chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Disorientation, Facial pain, Fall, Headache
Clinical narrative: Patient came into the pharmacy ~6:00 pm as he just booked a covid vaccine appointment. We did not have any out therefore we had to allow it to warm to room temperature prior to administration. The patient completed paperwork while waiting. We administered the vaccine in the left arm ~6:30 pm. The patient was told to sit down and wait for 15 minutes as this was his first covid vaccination. The patient was sitting on his phone ~6:40 pm and appeared ok.  At ~ 6:45 the patient stood up and immediately passed out. He fell flat on his face leading to his lip being cut open and bleeding as well as his nose was bleeding. He was very disoriented. We provided ice on the back of his neck, left him laying where he fell as he hit a cement floor, and provided ice and a towel for his lip. He slowly came to full consciousness ~6:55 pm and was able to answer any questions. He complained of his face and head hurting therefore we called the rescue. Upon arrival the rescue checked the spine and neck then had him sit on the floor and obtained vitals which were normal. After the patient was sitting for 5 minutes on the floor, they had him move to the chair. Upon him sitting in the chair he began to complain of stomach pain and distorted vision. The rescue team made the decision to take him to the ER.
Age: 20.0
Sex: M
Vaccine: COVID19-2
Symptoms: Lip injury, Loss of consciousness, Metamorphopsia, Nasal injury
Clinical narrative: Patient came into the pharmacy ~6:00 pm as he just booked a covid vaccine appointment. We did not have any out therefore we had to allow it to warm to room temperature prior to administration. The patient completed paperwork while waiting. We administered the vaccine in the left arm ~6:30 pm. The patient was told to sit down and wait for 15 minutes as this was his first covid vaccination. The patient was sitting on his phone ~6:40 pm and appeared ok.  At ~ 6:45 the patient stood up and immediately passed out. He fell flat on his face leading to his lip being cut open and bleeding as well as his nose was bleeding. He was very disoriented. We provided ice on the back of his neck, left him laying where he fell as he hit a cement floor, and provided ice and a towel for his lip. He slowly came to full consciousness ~6:55 pm and was able to answer any questions. He complained of his face and head hurting therefore we called the rescue. Upon arrival the rescue checked the spine and neck then had him sit on the floor and obtained vitals which were normal. After the patient was sitting for 5 minutes on the floor, they had him move to the chair. Upon him sitting in the chair he began to complain of stomach pain and distorted vision. The rescue team made the decision to take him to the ER.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PATIENT CAME IN FOR FLU VACCINE AND COVID BOOSTER. PATIENT IS 64 YEARS OLD BUT SHE WAS GIVEN THE FLU VACCINE FOR 65 AND OLDER (FLUAD). SHE WILL NOT BE 65 UNTIL FEBRUARY. NO ADVERSE EVENTS TO REPORT.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness, Night sweats, Pyrexia, Rash
Clinical narrative: Weakness, flu-like symptoms, night sweats and fever (2 nights), large bi-lateral rash covering most of torso and extending to back (I have photos.)
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Epilepsy
Clinical narrative: G40.909 EPILEPSY, UNSPECIFIED 10/1/2021 MODERATE DEHYDRATION
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Underdose
Clinical narrative: Patient flinched at vaccination and lost less than half of vaccine for administration. CDC recommended revaccinating with no lapse in time recommended.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lacunar stroke, Medical diet, Type 2 diabetes mellitus
Clinical narrative: ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 4/22/2023 DM 2 CONTROLLED BY DIET
Age: 67.0
Sex: M
Vaccine: PNC20
Symptoms: Angiogram pulmonary, Chest pain, Condition aggravated, Dyspnoea, Pulmonary embolism
Clinical narrative: Right Middle Lobe Pulmonary Embolism 12 days after Prevnar 20, shortness of breath, chest pain
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Hypotension
Clinical narrative: I95.9 HYPOTENSION 4/23/2023 ATRIAL FIBRILLATION, UNSPECIFIED R09.02 HYPOXIA 4/23/2023 ATRIAL FIBRILLATION, UNSPECIFIED
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Pruritus
Clinical narrative: itching since vaccination
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome, Pulmonary hypertension
Clinical narrative: G47.33 OBSTRUCTIVE SLEEP APNEA 4/27/2023 PULMONARY HTN G47.33 OBSTRUCTIVE SLEEP APNEA 4/27/2023 PULMONARY HTN
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Cervical radiculopathy, Hypersensitivity, Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA 4/21/2023 CERVICAL RADICULOPATHY ALLERGIC REACTION, INIT 4/28/2023 CERVICAL RADICULOPATHY
