his prescriber diagnosed it as aplastic anemia. He said he is doing a lot better now and that his red blood cell count is coming back up
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Cough, Malaise, Pyrexia, Respiratory tract congestion
Clinical narrative: General malaise, fevers/chills, congestion, rhinorrhea, cough
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory viral panel, Rhinorrhoea
Clinical narrative: General malaise, fevers/chills, congestion, rhinorrhea, cough
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site inflammation, Injection site swelling
Clinical narrative: PATIENT STATED SHE WAS VERY SICK AFTER SHINGLES VACCINE. HER ARM IS SWOLLEN, RED AND SENSITIVE TO TOUCH AT INJECTION SITE, AND HARD. THE AREA IS SOFTBALL SIZE, INFLAMED, AND HOT.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Malaise
Clinical narrative: PATIENT STATED SHE WAS VERY SICK AFTER SHINGLES VACCINE. HER ARM IS SWOLLEN, RED AND SENSITIVE TO TOUCH AT INJECTION SITE, AND HARD. THE AREA IS SOFTBALL SIZE, INFLAMED, AND HOT.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Dermal filler reaction, Inflammation, Injection site pain, Injection site rash
Clinical narrative: Between 18-24 h after the shot - I experienced myalgias, R axilla pain/swelling, non-stop sneezing, and facial swelling/tenderness in areas where I had received HA filler approximately 15 months prior.   At 48 h, I also developed a large tender, erythematous, circular rash a couple of inches below the injection site.  Antihistamines immediately relieved the sneezing, but the facial swelling and arm rash remains at 72h. I am currently taking a short course of prednisone to try to reduce the inflammation.    I believe this is a delayed hypersensitivity reaction to the filler triggered by this vaccination.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Oedema peripheral, Rash erythematous, Sneezing, Swelling face
Clinical narrative: Between 18-24 h after the shot - I experienced myalgias, R axilla pain/swelling, non-stop sneezing, and facial swelling/tenderness in areas where I had received HA filler approximately 15 months prior.   At 48 h, I also developed a large tender, erythematous, circular rash a couple of inches below the injection site.  Antihistamines immediately relieved the sneezing, but the facial swelling and arm rash remains at 72h. I am currently taking a short course of prednisone to try to reduce the inflammation.    I believe this is a delayed hypersensitivity reaction to the filler triggered by this vaccination.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Between 18-24 h after the shot - I experienced myalgias, R axilla pain/swelling, non-stop sneezing, and facial swelling/tenderness in areas where I had received HA filler approximately 15 months prior.   At 48 h, I also developed a large tender, erythematous, circular rash a couple of inches below the injection site.  Antihistamines immediately relieved the sneezing, but the facial swelling and arm rash remains at 72h. I am currently taking a short course of prednisone to try to reduce the inflammation.    I believe this is a delayed hypersensitivity reaction to the filler triggered by this vaccination.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Cellulitis, Rash
Clinical narrative: Rash in left axilla that developed into cellulitis requiring antibiotics
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Cough, Malaise, Pyrexia, Respiratory tract congestion
Clinical narrative: General malaise, fevers/chills, congestion, rhinorrhea, cough
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Respiratory viral panel, Rhinorrhoea
Clinical narrative: General malaise, fevers/chills, congestion, rhinorrhea, cough
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Contusion, Fatigue, Malaise, Pain, Pain in extremity
Clinical narrative: Fever, fatigue, body aches, general unwell feeling, sore leg, bruise
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Fever, fatigue, body aches, general unwell feeling, sore leg, bruise
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Feeling hot, Headache, Pain
Clinical narrative: At about 10 hours after the vaccine, I had chills that lasted a few hours, then heat that lasted a few more. Headache and aches as well. I've never had a reaction to a vaccine like that before.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Cough, Malaise, Pyrexia, Respiratory tract congestion
Clinical narrative: General malaise, fevers/chills, congestion, rhinorrhea, cough
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: General malaise, fevers/chills, congestion, rhinorrhea, cough
Age: 16.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Notified by office manager
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Malaise, Pyrexia, Respiratory tract congestion
Clinical narrative: General malaise, fevers/chills, congestion, rhinorrhea, cough
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: General malaise, fevers/chills, congestion, rhinorrhea, cough
Age: 91.0
Sex: M
Vaccine: FLU4
Symptoms: Product substitution error
