chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: Pneumococcal infection; This spontaneous report has been downloaded from Regulatory Authority.  This report concerns an adult female patient aged 60 to 64 years old. 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 pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical location and route of administration were not provided).  In 2023, the patient experienced Pneumococcal infection. Streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event was unknown. No causality assessment was provided.    Upon internal review, the event Pneumococcal infection was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: No data provided; This spontaneous report has been downloaded from regulatory authority referring to an Adult male patient (age group reported as 50-54). The patient's medical history, concurrent conditions, and concomitant therapies were not reported. Vaccination history was mentioned as vaccine/s given (details not provided).  On an unknown date, the patient was vaccinated with the first, second and third dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose, lot #, expiry date, route of administration, and anatomical location were not provided).  On an unspecified day in 2023, the patient experienced pneumococcal infection (reported as no data provided). In addition, streptococcus pneumoniae serotyping was reported as not available. At the time of reporting the outcome of the event was not provided.  The causal relationship between the event and the suspect vaccine was not reported.   Upon internal review, the event of pneumococcal infection was determined to be medically significant.  Additional information is not expected.
Sex: M
Vaccine: PNC13, PNC15, PPV
Symptoms: Pneumococcal infection, Streptococcus test
Clinical narrative: Pneumococcal infection; This spontaneous report has been downloaded from Diseases Surveillance System (DSS) and refers to a child male patient of unknown exact age (age group was reported as: 2 to 4 years).  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (manufacturer unknown), formulation: injection; or with pneumococcal 15v conj vaccine (crm197) (manufacturer unknown), formulation: injection (lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis (vaccine type unknown). On unknown dates, the patient was vaccinated with two doses of pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) for prophylaxis (formulation, lot #, expiration date, exact dose, route of administration and anatomical location were not provided).   On an unspecified date in 2023, the patient experienced pneumococcal infection. On an unknown exact date in 2023, the Streptococcus pneumoniae serotyping was performed, and the result was not available. At the time of reporting, the outcome of pneumococcal infection was unknown.   The causal relationship between suspect vaccines and the event was unknown.   Upon internal review, the event pneumococcal infection was determined to be medically significant.
Age: 80.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Anal incontinence, Diarrhoea, Dysstasia, Gait disturbance, Mobility decreased
Clinical narrative: Pt acute lower extremity weakness following a recent COVID-19 booster vaccination. The onset of symptoms was noted on the day following the vaccination, when the patient experienced difficulty standing from a seated position due to perceived leg weakness. She states that the morning of she was able to walk to the kitchen, make breakfast then when she sat down she couldn't no stand back up. Noted to not be able to move out of chair for 60 hours which led to urinary and fecal incontinence. Reportedly husband was also at home to help her?The patient reported no associated back pain or new urinary incontinence, although she did note a history of occasional incontinence.   The patient also reported new onset diarrhea, which began the night prior to the consultation. The patient was able to ambulate with a walker prior to this episode, but described her gait as more of a shuffle. The patient denied any recent changes in vision, swallowing, or speech, although she did note occasional speech changes thought to be related to psychiatric medication.   The patient also reported a history of a psychiatric breakdown in the summer of 2013, with subsequent ups and downs in her mental health. She has been under the care of a geriatric psychiatrist for the past year, which has reportedly been helpful. The patient also has a history of asthma, but reported no recent changes or exacerbations.   The patient reported some long-standing tingling in the feet, but denied any new numbness or tingling. She also denied any recent muscle pain or cramps, chest pain, or unusual sensations in the back. The patient's primary concern was the new onset lower extremity weakness, which she described as her legs not supporting her, leading to difficulty standing and walking.
