chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Syncope; This serious case was reported by a other health professional and described the occurrence of syncope in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number 3L339, expiry date 30-JAN-2027) for prophylaxis.   On 09-OCT-2024, the patient received Bexsero (intramuscular) .5 ml. On 09-OCT-2024, less than a day after receiving Bexsero, the patient experienced syncope (Verbatim: Syncope) (serious criteria GSK medically significant). On 09-OCT-2024, the outcome of the syncope was resolved.   It was unknown if the reporter considered the syncope to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the syncope to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date:16-OCT-2024 The reporter reported that patient took Bexsero vaccine and experienced syncope. The case is linked with case US2024127480, reported by the same reporter for different patient.; Sender's Comments: Syncope is a listed event which is considered related to GSK vaccine Bexsero and Bexsero PRE-FILLED SYRINGE DEVICE. US-GSK-US2024127480:Smae reporter/Different patient
Sex: U
Vaccine: RSV
Symptoms: Arthralgia
Clinical narrative: Have all of them but joint pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced joint pain (Verbatim: Have all of them but joint pain). The outcome of the joint pain was not reported.   It was unknown if the reporter considered the joint pain to be related to Arexvy.     It was unknown if the company considered the joint pain to be related to Arexvy.   Additional Information: GSK receipt date: 09-OCT-2024 Patient reported that he/she had all of them but joint pain
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I came down with Shingles almost 3 weeks ago; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I came down with Shingles almost 3 weeks ago). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-OCT-2024 This case was reported by a patient via interactive digital media. The patient came down with shingles almost three weeks ago because she/he had the Shingrix vaccine it was not too bad, could had been way worse. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash pustular, Vaccination failure
Clinical narrative: Rash/ pustules have formed a large swath starting at my spine and wrapping around my left hip and stops above my pubic bone.; Rash only developed a couple of days ago.; Suspected vaccination failure; I am vaccinated against shingles, but developed shingles a week ago.; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In OCT-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I am vaccinated against shingles, but developed shingles a week ago.) and rash (Verbatim: Rash only developed a couple of days ago.). On an unknown date, the patient experienced pustule (Verbatim: Rash/ pustules have formed a large swath starting at my spine and wrapping around my left hip and stops above my pubic bone.). The outcome of the vaccination failure, shingles, pustule and rash were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pustule and rash to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, pustule and rash to be related to Shingles vaccine.   Additional Information: GSK receipt Date: 19-OCT-2024 This case was reported by a patient via interactive digital media. Patient was vaccinated against Shingles but developed shingles a week ago of the day of reporting.  Rash only developed a couple of days ago of the day of reporting.  Rash or pustules had formed a large swath starting at his/her spine and wrapping around his/her left hip and stops above his/her pubic bone. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; My husband got both vaccines and still got a horrible case of shingles!; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: My husband got both vaccines and still got a horrible case of shingles!). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 19-OCT-2024 This case was reported by the patient's wife via interactive digital media. The patient got both vaccines and still got a horrible case of shingles. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine(1st dose) and Shingles vaccine(2nd dose).
Sex: M
Vaccine: VARZOS
Symptoms: Injection site haemorrhage, Underdose
Clinical narrative: needle entered to patient's arm because there was a blood spot; Accidental underdose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (Patient took 1st dose of shingrix  on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site hemorrhage (Verbatim: needle entered to patient's arm because there was a blood spot) and accidental underdose (Verbatim: Accidental underdose). The outcome of the injection site hemorrhage was not reported and the outcome of the accidental underdose was unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to Shingrix.     It was unknown if the company considered the injection site hemorrhage to be related to Shingrix.   Additional Information: GSK receipt date: 26 Sept 2024 The pharmacist reported that due to a syringe malfunction, a patient was injected with Shingrix 2nd dose vaccine and medication came out. The reporter stated that the needle entered to patient's arm because there was a blood spot but then, liquid vaccine came out, which led to accidental underdose. The reporter stated that she was using a retractable needle and she believed that was the cause that the vaccine leaked out. It was unknown if patient received any amount of Shingrix vaccination or not
Age: 80.0
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 80 year old patient (that has myasthenia gravis) received a first dose of Menveo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 80-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA988A) for prophylaxis.   Concurrent medical conditions included myasthenia gravis.   On 08-MAY-2024, the patient received the 1st dose of Menveo. On 08-MAY-2024, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: 80 year old patient (that has myasthenia gravis) received a first dose of Menveo). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 17-OCT-2024 The pharmacist reported that an 80 year old patient (that has myasthenia gravis)received Menveo vaccine, which led to inappropriate age at vaccine administration. On 11-JUN-2024 they started a treatment with Soliris that was being given every 2 weeks. The patient was also receiving intravenous immunoglobulins. The caller was concerned about timing for the second dose of Menveo after Soliris.