Clinical narrative: Flu vaccine provided to patient was funded by state. Patient does not meet criteria.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient is not experiencing an adverse event, per se but need to report a duplicate vaccine administration. Patient did not remember getting a flu shot at pharmacy on 9/18/23 and then presented to our store on 12/11 and requested this year's flu shot. I administered the vaccine then we discovered that it was a duplication.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient received incorrect Covid dose - received dose for 6 month - 4 year old age group instead of the correct 5-11 year vaccine.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Chills, Cough, Malaise, Pyrexia, Respiratory tract congestion
Clinical narrative: General malaise, fevers/chills, congestion, rhinorrhea, cough
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: General malaise, fevers/chills, congestion, rhinorrhea, cough
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: shoulder/arm pain beginning within 48 hours after administration and lasting 2 months
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain in extremity, Restless legs syndrome
Clinical narrative: On the night of the vaccine, I had an extreme case of Restless Leg Syndrome. Next morning, my thighs felt weak and rubbery and ached as if I had climbed a mountain. Had to keep a heating pad on them all day. Now it is three days later and my thighs are still weak and achy, though not as intensely. My upper arms feel weak as well now.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Headache, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Sore throat, headache
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: staff member mixed the acthib with sterile water instead of the sodium chloride solution that comes with the kit for reconstitution then injected patient.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Pruritus
Clinical narrative: pt received arexvy on 12/08/2023 and came in today with an itchy arm that was red. I advised her to monitor it and seek medical attention if it worsens. advised her to use hydrocortisone cream for itch or bennadryl
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Immediate post-injection reaction, Shoulder injury related to vaccine administration
Clinical narrative: The patient instantly felt pain in the shoulder.  The patient continued to have shoulder pain and saw an orthopedic doctor who diagnosed SIRVA.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered, Expired product administered
Clinical narrative: The Moderna monovalent Covid-19 vaccine is no longer authorized for use.  Also, the particular lot # expired on February 13, 2023.
Age: 14.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: On the day of the vaccine administration, MenQuadfi was ordered and the nurse verified with MA if the vaccine was correct. She was told yes the medication was correct and the medication was administered. On 12/6/23 the MA was instructed to give MenQuadfi to a different patient and at that time discovered that it was different that the medication she had previously informed the nurse was the correct medication. She realized that Bexero was the vaccine that she told the nurse to administer. Upon researching EMR, found patient that was given Bexero.  Prescribing Nurse Practitioner, Assistant Medical Director, and patient's caregiver informed of incident. Patient has been scheduled to come back to receive MenQuadfi.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised oedema, Laboratory test, Military service, Pharyngeal swelling, Swelling face
Clinical narrative: Within the hour of receiving this vaccine my entire body including face and throat was swollen and covered in hives.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Within the hour of receiving this vaccine my entire body including face and throat was swollen and covered in hives.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given 12/7/23 Vaccine transaction expiry report states 12/04/23
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Sleep disorder
Clinical narrative: Rec'd vaccine w/o difficulty.  15 min. observation w/o c/o pain or discomfort. Resident reports that on the evening of 11/30/23 on for the following 7 nights she was unable to sleep due to onset  of developing stabbing injection site pain which lasted until 12/07/23 when it resolved itself without any treatment at home or via a healthcare professional.  Case reports having  "many COVID vaccines and nothing every hurt like this."  Resident continues to explain, "The pain then went all around that part of my arm and into my back where it would seem to stay."  Resident then explained that during the daytime there was a significant decrease in pain.  Resident reports that she has slept in a recliner chair for years.  Resident also reports significant hardening of the injection site area.  She lives alone and is unable to see if the arm became red, or swollen. the pain then further described as an achy pain that left her sleepless for 8 days. "no, position change did not change the pain."  "I had to get up and walk around to distract myself from the pain   No futher information  provided.
