chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Tachypnoea, Urticaria
Clinical narrative: Reported Symptoms:  10002218:ANAPHYLAXIS;  10008493:CHEST TIGHTNESS OF;  10020197:HIVES;  10037087:PRURITUS;  10037844: RASH;  10040604:SHORTNESS OF BREATH;  10043088:TACHYPNEA;     Narrative: This was documented by Primary Care Clinical Pharmacy Practitioner - described in progress note and documented in our chart.  However, the vaccine was not administered at the clinic and additional details are not available for report. Was able to find vaccine record via vaccination record website.  Other Relevant HX:  Other: shortness of breath, chest tightness, itching/hives
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Reported Symptoms:  10037087:PRURITUS;  10046735:URTICARIA;     Narrative:  54 yo M receiving annual flu vaccine.  Patient reported full body itching after administration.  Patient reported to urgent care and received hydroxyzine and methylprednisone and symptoms resolved   Other Relevant HX:  Other:  URTICARIA
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Reported Symptoms: 10002218:ANAPHYLAXIS; Narrative: Other Relevant HX: Other
Sex: F
Vaccine: FLUX
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Reported Symptoms:  10014214:EDEMA ARMS;  10037844:RASH; 10046735:URTICARIA;     Narrative:  60 yo F with recent vesting exam in the clinic.  Patient reported previous reaction to flu vaccine of itching  Other Relevant HX:   Other: URTICARIA; EDEMA OF ARM
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: Pt reported a rash from first dose of covid vaccine. This patient reported this when starting care with facility so no info available about this specific vaccination given at NON-facility site. Other Relevant HX: Other: RASH
Age: 23.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Reported Symptoms: Narrative: Nurse pulled a Shingrix vaccine NDC: 58160082311, Diluent Lot#2T92N, Vaccine powder Lot#747N3. During first attempt to reconstitute nurse added diluent and mixed following instructions. After reconstitution and pulling reconstituted vaccine up in syringe the syringe contained less than 0.3 mL, which is lower than the expected 0.5 mL. The product was discarded and a new set of diluent and vaccine powder for reconstitution (with same lot #s as above) was procured and mixed per package instructions and was able to get 0.5 mL. Other Relevant Hx: Other: Product problem.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Reported Symptoms:  10037087:PRURITUS;  10042674:SWELLING; 10046735:URTICARIA;    Narrative:  Pt reported history of URTICARIA; PRURITUS; SWELLING attributed to covid vaccine given in the past, not given at clinic so NO INFORMATION AVAILABLE.   Other Relevant HX:  Other:  URTICARIA; PRURITUS; SWELLING
Age: 29.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tachyarrhythmia, Tachycardia
Clinical narrative: Reported Symptoms: 10043071:TACHYCARDIA; 10049447:TACHYARRHYTHMIA; Narrative: Pt provided historical report of tachyarrhythmia attributed to covid vaccine, NOT GIVEN AT facility. NO INFORMATION available. Other Relevant HX: Other: TACHYARRHYTHMIA
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cellulitis, Local reaction, Pain, Swelling
Clinical narrative: Reported Symptoms:  10042674:SWELLING;     Narrative: Pt developed localized reaction from Covid booster vs cellulitis. Pt went to ER to rule out a DVT which was negative.  Pt was treated for cellulitis with Keflex prescription 1000 mg BID x 7 days and advised can take OTC tylenol or ibuprofen for pain and to use ice packs to help with swelling/pain.   Other Relevant HX: Other:  SWELLING
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Reported Symptoms:  10016256:FATIGUE;   Narrative:  Other Relevant HX:
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Cough, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: Hospitalized 5/25/23-5/29/23 Congestion, cough, SOB, sore throat, body aches, hypoxia, tachycardia, dyspnea, fatigue, malaise, decreased appetite, respiratory failure, sepsis, AKI,
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Malaise, Oropharyngeal pain, Pain, Respiratory failure
Clinical narrative: Hospitalized 5/25/23-5/29/23 Congestion, cough, SOB, sore throat, body aches, hypoxia, tachycardia, dyspnea, fatigue, malaise, decreased appetite, respiratory failure, sepsis, AKI,
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Sepsis, Tachycardia
Clinical narrative: Hospitalized 5/25/23-5/29/23 Congestion, cough, SOB, sore throat, body aches, hypoxia, tachycardia, dyspnea, fatigue, malaise, decreased appetite, respiratory failure, sepsis, AKI,
Sex: U
Vaccine: COVID19
Symptoms: Detoxification, Echocardiogram, Electrocardiogram, Laboratory test, Magnetic resonance imaging heart
Clinical narrative: JANSSEN #1 5/17/2021 DEVELOPED COVID VACCINE SUBCLINICAL MYOPERICARDITIS.  TREATED WITH COLCHICINE, BISOPROLOL, RAMIPRIL, AND PROTOCOL BASE SPIKE PROTEIN DETOXIFICATION.