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism, Urinary tract infection
Clinical narrative: I26.99 ACUTE PULMONARY EMBOLISM 4/16/2023 UTI (URINARY TRACT INFECTION) I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 4/16/2023 UTI (URINARY TRACT INFECTION)
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Hypoxia
Clinical narrative: HYPOXIA 5/2/2023 LEFT LEG CELLULITIS
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Pseudarthrosis, Spinal fusion surgery
Clinical narrative: HYPOTENSION 4/17/2023 PSEUDARTHROSIS AFTER SPINAL FUSION
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial flutter, Hypotension
Clinical narrative: HYPOTENSION 3/27/2023 ATRIAL FLUTTER, UNSPECIFIED
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/9/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection.  Vaccine Site: PHARMACY
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue
Clinical narrative: Excessive fatigue, later in the day after the vaccine; 12 hour sleep overnight; still fatigued the next day.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Developed intermittent sharp pains that feel just like bee stings.  Occurs mostly on feet and hands.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Lt upper arm--upper arm lateral side, 3 inch x 2 inch erythematous arm more intense redness in the center, a little warm to touch , not indurated, not very tender.
Age: 46.0
Sex: F
Vaccine: HPV9
Symptoms: Wrong patient
Clinical narrative: HPV VACCINE GIVEN TO WRONG PATIENT
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Oropharyngeal pain, Urticaria
Clinical narrative: States he woke up with hives on his chest and back the next morning after receiving the vaccine.
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Conjunctivitis, Ear infection, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Per spouse, patient was beginning to experience symptoms of runny nose, sore throat, muscle aches, pink eye, and fever several hours in the evening on the day of vaccination.  Patient saw his physician approx. 1 week after the vaccination for ear infection.
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Rhinorrhoea
Clinical narrative: Per spouse, patient was beginning to experience symptoms of runny nose, sore throat, muscle aches, pink eye, and fever several hours in the evening on the day of vaccination.  Patient saw his physician approx. 1 week after the vaccination for ear infection.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Hyperhidrosis, Presyncope, Visual impairment
Clinical narrative: After administering vaccine. Patient indicates that she is seeing cloudy and is observed to be sweaty. Vital signs is taken and the patient is placed in the "Trendelenburg position". Proceeded to call the patient to evaluate her.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 68.0
Sex: F
Vaccine: YF
Symptoms: Appetite disorder, Cough, Decreased appetite, Dyspepsia, Dyspnoea
Clinical narrative: Appetite changes and fever and soreness in muscles. cough. breathing issue, having trouble taking deep breath. headaches. night sweats. within 7-10 days I could not put any pressure or weight on my left foot which was swollen, and my upper leg muscle was sore. I did an ultrasound on my leg to check for blood clots. I was also told I had a sinus/ upper respiratory infection. I still have fever off and on. the soreness continues.  Upper part of both legs is sore. Compression socks were prescribed.  Indigestion and no apatite persist. Weight loss. Tylenol for fever.
Age: 68.0
Sex: F
Vaccine: YF
Symptoms: Headache, Myalgia, Night sweats, Pain in extremity, Peripheral swelling
Clinical narrative: Appetite changes and fever and soreness in muscles. cough. breathing issue, having trouble taking deep breath. headaches. night sweats. within 7-10 days I could not put any pressure or weight on my left foot which was swollen, and my upper leg muscle was sore. I did an ultrasound on my leg to check for blood clots. I was also told I had a sinus/ upper respiratory infection. I still have fever off and on. the soreness continues.  Upper part of both legs is sore. Compression socks were prescribed.  Indigestion and no apatite persist. Weight loss. Tylenol for fever.
Age: 68.0
Sex: F
Vaccine: YF
Symptoms: Pyrexia, Sinusitis, Ultrasound Doppler, Upper respiratory tract infection, Weight decreased
Clinical narrative: Appetite changes and fever and soreness in muscles. cough. breathing issue, having trouble taking deep breath. headaches. night sweats. within 7-10 days I could not put any pressure or weight on my left foot which was swollen, and my upper leg muscle was sore. I did an ultrasound on my leg to check for blood clots. I was also told I had a sinus/ upper respiratory infection. I still have fever off and on. the soreness continues.  Upper part of both legs is sore. Compression socks were prescribed.  Indigestion and no apatite persist. Weight loss. Tylenol for fever.