Age: 80.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Muscular weakness, Urinary incontinence, Walking aid user
Clinical narrative: Pt acute lower extremity weakness following a recent COVID-19 booster vaccination. The onset of symptoms was noted on the day following the vaccination, when the patient experienced difficulty standing from a seated position due to perceived leg weakness. She states that the morning of she was able to walk to the kitchen, make breakfast then when she sat down she couldn't no stand back up. Noted to not be able to move out of chair for 60 hours which led to urinary and fecal incontinence. Reportedly husband was also at home to help her?The patient reported no associated back pain or new urinary incontinence, although she did note a history of occasional incontinence.   The patient also reported new onset diarrhea, which began the night prior to the consultation. The patient was able to ambulate with a walker prior to this episode, but described her gait as more of a shuffle. The patient denied any recent changes in vision, swallowing, or speech, although she did note occasional speech changes thought to be related to psychiatric medication.   The patient also reported a history of a psychiatric breakdown in the summer of 2013, with subsequent ups and downs in her mental health. She has been under the care of a geriatric psychiatrist for the past year, which has reportedly been helpful. The patient also has a history of asthma, but reported no recent changes or exacerbations.   The patient reported some long-standing tingling in the feet, but denied any new numbness or tingling. She also denied any recent muscle pain or cramps, chest pain, or unusual sensations in the back. The patient's primary concern was the new onset lower extremity weakness, which she described as her legs not supporting her, leading to difficulty standing and walking.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Shoulder injury related to vaccine administration
Clinical narrative: Patient alleges range of motion issues and pain in left deltoid (SIRVA)
Age: 21.0
Sex: M
Vaccine: ADEN_4_7, FLU3, HEPA, IPV, MMR, MNQ, PNC21, TDAP, VARCEL
Symptoms: Lip swelling, Swelling face, Throat irritation, Throat tightness, Urticaria
Clinical narrative: Patient reported to Clinic with Lip and facial swelling, urticaria, throat itchiness and tightening. Symptoms first started after receiving Bicillin injection and became worse after receiving other vaccines listed above. Patient was given EpiPen to the L thigh at 1043, PO Benadryl 50mg and transported to the ER via ambulance
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Aphonia, Burning sensation, Injection site rash, Laryngitis, Pruritus
Clinical narrative: rash at site of injection 45 minutes after dose given. Followed by rash on chest and neck. itching and burning. Woke up the next day with laryngitis. loss of voice, continues on 12/02/2024.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: rash at site of injection 45 minutes after dose given. Followed by rash on chest and neck. itching and burning. Woke up the next day with laryngitis. loss of voice, continues on 12/02/2024.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient presented for her routine 11 your physical. She received a 2 vaccines in the right arm and 1 vaccine in the left arm. The next day she had right arm swelling and redness. This was associated with a fever to 101. She was feeling dizzy and tired. Over the next 24 hours she improved but the redness around the injection sites in the right arm persisted so she was seen in the office around 48 hours after the beginning of symptoms.  There was a 10 x 10 cm of erythema without induration over the right lateral arm associated with the areas of immunization. This continued to spread from her shoulder to her elbow. Persisted for 7 days post immunization before resolution.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Pt was given a second flu shot of this year
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Angiogram, Bell's palsy, Blood folate, Blood thyroid stimulating hormone, Borrelia test
Clinical narrative: Patient received flu vaccine on 10/30/24. She states about 2 days after receiving the vaccine she had neck and ear pain on the right side that lasted for several weeks. On 11/22/24 she developed numbness and drooping on the right side of her face and went to the emergency room and after workup she was dx'd with Bell's Palsy and was treated with Valtrex and Prednisone. On 11/24 she went back to the emergency room with worsening sx and was kept for 24-hour observation with additional imaging and lab studies done. She was treated with high dose Methyl prednisone for Dx consistent with Bell's Palsy . Patient was advised to report that she had a flu vaccine to the CDC by her admitting physician.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: C-reactive protein, Computerised tomogram, Ear pain, Facial paralysis, Full blood count
Clinical narrative: Patient received flu vaccine on 10/30/24. She states about 2 days after receiving the vaccine she had neck and ear pain on the right side that lasted for several weeks. On 11/22/24 she developed numbness and drooping on the right side of her face and went to the emergency room and after workup she was dx'd with Bell's Palsy and was treated with Valtrex and Prednisone. On 11/24 she went back to the emergency room with worsening sx and was kept for 24-hour observation with additional imaging and lab studies done. She was treated with high dose Methyl prednisone for Dx consistent with Bell's Palsy . Patient was advised to report that she had a flu vaccine to the CDC by her admitting physician.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Glycosylated haemoglobin, Hypoaesthesia, Influenza virus test, Magnetic resonance imaging head, Metabolic function test