Sex: U
Vaccine: COVID19
Symptoms: Myopericarditis
Clinical narrative: JANSSEN #1 5/17/2021 DEVELOPED COVID VACCINE SUBCLINICAL MYOPERICARDITIS.  TREATED WITH COLCHICINE, BISOPROLOL, RAMIPRIL, AND PROTOCOL BASE SPIKE PROTEIN DETOXIFICATION.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Hypoxia, Pneumonia, Respiratory failure
Clinical narrative: Hospitalized 5/27/23-6/5/23 chills, SOB, hypoxia, dyspnea, tachycardia, respiratory failure, PNA,
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Hospitalized 5/27/23-6/5/23 chills, SOB, hypoxia, dyspnea, tachycardia, respiratory failure, PNA,
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Muscular weakness, Musculoskeletal stiffness, Myalgia, Tenderness
Clinical narrative: Muscle pain and tenderness, minimum  range of motion, stiffness/weakness in shoulder/arm
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Asthenia, Cough, Decreased appetite, Urine output decreased
Clinical narrative: Hospitalized 5/28/23-5/30/23 weakness, decreased appetite, decreased urination, cough, AKI, debility,
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Impaired work ability, Muscle spasms, Muscle twitching, Muscular weakness, Pain
Clinical narrative: On 7/29/2024 after the vaccination.  Pt could not move her arm without severe pain, mild tingling in her fingers and spasming/twitching in her arm.  Patient has no prior history of adverse reactions to vaccinations.  Pain is so severe she could not work on 7/30/2024 due to not being able to lift weight with arm or move arm without pain.  Mother tried alternation ibuprofen and Tylenol , massaging the site, applying hot and cold compresses.  No redness, lump or swelling at the site.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Paraesthesia
Clinical narrative: On 7/29/2024 after the vaccination.  Pt could not move her arm without severe pain, mild tingling in her fingers and spasming/twitching in her arm.  Patient has no prior history of adverse reactions to vaccinations.  Pain is so severe she could not work on 7/30/2024 due to not being able to lift weight with arm or move arm without pain.  Mother tried alternation ibuprofen and Tylenol , massaging the site, applying hot and cold compresses.  No redness, lump or swelling at the site.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: pain radiated from injection site to forearm. Started about 10 days after injection and lasted for about 1 week.
Age: 80.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Nausea
Clinical narrative: Patient experienced nausea later that afternoon after the injection and the next day.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Hypoxia, Lethargy, Respiratory failure
Clinical narrative: Hospitalized 5/31/23-6/3/23 weakness, lethargic, decreased appetite, hypoxia, respiratory failure,
Age: 31.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Provider ordered Peds dose of Hep A vaccine for an adult patient.  . Vaccine was given, which is a half dose for adult patient. Patient notified and will present to clinic for another dose of Peds vaccine to equal adult dosing.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Confusional state, Cough, Dizziness, Encephalopathy
Clinical narrative: Hospitalized 7/30/23-8/3/23 fever, decreased intake and output, sore throat, cough, confusion, dizziness, UTI, AKI, hyperkalemia, encephalopathy,
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperkalaemia, Hypophagia, Oropharyngeal pain, Pyrexia, Urinary tract infection
Clinical narrative: Hospitalized 7/30/23-8/3/23 fever, decreased intake and output, sore throat, cough, confusion, dizziness, UTI, AKI, hyperkalemia, encephalopathy,
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Atrial fibrillation, Cough, Decreased appetite, Dyspnoea
Clinical narrative: Hospitalized 9/12/23-9/25/23 a-fib with rvr, UTI, hyponatremia, hyperglycemia, weakness with falls, decreased appetite, nausea, SOB, cough,
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hyperglycaemia, Hyponatraemia, Nausea, Urinary tract infection
Clinical narrative: Hospitalized 9/12/23-9/25/23 a-fib with rvr, UTI, hyponatremia, hyperglycemia, weakness with falls, decreased appetite, nausea, SOB, cough,
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Rotateq was given after expiration date.  Call to Merck, representative stated no recommendation for re vaccination.  No adverse reaction reported.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aspiration bone marrow abnormal, Atrial fibrillation, Cardiac ablation, Haematocrit increased, Haemoglobin increased
Clinical narrative: 1. A-Fib diagnosed by Dr. Tx w/Rx: Eliquis 5 mg 2x daily, and Metoprolol Succ ER 25 mg 1x daily 7/19/2024 :Received Pulsed-Field Ablation by Dr.  2. POLYCYTHEMIA VERA: labs and testing confirmed diagnosis from JAK - 2 acquired gene mutation   6/28/2022 - Labwork from visit with primary care physician Dr. revealed: HEMATOCRIT increased to 46.7 (from 41.6 in 2017);  PLATELETS increased to 656 (from 351 in 2017); HEMAGLOBIN increased to 15.4 (from 13.7 in 2017);  RBC increased to 5.07 (from 4.64 in 2017) WBC increased to 9.0 (from 7.5 in 2017
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Janus kinase 2 mutation, Laboratory test abnormal, Platelet count increased, Polycythaemia vera, Red blood cell count increased
Clinical narrative: 1. A-Fib diagnosed by Dr. Tx w/Rx: Eliquis 5 mg 2x daily, and Metoprolol Succ ER 25 mg 1x daily 7/19/2024 :Received Pulsed-Field Ablation by Dr.  2. POLYCYTHEMIA VERA: labs and testing confirmed diagnosis from JAK - 2 acquired gene mutation   6/28/2022 - Labwork from visit with primary care physician Dr. revealed: HEMATOCRIT increased to 46.7 (from 41.6 in 2017);  PLATELETS increased to 656 (from 351 in 2017); HEMAGLOBIN increased to 15.4 (from 13.7 in 2017);  RBC increased to 5.07 (from 4.64 in 2017) WBC increased to 9.0 (from 7.5 in 2017