Age: 19.0
Sex: M
Vaccine: ANTH, JEV1, TYP, YF
Symptoms: Angioedema, Dyspnoea, Paraesthesia oral, Wheezing
Clinical narrative: Pt received YF, JEV, Anthrax and typhoid vaccines at about 1045 waited in area x 15 minutes. Left to barracks, started feeling tingling sensation in his lips, then started having difficulty breathing. Called his supervisor to inform of sx, advised to return to vaccination location where he was noted to have facial angioedema and audible wheezing at 1120 am.  Vitals signs obtained BP: 136/78 HR 113 RR: 21. Epipen administered in Left thigh Symptoms subsided 5 minutes after Epipen administered Pt then escorted to the ER
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 6 year old patient given formulation of vaccine specified for patients 12 and older. No immediate signs and symptoms noted
Age: 9.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: THE PATIENT WAS INJECTED WITH AN RSV ABRYVSO SHOT BY AN IMMUNIZATION CERTIFIED TECHNICIAN. THE  STAYED 30 MINUTES AFTER BEING VACCINATED AND NO ALLERGIC REACTIONS WERE OBSERVED. WE DID GIVE THE PATIENT'S MOTHER A CALL LATER IN THE AFTERNOON TO CHECK ON THE PATIENT. SHE WAS OK AND JUST REPORTED HAVING A SORE ARM. WE ARE REGULARLY CHECKING ON THE PATIENT TO MONITOR ANY NEW SIDE EFFECTS THAT MAY HAVE COME UP.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: PT CALLED AND REPORTED LOCAL REDNESS, PAIN AND SWELLING AT THE INJECTION SITE.  SHE ALSO SAID SHE HAD A SMALL (QUARTER SIZED) RASH ON HER CHEST.  SHE APPLIED SOME CORTISONE CREAM TO THE RASH.
Age: 15.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Blood glucose normal, Blood test normal, Computerised tomogram head normal, Computerised tomogram thorax, Dizziness
Clinical narrative: Patient on 12/10 at approximately 10:00 am, reported feeling hot, then she felt ?funny? (later described as dizzy). Then she passed out, I, her mom caught her and lowered her to the floor.  In less than a minute she regained consciousness. She had a headache and slept from 1-2 hours. With advice of triage nurse took her to the ER. While waiting to be  seen, she was sitting and said she?s hot and passed out. I held her head and yelled for a nurse. They put her on an IV and ran tests. Nothing showed up out of the ordinary.
Age: 15.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Feeling hot, Headache, Loss of consciousness
Clinical narrative: Patient on 12/10 at approximately 10:00 am, reported feeling hot, then she felt ?funny? (later described as dizzy). Then she passed out, I, her mom caught her and lowered her to the floor.  In less than a minute she regained consciousness. She had a headache and slept from 1-2 hours. With advice of triage nurse took her to the ER. While waiting to be  seen, she was sitting and said she?s hot and passed out. I held her head and yelled for a nurse. They put her on an IV and ran tests. Nothing showed up out of the ordinary.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Product expiration date issue
Clinical narrative: Vaccine given Dec11, 2023 Vaccine Expiry date in transaction receipt showed 12/04/23. Vaccine expiry date in the vial is 01/04/24
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Hospitalized with covid
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin irritation, Tryptase increased
Clinical narrative: Patient has had an extreme increase in Tryptase levels leading to constant itching and irritation of skin. Symptoms started shortly after the 2nd dose of the covid vaccine being administered. Levels continue to rise despite multiple medications being added to remediate the issue.
Age: 58.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Arteriogram coronary abnormal, Blood potassium decreased, Cardiac monitoring abnormal, Cardiomegaly, Chills
Clinical narrative: On wednesday night, had a syncopal episode, chills and achiness. Thursday evening had an irregular heart rate, dizziness, lightheadedness. Went to ER. Monitor showed PVC's. had CT angiogram due to elevated d-dimer. CT read as mild cardiomegaly with trace pericardial effusion. Neg for PE. Admitted observation to be monitored.