Clinical narrative: Patient received flu vaccine on 10/30/24. She states about 2 days after receiving the vaccine she had neck and ear pain on the right side that lasted for several weeks. On 11/22/24 she developed numbness and drooping on the right side of her face and went to the emergency room and after workup she was dx'd with Bell's Palsy and was treated with Valtrex and Prednisone. On 11/24 she went back to the emergency room with worsening sx and was kept for 24-hour observation with additional imaging and lab studies done. She was treated with high dose Methyl prednisone for Dx consistent with Bell's Palsy . Patient was advised to report that she had a flu vaccine to the CDC by her admitting physician.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Red blood cell sedimentation rate, Respiratory syncytial virus test, SARS-CoV-2 test, Treponema test
Clinical narrative: Patient received flu vaccine on 10/30/24. She states about 2 days after receiving the vaccine she had neck and ear pain on the right side that lasted for several weeks. On 11/22/24 she developed numbness and drooping on the right side of her face and went to the emergency room and after workup she was dx'd with Bell's Palsy and was treated with Valtrex and Prednisone. On 11/24 she went back to the emergency room with worsening sx and was kept for 24-hour observation with additional imaging and lab studies done. She was treated with high dose Methyl prednisone for Dx consistent with Bell's Palsy . Patient was advised to report that she had a flu vaccine to the CDC by her admitting physician.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Vitamin B12
Clinical narrative: Patient received flu vaccine on 10/30/24. She states about 2 days after receiving the vaccine she had neck and ear pain on the right side that lasted for several weeks. On 11/22/24 she developed numbness and drooping on the right side of her face and went to the emergency room and after workup she was dx'd with Bell's Palsy and was treated with Valtrex and Prednisone. On 11/24 she went back to the emergency room with worsening sx and was kept for 24-hour observation with additional imaging and lab studies done. She was treated with high dose Methyl prednisone for Dx consistent with Bell's Palsy . Patient was advised to report that she had a flu vaccine to the CDC by her admitting physician.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Head discomfort, Headache, Hypoaesthesia, Migraine
Clinical narrative: "Couple hours after receiving my flu shot I felt very tired, nausea, and began to feel head pressure. Middle of night starting having a bad headache and by morning evolved into a migraine. I had a migraine for almost 72 hours with some relief using Excedrin. By Tuesday began to feel arm pain that radiates up the shoulder, scapula, and neck, and down to forearm. Tuesday night into Weds began to have numbness and tingling on and off while lying down. Pain in arm is worse and still have some numbness and tingling. Hand cramping beginning Thursday morning. Last two nights I have been waking up several times from the pain and numbness and tingling"
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Nausea, Pain, Pain in extremity, Paraesthesia
Clinical narrative: "Couple hours after receiving my flu shot I felt very tired, nausea, and began to feel head pressure. Middle of night starting having a bad headache and by morning evolved into a migraine. I had a migraine for almost 72 hours with some relief using Excedrin. By Tuesday began to feel arm pain that radiates up the shoulder, scapula, and neck, and down to forearm. Tuesday night into Weds began to have numbness and tingling on and off while lying down. Pain in arm is worse and still have some numbness and tingling. Hand cramping beginning Thursday morning. Last two nights I have been waking up several times from the pain and numbness and tingling"
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder
Clinical narrative: "Couple hours after receiving my flu shot I felt very tired, nausea, and began to feel head pressure. Middle of night starting having a bad headache and by morning evolved into a migraine. I had a migraine for almost 72 hours with some relief using Excedrin. By Tuesday began to feel arm pain that radiates up the shoulder, scapula, and neck, and down to forearm. Tuesday night into Weds began to have numbness and tingling on and off while lying down. Pain in arm is worse and still have some numbness and tingling. Hand cramping beginning Thursday morning. Last two nights I have been waking up several times from the pain and numbness and tingling"
Sex: M
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Eye swelling, Urticaria
Clinical narrative: Within 2 hours of vaccination, patient had swollen eyes and profuse hives covering body and face.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Sleep disorder
Clinical narrative: Patient describes a "vice grip" down arm to fingers lasting for 5 minutes that then resolves. It is happening daily since the vaccine administration and wakes her out of a sleep. Patient has been advised to contact her PCP for evaluation.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Fluad 65+ ordered by provider and given by nurse to 59yo
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: High Dose influenza vaccine given to patient age 21 yrs.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Dizziness, Eyelid function disorder, Gaze palsy, Hyperhidrosis
Clinical narrative: Pt presented to the office for a nurse visit tdap vaccination. Pt has hx of vasovagle incidents post immunization. Pt's mother was with her for this visit. Pt laid on examination table in exam room 6. Vaccine was administered by MA. This RN was present during immunization administration.   Pt continued to lay on examination table, reported feeling sweaty and dizzy. Provided an ice pack for head and a cool cloth.   Pt then reported that she needed to vomit. This RN sat patient up on exam table slightly to avoid aspiration during emesis.   Pt dry heaved twice and then slid down the exam table, eyes rolled into back of her head, her body became rigid and she started convulsing. This lasted approximately 8 seconds.  pupils were dilated. In the event that she had a syncopal incident we did elevate her legs above her heart while examined by provider.  After examination, patient rested on exam table. Patient reported feeling dizzy and having a stomachache, and also that her eyes were "stuck shut" and she was extremely sleepy.  Bp taken on R arm, 85/48 and 88/50.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle rigidity, Mydriasis, Retching, Seizure, Somnolence