Age: 9.0
Sex: U
Vaccine: UNK
Symptoms: Erythema
Clinical narrative: Redness; This spontaneous case (out of a cluster of 02 cases), initially received on 10-Oct-2024, was reported by a health professional and concerns a child patient.  There were no patient history, allergy, and concomitant medication reported. There was no product complaint associated.   Administration of company suspect drug:  On 07-Oct-2024, the patient received Flucelvax (TIV) for Indication not reported., Dose regimen: Not reported, Route of Administration: Pre-filled syringe (PFS), Lot number: No batch number available, and would be requested upon follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes:  On 08-Oct-2024, the patient experienced Redness (outcome: Not Reported).  The first patient reported redness on 08-Oct-2024 and was seen on 09-Oct-2024. The patient has not called back or followed-up further.  Treatment measures associated with event received supportive care.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment:   The reporter did not provide a seriousness or causality assessment.; Reporter's Comments: The event considered related to the administration of Flucelvax (TIV).
Sex: U
Vaccine: TTOX, UNK, UNK
Symptoms: Cellulitis, Erythema
Clinical narrative: Cellulites; Erythema in both arms; This spontaneous case (out of a cluster of 02 cases), initially received on 10-Oct-2024, was reported by a health professional and concerns an adolescent patient.  Administration of company suspect drug: On an unknown date in Sep-2024, (also reported as late September), the patient received Flucelvax (TIV) for Indication not reported, Dose regimen: Not reported, Route of Administration: Pre-filled syringe (PFS), Lot number: No batch number available, and would be requested upon follow-up.  Non-company suspect drugs: On an unknown date, the patient received Meningococcal vaccine A (Meningococcal vaccine A) for Indication not reported, Dose regimen: Not reported, Route of Administration: Not Reported, Lot number: No batch number available, and would be requested upon follow-up.  On an unknown date, the patient received Tetanus vaccine (Tetanus vaccine toxoid) for Indication not reported, Dose regimen: Not reported, Route of Administration: Not Reported, Lot number: No batch number available, and would be requested upon follow-up.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Cellulites (outcome: Not Reported). On an unknown date in 2024, the patient experienced Erythema in both arms (outcome: Not Reported).  The second received vaccine in late September. Patient also received a Meningitis-A and Tetanus vaccine in the opposite arm. The patient reported erythema in both arms. Was treated for Cellulitis at the parent request and recommended Motrin. Patient had not followed-up further.  Flucelvax (TIV) action taken: Not Applicable Treatment medication: Motrin  Reporter's assessment:   The reporter did not provide a seriousness or causality assessment for both the events.; Reporter's Comments: The event Erythema in both arms is considered related and the event Cellulites is considered unassessable to the administration of Flucelvax (TIV).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Tinnitus
Clinical narrative: Started having tinnitus  symptoms that have worsened over time and are now constant.  Started having irregular menstrual cycles.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received standard-dose when high dose was available No adverse event occurred
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Urticaria
Clinical narrative: Pt states he received the vaccine and return back to work, while at work he presented hives on his face and started to feel lightheaded. Benadryl 25 mg po IV: 0.9 NS 1,000 ml Solumedrol 125 mg diluted. Pt will start n Medrol and Benadryl PRN.