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: White blood cell count increased
Clinical narrative: 1. A-Fib diagnosed by Dr. Tx w/Rx: Eliquis 5 mg 2x daily, and Metoprolol Succ ER 25 mg 1x daily 7/19/2024 :Received Pulsed-Field Ablation by Dr.  2. POLYCYTHEMIA VERA: labs and testing confirmed diagnosis from JAK - 2 acquired gene mutation   6/28/2022 - Labwork from visit with primary care physician Dr. revealed: HEMATOCRIT increased to 46.7 (from 41.6 in 2017);  PLATELETS increased to 656 (from 351 in 2017); HEMAGLOBIN increased to 15.4 (from 13.7 in 2017);  RBC increased to 5.07 (from 4.64 in 2017) WBC increased to 9.0 (from 7.5 in 2017
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Asthenia, Cough, Dyspnoea, Hypoxia
Clinical narrative: Hospitalized 9/14/23-9/22/23 hypoxia, altered mental status, wheezing, rhonchi, PNA, respiratory failure, SOB, cough, sepsis, AKI, metabolic encephalopathy, debility,
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Mental status changes, Metabolic encephalopathy, Pneumonia, Respiratory failure, Rhonchi
Clinical narrative: Hospitalized 9/14/23-9/22/23 hypoxia, altered mental status, wheezing, rhonchi, PNA, respiratory failure, SOB, cough, sepsis, AKI, metabolic encephalopathy, debility,
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Sepsis, Wheezing
Clinical narrative: Hospitalized 9/14/23-9/22/23 hypoxia, altered mental status, wheezing, rhonchi, PNA, respiratory failure, SOB, cough, sepsis, AKI, metabolic encephalopathy, debility,
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Nausea, Peripheral swelling, Pruritus, Swelling face
Clinical narrative: Pt seen for virtual visit 8/29/22  presents with nausea , hives , facial and hand puffiness today s/p receiving COVID-19 PFIZER booster 4 days ago. She took benadryl with some help with itching but does not feel the puffiness of the hand and face has not improved History of the same kind of reaction s/p her first 2 covid vaccine . Diag with Idiopathic anaphylaxis. Started on High dose steroids with taper, round the clock benadryl and pepcid. She states the symptoms took near 3 weeks to resolve at the time. Denies swelling of the throat or difficulty breathing Denies cp Denies dizziness Denies any new foods or drinks.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Pt seen for virtual visit 8/29/22  presents with nausea , hives , facial and hand puffiness today s/p receiving COVID-19 PFIZER booster 4 days ago. She took benadryl with some help with itching but does not feel the puffiness of the hand and face has not improved History of the same kind of reaction s/p her first 2 covid vaccine . Diag with Idiopathic anaphylaxis. Started on High dose steroids with taper, round the clock benadryl and pepcid. She states the symptoms took near 3 weeks to resolve at the time. Denies swelling of the throat or difficulty breathing Denies cp Denies dizziness Denies any new foods or drinks.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Hyponatraemia, Pneumonia
Clinical narrative: Hospitalized 9/14/23-9/17/23 PNA, hyponatremia, cough, fatigue,
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Altered visual depth perception, Angiogram, Brain fog, Computerised tomogram head abnormal, Haemorrhage intracranial
Clinical narrative: Patient had headache on 7/12/24, it persisted then experienced tunnel vision in left eye and vomiting. Had to pull over car and take Uber to emergency room on 7/14/24. CT scan revealed an intracranial hemorrhage, patient was moved to ICU in the same hospital. An MRI and angiogram were performed. Patient experienced a false aneurysm in right leg where angiogram incision into ephemeral artery occurred. Patient released from hospital on 7/20/24 and instructed to remain on high blood pressure, anti seizure meds and sodium pills. Patient still experiences brain fog, equilibrium and depth perception issues, is not driving and cannot resume his normal day to day activities.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Impaired driving ability, Intensive care, Loss of personal independence in daily activities, Magnetic resonance imaging
Clinical narrative: Patient had headache on 7/12/24, it persisted then experienced tunnel vision in left eye and vomiting. Had to pull over car and take Uber to emergency room on 7/14/24. CT scan revealed an intracranial hemorrhage, patient was moved to ICU in the same hospital. An MRI and angiogram were performed. Patient experienced a false aneurysm in right leg where angiogram incision into ephemeral artery occurred. Patient released from hospital on 7/20/24 and instructed to remain on high blood pressure, anti seizure meds and sodium pills. Patient still experiences brain fog, equilibrium and depth perception issues, is not driving and cannot resume his normal day to day activities.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tunnel vision, Vascular pseudoaneurysm, Vomiting
Clinical narrative: Patient had headache on 7/12/24, it persisted then experienced tunnel vision in left eye and vomiting. Had to pull over car and take Uber to emergency room on 7/14/24. CT scan revealed an intracranial hemorrhage, patient was moved to ICU in the same hospital. An MRI and angiogram were performed. Patient experienced a false aneurysm in right leg where angiogram incision into ephemeral artery occurred. Patient released from hospital on 7/20/24 and instructed to remain on high blood pressure, anti seizure meds and sodium pills. Patient still experiences brain fog, equilibrium and depth perception issues, is not driving and cannot resume his normal day to day activities.