Clinical narrative: Pt presented to the office for a nurse visit tdap vaccination. Pt has hx of vasovagle incidents post immunization. Pt's mother was with her for this visit. Pt laid on examination table in exam room 6. Vaccine was administered by MA. This RN was present during immunization administration.   Pt continued to lay on examination table, reported feeling sweaty and dizzy. Provided an ice pack for head and a cool cloth.   Pt then reported that she needed to vomit. This RN sat patient up on exam table slightly to avoid aspiration during emesis.   Pt dry heaved twice and then slid down the exam table, eyes rolled into back of her head, her body became rigid and she started convulsing. This lasted approximately 8 seconds.  pupils were dilated. In the event that she had a syncopal incident we did elevate her legs above her heart while examined by provider.  After examination, patient rested on exam table. Patient reported feeling dizzy and having a stomachache, and also that her eyes were "stuck shut" and she was extremely sleepy.  Bp taken on R arm, 85/48 and 88/50.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Headache, Injection site pain, Injection site rash, Vomiting
Clinical narrative: Rash around the injection site the next day and is still there a week later. Still complaining of pain in the injection site of vaccination. She has thrown up 5 times and complained of headaches since the shot. We took her to the ER On Dec. 1st and they said it was a possible reaction to the vaccination.
Age: 86.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient presented to pharmacy on 12/01 complaining of severe pain in left arm. She had it wrapped and said she cannot lift it. She said it started hurting after her vaccinations on 11/20, but had progressed to severe pain by 12/01. Patient was referred to her physician and counseled on over the counter management of her pain.
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: The pt received a 2nd vaccine of RSV when they were only indicated for a single vaccine per guidelines
Age: 65.0
Sex: F
Vaccine: COVID19, FLU3, VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: I woke up with hives on inside arms, behind knees, on hips & a few on buttocks  on 11/15. 2nd day after vax. Every day since.  Benadryl relieves itching & controls hives. Bathing with epsom salt as well for relief. I didn't take benadryl yesterday as preventative & had hives on face as well as the other places. (Pillow side)
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Patient almost passed out in the treatment room. Vitals signs were stable. Seen by provider.
Age: 71.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient did not experience adverse events, but this is being reported because the patient received the 3rd dose in the vaccination series too early. The patient thought he was receiving the 2nd dose in the series but remembered later that he had already received the 2nd dose. The first dose was given 8/17/2024, the second dose was given 9/16/2024 and therefore the patient received the 3rd dose on 11/21/2024 (which should have been administered after 02/17/2025).
Age: 64.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient did not experience adverse events, but this is being reported because the patient received the 3rd dose in the vaccination series too early. The patient thought she was receiving the 2nd dose in the series but remembered later that she had already received the 2nd dose. The first dose was given 8/17/2024, the second dose was given 9/16/2024 and therefore the patient received the 3rd dose on 11/21/2024 (which should have been administered after 02/17/2025).
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Syncope
Clinical narrative: Patient received vaccine stood up walked around for less than a minute before getting light headed and having a syncopal episode
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Nausea, Pallor
Clinical narrative: Patient was fine immediately following administration of vaccines. Patient proceeded to lab without incident to have blood drawn. Patient and mother were with registration making follow up appointments, patient became ashen and nauseated. Patient was assisted into a wheelchair, provided with apple juice and animal crackers, and brought back to an exam room. Patient vomited less than 4 mL. Patient rested in room and ambulated out of clinic unassisted once symptoms resolved.
Age: 41.0
Sex: M
Vaccine: UNK
Symptoms: Dizziness, Pyrexia, Vertigo
Clinical narrative: Within a day or two of the vaccine I got a high fever between 103-104.  Subsequently, I began to experience significant dizziness and vertigo like symptoms to the point of feeling as though I was going to pass out.  While my immune system was compromised, I developed an upper respiratory infection and ear infection that lasted several weeks, followed by COVID-19.  I also experienced an adverse reaction to my 2023 seasonal influenza vaccine (I do not know the identifying details of the vaccine), which resulted in a high fever and vertigo-like symptoms.  I am still recovering from the current illness.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RSV, RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Arexvy given to 4 month old patient
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Patient received a Kinrix vaccine instead of a flu vaccine,
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC20, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Adverse event - Providers administered Proquad AND Varivax vaccines on the same date on different extremity locations.  This was the first dose of MMR and Varicella for this client. We called the manufacture  for guidance.  Guidance provided was to perform a VAERS adverse report. The client did not report any adverse side effects. The manufacture states depending on the providers discretion, but the child should continue with the required childhood series, omitting the additional varicella dose that was given on the date of administration.  No significant adverse side effects have been reported when giving Proquad and Varivax on the same date. The manufacture, Merck & Co, reports that the same common side-effects are reported when these vaccines are administered  as recommended, as well as when given subsequent doses.