Age: 26.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Confusional state, Dyskinesia, Dysphagia, Feeling hot, Hypotonia
Clinical narrative: Pt stated hy of mult. syncopal events w/vaccines last 4 years. No issues in childhood, prepped ice packs, given alcohol swab (smell for sensory distraction), fan directed at pt. feeling well at time. Approx 4pm Flublok given RA, tolerated well w/distraction Approx 403pm moderna given LA, once needle withdrawn from deltoid patient stated "I'm getting hot" approx 404/05 PM - Pt slumped to side/went limp. ++ pallor, LOC. About 3 secs later eyes opened, dilated BIL. Jerking movements observed. Not arousable to voice. Slumped again to side. Approx 5 secs later, pt regained consciousness and picked up conversation from pre-syncope. Some confusion on wakening but cleared w/i 1 min. water given, ice packs applied. RN remained w/patient for recovery, but during conversation (discussing vaccines), patient stated can we talk about something else?" and proceeded to have another syncopal episode (approx 410 pm) jerking movements again noted, LOC. This episode slightly longer (or just seemed so), possibly 7-10 secs. Required shaking of shoulders to arouse. ++ pallor. Confused on wakening; states blurred vision and B/L ear numbness- kept trying to find his ears (uncoordinated, slow mvmnts) to grab them to "test feeling" Pt stating symptom new to him - "harder to swallow", points to R side of neck. MD to bedside to assess esp d/t new symptom in s/o vaccines. -assessment WNL (inc. throat) - BP 102/70, HR 66 - more water, ice given - color improved, vision improved  Of note, hard to discern quirky personality vs. mild acute cognitiive symptoms. No hx moderna prior to 10/25/24. Last syncopal w/Tdap 2022. Recovered w/RN observation x 10 mins more and assisted to standing. Denied nausea, dizziness, blurred vision. Left clinic feeling much better. Encouraged booking annual wellness appt over next few weeks for comprehensive assessment. VAERS done by treating RN.
Age: 26.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Loss of consciousness, Mydriasis, Pallor, Posture abnormal, Unresponsive to stimuli
Clinical narrative: Pt stated hy of mult. syncopal events w/vaccines last 4 years. No issues in childhood, prepped ice packs, given alcohol swab (smell for sensory distraction), fan directed at pt. feeling well at time. Approx 4pm Flublok given RA, tolerated well w/distraction Approx 403pm moderna given LA, once needle withdrawn from deltoid patient stated "I'm getting hot" approx 404/05 PM - Pt slumped to side/went limp. ++ pallor, LOC. About 3 secs later eyes opened, dilated BIL. Jerking movements observed. Not arousable to voice. Slumped again to side. Approx 5 secs later, pt regained consciousness and picked up conversation from pre-syncope. Some confusion on wakening but cleared w/i 1 min. water given, ice packs applied. RN remained w/patient for recovery, but during conversation (discussing vaccines), patient stated can we talk about something else?" and proceeded to have another syncopal episode (approx 410 pm) jerking movements again noted, LOC. This episode slightly longer (or just seemed so), possibly 7-10 secs. Required shaking of shoulders to arouse. ++ pallor. Confused on wakening; states blurred vision and B/L ear numbness- kept trying to find his ears (uncoordinated, slow mvmnts) to grab them to "test feeling" Pt stating symptom new to him - "harder to swallow", points to R side of neck. MD to bedside to assess esp d/t new symptom in s/o vaccines. -assessment WNL (inc. throat) - BP 102/70, HR 66 - more water, ice given - color improved, vision improved  Of note, hard to discern quirky personality vs. mild acute cognitiive symptoms. No hx moderna prior to 10/25/24. Last syncopal w/Tdap 2022. Recovered w/RN observation x 10 mins more and assisted to standing. Denied nausea, dizziness, blurred vision. Left clinic feeling much better. Encouraged booking annual wellness appt over next few weeks for comprehensive assessment. VAERS done by treating RN.
Age: 26.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Vision blurred
Clinical narrative: Pt stated hy of mult. syncopal events w/vaccines last 4 years. No issues in childhood, prepped ice packs, given alcohol swab (smell for sensory distraction), fan directed at pt. feeling well at time. Approx 4pm Flublok given RA, tolerated well w/distraction Approx 403pm moderna given LA, once needle withdrawn from deltoid patient stated "I'm getting hot" approx 404/05 PM - Pt slumped to side/went limp. ++ pallor, LOC. About 3 secs later eyes opened, dilated BIL. Jerking movements observed. Not arousable to voice. Slumped again to side. Approx 5 secs later, pt regained consciousness and picked up conversation from pre-syncope. Some confusion on wakening but cleared w/i 1 min. water given, ice packs applied. RN remained w/patient for recovery, but during conversation (discussing vaccines), patient stated can we talk about something else?" and proceeded to have another syncopal episode (approx 410 pm) jerking movements again noted, LOC. This episode slightly longer (or just seemed so), possibly 7-10 secs. Required shaking of shoulders to arouse. ++ pallor. Confused on wakening; states blurred vision and B/L ear numbness- kept trying to find his ears (uncoordinated, slow mvmnts) to grab them to "test feeling" Pt stating symptom new to him - "harder to swallow", points to R side of neck. MD to bedside to assess esp d/t new symptom in s/o vaccines. -assessment WNL (inc. throat) - BP 102/70, HR 66 - more water, ice given - color improved, vision improved  Of note, hard to discern quirky personality vs. mild acute cognitiive symptoms. No hx moderna prior to 10/25/24. Last syncopal w/Tdap 2022. Recovered w/RN observation x 10 mins more and assisted to standing. Denied nausea, dizziness, blurred vision. Left clinic feeling much better. Encouraged booking annual wellness appt over next few weeks for comprehensive assessment. VAERS done by treating RN.