Age: 72.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incomplete course of vaccination, Injection site pain, Joint range of motion decreased, Pain in extremity, Sleep disorder
Clinical narrative: Right shoulder that flue shot was put in was very painful with less range of motion.  I was given a cortizone shot in back of shoulder and it didn't help a lot.  I returned to the orthopedic doctor with continuing pain and got antoher shot in shoulder, which did nothing for pain.  I also went to Physical therapy several times.  That was so painful that I didn't continue after the original scheudled treatments.  The pain is sitll in my shoudler and goes down my arm and sometimes in my hand.  If i lay on my right side to sleep, i hav eto turn over after a few mintues.  I still have limited range of motion.
Age: 72.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: X-ray limb abnormal
Clinical narrative: Right shoulder that flue shot was put in was very painful with less range of motion.  I was given a cortizone shot in back of shoulder and it didn't help a lot.  I returned to the orthopedic doctor with continuing pain and got antoher shot in shoulder, which did nothing for pain.  I also went to Physical therapy several times.  That was so painful that I didn't continue after the original scheudled treatments.  The pain is sitll in my shoudler and goes down my arm and sometimes in my hand.  If i lay on my right side to sleep, i hav eto turn over after a few mintues.  I still have limited range of motion.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Asthenia, Dehydration, Dyspnoea, Dysuria
Clinical narrative: Hospitalized 10/14/23-10/16/23 weakness, fatigue, dysuria, SOB, hypokalemia, AKI, dehydration, elevated troponin, PE,
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypokalaemia, Troponin increased
Clinical narrative: Hospitalized 10/14/23-10/16/23 weakness, fatigue, dysuria, SOB, hypokalemia, AKI, dehydration, elevated troponin, PE,
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Diarrhoea, Dyspnoea
Clinical narrative: "Hospitalized 10/16/23-10/20/23 hypoxia, cough, fever with chills, SOB, diarrhea, respiratory failure, debility, dyspnea, wheezing, "
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Pyrexia, Respiratory failure, Wheezing
Clinical narrative: "Hospitalized 10/16/23-10/20/23 hypoxia, cough, fever with chills, SOB, diarrhea, respiratory failure, debility, dyspnea, wheezing, "
Age: 79.0
Sex: M
Vaccine: RSV, TDAP
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: PATIENT CALLED PCP COMPLAINING OF FEVER AND DIFFICULTY BREATHING. PATIENT HAD BEEN ASLEEP AND SYMPTOMS AWOKE PATIENT IN THE MORNING. NURSE FROM PCP CALLED PHARMACY AND ALLERTED US TO THE EVENT AND REQUEST RECORDS OF THE VACCINATIONS. NURSE STATED PT WAS NOT HAVING DIFFICULTY BREATHING DURING HER CONVERSATION WITH THE SMAE MORNING OF THE EVENT.  NURSE STATED THAT PT WAS RECOVERING AT THIS POINT.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: cellulitis and redness of entire left upper arm
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Bone pain, Chills, Feeling cold, Gait disturbance
Clinical narrative: She got her vaccine, no problem at first.  Later that evening she started getting real cold, and then went into uncontrollable shivering which was horrible.  She went to bed early and covered herself up with 20 blankets to get warm, and then all night long she had such pain.  It was strange as it would be in one spot and then would be moving to another spot, adn felt like she ws having a heart attach at first.  It would start and then stay for a few seconds and move to another one.  Her feet felt like she was being stabbed by needless and was up the whole night.  The pain was absolutely terrible.  Her bones, muscles were in pain.  She could hardy walk when she got out of be this morning.  She got better as she mvoed around this morning.  She took Tylenol as her hips and lower back are hurting her.  The read out from pharmacy mentioned one of the reactions that does not happen very much was something that is called GBS.  She was afraid of that and called the pharmacist and explained what happened and she said that she would be concerned about GBS also as she had not heard of such a reaction after the vaccine.  Was told that if it comes back again to go to UC if she cannot get to see her doctor before that.  She was told to discuss with him whether to have her second shot or not.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: She got her vaccine, no problem at first.  Later that evening she started getting real cold, and then went into uncontrollable shivering which was horrible.  She went to bed early and covered herself up with 20 blankets to get warm, and then all night long she had such pain.  It was strange as it would be in one spot and then would be moving to another spot, adn felt like she ws having a heart attach at first.  It would start and then stay for a few seconds and move to another one.  Her feet felt like she was being stabbed by needless and was up the whole night.  The pain was absolutely terrible.  Her bones, muscles were in pain.  She could hardy walk when she got out of be this morning.  She got better as she mvoed around this morning.  She took Tylenol as her hips and lower back are hurting her.  The read out from pharmacy mentioned one of the reactions that does not happen very much was something that is called GBS.  She was afraid of that and called the pharmacist and explained what happened and she said that she would be concerned about GBS also as she had not heard of such a reaction after the vaccine.  Was told that if it comes back again to go to UC if she cannot get to see her doctor before that.  She was told to discuss with him whether to have her second shot or not.