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given 2 doses of seasonal flu vaccine.  Patient did not realize he had already had 2024 seasonal flu shot and asked to get dose. Pharmacy did not verify dosing and gave 2nd dose to patient.   Patient does not report any adverse effects from having 2 doses.
Age: 0.08
Sex: F
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired by 2 days when given. Patient's mother was still in clinic when it was discovered. She was notified as well as the physician and immunization coordinators. Patient tolerated dosing well. Mother was informed that the dose would be invalid in database and need to be readministered at a minimum 28 days from previous. Patient's mother verbalized understanding and had no questions.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia, Pruritus
Clinical narrative: Itchy arm, and the itchiness went all the way down her left side of body to left foot.    Numbness & tingling  all the way down left arm. Zyrtec (over the counter was taken).
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Urticaria
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: splotches of itchy red rash broke out in various parts of my body (mainly head and trunk) at first and then as the days and weeks went on, they would stop being itchy and red due to application of cortisone and then other small rash areas would break out.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Facial paresis, Guillain-Barre syndrome, Hypoaesthesia, Limb discomfort, Paraesthesia
Clinical narrative: B/L Facial weakness and numbness with B/L lower extremity tingling, numbness and heaviness . Atypical GBS
Age: 81.0
Sex: F
Vaccine: PNC20
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Resident has no adverse effects at this time. She is being monitored for signs and symptoms for 3 days post vaccination error.  Resident was given Prevnar 20 on 11/22/2024, she was suppose to receive the Spikevax on 11/29/2024 but was inadvertently given another Prevanr 20 vaccine on 11/29/2024.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given high dose flu vaccination vs  standard dose
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Pt received total number of 2 doses
Age: 21.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pediatric Kinrix (dtap & polio) vaccine was administered to adult 21 year old male patient on 11/06/2024 by floor nurse in error. Patient has not reported any adverse effective as of this time. Consoled with CDC patient has been contacted to schedule recommended Tdap dose.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose of Hep A was inadvertently administered 9 days early. Second Dose will be repeated on or after 05/15/2025. Parent was notified of need to repeat dose and verbalized understanding and declines questions or concerns at this time.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Wrong product administered
Clinical narrative: Patient was vaccinated with Quadracel as the fourth dose of DTaP per ACIP, Quadracel can only be utilized to vaccinate patients 4-6 years old as the 5th dose in the DTaP series and the 4th or 5th dose of polio. This was patient 4th dose of DTaP should have been given DTaP and IPV separate vaccines. Dose is considered valid and dose not need to be repeated per Immunization Program nurse.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Child received flu vaccine at HU on 10/14/24 in local clinic with Mom present. The Mom had filled out a flu form for the school clinic on 10/23/24 and did not notify the school to pull the completed form for the school clinic.  Therefore, child was called and given the flu vaccine in the school flu clinic.  The child did not indicate to HU staff that they had already received the vaccine on 10/14/24. Mom called HU to state child had received the second dose of the flu vaccine 10/23/24.  Mom was instructed to observe for fever, redness at injection site, muscle aches. Called mom on 10/24/24 and she states no s/e noted. (See cont. sheet)  This was reported to  Immunization Program MD, Dr. And what guidance was given. (Dr instructed that nothing further needed to be done, to educate the mom on symptoms to expect and to follow up with PCP if children develop high fever if mom has any other concerns.)
Age: 43.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: RSV vaccine was given on 11/14/24 and a second dose was administered on 11/27/24
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Child received flu vaccine at HU on 10/14/24 in local clinic with Mom present. The Mom had filled out a flu form for the school clinic on 10/23/24 and did not notify the school to pull the completed form for the school clinic.  Therefore, child was called and given the flu vaccine in the school flu clinic.  The child did not indicate to HU staff that they had already received the vaccine on 10/14/24. Mom called HU to state child had received the second dose of the flu vaccine 10/23/24.  Mom was instructed to observe for fever, redness at injection site, muscle aches. Called mom on 10/24/24 and she states no s/e noted. (See cont. sheet) This was reported to  Immunization Program MD, Dr. And what guidance was given. (Dr instructed that nothing further needed to be done, to educate the mom on symptoms to expect and to follow up with PCP if children develop high fever if mom has any other concerns.)