Sex: M
Vaccine: DTPIHI, PNC15, PPV
Symptoms: Dyskinesia, Movement disorder, Muscle tightness, Musculoskeletal stiffness, Seizure
Clinical narrative: Movement disorder; Seizure; Information was obtained on a request by The Company from the agency via a Public Case Detail concerning male patient of unknown age.  This spontaneous report was received from the patient's parent. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 11-FEB-2022, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (manufacturer unknown) injection (anatomical location, strength, lot #, expiry date, route of administration, and indication were not provided) or pneumococcal 15v conj vaccine (crm197) (manufacturer unknown) injection (anatomical location, strength, lot #, expiry date, route of administration, and indication were not provided); and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag, hib vaccine conj (tet tox), pertussis vaccine whole cell, tetanus vaccine toxoid (reported also as diphtheria toxoid; haemophilus influenza type b polyribose ribitol phosphate; hepatitis b surface antigen recombinant; pertactin; pertussis filamentous haemagglutinin; pertussis toxoid; poliovirus; tetanus toxoid) (anatomical location, strength, formulation, lot #, expiry date, route of administration, and indication were not provided).  On 18-FEB-2022, within seven days of receiving the vaccination, the patient ("my son") started displaying unusual facial and upper body movements. In each episode, his facial muscles would tighten (i.e. his eyes and eyebrows would pull back, and his mouth would tighten and pull back in a wide "o" shape), his neck would stiffen and his upper body (upper back, arms and shoulders) would also stiffen backward. This was subtle at first and occurred once every day or two. On 25-FEB-2022, this movement became more exaggerated such that he nearly threw himself out of the parent's hold. During this time, he also had three episodes where his head suddenly started shaking rapidly (left-right). This appeared to look like a convulsion/ seizure, but lasted about four seconds, so was difficult to observe. On 03-MAR-2022, the head shaking occurred, lasting approximately ten seconds. In the 20 minutes following this, he displayed the head and upper body movement - several episodes lasting, a few seconds each. This was evidenced by the trip to emergency department (ED). The episodes seemed to decline in frequency and length over the coming weeks, eventually ceasing by the end of March 2022. On 31-MAR-2022, the patient recovered from the event of seizure. On 18-FEB-2024, the patient experienced movement disorder. At the time of reporting, the outcome of the event movement disorder was not known.  The reporting institution considered both events to be related to suspect vaccines.  Upon internal review, the event of seizure was determined to be medically significant.