Age: 51.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Chest pain
Clinical narrative: Patient was okay immediately following vaccination. Patient went home and called approximately an hour and 15 minutes later describing a sharp chest pain that had started over the past 15 minutes. Patient did not describe the pain as crushing and was not radiating to the left arm. Patient was instructed to seek medical attention. Patient told pharmacy he would call for EMS. Have attempted to follow up with patient since without success.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, DTPPVHBHPB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pediarix & Vaxellis both given same day. Dr called Mother to go over what had happened and explained what affects it has on pt - mother reported no adverse effects.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dizziness, Dyspnoea, Fibrin D dimer increased
Clinical narrative: Hospitalized 11/3/23-11/6/23 chills, cough, dizziness, nausea, congestion, hypoxia, SOB, elevated d-dimer, headache, respiratory failure, PNA, "
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoxia, Nausea, Pneumonia, Respiratory failure
Clinical narrative: Hospitalized 11/3/23-11/6/23 chills, cough, dizziness, nausea, congestion, hypoxia, SOB, elevated d-dimer, headache, respiratory failure, PNA, "
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion
Clinical narrative: Hospitalized 11/3/23-11/6/23 chills, cough, dizziness, nausea, congestion, hypoxia, SOB, elevated d-dimer, headache, respiratory failure, PNA, "
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Dysuria, Fall, Herpes zoster
Clinical narrative: Hospitalized 11/19/23-11/30/23 fall, dysuria, weakness, edema BLE, metabolic encephalopathy, shingles, elevated troponin, cough, PNA, debility,
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic encephalopathy, Oedema peripheral, Pneumonia, Troponin increased
Clinical narrative: Hospitalized 11/19/23-11/30/23 fall, dysuria, weakness, edema BLE, metabolic encephalopathy, shingles, elevated troponin, cough, PNA, debility,
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Cough, Diarrhoea, Hypoxia, Incontinence
Clinical narrative: Hospitalized 11/18/23-11/22/23 lethargic, diarrhea, incontinence, hypoxia, confusion, cough, PNA, respiratory failure, sepsis, metabolic encephalopathy,
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Metabolic encephalopathy, Pneumonia, Respiratory failure, Sepsis
Clinical narrative: Hospitalized 11/18/23-11/22/23 lethargic, diarrhea, incontinence, hypoxia, confusion, cough, PNA, respiratory failure, sepsis, metabolic encephalopathy,
Age: 7.0
Sex: M
Vaccine: HEPA, IPV, TDAP, VARCEL
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Patient developed swelling, tenderness at injection site of right arm immediately after injection. No rash or systemic symptoms noted. Patient improved with ice and Motrin in office but was noted to have slight bruise/continued swelling at site. Unclear if swelling so quickly after vaccination was due to possible allergy or administration of vaccine. No reaction was noted in left arm sites
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Urticaria
Clinical narrative: Pt reported in office on 7/30/2024 that she had a rash and broke out in hives in her left arm in the evening post immunization.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Rash, Rash macular, Rash papular
Clinical narrative: Rash began to arms, legs.  Small macular, raised rash. Extended onto abdomen and face.  No fever, not painful or itching, no swelling.
Age: 67.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: No symptoms patient reported to be fine.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site bruising, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Patient informed the office via message roughly 1 week after vaccine was administered. Patient informed us that her arm had 2-3 lumps present with some pain and bruising. Did note pain at injection site with previous vaccines but has not encountered something like this before. Noted that the day following the administration of her 2nd Men B vaccine, that she had some tenderness with swelling in her arm. We asked patient to attach a photo for review and noticed a sizeable lump at the injection site. Message was routed to a physician in office for review and patient was advised to place ice on it if she did not have a fever or pain that was spreading elsewhere. Was also advised to use Mortin for inflammation. Patient was informed that she could make an office visit or could be evaluated in a Urgent Care if she felt it was needed.