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain, Pain in extremity, Periarthritis
Clinical narrative: Arm became so sore she could not move or use it.  Arm was not sore to touch, only when she tried to move it.  patient tried tylenol and that did not help.  she went to primary care dr and was given prednisone on 10/7/24 which worked while she was taking it and stopped working once she stopped the medication. patient then followed up with orthopedic dr who diagnosed her with adhesive capsulitis or frozen shoulder on 11/8/24.  she was given a fluoroscopy guided injection on 11/27/24which seems to have worked for the patient.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Neurological symptom
Clinical narrative: Currently hospitalized for symptoms of Guilian Barre Syndrome
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Blood pressure decreased, Dizziness
Clinical narrative: Pt felt light headed, Blood pressure dropped from 121/69 to 95/54. After 10 minutes and some water pt blood pressure went up to 109/68
Age: 69.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Provider gave me a verbal order for Hep A vaccine, while in med room I accidentally grabbed the Hep A pediatric vaccine, and it wasn't until I went into the chart to document the vaccine that the lot and other vaccine information where not matching the already ordered vaccine by the provider. Once I realized my mistake, I let my team lead know and she advised me to do an RER and do a VARIS report, notified provider and he assured that the patient would not be in harm for this, but she would need to come back to get full dose. Tried calling the patient twice to notify her but have been unsuccessful in reaching her. Will try again later today, and send a letter.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There was no adverse reaction.  Patient was given the vaccine at an earlier date 02/08/2024 (nurse visit).  Patient received two RSV vaccines and this is a one time vaccination.  Patient was notified and gave a verbal understanding.  Patient had no concerns.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Approximately 2 days post vaccine,  a welt appeared at the vaccine injection site and is still present 4 days later. No other known adverse events to report.
Age: 59.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Acute kidney injury, Blood creatinine increased, Blood lactate dehydrogenase increased, Blood urea nitrogen/creatinine ratio increased, Computerised tomogram abdomen normal
Clinical narrative: 11-12-2024 Presented to ED with AKI and anemia. Cr= 6.8 (baseline 07)           H/H 6.2/17.1 Pt reports suffering from migraines every day since receiving vaccines.  Reports nausea and vomiting daily. Labs on presentation to this facility this evening are notable for normocytic anemia, thrombocytopenia, elevated ferritin, elevated LDH, hyponatremia, BUN/Cr of 73/6.8mg/dL (baseline 0.7mg/dL). CT abdomen/pelvis appears to not show any acute process of the urinary system.    In terms of her renal history, she denies hospitalizations for prior AKI or AKI requiring RRT.
Age: 59.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Condition aggravated, Haematocrit decreased, Haemoglobin decreased, Hyponatraemia, Migraine
Clinical narrative: 11-12-2024 Presented to ED with AKI and anemia. Cr= 6.8 (baseline 07)           H/H 6.2/17.1 Pt reports suffering from migraines every day since receiving vaccines.  Reports nausea and vomiting daily. Labs on presentation to this facility this evening are notable for normocytic anemia, thrombocytopenia, elevated ferritin, elevated LDH, hyponatremia, BUN/Cr of 73/6.8mg/dL (baseline 0.7mg/dL). CT abdomen/pelvis appears to not show any acute process of the urinary system.    In terms of her renal history, she denies hospitalizations for prior AKI or AKI requiring RRT.
Age: 59.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Nausea, Normocytic anaemia, Plasmapheresis, Red blood cell schistocytes present, Serum ferritin increased
Clinical narrative: 11-12-2024 Presented to ED with AKI and anemia. Cr= 6.8 (baseline 07)           H/H 6.2/17.1 Pt reports suffering from migraines every day since receiving vaccines.  Reports nausea and vomiting daily. Labs on presentation to this facility this evening are notable for normocytic anemia, thrombocytopenia, elevated ferritin, elevated LDH, hyponatremia, BUN/Cr of 73/6.8mg/dL (baseline 0.7mg/dL). CT abdomen/pelvis appears to not show any acute process of the urinary system.    In terms of her renal history, she denies hospitalizations for prior AKI or AKI requiring RRT.