Sex: M
Vaccine: DTPIHI, PNC15, PPV
Symptoms: Tremor
Clinical narrative: Movement disorder; Seizure; Information was obtained on a request by The Company from the agency via a Public Case Detail concerning male patient of unknown age.  This spontaneous report was received from the patient's parent. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 11-FEB-2022, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (manufacturer unknown) injection (anatomical location, strength, lot #, expiry date, route of administration, and indication were not provided) or pneumococcal 15v conj vaccine (crm197) (manufacturer unknown) injection (anatomical location, strength, lot #, expiry date, route of administration, and indication were not provided); and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag, hib vaccine conj (tet tox), pertussis vaccine whole cell, tetanus vaccine toxoid (reported also as diphtheria toxoid; haemophilus influenza type b polyribose ribitol phosphate; hepatitis b surface antigen recombinant; pertactin; pertussis filamentous haemagglutinin; pertussis toxoid; poliovirus; tetanus toxoid) (anatomical location, strength, formulation, lot #, expiry date, route of administration, and indication were not provided).  On 18-FEB-2022, within seven days of receiving the vaccination, the patient ("my son") started displaying unusual facial and upper body movements. In each episode, his facial muscles would tighten (i.e. his eyes and eyebrows would pull back, and his mouth would tighten and pull back in a wide "o" shape), his neck would stiffen and his upper body (upper back, arms and shoulders) would also stiffen backward. This was subtle at first and occurred once every day or two. On 25-FEB-2022, this movement became more exaggerated such that he nearly threw himself out of the parent's hold. During this time, he also had three episodes where his head suddenly started shaking rapidly (left-right). This appeared to look like a convulsion/ seizure, but lasted about four seconds, so was difficult to observe. On 03-MAR-2022, the head shaking occurred, lasting approximately ten seconds. In the 20 minutes following this, he displayed the head and upper body movement - several episodes lasting, a few seconds each. This was evidenced by the trip to emergency department (ED). The episodes seemed to decline in frequency and length over the coming weeks, eventually ceasing by the end of March 2022. On 31-MAR-2022, the patient recovered from the event of seizure. On 18-FEB-2024, the patient experienced movement disorder. At the time of reporting, the outcome of the event movement disorder was not known.  The reporting institution considered both events to be related to suspect vaccines.  Upon internal review, the event of seizure was determined to be medically significant.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Fatigue, Hypoaesthesia, Loss of personal independence in daily activities, Muscular weakness, Pain in extremity
Clinical narrative: Pain and tingling and numbness in left arm starting 4 hours after vaccine.  Color change, arm appeared purple, weak.  No significant redness or swelling at site.  Very tired.  Pain and fatigue still present 4 days later, difficulty changing clothes, etc due to pain.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Paraesthesia, Skin discolouration
Clinical narrative: Pain and tingling and numbness in left arm starting 4 hours after vaccine.  Color change, arm appeared purple, weak.  No significant redness or swelling at site.  Very tired.  Pain and fatigue still present 4 days later, difficulty changing clothes, etc due to pain.
Age: 91.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: patient informed Cpht  that this was her second RSV vaccine after it was already administered.  Ins never flagger the processer that this vaccine was already given a year ago.
Age: 59.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: The patient experienced immediate swelling at the injection site after receiving the influenza vaccine. This vaccine was given after the covid-19 vaccine. The patient remained for monitoring for approximately fifteen minutes before leaving the pharmacy. The patient did not answer a follow-up phone call later that day.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nausea, Vomiting
Clinical narrative: Extreme lethargy and nausea/vomiting symptoms. Symptoms started a couple of hours after receiving vaccine. Her sister who accompanied her, also received the COVID-19 vaccine and experienced similar symptoms.
Age: 14.0
Sex: M
Vaccine: HEPA, IPV, MNQ, TDAP, VARCEL
Symptoms: Dyskinesia, Syncope
Clinical narrative: Syncope with abnormal body movement witnessed by RN and 2nd-RN.  Glucose given immediately after patient stable, ice-pack placed to forehead, and supine position with legs elevated to heart level.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vomiting
Clinical narrative: Extreme fatigue, and nausea/vomiting symptoms. Symptoms started a couple of hours after receiving the vaccine. Her sister who accompanied her, also received the COVID-19 vaccine and experienced similar symptoms.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Nausea, Rash erythematous
Clinical narrative: arm at injection site was swollen well beyond the injection site very painful has rash surrounding that very red felt nauseous since taking
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Throat irritation
Clinical narrative: Patient was given first HPV vaccine today in clinic by another nurse. Mom then requested flu vaccine and the nurse sent them to the clerk to fill out a form to receive flu vaccine. I called patient back to a room for a flu shot. Mom reports Patient told her that her throat is itching and states she just received her first HPV vaccine about 5 minutes ago. I spoke with RN, CDNS, who is here in clinic and she states that if mom is concerned that it is an allergic reaction she can go ahead and take her to the Emergency Room across the street. Mom agrees and she and patient leave to go to the ER. Child had no difficulty breathing, or any other symptoms. She was walking, talking and not in distress.
Age: 5.0
Sex: M
Vaccine: MMRV, UNK
Symptoms: Erythema, Feeling hot, Pain in extremity
Clinical narrative: FATHER REPORTED TO HEALTH UNIT AT 24 HOURS HAD QAURTER SIZE REDNESS THAN AT 48 HOURS HAD SIFTBALL SIZE REDNESS WITH SOME HEAT IN AREA CAME IN TO HEALTH DEPTMATMENT ON 10/22/24 AND IT WAS ALL RESOLVED BY THEN ARM STILL SORE CHILD SAYS
Age: 1.08
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Vaccine given twice to same patient.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a second dose of RSV (Abrysvo) vaccine. He received his first dose on 10/11/2023 and the second dose on 10/23/2024. Patient is not having any signs or symptoms of adverse reaction.