Age: 58.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Computerised tomogram thorax abnormal, Dizziness, Echocardiogram normal, Fibrin D dimer increased, Heart rate irregular
Clinical narrative: On wednesday night, had a syncopal episode, chills and achiness. Thursday evening had an irregular heart rate, dizziness, lightheadedness. Went to ER. Monitor showed PVC's. had CT angiogram due to elevated d-dimer. CT read as mild cardiomegaly with trace pericardial effusion. Neg for PE. Admitted observation to be monitored.
Age: 58.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Pain, Pericardial effusion, Syncope, Troponin normal, Ventricular extrasystoles
Clinical narrative: On wednesday night, had a syncopal episode, chills and achiness. Thursday evening had an irregular heart rate, dizziness, lightheadedness. Went to ER. Monitor showed PVC's. had CT angiogram due to elevated d-dimer. CT read as mild cardiomegaly with trace pericardial effusion. Neg for PE. Admitted observation to be monitored.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Injection site pain, Insomnia, Mobility decreased, Muscle discomfort
Clinical narrative: pt received an Arexvy vaccine dose and feels that it was given too high in her arm.  She had pain in her upper arm and shoulder almost immediately and stated that she had trouble sleeping for a couple days and has had limited mobility and continues to have pain.  She sought treatment with her provider who told her that they felt it was muscle related and to treat the symptoms and to monitor and see how it heals
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Product administered at inappropriate site
Clinical narrative: pt received an Arexvy vaccine dose and feels that it was given too high in her arm.  She had pain in her upper arm and shoulder almost immediately and stated that she had trouble sleeping for a couple days and has had limited mobility and continues to have pain.  She sought treatment with her provider who told her that they felt it was muscle related and to treat the symptoms and to monitor and see how it heals
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anion gap, Blindness, Blood calcium normal, Blood chloride decreased, Blood creatinine increased
Clinical narrative: Central retinal artery occlusion right eye. Vision loss started about 4 hours after COVID vaccine booster.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood glucose normal, Blood potassium normal, Blood sodium decreased, Blood thromboplastin, Blood urea normal
Clinical narrative: Central retinal artery occlusion right eye. Vision loss started about 4 hours after COVID vaccine booster.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: C-reactive protein normal, Carbon dioxide normal, Glomerular filtration rate normal, Haematocrit decreased, Haemoglobin normal
Clinical narrative: Central retinal artery occlusion right eye. Vision loss started about 4 hours after COVID vaccine booster.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mean cell haemoglobin concentration increased, Mean cell haemoglobin increased, Mean cell volume normal, Platelet count normal, Prothrombin time prolonged
Clinical narrative: Central retinal artery occlusion right eye. Vision loss started about 4 hours after COVID vaccine booster.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Red blood cell count decreased, Red blood cell nucleated morphology, Red blood cell sedimentation rate increased, Red cell distribution width, Red cell distribution width normal
Clinical narrative: Central retinal artery occlusion right eye. Vision loss started about 4 hours after COVID vaccine booster.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Retinal artery occlusion, White blood cell count normal
Clinical narrative: Central retinal artery occlusion right eye. Vision loss started about 4 hours after COVID vaccine booster.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Confusional state, Hypoaesthesia, Lethargy
Clinical narrative: Please Be advised  RSV vaccine was given by pharmacy, not Primary care  I do not know the type of vaccine or other information. Please contact patient for name of pharmacy  patient had shot in am,  by pm  felt leg numbness, this resolved after a time  however, she became lethargic and confused.  This lasted 24 hours.  She felt weak
Age: 12.0
Sex: M
Vaccine: PNC20
Symptoms: Wrong product administered
Clinical narrative: Patient was due to receive Meningococcal (Menveo) vaccine and received the Prevnar 20 in error.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Product substitution error
Clinical narrative: Flu vaccine given was under state funding. Pt does not meet criteria. Pt received an appropriate vaccine with incorrect funding source.