Age: 59.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Thrombocytopenia, Vomiting
Clinical narrative: 11-12-2024 Presented to ED with AKI and anemia. Cr= 6.8 (baseline 07)           H/H 6.2/17.1 Pt reports suffering from migraines every day since receiving vaccines.  Reports nausea and vomiting daily. Labs on presentation to this facility this evening are notable for normocytic anemia, thrombocytopenia, elevated ferritin, elevated LDH, hyponatremia, BUN/Cr of 73/6.8mg/dL (baseline 0.7mg/dL). CT abdomen/pelvis appears to not show any acute process of the urinary system.    In terms of her renal history, she denies hospitalizations for prior AKI or AKI requiring RRT.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Left arm pain
Age: 29.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Erythema, Joint swelling, Joint warmth, Urticaria
Clinical narrative: Hives that began in small patches on day 1 and became widespread by day 2. Severe for several days. Returned to random intermittent patches by day 7. STILL occurring intermittently on different parts of my body and it is now 1.5 weeks since receiving vaccine. Additionally, developed severe, migratory joint pain on day 3 of symptoms that continued for several days. Joints would intermittently swell, become warm and erythematous , then improve by the next day.  Joint pain totally resolved by day 8. I am an internal medicine physician, thus treated myself with Zyrtec 10mg BID for 1 week and ice packs/Tylenol for joint pain. I also stopped the esomeprazole as that was a new medicine for me, in the event that it caused the hives, but unlikely as I have tolerated Omeprazole many times in the past. I have never had a reaction to a vaccine before.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient presented to the pharmacy with redness, swelling and pain on the left arm which she noticed 2 days after receiving a flu shot. The affected area was about 4 to 5 inches away from the site of injection. Patient was still wearing the band-aid that was applied over the injection site when she presented with symptoms. Pharmacist counseled patient to take claritin, tylenol,  apply cold compress and follow up with her PCP. Patient saw her PCP days later  and was prescribed  some loratadine and ondansetron. During the last phone conversation with patient, the swelling and redness had improved and patient reports feeling better
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Lip swelling, Pyrexia
Clinical narrative: Received covid vaccine at clinic.  Developed fever overnight with rigors, headache, diarrhea. Developed severe lip swelling at 1100 on 11/26/24 and reported to urgent care at 1300.  Treated with Prednisone."
Age: 70.0
Sex: F
Vaccine: COVID19, PNC20, VARZOS
Symptoms: Memory impairment
Clinical narrative: MEMORY LAPSE
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Extra dose of RSV given on 9/5/24; initial dose given 10/18/23. Pt also had an extra dose of Shingles vaccine in 11/2022. Initial shingles vaccines administered in 10/2020 and 2/2021. Pt is aware of receiving extra doses. She has not had any side effects
Age: 62.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: patient states she has limited range of motion in her arm and very painful
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Muscle injury
Clinical narrative: Colleague received the flu vaccine on 11/07/2024 to her left deltoid. Colleague states her arm was painful at the injection site, but the pain resolved the next day, and she continued to be pain free for about 4 days.  Colleague states that pain returned and was having difficultly lifting her arm. States that pain improved with NSAIDs. Denies any injury to the site. Colleague seen at Occupational Health Services on 11/26/2024 and cleared to continue regular duty work with diagnosis: 1. Muscle injury 2. Adverse effect of influenza vaccine.  Treatment plan: local heat and stretch 2-3 times a day. Aleve twice a day for 3 days then as needed. To follow up with Occupational Health on 12/2/2024.
Age: 51.0
Sex: F
Vaccine: PNC20
Symptoms: Body temperature increased, Injection site induration, Injection site reaction, Injection site warmth, Pruritus
Clinical narrative: developed an acute red, indurated, hot rash on the right deltoid/bicep area about 18 hours after administration of Prevnar 20. has increased in size over the last 6 days. currently 4.5 x 5 inches in diameter +generalized itching of the right arm. intermittent temp up to 101.2.