Age: 12.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt incorrectly given DTaP instead of TDaP. Mom and pt immediately notified. No side effects reported
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Autopsy, Brain oedema, Choking, Condition aggravated, Congestive hepatopathy
Clinical narrative: Patient immediately following these vaccines developed a slightly higher than 100 degree fever along with a choking/gagging cough that would make his face bright red. These symptoms lasted for 4 days after. Exactly 9 days later he died in his sleep in the early morning of November 15, 2023. The autopsy report diagnosed patient with pulmonary and cerebral edema along with congestion of the leptomeninges and liver. I understand that encephalitis is a side effect of the Dtap which is what I believed patient died from.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Cough, Death, Erythema, Immediate post-injection reaction, Nervous system disorder
Clinical narrative: Patient immediately following these vaccines developed a slightly higher than 100 degree fever along with a choking/gagging cough that would make his face bright red. These symptoms lasted for 4 days after. Exactly 9 days later he died in his sleep in the early morning of November 15, 2023. The autopsy report diagnosed patient with pulmonary and cerebral edema along with congestion of the leptomeninges and liver. I understand that encephalitis is a side effect of the Dtap which is what I believed patient died from.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Pulmonary oedema, Retching
Clinical narrative: Patient immediately following these vaccines developed a slightly higher than 100 degree fever along with a choking/gagging cough that would make his face bright red. These symptoms lasted for 4 days after. Exactly 9 days later he died in his sleep in the early morning of November 15, 2023. The autopsy report diagnosed patient with pulmonary and cerebral edema along with congestion of the leptomeninges and liver. I understand that encephalitis is a side effect of the Dtap which is what I believed patient died from.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: cellulitis around injection site, redness, pain, swelling,  fluid filled lump on opposite side of injection site. md prescribed cephalexin 500mg 4x/day.  3 days later prescribed doxycycline 100mg 2x/day. also, received antibiotic shot at md office.  Redness and swelling has gone down but lump remained.
Age: 38.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: 7/30/24 Patient contacted and had no adverse reactions.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: Body rash, body redness, high to low-grade fever for about 4 days
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash, Urticaria
Clinical narrative: Rash/hives on both thighs.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Fever to 104.4 oral
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiomegaly, Echocardiogram, Electrocardiogram, Laboratory test, Muscle tightness
Clinical narrative: He got the vaccine, was focusing on his wife's condition and was not aware that he was having any problems.  She died 3 months after getting her J&J vaccine.  He then went to his doctor for a FU and said that he had an enlarged heart in 2023, which he did not have any issues with prior to the vaccine that he was aware of.  He walks up to 5 miles a week and has some persistent pressure knot in his back, and has to stretch his arms to alleviate the tightness, and sometimes has to sit down for it to relieve some.  He is jogging  very lightly and slowly and he feels this could be related to his heart.  When he saw his PCP in 2022 he increased his BP medicine in 2022 with adding Losartan.  Last July of 2023 he did some heart testing as he had found the enlarged heart, and he connected the dots and realized this may be related to the vaccines that he received.  He feels it is hidden on the internet and all over that they are hiding the side effects from the vaccines.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, VARCEL
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Patient was given 3 separate injections- 2 in right arm and 1 in left arm. She did well during injections and remained seated while I applied fluoride varnish to teeth. She stood up to change seats with her sister who also wanted fluoride varnish. Dad noticed while moving to another chair she looked pale and helped her into a seated position where she appeared to lose consciousness for a few seconds. Mom, Dad and I immediately moved her to the exam table and elevated her feet. She was given juice, water and a snack. She appeared to fully recover in less than 5 minutes but was monitored for 15 minutes afterwards. Clinic supervisor was notified and subsequently escorted family out of the building.
Age: 1.67
Sex: M
Vaccine: DTAP
Symptoms: Injection site induration, Injection site reaction, Injection site warmth, Rash papular, Urticaria
Clinical narrative: 2 days after the injection the site got hot, firm, a raised rash that resembled large hives. Pt was advised to be given Benadryl x4 days with no improvement for 2 days and then improvement noticed on days 3 and 4. Pt was also given Ibuprofen for 2 days after the start of symptoms.  As of today (7 days out) same skin color, area is still firm but not as much as before, and normal skin temperature.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Syncope, Vomiting
Clinical narrative: At approximately 10:25am, while administering the HPV vaccine to the patient, the patient experienced a syncopal episode. He lost consciousness for approximately 2 seconds, during which he was supported by the nurse and his mother who were both at his side. He did not hit the ground as he was safely guided to a reclined position by his mother and the nurse. Following the syncopal episode, the patient vomited. Cold compresses were offered and applied to patients' neck and forehead. Immediate interventions included ensuring an open airway and placing the patient in a safe position. The patient remained conscious and alert after regaining consciousness. At 10:35am the nurse notified supervisor of adverse event, patient was observed for an additional 30 minutes post-event for any further signs of distress or complications. Post-event, He reported feeling lightheaded but denied any pain or discomfort. His color and demeanor returned to baseline, and he was able to tolerate oral intake of water without further incident. The patient was advised to remain seated and well-hydrated for the remainder of the clinic visit. His mother was instructed to monitor him closely at home for any recurrent symptoms or concerns. Additionally, the patient was provided with educational materials regarding post-vaccination reactions, including syncopal episodes, and instructed to follow up with his primary care provider if any further issues arise. The patient's mother expressed her understanding of the event and verbalized intent to follow the provided recommendations. Contact information was exchanged for further follow-up if necessary
Age: 12.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Dizziness, Infertility female, Interchange of vaccine products, Ultrasound scan vagina abnormal, Uterine disorder
Clinical narrative: PATIENT REPORTED IN JULY 2024 THAT SHE HAS HAD MONTHS OF SUFFERING WITH UTERINE FIBROIDS AND LIGHT HEADEDNESS.  PATIENT WAS SEEN ON SEPTEMBER 18, 2017 FOR A VAGINAL ULDTRASOUND.  PATIENT REPORTS GROWTH ON RIGHT SIDE OF UTERUS.  PATIENT IS HAVING ISSUES WITH INFERTILITY AND FEELS GARDASIL MAY HAVE CAUSED THIS. Patient was administered 3 total Gardasil vaccinations per immunization record with first dose (listed above) given 11/16/2010. Second dose was HPV 4 (Gardisil), lot: H021608, exp 8/13/2015, intramuscularly administered to LD on 7/30/2013. 3rd dose was HPV 2 (Cervarix), lot and exp unknown, and was administered on 12/18/2013 at Clinic.
Age: 12.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Uterine leiomyoma
Clinical narrative: PATIENT REPORTED IN JULY 2024 THAT SHE HAS HAD MONTHS OF SUFFERING WITH UTERINE FIBROIDS AND LIGHT HEADEDNESS.  PATIENT WAS SEEN ON SEPTEMBER 18, 2017 FOR A VAGINAL ULDTRASOUND.  PATIENT REPORTS GROWTH ON RIGHT SIDE OF UTERUS.  PATIENT IS HAVING ISSUES WITH INFERTILITY AND FEELS GARDASIL MAY HAVE CAUSED THIS. Patient was administered 3 total Gardasil vaccinations per immunization record with first dose (listed above) given 11/16/2010. Second dose was HPV 4 (Gardisil), lot: H021608, exp 8/13/2015, intramuscularly administered to LD on 7/30/2013. 3rd dose was HPV 2 (Cervarix), lot and exp unknown, and was administered on 12/18/2013 at Clinic.
Age: 74.0
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Hyperhidrosis, Hypophagia, Nausea, Pallor
Clinical narrative: Patient said he was feeling nauseous after getting the vaccines at around 3:30pm. He was pale, sweating from head to toe and mentioned he hasn't eaten since 10:30am. We gave him water and  called EMS and they checked his vital signs.  After 20-30 minutes the patient said he felt better and left with his spouse.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Rotavirus was given to patient when patient has out aged vaccine per cdc guidelines - patient did not have a reaction at time of administration.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Incorrect dose administered
Clinical narrative: Due to miscommunication, patient received double dose of the above listed vaccines during the same visit. clinician notified patient mother. Medical director reviewed case, spoke with GSK about Rotarix and advised no risk to patient but also no data about evidence of harm. Nurse manager spoke with vaccine unit who also confirmed no severe risk to patient.  Nurse will check-in with patient tomorrow. Emergency precautions provided and when to seek care. Internal review filed.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19-2, UNK
Symptoms: Chest pain, Cough, Fatigue, Hyperhidrosis, SARS-CoV-2 test
Clinical narrative: Chest pain, dry cough, sweating, fatigue
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Syncope
Clinical narrative: Patient fainted after I administered vaccine HPV9
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient received a pediatric dose of Hep B instead of an adult dose. When documenting the vaccine in chart the CMA documented that an adult dose with a different lot number was given. This wasn't discovered by management until a month later during the inventory count. I did reach out to the help desk. I was advised that the patient would need to come in and be given a full adult dose to be considered immune.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site induration, Injection site nodule, Injection site reaction, Injection site warmth, Rash papular
Clinical narrative: Parents of the child vaccine recipient reported that the child had a hard knot at the injections site, along with a raised rash that extended over a majority of the right deltoid area. The rash was described as "hot to the touch" and The parents noticed these symptoms approximately 24 hours after the child received vaccinations. The child had not received any medical treatment at the time of parent's reporting of symptoms.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site induration, Injection site nodule, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Parents of the child vaccine recipient reported that the child had a hard knot at the injections site, along with a raised rash that extended over the right deltoid and spreading to almost the elbow of the right upper arm. The rash was described as "hot to the touch" and painful.  The parents also stated there was a smaller tender area on the left deltoid at that injection site, however it had not developed the hard raised spreading rash that developed on the right deltoid. The parents noticed these symptoms approximately 24 hours after the child received vaccinations. The child had not received any medical treatment at the time of parent's reporting of symptoms.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Rash, Rash papular
Clinical narrative: Parents of the child vaccine recipient reported that the child had a hard knot at the injections site, along with a raised rash that extended over the right deltoid and spreading to almost the elbow of the right upper arm. The rash was described as "hot to the touch" and painful.  The parents also stated there was a smaller tender area on the left deltoid at that injection site, however it had not developed the hard raised spreading rash that developed on the right deltoid. The parents noticed these symptoms approximately 24 hours after the child received vaccinations. The child had not received any medical treatment at the time of parent's reporting of symptoms.
Age: 13.0
Sex: F
Vaccine: HEPA, IPV, MNQ, VARCEL
Symptoms: Urticaria
Clinical narrative: Developed hives on the right arm and left leg five minutes after vaccines were administered. No difficulty breathing or swelling of tongue or lips. Paramedics were called. Paramedics completed their assessment and asked the client?s mother if she would like to have the child transported to the E.R. and the mother declined. The mother was advised to wait in the clinic under observation for one hour with the RN. Paramedics did not administer any medication to the client. The client?s mother was provided the contact information for a pediatrician and instructed to follow-up regarding the incident that occurred after receiving the vaccines on today?s visit.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Ataxia, Dizziness, Nystagmus, Vertigo
Clinical narrative: 7/25/24 vertigo at 11 am, little ataxic,  7/26/24 vertigo, nystagmus, dizziness - to see ENT
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Patient has a bump and pain at injection site.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HCP called to report TE where product was administered to a patient. No additional AE/PQC.   ROTATEQ : X025233   07/03/2025  47.6F FOR 0 HOURS 54 MINUTES 0 SECONDS NO PREVIOUS EXCURSION; This spontaneous report was received from a Medical Assistant and refers to an 8-week-old male patient. His medical history, concurrent conditions and concomitant therapies were not provided.  On 25-JUN-2024, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #X025233, expiration date: 03-JUL-2025, administered for prophylaxis (strength, and route of administration were not provided) and the product was after a temperature excursion; 47.6 F for 0 hours 54 minutes 0 seconds (product storage error). No previous excursion. No additional adverse events.; Sender's Comments:  US-009507513-2407USA001607:
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report a TE with VAQTA. Administered after being improperly stored; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-JUL-2024, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, vial 25/0.5, lot # x025342, expiration date: 12-MAY-2025, administered for prophylaxis (exact dose, and route of administration were not provided).  On 01-JUL-2024, the hepatitis a vaccine, inactivated (VAQTA) was administered after being improperly stored (a temperature excursion [TE] was noted) (product storage error). No adverse effects were reported. No additional adverse event (AE) and no product quality complaint (PQC) were noted.
Age: 5.0
Sex: M
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product preparation error
Clinical narrative: administered PROQUAD to a patient and did not use the recommended sterile diluent supplied with the product. HCP states the diluent she used was sterile sodium chloride; No symptoms reported / No additional AE/No PQC.; This spontaneous report has been received from a registered nurse referring to a 5-year-old male patient. Information regarding the patient's medical history, concurrent conditions, concomitant medications, drug allergies or reactions were not provided.   On 17-JUL-2024, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, albumin status rHA, 0.5 milliliter, lot number: X026597 and expiration date was 11-MAY-2025, administered for prophylaxis (strength, and route of administration were not provided) but nurse did not use the recommended sterile diluent supplied with the product, she used sterile sodium chloride, lot number GP3543, expiration date: 01-OCT-2024, unable to confirm amount (strength, formulation, route of administration, and indication were not provided) (product preparation error). No symptoms reported. No additional AE/No PQC.
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: she is experiencing full body hives; This spontaneous report was received from a female consumer and referring to herself.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  n an unknown date, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  It was reported that the patient was experiencing full body hives since receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Urticaria). She experienced the hives after receiving the 2nd dose. The hives have lasted for over a month. She asked if there were any resources available that address or mention the constant hives as a side effect. She has the product information (PI) and PPI and did not see anything for constant hives. There was no additional documentation beyond the PI and PPI. She said she has already consult with her physician. She said it was discouraging that there was no additional information on constant hives beyond the PI and PPI. She was not willing to provide any personal information.  At time of reporting, the outcome of the event was unknown. The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided. The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not applicable.
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/; a dose of PROQUAD was inadvertently administered to a 17 year old.; This spontaneous report was received from a medical assistant and refers to a 17-year-old patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 18-JUL-2024, the 17-year-old patient was vaccinated inadvertently with 1 dosage form/dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, therapy type: rHA, lot #X011982, expiration date: 22-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product administered to patient of inappropriate age). It was stated no patient symptoms have been reported. No additional adverse event (AE) reported (No adverse event).