Age: 76.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 76.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with COVID
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Product substitution error
Clinical narrative: Flu vaccine given was under state funding. Pt does not mee criteria. Pt received an appropriate vaccine with incorrect funding source.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Red splotchy rash with bumps and persistent itchiness. Present around the neck, chest, and down the length of the arm
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain at the injection site for a month
Age: 11.0
Sex: M
Vaccine: HEP, MMRV, MNQ, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Child was inadvertently given an MMRV they did not need on this date by one of the staff members in our clinic. The child and mother presented this day with an immunization record that was translated to english and upon this appointment, two valid MMR doses and a Varicella Disease History were both missed on the overview of the shot record resulting in this child receiving a MMRV they did not need. On 12-11-23 the child presented for their second MMRV and this was caught. No adverse effects noted at this time.
Age: 92.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Hospitalized with COVID
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Insomnia, Pyrexia, Skin warm, Sleep disorder, Tremor
Clinical narrative: Parents report waking up from sleep on 12/10/23 at about 9;30 pm with shaking (tremors) of the body occuring at least 5 times within an hour, preventing him from sleeping. He also had fever but temperature was not taken but felt very hot to touch. He had been well after the vaccines given separately of MMR and Varicella.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Days 1-4: Sore arm, severe fatigue, muscle/joint pain, headache, shivering, felt feverish. Days 3-4: Listed symptoms plus several transient itchy rashes with small red bumps, appearing in seemingly random areas, less visible on day 4.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: Days 1-4: Sore arm, severe fatigue, muscle/joint pain, headache, shivering, felt feverish. Days 3-4: Listed symptoms plus several transient itchy rashes with small red bumps, appearing in seemingly random areas, less visible on day 4.
Age: 60.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inadvertently given earlier than recommended for second dose
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: physician ordered MMR and Varicella-seperate, patient was given MMRV and varicella-thus getting extra varicella
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Mobility decreased
Clinical narrative: couldn't lie down, back pain
Age: 0.75
Sex: F
Vaccine: FLU4, HEPA, MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Menveo-1 was given to a patient less than 10 years old.
Age: 5.0
Sex: M
Vaccine: COVID19, UNK, COVID19, FLU4
Symptoms: Borrelia test, Electrocardiogram normal, Facial nerve disorder, Facial paralysis, Ocular discomfort
Clinical narrative: Patient had covid and flu shots on Wednesday 6/6/23. On Saturday 6/9/23 patient developed right sided facial droop and eye discomfort. Patient presented to the ED on 12/11/23 and was found to have a facial nerve palsy concerning for Bell's palsy secondary to lyme vs covid and flu vaccines. He recently completed a course of amoxicillin for strep pharyngitis about a week ago. EKG unremarkable and lyme testing sent. He was prescribed doxycycline and artificial tears for eye discomfort.
Age: 5.0
Sex: M
Vaccine: COVID19, UNK, COVID19, FLU4
Symptoms: Bell's palsy, Borrelia test negative, Eye pain
Clinical narrative: Patient had covid and flu shots on Wednesday 6/6/23. On Saturday 6/9/23 patient developed right sided facial droop and eye discomfort. Patient presented to the ED on 12/11/23 and was found to have a facial nerve palsy concerning for Bell's palsy secondary to lyme vs covid and flu vaccines. He recently completed a course of amoxicillin for strep pharyngitis about a week ago. EKG unremarkable and lyme testing sent. He was prescribed doxycycline and artificial tears for eye discomfort.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: There are concerns that the vaccine was not diluted before given.  The nurse does not recall if diluted into 3 doses or not and we are short some doses of the vaccine for that time period.  Patient did well and aware of possibility that he was given a higher initial dose.