Age: 51.0
Sex: F
Vaccine: PNC20
Symptoms: Rash erythematous
Clinical narrative: developed an acute red, indurated, hot rash on the right deltoid/bicep area about 18 hours after administration of Prevnar 20. has increased in size over the last 6 days. currently 4.5 x 5 inches in diameter +generalized itching of the right arm. intermittent temp up to 101.2.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation issue
Clinical narrative: vaccine was given without being reconstituted there were no symptoms, or signs of reaction during time of adverse event.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pain, Peripheral swelling, Pruritus
Clinical narrative: Reaction to Shingles vaccines. Very itchy and swollen arm for about 1 week. Today is my third week with very sore arm. First dose reaction was  also itchy and swollen for about 1 week. Pain also 1 week.  The second dose is still hurting.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus, Rash
Clinical narrative: headache, itch and rash on inner thighs and armpits for two days following vaccination. Treated with motrin, cortaid cream. Itch was most intense in evening and early morning.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain, Injection site swelling
Clinical narrative: Arm a bit swollen at injection site.  Swelling went down, but patient reports tenderness at injection site and painful elbow persists weeks after injection.  Patient going to follow up with primary MD later this week.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: patient began experiencing numbness in the right face to right hand one day after receiving a flu shot. she went to the hospital where they could not rule out a tia, but the symptoms have resolved
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient has swelled arm, red, warm to touch, had pain and is still stiff. Started Sunday morning and has lasted for over 24 hours, but did not appear until 48 hours after vaccination.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient complained of pain, redness, and itchiness at the injection site
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal disorder
Clinical narrative: Patient reports inability to use arm after injection.  Was given a round of oral steroids and then a steroid injection 2 weeks later.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Differential white blood cell count, Full blood count, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Patient received Tdap and Menquadfi on left thigh, red rash about 5-6 inches that covered front on the thigh to the back of the thigh. Red, lighter colored in the center, hot to the touch, patient states it was itchy. Received flu vaccine in the right thigh, rash not as big, about the size of a quarter; also, lighter colored in the center, hot to touch and itchy. Rash did not appear same day but appeared 6 days later. no anaphylaxis noted. A few red patches on feet near ankle, bottom on feet and on the back. Denies fever.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Rash pruritic
Clinical narrative: Patient received Tdap and Menquadfi on left thigh, red rash about 5-6 inches that covered front on the thigh to the back of the thigh. Red, lighter colored in the center, hot to the touch, patient states it was itchy. Received flu vaccine in the right thigh, rash not as big, about the size of a quarter; also, lighter colored in the center, hot to touch and itchy. Rash did not appear same day but appeared 6 days later. no anaphylaxis noted. A few red patches on feet near ankle, bottom on feet and on the back. Denies fever.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Cellulitis, Erythema, Gait disturbance, Myalgia, Pain
Clinical narrative: High grade fever of 103, severe muscle pain with limited ambulation and cellulitis that led patient in the ER for treatment.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia, Swelling
Clinical narrative: High grade fever of 103, severe muscle pain with limited ambulation and cellulitis that led patient in the ER for treatment.
Age: 39.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Nausea, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Approximately 2 hours after injection, the thumb on my right arm (Covid vaccine arm) swelled up and was in moderate pain. The following morning, about 6/7am, I could not drink water  or eat any food without feeling nauseated. I started to have the chills and by noon had a low grade fever. At about 4 pm the day after the vaccination, I awoke from a nap with a Black Hairy Tongue (BHT). I then used my tongue scrapper and brushed my teeth. My BHT was mostly gone within a couple of hours. Most of the adverse events had subsided within 24 hours after the injection. Though my thumb is still sore almost a week later.
Age: 39.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Trichoglossia
Clinical narrative: Approximately 2 hours after injection, the thumb on my right arm (Covid vaccine arm) swelled up and was in moderate pain. The following morning, about 6/7am, I could not drink water  or eat any food without feeling nauseated. I started to have the chills and by noon had a low grade fever. At about 4 pm the day after the vaccination, I awoke from a nap with a Black Hairy Tongue (BHT). I then used my tongue scrapper and brushed my teeth. My BHT was mostly gone within a couple of hours. Most of the adverse events had subsided within 24 hours after the injection. Though my thumb is still sore almost a week later.
Age: 16.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Urticaria
Clinical narrative: urticaria both wrists then hands then arms then torso, resolved after 5 days
Age: 69.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Fatigue, Pruritus, Somnolence
Clinical narrative: Extreme fatigue/sleeping all day; severe itching in palms and soles
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: patient began experiencing nausea, vomiting, and diarrhea the day after receiving a flu shot. he is still experiencing some symptoms, but miilder
Sex: F
Vaccine: PNC13, PPV
Symptoms: Pneumococcal infection, Streptococcus test positive
Clinical narrative: No data provided; This spontaneous report has been downloaded from the regulatory authority referring to an adult female patient (age: 45-49 years old). The patient's medical history, historical drugs, vaccination history, known allergies, concurrent conditions, and concomitant drugs were not reported.   On an unknown date in 2023, the patient was vaccinated with the first doses of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical location, and route of administration were not provided); and  pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) (strength, formulation, dose, lot #, expiry date, anatomical location, route of administration, and indication were not provided).  On an unknown date in 2023, the patient experienced a pneumococcal infection for which Streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event had not been reported.    The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported. Upon internal review, the event pneumococcal infection was determined to be medically significant.