Age: 6.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Blood glucose normal, Fall, Head injury, Presyncope
Clinical narrative: After receiving  vaccinations the client stood and walked to the door. He fell backwards and likely hit his head on the floor. To the nurse present this appeared to be a vasovagal response. The mother stated her concern that the boy was having a seizure. She confirmed that he did not have any history of seizures. The boy woke up after a few seconds and was able to answer the nurses questions. He denied hitting his head, denied any pain. The nurse placed a cool pack under the child's head for comfort. No lumps were noted. 911 was called. Ambulance Paramedics responded within a few minutes as they were located nearby. The paramedics assessed blood pressure, pulse, blood sugar. Results within normal limits. Paramedics stated that they did not believe there was any seizure activity. The child was not transported and he walked out of the clinic with the mother.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: 11 y/o female given Flu vaccine at school flu clinic by DH staff.  Consent form was signed by parent and turned into the school nurse for the flu vaccine to be given by DH.  Approximately 30 minutes after the flu vaccine was given, the child came back into the room where the vaccines were given and informed us that she had gotten a flu vaccine yesterday but failed to tell us before she got one today.   No adverse reaction noted.  Child denies any reactions.  TC by school nurse to parent, who states that she did receive a flu vaccine 10/21/22 at her PCP and apologized that she failed to inform the school that she didn't need it today.  Advised parent to observe for any side effects such as high fever, seizure, hives, difficulty breathing, weakness, etc.   School nurse states she will observe her and will give her Tylenol if needed.   Phone call made to parent, 10/23/24 at 3:45pm to check on the status of the child and parent states they are at cheer practice now and that Kensington is doing just fine.  States her arm is a little sore but that is all. She apologized again that she failed to let us know she had gotten a flu shot the previous day. Lot# and Influenza vaccine type not listed in computer but it is documented she did receive a flu vaccine 10/21/24 by a private provider.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received an extra dose of Fluad influenza vaccine 3 months after the 1st dose. patient reported that she had no side adverse events
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: pediatric dose given to an adult
Age: 14.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 6m-11 year dose of CoVid vaccine  administered.  Patient is 14 years.
Age: 65.0
Sex: F
Vaccine: ANTH
Symptoms: Chest discomfort, Muscle tightness
Clinical narrative: The adverse event was a tightening in my chest and back. It was mimicking a panic attack or heart attacek but never having either one of those things i am imagining that this how they feel. I did not go for any treatment, as I have never had a panic attack or a heart attack. There were two precipitating factors that day the influenza shot and my grandson became irate and stormed out of the house about 3:45 PM. The onset of the tightness in my chest and back began at about that time.
Age: 57.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chills, Contusion, Headache, Injection site pain, Pain
Clinical narrative: Fever, chills, body aches, headache, injection site pain, swelling, and bruising. For 36 hours, slowly improving.
Age: 57.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pyrexia, Swelling
Clinical narrative: Fever, chills, body aches, headache, injection site pain, swelling, and bruising. For 36 hours, slowly improving.
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Parotid gland enlargement, Salivary gland enlargement
Clinical narrative: I developed significant swelling of my parotid and submandibular glands bilaterally.  This started upon awakening the morning following the vaccination and worsened every day until I had to seek emergency care at an emergency department  on October 26. I received IM steroid medication as well as a course of oral steroids.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received an extra dose of Fluad influenza vaccine 3 months after the 1 st dose. patient reported that he had no side adverse events
Age: 21.0
Sex: M
Vaccine: COVID19, FLU3, HEP, HPV9, IPV
Symptoms: Extra dose administered, Fatigue
Clinical narrative: Following a miscommunication on the paperwork given to the clinic regarding which vaccines were needed for the patient, patient received a 2nd dose of Covid Spikevax 2024-25 11 days after receiving his first dose at a private pharmacy. Follow up call showed patient felt slightly tired over the weekend but believed this was due to his work schedule vs the vaccine. He was not ill and no other side effects were noted by patient.
Age: 37.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Patient, 36 weeks pregnant at time of vaccination, estimated delivery early/first week of November 2024. No adverse event known, patient had no reporting of side effects. Patient informed of the event the 2 days after vaccination because she did not answer the previous days (day of vaccination)  when I reached out.