Age: 68.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Bell's palsy, Borrelia test, Computerised tomogram head normal, Differential white blood cell count, Facial paralysis
Clinical narrative: Woke up with facial paralysis on morning of 10/13/23. Went to emergency room at Hospital, CT scan on 10/13 negative for stroke; admitted to hospital; MRI on 10/14 negative for stroke; final diagnosis is Bell's Palsy; condition unchanged as of 12/11/23
Age: 68.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Full blood count, Lipids, Magnetic resonance imaging head normal, Metabolic function test
Clinical narrative: Woke up with facial paralysis on morning of 10/13/23. Went to emergency room at Hospital, CT scan on 10/13 negative for stroke; admitted to hospital; MRI on 10/14 negative for stroke; final diagnosis is Bell's Palsy; condition unchanged as of 12/11/23
Age: 0.58
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Flu vaccine #2 was given 21 days after Flu vaccine #1 was given.  It was given 7 days to early since there is supposed to be 28 days between Flu vaccine #1 and Flu vaccine #2.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall, Mydriasis, Pallor, Syncope
Clinical narrative: Received IM Fluzone, first time in deltoid (previously vastus lateralis). She had no immediate issues and stood without issues. Her sister then received the same vaccine (age 15), same lot. We ambulated a few minutes around the store and while at checkout pt. had a brief witness syncopal episode. She fell backward onto the floor in the store, onto her back first and then with her head following. Eyes never closed but pupils were dilated more before returning to a normal size. She was pale. She was not verbally responsive for a brief moment, less than 5 seconds. She was oriented, no witnesses seizure activity, no loss of bowel or bladder. She remained pale for roughly 8 minutes. She recalled feeling dizzy prior to the episode.
Age: 24.0
Sex: M
Vaccine: COVID19, FLUR4
Symptoms: Dyspnoea, Hypoaesthesia, Loss of consciousness, Malaise, Mydriasis
Clinical narrative: Approx 7 to 10 min after vaccination I was alerted by someone waiting for their vaccine that patient wasn't doing well.  I went out to see and he looked pale.  He was having a hard time breathing, told me his arms felt numb.  His pupils were dilated.  He was sitting on the floor when I got out there.  I immediately tried to get him to lie down and put his feet up on a chair.  He passed out, I told Tech to call 911 and I went into phcy to get EpiPen.  When I returned he was awake and wondered what had happened. EMTs arrived within 10 minutes, took my version of events and took over.  They eventually transported him to the ED
Age: 24.0
Sex: M
Vaccine: COVID19, FLUR4
Symptoms: Pallor
Clinical narrative: Approx 7 to 10 min after vaccination I was alerted by someone waiting for their vaccine that patient wasn't doing well.  I went out to see and he looked pale.  He was having a hard time breathing, told me his arms felt numb.  His pupils were dilated.  He was sitting on the floor when I got out there.  I immediately tried to get him to lie down and put his feet up on a chair.  He passed out, I told Tech to call 911 and I went into phcy to get EpiPen.  When I returned he was awake and wondered what had happened. EMTs arrived within 10 minutes, took my version of events and took over.  They eventually transported him to the ED
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Hypoaesthesia, Neuralgia, Neuritis
Clinical narrative: Started 2nd day post injection of Covid Vaccination ( Spikevax). Lt shoulder pain, someone severe, took Tylenol, naproxen intermittently ; progresed gradually to the rest of Lt arm, acomppanied by tingling, burnint pain, numbness in distal part of fingers; Neuritis or Neuralgia of my Left arm until now (12/11/2023).-  Practically I didn?t have pain after my previous 4 shots of Covid (Moderna) vaccination.-
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Started 2nd day post injection of Covid Vaccination ( Spikevax). Lt shoulder pain, someone severe, took Tylenol, naproxen intermittently ; progresed gradually to the rest of Lt arm, acomppanied by tingling, burnint pain, numbness in distal part of fingers; Neuritis or Neuralgia of my Left arm until now (12/11/2023).-  Practically I didn?t have pain after my previous 4 shots of Covid (Moderna) vaccination.-
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives with itching
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Cellulitis, Local reaction, Skin disorder
Clinical narrative: Large local reaction followed by skin breakdown and cellulitis.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: About 2 months after vaccines I developed Palmer and planter psoriasis I have never had this prior to vaccination
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid (start date: 20Nov2023, stop date: 25Nov2023). Clinical course: Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Endotracheal intubation, Injection site reaction, Pneumonia, Rash erythematous, Rash vesicular