Age: 3.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: Patient given 1 dose of Proquad and 1 dose of Varivax
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient is of age to receive the vaccine. Per system it is only approved for dose 5 of DTAP and dose 4 OF IPV. Patient was behind on vaccines which made the DTAP 4th dose and IPV 3rd dose. Patient will receive to get the 4th dose of DTAP in 6 months.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: unknow
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Sepsis
Clinical narrative: RECENT WEIGHT READING(S) 08/23/23 73.7 kg (162 lb 6.4 oz)   Room number:  TBD  Phone number: TBD  Indicate if there are obstacles:  covid isolation  Ends 9/1/23    Diagnosis:   COVID-19 DISEASE   ? SEPSIS WO ACUTE ORGAN DYSFUNCTION     Reason for Transportation:  Medically frail, requires assist    9/2/2023 Arrival Time:  5:00am Chair Time: 5:15am Return Time:  9:15 am
Age: 81.0
Sex: F
Vaccine: PNC20
Symptoms: Abdominal pain upper, Chills, Headache, Nausea, Sleep disorder
Clinical narrative: Patient has headache and chills, then woke up at 2am with intense stomach pain, nausea and vomiting. After waking up yesterday patient only had headache and chills, today (8/31/23) she is back to feeling normal no symptoms.
Age: 81.0
Sex: F
Vaccine: PNC20
Symptoms: Vomiting
Clinical narrative: Patient has headache and chills, then woke up at 2am with intense stomach pain, nausea and vomiting. After waking up yesterday patient only had headache and chills, today (8/31/23) she is back to feeling normal no symptoms.
Age: 1.0
Sex: M
Vaccine: DTAPIPV, MMR, UNK
Symptoms: No adverse event, Product administration error, Wrong product administered
Clinical narrative: ADMINISTRATION ERROR:   He got his vaccine, was very busy this morning and she accidentally grabbed the wrong vile.  He was supposed to get the pneumococcal vaccine instead of the Quadracel vaccine.  He has not had any reaction at this point.  They also informed the mother of the error, and notified her that they were going to report it to VAERS.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection.  Vaccine Site: Pharmacy,
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 16.0
Sex: M
Vaccine: HEP, IPV, MMRV, MNQ, TDAP, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Patient received ProQuad and Varivax on same day.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Haematochezia, Infant irritability
Clinical narrative: Dose administered on 8/29/23.  mom contacted our office reporting hematochezia x 3 on 8/30/23.  no vomiting, mild fussiness.  Had three subsequent normal stools, but then had another episode of hematochezia 8/31/23.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9, IPV, MNQ, TDAP, VARCEL
Symptoms: Fall, Muscle rigidity, Unresponsive to stimuli
Clinical narrative: About 5 minutes following injection of all 6 vaccines, pt was sitting in chair and upper body fell forward. RN rushed to sit her up, eyes were open, arms out and rigid, possible seizure, lasted about 5 seconds.  Pt then began blinking and looking around, not responding. Pt was able to squeeze both hands on command.  About 2 minutes after pt was able to nod responding that she was okay, shook her head saying no pain.  About 2 minutes later pt asked to lay down on exam table. Juice and snacks provided, pt only wanted juice. Pt was now able to respond verbally.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Product administration error, Product preparation issue
Clinical narrative: Administration error occurred, the orange top and grey top weren't mixed. Client was given the grey top vaccine bottle, this has the  C, W, Y. Client wasn't given the orange top vaccine bottle that covers A.
Age: 14.0
Sex: M
Vaccine: HEP, IPV, MMRV, MNQ, TDAP, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient received ProQuad and Varivax on same day.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Breathing-related sleep disorder, Hypoventilation, Hypoxia, Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 4/25/2023 ACUTE RESPIRATORY FAILURE WITH HYPOXIA SLEEP RELATED HYPOVENTILATION OR HYPOXEMIA 4/25/2023 ACUTE RESPIRATORY FAILURE WITH HYPOXIA
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 23.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: MA noticed when inputting administration of mpox vaccine that vaccine had expired on box 10/2024, BUD 8/8/2023. DPH delivered 6/13/2023 (likely same day pulled out of frozen storage) and marked BUD 8/8/2023. No adverse effects noted to patient after vaccine.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Spinal cord compression
Clinical narrative: G62.9 NEUROPATHY 11/16/2022 SPINAL CORD COMPRESSION
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Cholecystitis, Cholecystitis acute, Transient ischaemic attack
Clinical narrative: G45.9 TRANSIENT CEREBRAL ISCHEMIA 4/9/2023 ACUTE CHOLECYSTITIS G45.9 TRANSIENT CEREBRAL ISCHEMIA 4/9/2023 ACALCULOUS CHOLECYSTITIS
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccinr after BUD
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Patient got shingles 3 days after vaccination on R face.  severe sx- went to ER.  I noticed it is not listed as an adverse effect on LExapro, but there are case reports.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Hospitalization for COVID-19
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Hyperhidrosis, Loss of consciousness, Presyncope
Clinical narrative: At approximately 11:10 am the patient received her last vaccine and she got off of the exam table and walked from the exam room to her mom in the waiting room.  She sat down next to her mom and began talking to her.  A second later she vasovagal, slumping in her chair.  She was awake a second later.  She was diaphoretic and talking to her mom.  I called emergency services and checked her pulse.  We got her ice packs and I stayed with the patient and her mom until emergency services came.  They assessed her and all her vitals were okay okay.  They cleared her and she went home.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Hospitalization for COVID-19
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired vaccine. Vaccine expired on 8/24/2023
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Hospitalization for COVID-19
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Hospitalization for COVID-19
Sex: U
Vaccine: COVID19-2, VARZOS
Symptoms: Injury associated with device
Clinical narrative: Foster parent reported vaccine administration error. Per the foster mom on 7/15/2023, the foster parents went into pharmacy store for patient's COVID-19 vaccine, and the foster dad went in to receive his shingles vaccine. Foster parent reports pharmacy stated to her the shingles vaccine needle (intended for patient's foster dad) ?poked? patient, but pharmacy withdrew the needle and did not administer the actual shingles vaccines. Pharmacy states the needle only poked patient.
Age: 61.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth, Pain, Pain in extremity
Clinical narrative: pt came to pharmacy on 8/31/2023 claiming that she had reaction to the vaccine she got on 8/27/2023 in her right arm. pt received RSV vaccine on her right arm. her arm is still sore and she has pain when she lift her arm. the injection site is feverish and little bit red, it also started bruising . pt tried tylenol and ice pack and that did not help. pt will keep monitoring and contact dr if it gets worse.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Hospitalization for COVID-19
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: documentation on client's chart reflects client received Pfizer Bivalent for 6mo-4yr old, lot# GK1667, dose 3mcg/0.2 mL in 2mL injection to left deltoid. Client and his mother agreed to receive the proper dose for 5 year old which should have been Pfizer Bivalent for 5-11 year old, lot number GK1657, dose 10mcg/0.2 mL. This nurse believes the client received the proper dose and an error was made in charting . Nevertheless, the incorrect dose was charted and uploaded to system.  Error was discovered 7/31/23 upon client's return to clinic. Client's mother reported no obvious side effects or distress after vaccination.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Abdominal X-ray, Blood bicarbonate decreased, Blood potassium normal, Enema administration, Full blood count normal
Clinical narrative: Intussusception-presented to the ED with bright red blood per rectum and irritability. Intussusception resolved with  air enema which resolved symptoms.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Gastrointestinal pathogen panel, Infant irritability, Intussusception, Metabolic function test abnormal, Rectal haemorrhage
Clinical narrative: Intussusception-presented to the ED with bright red blood per rectum and irritability. Intussusception resolved with  air enema which resolved symptoms.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Respiratory pathogen panel, Small intestinal intussusception reduction, Soft tissue disorder, Ultrasound abdomen abnormal, X-ray abnormal
Clinical narrative: Intussusception-presented to the ED with bright red blood per rectum and irritability. Intussusception resolved with  air enema which resolved symptoms.
Age: 83.0
Sex: M
Vaccine: TD, VARZOS
Symptoms: Guillain-Barre syndrome, Intensive care, Paralysis, Transfusion
Clinical narrative: Paralyzed feet, started about a week after receiving vaccines, stated from Dr that it was Guillian Barre syndrome. Received transfusion while in the hospital and in the ICU for 2 weeks. In a long term care facility now
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Hospitalization for COVID-19
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Dysphemia, Fatigue, Hyperhidrosis, Hyporesponsive to stimuli, Loss of consciousness
Clinical narrative: After administration of Hep B vaccination, patient was talking to mother and nurse. Then patient suddenly passed out, aroused with sternal rub and ammonia inhalant. Skin pale, diaphoretic. Cool cloth applied. Patient alert and oriented x 3 Patient slow to respond and to answering questions. Patient complains of nausea with dry heaves. Refused to lay back in chair or have legs elevated due to nausea and wanting to sit up. Patient states vision is blurry. Appears to stare off into ?space.? Pupils equal and reactive. Patient drank a few sips of juice without difficulty.  Patient complains of being tired. Stuttering words, which mother states is not normal.Mother states that patient has not had any reaction to vaccines in the past. 82/52-67-14. Spo2 96% room air. Emergency services called and arrived. Report given. No change in condition. Left via stretcher, alert, pale with mother following. Transferred to ER via squad.
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Nausea, Pallor, Retching, Staring, Vision blurred
Clinical narrative: After administration of Hep B vaccination, patient was talking to mother and nurse. Then patient suddenly passed out, aroused with sternal rub and ammonia inhalant. Skin pale, diaphoretic. Cool cloth applied. Patient alert and oriented x 3 Patient slow to respond and to answering questions. Patient complains of nausea with dry heaves. Refused to lay back in chair or have legs elevated due to nausea and wanting to sit up. Patient states vision is blurry. Appears to stare off into ?space.? Pupils equal and reactive. Patient drank a few sips of juice without difficulty.  Patient complains of being tired. Stuttering words, which mother states is not normal.Mother states that patient has not had any reaction to vaccines in the past. 82/52-67-14. Spo2 96% room air. Emergency services called and arrived. Report given. No change in condition. Left via stretcher, alert, pale with mother following. Transferred to ER via squad.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Hep A (Havrix) adult dose vaccine given to 12 month old, instead of pediatric dose.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Fatigue, Influenza virus test negative, Pain, Peripheral swelling
Clinical narrative: On the evening of 8/27/23 patient noticed some soreness and swelling near vaccination site. Over the next few days the swelling and a red, hot to the touch, outline moved downward almost to the wrist. Patient had body aches and fatigue but no fever. During the visit patient was tested for the flu and the result was negative.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Skin warm, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: On the evening of 8/27/23 patient noticed some soreness and swelling near vaccination site. Over the next few days the swelling and a red, hot to the touch, outline moved downward almost to the wrist. Patient had body aches and fatigue but no fever. During the visit patient was tested for the flu and the result was negative.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Headache, Pain, Paraesthesia, Tension headache
Clinical narrative: Tingling in arms and legs Also head and face. Headaches pain and tension
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Sleep disorder, Tremor
Clinical narrative: on 8/31/23 pt reports to us that after the shingrix vaccine on 3/12/23 he had pain for approx 5 months (could not sleep on the left side) now at the 5 month mark he is experiencing a tremor in the left hand/arm.  He had trauma to that arm and some nerve damage from a previous incident years ago but nothing to this extent.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Condition aggravated, Migraine, Pain, Pyrexia
Clinical narrative: Abrupt onset of fever (T-102) and intractable migraine the evening of the vaccine administration.  Fever resolved <4days. Intractable Migraine has persisted 8/18-8/31/2023 (OV by PCP 8/31/2023) - Pain Level 7/10 (highest with current migraine 8/10). Referred to Hospital and Clinics - Neurology Clinic (referral entered 8/31/2023). Patient has a history of chronic migraines; last visit/treatment (nerve block) for migraines 4/2023.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Seizure
Clinical narrative: seizure at 2:30 am on 8/31. SEizure lasted 1.5 min.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Aspiration pleural cavity, Asthenia, Chest tube insertion, Death
Clinical narrative: She was admitted due to acute on chronic hypoxemic and hypercapnic respiratory failure.  She was using noninvasive ventilation at night and as needed during the day when she was admitted.  She also had issues with recurrent left-sided pleural effusion that required recurrent thoracentesis.     Her hospitalization was characterized by recurrent and progressive hypercapnia in association with weakness that was generalized despite working with occupational and physical therapy.  She had a small bore chest tube placed by Interventional Radiology for her pleural effusion.  This did not provide significant improvement in her overall cardiopulmonary status.  She continued to have progressive hypercapnia despite noninvasive ventilation characterized by delirium.  Her family eventually decided to transition her from active care to comfort care with palliation.  She died on July 13, 2023 at 1955.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Delirium, Hypercapnia, Mechanical ventilation, Pleural effusion, Respiratory failure
Clinical narrative: She was admitted due to acute on chronic hypoxemic and hypercapnic respiratory failure.  She was using noninvasive ventilation at night and as needed during the day when she was admitted.  She also had issues with recurrent left-sided pleural effusion that required recurrent thoracentesis.     Her hospitalization was characterized by recurrent and progressive hypercapnia in association with weakness that was generalized despite working with occupational and physical therapy.  She had a small bore chest tube placed by Interventional Radiology for her pleural effusion.  This did not provide significant improvement in her overall cardiopulmonary status.  She continued to have progressive hypercapnia despite noninvasive ventilation characterized by delirium.  Her family eventually decided to transition her from active care to comfort care with palliation.  She died on July 13, 2023 at 1955.
Age: 75.0
Sex: F
Vaccine: DTAP
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Pyrexia, Swollen tongue
Clinical narrative: Tongue Swelling, Fever, Redness around injection and swelling, dizziness
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm
Clinical narrative: Tumor
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Lymphadenopathy, Pyrexia, Rash
Clinical narrative: fever, rash, swollen groin lymph nodes
Age: 1.33
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Irritability, Pyrexia, Vaccination site erythema
Clinical narrative: Area of erythema 11x9cm developed over left thigh vaccination site; +associated fever and fussiness. Symptoms developed 48 hours after vaccination.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient developed redness around the site of injection. It was also warm to the touch
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood loss anaemia, Obstructive sleep apnoea syndrome
Clinical narrative: G47.33 ADULT OBSTRUCTIVE SLEEP APNEA 11/15/2022 ANEMIA DUE TO BLOOD LOSS
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome, Sinus bradycardia
Clinical narrative: G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 4/12/2023 SINUS BRADYCARDIA
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No side effects. No medical adverse event; Patient given an VARIVAX injection during Temperature Excursion.  No side effects.; On 01-AUG-2023, 1 day after onset of therapy the patient experienced product storage error.  On an unknown date the patient experienced no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to varicella virus vaccine live (Oka/Merck)(VARIVAX).     This spontaneous report was received from an office manager and refers to a 22-month-old. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 01-AUG-2023 the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneous injection, one time, lot #u025202, expiration date: 13-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided) in the left arm.  The administered dose of the vaccine experienced a temperature excursion on 27-JUL-2023. Temperature and time ranges not reported.  There was no adverse effect reported. No product quality complaint was involved
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: expired MMR II was administered. Patient does not report sigs/symptoms of adverse effects.; expired MMR II was administered. Patient does not report sigs/symptoms of adverse effects.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-AUG-2023 the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) subcutaneous injection, expiration date: 14-JUN-2023, administered for prophylaxis (strength, lot #, and route of administration were not provided). Patient did not report signs/symptoms of adverse effects.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Patient involved do not experiencing symptoms at this time; Medical Assistant calling to report administration of expired VARIVAX.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-AUG-2023, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, two doses series, lot #U022321, expiration date: 15-JUL-2023, administered for prophylaxis (strength, and route of administration were not provided). Patient involved did not experience symptoms at this time.
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No clinical symptoms and side effects. No additional AE/PQC; she received first dose of GARDASIL 9 series over a year ago approximately, and then received 3 additional doses for a total of 4 doses of GARDASIL 9; This spontaneous report was received from a Pharmacist and refers to a female patient of unknown age. Her medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date in 2022 (over a year ago approximately), 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 (anatomical location, strength, lot #, expiry date, and route of administration were not provided). Then, the patient received 3 additional doses for a total of 4 doses of suspect therapy (extra dose administered). No clinical symptoms and side effects. No additional adverse events.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No adverse effects were reported; MMR II was inadvertently administered to a patient today 8/23/2023, and it expired on 8/4/2023; This spontaneous report was received from a physician referring to a 34 year old patient. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 23-AUG-2023, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 milliliter, lot # U024229, expiration date: 04-AUG-2023 (strength, route, dose number, anatomical location and indication were not provided) for prophylaxis (expired product administered).  The healt care professional also asked about the need for revaccination.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: second dose 03SEP2014; This spontaneous report has been received from a physician via immunization record from a legal case in litigation (# 2307USA009419), concerning a 11-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were captured # 2307USA009419.  On 13-JAN-2004, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (manufacturer unknown) for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). On 03-SEP-2014, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (manufacturer unknown) (product administered to patient of inappropriate age).; Sender's Comments:  US-009507513-2307USA009419: US-009507513-2308USA008903:
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV
Symptoms: Hair growth abnormal
Clinical narrative: patient received PEDVAXHIB, PEDIARIX, and HAVRIX at the same time. / follo-up visit during the past 2 weeks the physician noticed a patch of hair had grown in the spot on the patients thigh where all these products had been administered; This spontaneous report was received from a physician referring to a female patient of unknown age. The patient's concurrent conditions, medical history or concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) for prophylaxis (lot#, expiry date, dose and route of administration were not provided), diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX) (lot#, expiry date, dose and route of administration were not provided) and hepatitis a vaccine inact (HAVRIX) at the same time.  On an unspecified date in August 2023 (reported as "past 2 weeks") during a follow up visit the physician noticed a patch of hair had grown in the spot on the patient's thigh (unknown if left or right thigh) where all three of these products had been administered (hair growth abnormal).  At the time of the reporting the outcome of the vent was unknown. The causal relationship between the event with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) or the suspect therapies was not provided.
Sex: M
Vaccine: RSV
Symptoms: Incorrect dose administered
Clinical narrative: Possible overdose; This non-serious case was reported by a consumer and described the occurrence of overdose in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number G9577) for prophylaxis.   Concurrent medical conditions included hypertension and blood cholesterol increased.   On 21-AUG-2023, the patient received Arexvy 1 ml. On 21-AUG-2023, an unknown time after receiving Arexvy, the patient experienced overdose (Verbatim: Possible overdose).  The outcome of the overdose was unknown.   Additional Information: GSK Receipt Date: 22-AUG-2023 The patient self-reported this case. The patient was receiving concomitant including Generic Ziac for hypertension and Generic Crestor for high cholesterol. The patient stated he received the vaccine at a local pharmacy. Their report indicates that he got a 1 ml dose, but GSK PI (package insert) shows that a standard dose was 0.5 ml. The patient asked if all this was correct, did he had something to worry about. The reporter gave permission to contact. The patient received vaccine dose more than recommended, which led to overdose.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: I tested positive for Covid-19 using an antigen self test at home; Saturday evening I did not feel well; This non-serious case was reported by a consumer and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-AUG-2023, the patient received the 2nd dose of Shingrix. On 19-AUG-2023, less than a day after receiving Shingrix, the patient experienced feeling unwell (Verbatim: Saturday evening I did not feel well). On 21-AUG-2023, the patient experienced covid-19 (Verbatim: I tested positive for Covid-19 using an antigen self test at home).The outcome of the feeling unwell was not reported and the outcome of the covid-19 was not resolved.   It was unknown if the reporter considered the feeling unwell and covid-19 to be related to Shingrix.   It was unknown if the company considered the feeling unwell and covid-19 to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-AUG-2023 The patient received a Shingrix vaccine more than two months after the first.  The patient felt completely normal during the test and for the 9 hours.  On Saturday evening, he/she did not feel well and symptoms worsened.  At the time of reporting, the patient tested positive for Covid-19 using an antigen self-test at home.  The reporter wanted to know if there was any chance the Shingrix vaccine caused a false positive on the Covid-19 antigen self-test.  The reporter also wanted to know if he/she was truly positive for Covid-19, this invalidated his/her Shingrix vaccination or he/she should schedule a third one.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Limb discomfort, Mobility decreased
Clinical narrative: Cannot breath out nose; Arm feels really bad; he felt so exhausted like he was going to drop, felt super run down and he does not want to get up; Can barely lift arm; patient did not feel well; This non-serious case was reported by a consumer via call center representative and described the occurrence of difficulty breathing in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included smoker (the patient quit smoking about 2 years ago). Previously administered products included Shingrix (the patient received the 1st dose of Shingrix at the same time as a Covid booster and a pneumonia shot (unknown products) from his pharmacy and had pretty bad feeling, for the tolerance of previous dose refer case - US2023113475), Covid vaccine and Pneumococcal vaccine. Concurrent medical conditions included chronic obstructive pulmonary disease (diagnosed about 8 years ago), prostatic disorder and allergy. Concomitant products included tamsulosin and tadalafil (Cialis).   On 21-AUG-2023, the patient received the 2nd dose of Shingrix (right arm). On 21-AUG-2023, less than a day after receiving Shingrix, the patient experienced difficulty breathing (Verbatim: Cannot breath out nose), arm discomfort (Verbatim: Arm feels really bad), exhaustion (Verbatim: he felt so exhausted like he was going to drop, felt super run down and he does not want to get up), mobility decreased (Verbatim: Can barely lift arm) and feeling unwell (Verbatim: patient did not feel well).  The outcome of the difficulty breathing, arm discomfort, exhaustion and mobility decreased were not resolved and the outcome of the feeling unwell was not reported.   It was unknown if the reporter considered the difficulty breathing, arm discomfort, exhaustion, mobility decreased and feeling unwell to be related to Shingrix.     It was unknown if the company considered the difficulty breathing, arm discomfort, exhaustion, mobility decreased and feeling unwell to be related to Shingrix.   Linked case(s) involving the same patient:  US2023113475   Additional Information: GSK Receipt Date: 21-AUG-2023 The patient received 2nd dose of Shingrix between 12 and 1 PM on 21-AUG-2023 and came home and had half a beer with his lunch then all of a sudden about 2:30-3 PM, the patient felt so exhausted like he was going to drop, felt super run down and he does not want to get up, his arm felt really bad like it was run over by a freight train and he could barely lift it, and he could not breathe out of his nose at all. The patient took a couple of Allergy Relief Pills, prostate medication Tamsulosin and Cialis after he got home from his 2nd Shingrix. The patient reported all the information about other medications. The reporter consented to follow up. The consent to follow up with healthcare professional was obtained, however patient did not feel well and had limited information to provide.; Sender's Comments:  US-GSK-US2023113475:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Did not mix both vials correctly, but instead administer saline solution alone; Did not mix both vials correctly, but instead administer saline solution alone; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication 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 inappropriate preparation of medication (Verbatim: Did not mix both vials correctly, but instead administer saline solution alone) and inappropriate dose of vaccine administered (Verbatim: Did not mix both vials correctly, but instead administer saline solution alone).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-AUG-2023 The reporter reported that the office nurse incorrectly administered the Shingrix vaccine to the patient which did not mix both vials correctly and administered saline solution alone Only saline solution of shingrix administered to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: has trigeminal neuralgia and received some relief from symptoms after her Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included trigeminal neuralgia.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced unexpected therapeutic effect (Verbatim: has trigeminal neuralgia and received some relief from symptoms after her Shingrix).The outcome of the unexpected therapeutic effect was unknown.   Additional Information: GSK Receipt Date: 23-AUG-2023 The case was reported by patient's husband. The patient had trigeminal neuralgia and received some relief from symptoms after her Shingrix shots.  The reporter wanted to know if she could have additional shots.
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Illness
Clinical narrative: She is still having a joint pain and feels sore; was really sick after taking that shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of soreness of joint in a 86-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Additional patient notes included has no health issues and takes no Rx drugs..   In AUG-2023, the patient received RSV vaccine. In AUG-2023, an unknown time after receiving RSV vaccine, the patient experienced soreness of joint (Verbatim: She is still having a joint pain and feels sore) and sickness (Verbatim: was really sick after taking that shot).  The outcome of the soreness of joint was not resolved and the outcome of the sickness was not reported.   It was unknown if the reporter considered the soreness of joint and sickness to be related to RSV vaccine.     It was unknown if the company considered the soreness of joint and sickness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 21-AUG-2023 The case was received from the patient via interactive digital media. The patient's friend reported that she took her RVS vaccine a week ago (Aug-2023) in pharmacy. The patient was still having a joint pain and felt it sore. The patient was really sick. The patient was not having any health issues and no Rx drugs. She was not in need of shot was not knowing about any side effects of vaccine. The pharmacy did not asked questions about her health. The follow-up would not required per process.