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: MD asked for assistance to get patients vaccines completed. Assigned MAs for the day were out to lunch. MA jumped in to assist and started preening vaccines routinely given at 2 mo WWC. I asked MA if I could assist and she handed me Rotateq to give to patient while she finished prepping injectable vaccines. I entered patient room, identified patient, received verbally consent from mother and gave Rotateq vaccine orally. I came out of patient room and MA stated that actually she had not verified the order before giving me Rotateq vaccine. MA stated she sent a message to Dr. via computer to see if order was not placed for it in error. Dr. came out of patient room and stated that the reason she had not ordered Rotateq was due to infants age being over 15 weeks. Infant was 15.6 weeks and that dosing guidelines for Rotateq are to administer it and start series before 15 weeks. Dr. notified patient?s mother of vaccine error. I notified clinic manager and submitted both VAERS and incident report.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue
Clinical narrative: During administration of influenza high dose  vaccine, vaccine started to leak from the hub.  The patient reported that she did feel the vaccine going in when we first started administering the vaccine.  Unable to determine how much vaccine was administered before it started leaking. Patient was made aware at the time of administration. No adverse reaction to vaccination noted. DH Immunization Program MD, Dr notified. Dr recommended patient get re-vaccinated with either high dose influenza vaccine or standard adult influenza vaccine. Patient notified of MD recommendations to repeat vaccination on 10/24/24. Patient reported she was going to consult with her husband to determine if she is going to re-vaccinate, since she felt she had received some of the high dose vaccine. Patient stated she will call the office back or come into the office if she decided to re-vaccinate.  Patient denied any adverse reactions from the high dose flu vaccine.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: gave flublok instead of the indicated fluzone for 18 and under, called patients mom, patient had no adverse reaction to immunization
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Immediate post-injection reaction
Clinical narrative: Patient rec'd the influenza vaccine, immediately started to cough and then felt chest tightness.  His breathing remained unobstructed other than the coughing.  He felt chest tightness but was able to take deep breathes.  Pulse Ox was 94%  BP: 110/60. Patient given instructions
Age: 12.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: by error a 12 yrs. old received, adult dose of Hep A (1440EL.u./ml.
Age: 27.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had swelling and redness around injection site for 3 days
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered Pfizer COVID -19 5 yr - <12 yr  lot # LM2045 ( w/diluent 1.1ml ) 0.3 ml admin in rt thigh.
Age: 76.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Asthenia, Dysstasia, Feeding disorder, Muscular weakness, Pain in extremity
Clinical narrative: Arm pain , muscle weakness with shakiness, inability to stand with vertigo, unable. To eat or drink, runny nose(a lot) , weakness , could not stay awake! All for 24 hours
Age: 76.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Rhinorrhoea, Somnolence, Tremor, Vertigo
Clinical narrative: Arm pain , muscle weakness with shakiness, inability to stand with vertigo, unable. To eat or drink, runny nose(a lot) , weakness , could not stay awake! All for 24 hours
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Pt came in for her Covid-19 vaccine. Pt was given HD Fluzone instead.  Pt and the Doctor were notified. Pt states she will return in 2 weeks for her Covid vaccine.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Two vaccines drawn up out of single dose vial for 5-11 year olds. Vaccines administered correctly to patients, however should have been only one dose used from single dose vial.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Product administered at inappropriate site
Clinical narrative: Administered at incorrect site, right below deltoid. Had site swelling and redness 10 days following administration. Seen by Primary Health Medical Group - urgent care.  The injection site was consistent with a localized vaccine reaction, and advised that it should resolve with "conservative measures."
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head, Electrocardiogram, Hypoaesthesia, Muscle tightness, Paraesthesia
Clinical narrative: employee reported symptoms to EH on 9/9/24; states she received the vaccine with EMT in the ED at hospital on 9/30/2024; on the night of 10/1/24 states she developed right eye peripheral vision loss for a short period of time (resolved in the morning) and tingling/numbness to right temporal area down the right side of her face. encouraged by staff to notify her physician, went to the ER on 10/10/24 for repeat of vision issues, discharged home; states tingling/numbness to right side of face continues with tightness that starts in anterior right neck radiating to right posterior neck, also evaluated by Dr. on 10/23/24 and started on prednisone taper
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Visual field defect
Clinical narrative: employee reported symptoms to EH on 9/9/24; states she received the vaccine with EMT in the ED at hospital on 9/30/2024; on the night of 10/1/24 states she developed right eye peripheral vision loss for a short period of time (resolved in the morning) and tingling/numbness to right temporal area down the right side of her face. encouraged by staff to notify her physician, went to the ER on 10/10/24 for repeat of vision issues, discharged home; states tingling/numbness to right side of face continues with tightness that starts in anterior right neck radiating to right posterior neck, also evaluated by Dr. on 10/23/24 and started on prednisone taper
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Nervousness, Syncope
Clinical narrative: AFTER 2 MINUTES OF GIVING THE VACCINE THE PATIENT FAINTED FOR 3 MINUTES. I TRIED TO GIVE HER EPIPEN AND I CALLED EMS . THE FATHER SAID THAT SHE IS FINE NOW SHE IS NERVOUS AND I ENDED UP NOT GIVING HER THE EPIPEN. SHE WOKE UP AND SHE AITED 30 MINUTES IN THE PHARMACY AND SHE WENT HOME FINE
Age: 20.0
Sex: F
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Does given at incorrect interval.  This was dose 3, and was given too early in error.  It was only 2 months since last dose, and was given too early
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Headache, Vomiting
Clinical narrative: THE PATIENT WAS IN HE STORE WITH HIS FATHER AND HIS SISTER, SO AFTER I GAVE HIS SISTER THE VACCINE AND SHE FAINTED . BRET STARTED TO VOMIT AND HE SAID THAT HE HAS A STOMACH ACHES AND PAIN IN HIS HEAD .   I WATCHED HIM WHILE I WAS TAKING CARE OF HIS SISTER . HE DID NOT FAINT , HE LEFT THE PHARMACY FINE WITH HIS DAD AND HIS SISTER
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Patient reports a large red circle surrounding the area of injection
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Periarthritis, X-ray
Clinical narrative: ADHESIVE CAPSULITIS LEFT SHOULDER
Age: 6.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event
Clinical narrative: None to date
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Child transferred in from another state. Immunizations records were not yet put in system. Once we put the system in we seen that he did not need this dose. That he was already up to date. So he ended up getting a extra dose.
Age: 17.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Private Flublok for 18+ was given to 17 y/o child. The boxes both look very similar and when checked this morning 1 box of state Flublok and 1 box of Private Flublok were both placed into the state flublok cooler. All of the state Flublok had already been used earlier this morning and the only box left was an unopened Flublok. 1 pre-filled syringe was removed and administered. After recording lot # realized it did not match the same lot number as state Flublok that was pulled out of fridge this morning.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Patient stated the next afternoon after receiving covid-19 vaccine, she experienced severe blurred vision in both eyes that lasted up to 1 minute. Patient mentioned that it only occurred once during that period, however, she had not had that reaction occur from previous covid vaccinations.
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pruritus, Injection site rash, Rash erythematous
Clinical narrative: pt has large red rash on upper right arm where she received prevnar. it started day after the dose and today (d5) she started itching "so bad"- pt has been using cool compress and cortisone topically.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1, DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Echocardiogram normal, Heart rate increased, Supraventricular tachycardia
Clinical narrative: 4 hours after shots, heart rate spiked to 250s, was 280-290 upon arrival to hospital. Was given medicine to bring heart rate down immediately, flown by helicopter to different hospital, stayed for 4 days and was put on a beta blocker. Diagnosed with SVT
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1, DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Blood test normal, Cardiac monitoring, Echocardiogram normal, Intensive care, Respiratory pathogen panel
Clinical narrative: 4 hours after shots, heart rate spiked to 250s, was 280-290 upon arrival to hospital. Was given medicine to bring heart rate down immediately, flown by helicopter to different hospital, stayed for 4 days and was put on a beta blocker. Diagnosed with SVT
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1, DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Supraventricular tachycardia
Clinical narrative: 4 hours after shots, heart rate spiked to 250s, was 280-290 upon arrival to hospital. Was given medicine to bring heart rate down immediately, flown by helicopter to different hospital, stayed for 4 days and was put on a beta blocker. Diagnosed with SVT
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1, DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Echocardiogram normal, Heart rate increased, Supraventricular tachycardia
Clinical narrative: SVT- HR 280's  EMergency department treated with Adenosine and transfer to another facility PICU and cardiology. On continuous heart monitor, propranolol every 8 hours, and cardiology follow up