Clinical narrative: VZV (varicella zoster virus); pneumonia; This spontaneous report was received from other health care professional concerning a 15-month-old female patient. Her concurrent conditions included ARFGEF1 gene variant with developmental delay, decreased muscle tone and failure to thrive (FTT). The patient's medical history, drug reactions/allergies, and concomitant medications were not provided. It was reported that the patient had no recent VZV exposure, did not had chickenpox, nor prior history of herpes zoster or herpes zoster ophthalmicus.   On 20-OCT-2023, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 ml, administered as prophylaxis on the patient's left thigh, lot number X006980 with expiration date 07-MAR-2025 (route of administration was not reported).   On an unspecified date in 2023, the patient developed varicella zoster virus accompanied with vesicular, erythematosus, and crusty rash (Varicella zoster virus infection), she had 4 lesions in total distributed in her scalp, left thigh, lower back, and lower neck. According to the reporter, the rash did not occur at the side of injection following the vaccination. The patient was hospitalized due to the event. Additionally, the patient had a possible pneumonia (Pneumonia) that was under investigation at the time of the report, the patient's hospitalization was prolonged for pneumonia treatment with emerging contribution of varicella zoster virus (VZV) in the setting of steroid therapy while intubated. On 24-NOV-2023, a sample was taken from the patient's scalp lesion to perform polymerase chain reaction (PCR). On 04-DEC-2023, the Company obtained the results of this test, which showed that the final specimen result was vaccine strain, the VZV DNA was amplified and showed vaccine-type.  At the time of the report, the patient was in therapy with hydrocortisone, methylprednisolone, and prednisone. On an unknown date in 2023, the patient recovered from the events.   Causal relationship between varicella virus vaccine live (Oka/Merck) (VARIVAX) and the events was not reported. Upon internal review, the event pneumonia was determined to be medically significant.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Scab, Skin lesion, Varicella virus test positive, Varicella zoster virus infection
Clinical narrative: VZV (varicella zoster virus); pneumonia; This spontaneous report was received from other health care professional concerning a 15-month-old female patient. Her concurrent conditions included ARFGEF1 gene variant with developmental delay, decreased muscle tone and failure to thrive (FTT). The patient's medical history, drug reactions/allergies, and concomitant medications were not provided. It was reported that the patient had no recent VZV exposure, did not had chickenpox, nor prior history of herpes zoster or herpes zoster ophthalmicus.   On 20-OCT-2023, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 ml, administered as prophylaxis on the patient's left thigh, lot number X006980 with expiration date 07-MAR-2025 (route of administration was not reported).   On an unspecified date in 2023, the patient developed varicella zoster virus accompanied with vesicular, erythematosus, and crusty rash (Varicella zoster virus infection), she had 4 lesions in total distributed in her scalp, left thigh, lower back, and lower neck. According to the reporter, the rash did not occur at the side of injection following the vaccination. The patient was hospitalized due to the event. Additionally, the patient had a possible pneumonia (Pneumonia) that was under investigation at the time of the report, the patient's hospitalization was prolonged for pneumonia treatment with emerging contribution of varicella zoster virus (VZV) in the setting of steroid therapy while intubated. On 24-NOV-2023, a sample was taken from the patient's scalp lesion to perform polymerase chain reaction (PCR). On 04-DEC-2023, the Company obtained the results of this test, which showed that the final specimen result was vaccine strain, the VZV DNA was amplified and showed vaccine-type.  At the time of the report, the patient was in therapy with hydrocortisone, methylprednisolone, and prednisone. On an unknown date in 2023, the patient recovered from the events.   Causal relationship between varicella virus vaccine live (Oka/Merck) (VARIVAX) and the events was not reported. Upon internal review, the event pneumonia was determined to be medically significant.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no symptoms or side effects reported; a patient was administered PNEUMOVAX 23 on 01-DEC-2023, that expired on 20-OCT-2023; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On 01-DEC-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # W015900 has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent), expiration date reported as 20-OCT-2023), 0.5 ml, administered by a health care professional (HCP) for prophylaxis (route of administration not reported) (expired product administered). The expired dose did not experience any temperature excursions. The reporter confirmed that there were no symptoms or side effects reported (no adverse event).
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccination site pain
Clinical narrative: the most painful shot ever; This spontaneous report was received from pharmacist and refers to a 10-year-old female (currently 25-year-old). 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 in 2008, the patient started therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, (administered intramuscularly, exact dose, lot #, expiration date and anatomical location were not provided) for prophylaxis. On unknown days, the patient was vaccinated with second and third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (exact doses, lot #, expiration dates, routes of administration and anatomical locations were not provided) for prophylaxis.  On unknown day in 2008, the patient experienced that GARDASIL vaccine was 'the most painful shot ever' (Vaccination site pain). On an unknown date, the patient recovered from the event. The action taken with suspect vaccine regarding the event was reported as not applicable.   The causal relationship between the event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE/; during routine vaccination appointment on 12/5/2023, the patient moved during the administration process for PROQUAD, and did not receive the complete dose of PROQUAD.; This spontaneous report has been received from a physician and refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 05-DEC-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, 0.5 milliliter (ml), two dose series (dose number, frequency, route of administration vaccination scheme, anatomical location, lot number and expiration date were not provided), administered for prophylaxis. During the routine vaccination appointment, the patient moved during the administration process for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), and did not receive the complete dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (incorrect dose administered), the physician confirmed the patient involved did not report any medical concerns or symptoms related to the attempted administration.   No additional adverse event (AE) reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported; Caller reported vaccine administered after temperature excursion.  No other information provided.  No additional AEs or PQC reported.        ?    Names of vaccines involved (including lot/exp) ROTATEQ 1918229  3/15/2024        ?    Temperature 11; This spontaneous report was received from a registered nurse referring to a patient of unknown gender and age. The patient's concurrent condition, medical history and concomitant therapies were not reported.  On 05-DEC-2023, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# 1918229, expiry date: 15-MAR-2024) was stored at temperature of 11.4 degree Celsius (C) for 4 hours. There was no previous temperature excursion. After temperature excursion, on that day, the patient was vaccinated with the improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid orally as prophylaxis (dose not reported) (product storage error). There was no other information provided. No additional adverse events (AEs) (no adverse event).  This is one of 2 reports received from the same reporter.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt vaccinated with HPV4 on 12-AUG-2008, 01-JUN-2010 and 01-FEB-2012; Pt vaccinated with HPV4 on 12-AUG-2008, 01-JUN-2010 and 01-FEB-2012; This spontaneous report has been received from a lawyer, via a Memo, Plaintiff Fact Sheet and Medical Records from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (2311USA000042), concerning a currently 31-year-old female patient. Her historical vaccines included: DTP (Diphtheria, Tetanus, Pertussis), HAV ped (Hepatitis A), HAV ped/adol 2 dose sch (Hepatitis A), HBV ped/adol, 3dose sch (Hepatitis B), HIB PRP-OMP (Haemophilus influenzae b), MENcn-ACYW (Meningococcal conjugate, groups ACYW-135), MMR (Measles, Mumps, Rubella), POL-OPV (Polio, live virus), VAR (Varicella, chickenpox) and td 7yrs-adult (tetanus, diphtheria), adsorber.  On 12-AUG-2008, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown) (reported as HPV4 (Human papillomavirus, quadrivalent)) (formulation, dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  On 01-JUN-2010, she was vaccinated with the next dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown) (formulation, dose, route of administration, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). On 01-FEB-2012, she was vaccinated with the next dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown) (formulation, dose, route of administration, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration).  This is one of the few reports concerning the same patient.; Sender's Comments:  US-009507513-2311USA000042: US-009507513-2312USA003370: US-009507513-2312USA003367: US-009507513-2312USA003368: