chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HEP, HEPA, HPV9, IPV, MMRV, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Client was seen walking near the front waiting area by the window post vaccination while this nurse was clerking and making next appointment.  Nurse heard a loud noise up at the front waiting area and rush to see what it was. Nurse saw client on floor; checked airway, breathing and pulse.  Client was found to be breathing and consiouse. Had her lay down and RN began assessing her.  Provided a popsicle and translated to client and parents.  Had her continue laying down and did another check at about 10:28am.  Her BP was 90/60 and was alert and oriented x4 to person, place, time and event. Denied any pain at this time as well as feeling lightheadedness, nauseated or confused. Asked parents when was the last time client had eaten, they stated around 9pm -10pm yesterday.  Client was responding correctly to questions asked by both nurses. Continued to reported no pain, did not look emotionally stress. At this time, this nurse felt the back of clients head and did not feel any bumps/lumps nor saw any blood. Again, asked client if there was any pain felt and client stated, "no." Assisted client onto a chair and had her sit there for a few minutes. Educated the parents and client on the importance of recognizing warning sings like light-headedness, pallor and nausea.  Instructed client to lay down at the first sign of dizziness to help prevent loss of consciousness; client verbalized understanding. Client was assessed once more by RN and then myself prior client leaving clinic.  Cient was PERRLA; alert and oriented x4.   Client denied to have any pain, dizziness, lightheadedness, confusion, nausea nor feeling sick.  Assisted client to stand up and instructed her to walk a few steps forward; observed normal gait.  Arm and leg movement is quick and has no issues following movement instructions such as raising one hand than the other or push off feet off my hand.  Clients speech is clear.  Again client was questioned if there was any pain specially on her head, to which she refused.  Instructed parents to seek emergency help if they saws client declined or had concerns.  Reviewed symptoms to look out for and seek immediate medical assistance; parents verbalized understanding.  Nurse walked with client to parents vehicle outside alongside her parents and saw client get into her seat and put her seat vet on and drive away.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pain
Clinical narrative: redness on upper half of arm, pain. patient took Tylenol and used cortisone cream and ice treatment. I recommended Benadryl as well.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event
Clinical narrative: Pt had Tetanus listed as an allergy in her chart. She asked for the Tdap vaccine. She was aware of Tetanus in the vaccine and agreed to receive Tdap in office. No reaction while in office.
Age: 0.5
Sex: M
Vaccine: COVID19-2
Symptoms: Consciousness fluctuating, Lethargy
Clinical narrative: per Mom, after the injection, 20 minutes later, he started to become lethargic and was in and out consciousness for about 20 minutes. The parents rushed him to the ER.
Age: 13.0
Sex: F
Vaccine: COVID19-2, HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 13-year old patient was given heplisav-b, which is licensed for adults only.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Rash, Skin irritation
Clinical narrative: On 07/25/2023, patient approached the table requesting a Pfizer Covid vaccine. The client said she had never received a COVID vaccine before because she was ?nervous? but wanted to get one today because the security job she was applying for required it. RN, asked the patient for her demographic information and reviewed the patient's immunization record in the Registry to confirm vaccine eligibility. The patient stated that she was allergic to ?pollen, dander, and dust.? The client reported having a history of depression, anxiety, and a benign tumor on her adrenal gland. The patient said she had medical insurance and a primary care provider. RN, vaccinated the patient with a Pfizer Bivalent vaccine lot# GM1767 exp 07/31/2023 in the left deltoid at 8:14am.  The patient completed a 15 minute observation period after vaccination per the CDC guidelines. RN educated the client about possible side effects of vaccination and when to seek medical care.  The patient denied symptoms of distress and walked away with a steady gait.  At 9:18am, the patient returned to the table stating, ?I got a rash on my arms all of a sudden but then the rash went away.? RN, assessed the client's forearms and saw that both forearms had flat red areas of irritation.  The patient said the redness RN observed was there prior to the vaccine and that the new rash she experienced had come and gone away immediately.  The client denied itching or redness in any other area. The patient was alert and oriented x 4.  At 9:20am, the patient gave consent to RN to check her vital signs. BP 160/90 left arm, BP 158/98 right arm, pulse 100 and regular, SpO2 98%, respirations 20 and unlabored. The patient's skin was warm, dry, and appropriate color for ethnicity.  The client denied having a headache or blurred vision. RN referred the client to the neighborhood healthcare clinic on site for her blood pressure.  The client said she wanted to take a nap but would go after her nap. The patient said she smoked 1/3 pack of cigarettes a day.  The patient stayed for observation until 9:30am.  The client said the rash she had seen had not come back.  No new rash was visible to RN.  Repeat vitals at 9:30am were BP 158/98, pulse 102, SpO2 98%, respirations 20. RN reminded the client again to go to her doctor to discuss her heart rate and blood pressure. At 9:37 am,  the patient walked away with a steady gait.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Obesity, Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA 3/10/2023 SEVERE OBESITY, BMI 45-49.9, ADULT
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Albumin globulin ratio decreased, Anaphylactic reaction, Angiogram cerebral normal, Anti-thyroid antibody negative, Areflexia
Clinical narrative: Pt received vaccine on 7/5/23. She began having rhinorrhea around 7/10 or 7/12 so parents started treating with cetirizine & benadryl. Had a headache and possibly vomiting around 7/9. She began having a circumoral rash around 7/15 or 7/18 and parents went to urgent care on 7/21, was prescribed bactrim for the rash, and had two doses that night and the morning of 7/22 at about 10 am. She began having a blotchy rash on the hands around 11 am so parents presented to the emergency department thinking there was a reaction to the bactrim. From the time they left their house, patient was able to walk with slightly ataxic gait, and upon presentation to nearby ER (within approx 15 minutes), patient was unable to walk at all. She continued to have rapid ascending paralysis up to the upper arms. In the ER patient did have vomiting with the hand rash and was treated for anaphylaxis (benadryl, intramuscular epinephrine). Admitted to PICU and received IVIG x2 doses and now on high dose steroids. Has also been on antibiotics since 7/22 - 7/25 at time of filling the form. Developed fevers 2 days after IVIG treatments and has thick secretions/congestion. Her neurologic exam from 7/22 - 7/25 has stayed stable (complete weakness of lower extremities without any movement, no reflexes of lower extremities or upper extremities, and poor coordination of upper arms but can flex biceps and very subtly lift arm off the bed).
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Arteriogram carotid normal, Ascending flaccid paralysis, Ataxia, Bacterial test positive, Blood albumin decreased
Clinical narrative: Pt received vaccine on 7/5/23. She began having rhinorrhea around 7/10 or 7/12 so parents started treating with cetirizine & benadryl. Had a headache and possibly vomiting around 7/9. She began having a circumoral rash around 7/15 or 7/18 and parents went to urgent care on 7/21, was prescribed bactrim for the rash, and had two doses that night and the morning of 7/22 at about 10 am. She began having a blotchy rash on the hands around 11 am so parents presented to the emergency department thinking there was a reaction to the bactrim. From the time they left their house, patient was able to walk with slightly ataxic gait, and upon presentation to nearby ER (within approx 15 minutes), patient was unable to walk at all. She continued to have rapid ascending paralysis up to the upper arms. In the ER patient did have vomiting with the hand rash and was treated for anaphylaxis (benadryl, intramuscular epinephrine). Admitted to PICU and received IVIG x2 doses and now on high dose steroids. Has also been on antibiotics since 7/22 - 7/25 at time of filling the form. Developed fevers 2 days after IVIG treatments and has thick secretions/congestion. Her neurologic exam from 7/22 - 7/25 has stayed stable (complete weakness of lower extremities without any movement, no reflexes of lower extremities or upper extremities, and poor coordination of upper arms but can flex biceps and very subtly lift arm off the bed).
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Blood alkaline phosphatase normal, Blood creatinine decreased, Blood culture negative, Blood glucose normal, Blood iron normal
Clinical narrative: Pt received vaccine on 7/5/23. She began having rhinorrhea around 7/10 or 7/12 so parents started treating with cetirizine & benadryl. Had a headache and possibly vomiting around 7/9. She began having a circumoral rash around 7/15 or 7/18 and parents went to urgent care on 7/21, was prescribed bactrim for the rash, and had two doses that night and the morning of 7/22 at about 10 am. She began having a blotchy rash on the hands around 11 am so parents presented to the emergency department thinking there was a reaction to the bactrim. From the time they left their house, patient was able to walk with slightly ataxic gait, and upon presentation to nearby ER (within approx 15 minutes), patient was unable to walk at all. She continued to have rapid ascending paralysis up to the upper arms. In the ER patient did have vomiting with the hand rash and was treated for anaphylaxis (benadryl, intramuscular epinephrine). Admitted to PICU and received IVIG x2 doses and now on high dose steroids. Has also been on antibiotics since 7/22 - 7/25 at time of filling the form. Developed fevers 2 days after IVIG treatments and has thick secretions/congestion. Her neurologic exam from 7/22 - 7/25 has stayed stable (complete weakness of lower extremities without any movement, no reflexes of lower extremities or upper extremities, and poor coordination of upper arms but can flex biceps and very subtly lift arm off the bed).
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Blood lactate dehydrogenase, Blood test abnormal, Blood urea nitrogen/creatinine ratio increased, Borrelia test negative, C-reactive protein normal
Clinical narrative: Pt received vaccine on 7/5/23. She began having rhinorrhea around 7/10 or 7/12 so parents started treating with cetirizine & benadryl. Had a headache and possibly vomiting around 7/9. She began having a circumoral rash around 7/15 or 7/18 and parents went to urgent care on 7/21, was prescribed bactrim for the rash, and had two doses that night and the morning of 7/22 at about 10 am. She began having a blotchy rash on the hands around 11 am so parents presented to the emergency department thinking there was a reaction to the bactrim. From the time they left their house, patient was able to walk with slightly ataxic gait, and upon presentation to nearby ER (within approx 15 minutes), patient was unable to walk at all. She continued to have rapid ascending paralysis up to the upper arms. In the ER patient did have vomiting with the hand rash and was treated for anaphylaxis (benadryl, intramuscular epinephrine). Admitted to PICU and received IVIG x2 doses and now on high dose steroids. Has also been on antibiotics since 7/22 - 7/25 at time of filling the form. Developed fevers 2 days after IVIG treatments and has thick secretions/congestion. Her neurologic exam from 7/22 - 7/25 has stayed stable (complete weakness of lower extremities without any movement, no reflexes of lower extremities or upper extremities, and poor coordination of upper arms but can flex biceps and very subtly lift arm off the bed).
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: CSF glucose increased, CSF protein normal, CSF white blood cell count negative, Cerebrospinal fluid retention, Ceruloplasmin
Clinical narrative: Pt received vaccine on 7/5/23. She began having rhinorrhea around 7/10 or 7/12 so parents started treating with cetirizine & benadryl. Had a headache and possibly vomiting around 7/9. She began having a circumoral rash around 7/15 or 7/18 and parents went to urgent care on 7/21, was prescribed bactrim for the rash, and had two doses that night and the morning of 7/22 at about 10 am. She began having a blotchy rash on the hands around 11 am so parents presented to the emergency department thinking there was a reaction to the bactrim. From the time they left their house, patient was able to walk with slightly ataxic gait, and upon presentation to nearby ER (within approx 15 minutes), patient was unable to walk at all. She continued to have rapid ascending paralysis up to the upper arms. In the ER patient did have vomiting with the hand rash and was treated for anaphylaxis (benadryl, intramuscular epinephrine). Admitted to PICU and received IVIG x2 doses and now on high dose steroids. Has also been on antibiotics since 7/22 - 7/25 at time of filling the form. Developed fevers 2 days after IVIG treatments and has thick secretions/congestion. Her neurologic exam from 7/22 - 7/25 has stayed stable (complete weakness of lower extremities without any movement, no reflexes of lower extremities or upper extremities, and poor coordination of upper arms but can flex biceps and very subtly lift arm off the bed).
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Computerised tomogram head normal, Computerised tomogram spine, Coordination abnormal, Full blood count abnormal, Gait inability
Clinical narrative: Pt received vaccine on 7/5/23. She began having rhinorrhea around 7/10 or 7/12 so parents started treating with cetirizine & benadryl. Had a headache and possibly vomiting around 7/9. She began having a circumoral rash around 7/15 or 7/18 and parents went to urgent care on 7/21, was prescribed bactrim for the rash, and had two doses that night and the morning of 7/22 at about 10 am. She began having a blotchy rash on the hands around 11 am so parents presented to the emergency department thinking there was a reaction to the bactrim. From the time they left their house, patient was able to walk with slightly ataxic gait, and upon presentation to nearby ER (within approx 15 minutes), patient was unable to walk at all. She continued to have rapid ascending paralysis up to the upper arms. In the ER patient did have vomiting with the hand rash and was treated for anaphylaxis (benadryl, intramuscular epinephrine). Admitted to PICU and received IVIG x2 doses and now on high dose steroids. Has also been on antibiotics since 7/22 - 7/25 at time of filling the form. Developed fevers 2 days after IVIG treatments and has thick secretions/congestion. Her neurologic exam from 7/22 - 7/25 has stayed stable (complete weakness of lower extremities without any movement, no reflexes of lower extremities or upper extremities, and poor coordination of upper arms but can flex biceps and very subtly lift arm off the bed).
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Globulins increased, Haemoglobin decreased, Headache, Hyperaemia, Immunoglobulin therapy
Clinical narrative: Pt received vaccine on 7/5/23. She began having rhinorrhea around 7/10 or 7/12 so parents started treating with cetirizine & benadryl. Had a headache and possibly vomiting around 7/9. She began having a circumoral rash around 7/15 or 7/18 and parents went to urgent care on 7/21, was prescribed bactrim for the rash, and had two doses that night and the morning of 7/22 at about 10 am. She began having a blotchy rash on the hands around 11 am so parents presented to the emergency department thinking there was a reaction to the bactrim. From the time they left their house, patient was able to walk with slightly ataxic gait, and upon presentation to nearby ER (within approx 15 minutes), patient was unable to walk at all. She continued to have rapid ascending paralysis up to the upper arms. In the ER patient did have vomiting with the hand rash and was treated for anaphylaxis (benadryl, intramuscular epinephrine). Admitted to PICU and received IVIG x2 doses and now on high dose steroids. Has also been on antibiotics since 7/22 - 7/25 at time of filling the form. Developed fevers 2 days after IVIG treatments and has thick secretions/congestion. Her neurologic exam from 7/22 - 7/25 has stayed stable (complete weakness of lower extremities without any movement, no reflexes of lower extremities or upper extremities, and poor coordination of upper arms but can flex biceps and very subtly lift arm off the bed).
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Infection, Inflammation, Intensive care, Laboratory test, Localised oedema
Clinical narrative: Pt received vaccine on 7/5/23. She began having rhinorrhea around 7/10 or 7/12 so parents started treating with cetirizine & benadryl. Had a headache and possibly vomiting around 7/9. She began having a circumoral rash around 7/15 or 7/18 and parents went to urgent care on 7/21, was prescribed bactrim for the rash, and had two doses that night and the morning of 7/22 at about 10 am. She began having a blotchy rash on the hands around 11 am so parents presented to the emergency department thinking there was a reaction to the bactrim. From the time they left their house, patient was able to walk with slightly ataxic gait, and upon presentation to nearby ER (within approx 15 minutes), patient was unable to walk at all. She continued to have rapid ascending paralysis up to the upper arms. In the ER patient did have vomiting with the hand rash and was treated for anaphylaxis (benadryl, intramuscular epinephrine). Admitted to PICU and received IVIG x2 doses and now on high dose steroids. Has also been on antibiotics since 7/22 - 7/25 at time of filling the form. Developed fevers 2 days after IVIG treatments and has thick secretions/congestion. Her neurologic exam from 7/22 - 7/25 has stayed stable (complete weakness of lower extremities without any movement, no reflexes of lower extremities or upper extremities, and poor coordination of upper arms but can flex biceps and very subtly lift arm off the bed).
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Magnetic resonance imaging head normal, Magnetic resonance imaging spinal abnormal, Metabolic function test abnormal, Mobility decreased, Movement disorder
Clinical narrative: Pt received vaccine on 7/5/23. She began having rhinorrhea around 7/10 or 7/12 so parents started treating with cetirizine & benadryl. Had a headache and possibly vomiting around 7/9. She began having a circumoral rash around 7/15 or 7/18 and parents went to urgent care on 7/21, was prescribed bactrim for the rash, and had two doses that night and the morning of 7/22 at about 10 am. She began having a blotchy rash on the hands around 11 am so parents presented to the emergency department thinking there was a reaction to the bactrim. From the time they left their house, patient was able to walk with slightly ataxic gait, and upon presentation to nearby ER (within approx 15 minutes), patient was unable to walk at all. She continued to have rapid ascending paralysis up to the upper arms. In the ER patient did have vomiting with the hand rash and was treated for anaphylaxis (benadryl, intramuscular epinephrine). Admitted to PICU and received IVIG x2 doses and now on high dose steroids. Has also been on antibiotics since 7/22 - 7/25 at time of filling the form. Developed fevers 2 days after IVIG treatments and has thick secretions/congestion. Her neurologic exam from 7/22 - 7/25 has stayed stable (complete weakness of lower extremities without any movement, no reflexes of lower extremities or upper extremities, and poor coordination of upper arms but can flex biceps and very subtly lift arm off the bed).
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Muscular weakness, Musculoskeletal disorder, Neurological examination abnormal, Perioral dermatitis, Plasma cell count
Clinical narrative: Pt received vaccine on 7/5/23. She began having rhinorrhea around 7/10 or 7/12 so parents started treating with cetirizine & benadryl. Had a headache and possibly vomiting around 7/9. She began having a circumoral rash around 7/15 or 7/18 and parents went to urgent care on 7/21, was prescribed bactrim for the rash, and had two doses that night and the morning of 7/22 at about 10 am. She began having a blotchy rash on the hands around 11 am so parents presented to the emergency department thinking there was a reaction to the bactrim. From the time they left their house, patient was able to walk with slightly ataxic gait, and upon presentation to nearby ER (within approx 15 minutes), patient was unable to walk at all. She continued to have rapid ascending paralysis up to the upper arms. In the ER patient did have vomiting with the hand rash and was treated for anaphylaxis (benadryl, intramuscular epinephrine). Admitted to PICU and received IVIG x2 doses and now on high dose steroids. Has also been on antibiotics since 7/22 - 7/25 at time of filling the form. Developed fevers 2 days after IVIG treatments and has thick secretions/congestion. Her neurologic exam from 7/22 - 7/25 has stayed stable (complete weakness of lower extremities without any movement, no reflexes of lower extremities or upper extremities, and poor coordination of upper arms but can flex biceps and very subtly lift arm off the bed).
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Procalcitonin, Pyrexia, Rash, Rash macular, Respiratory tract congestion
Clinical narrative: Pt received vaccine on 7/5/23. She began having rhinorrhea around 7/10 or 7/12 so parents started treating with cetirizine & benadryl. Had a headache and possibly vomiting around 7/9. She began having a circumoral rash around 7/15 or 7/18 and parents went to urgent care on 7/21, was prescribed bactrim for the rash, and had two doses that night and the morning of 7/22 at about 10 am. She began having a blotchy rash on the hands around 11 am so parents presented to the emergency department thinking there was a reaction to the bactrim. From the time they left their house, patient was able to walk with slightly ataxic gait, and upon presentation to nearby ER (within approx 15 minutes), patient was unable to walk at all. She continued to have rapid ascending paralysis up to the upper arms. In the ER patient did have vomiting with the hand rash and was treated for anaphylaxis (benadryl, intramuscular epinephrine). Admitted to PICU and received IVIG x2 doses and now on high dose steroids. Has also been on antibiotics since 7/22 - 7/25 at time of filling the form. Developed fevers 2 days after IVIG treatments and has thick secretions/congestion. Her neurologic exam from 7/22 - 7/25 has stayed stable (complete weakness of lower extremities without any movement, no reflexes of lower extremities or upper extremities, and poor coordination of upper arms but can flex biceps and very subtly lift arm off the bed).
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Rhinorrhoea, Scan with contrast abnormal, Secretion discharge, Serum ferritin normal, Urine analysis abnormal
Clinical narrative: Pt received vaccine on 7/5/23. She began having rhinorrhea around 7/10 or 7/12 so parents started treating with cetirizine & benadryl. Had a headache and possibly vomiting around 7/9. She began having a circumoral rash around 7/15 or 7/18 and parents went to urgent care on 7/21, was prescribed bactrim for the rash, and had two doses that night and the morning of 7/22 at about 10 am. She began having a blotchy rash on the hands around 11 am so parents presented to the emergency department thinking there was a reaction to the bactrim. From the time they left their house, patient was able to walk with slightly ataxic gait, and upon presentation to nearby ER (within approx 15 minutes), patient was unable to walk at all. She continued to have rapid ascending paralysis up to the upper arms. In the ER patient did have vomiting with the hand rash and was treated for anaphylaxis (benadryl, intramuscular epinephrine). Admitted to PICU and received IVIG x2 doses and now on high dose steroids. Has also been on antibiotics since 7/22 - 7/25 at time of filling the form. Developed fevers 2 days after IVIG treatments and has thick secretions/congestion. Her neurologic exam from 7/22 - 7/25 has stayed stable (complete weakness of lower extremities without any movement, no reflexes of lower extremities or upper extremities, and poor coordination of upper arms but can flex biceps and very subtly lift arm off the bed).
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Pt received vaccine on 7/5/23. She began having rhinorrhea around 7/10 or 7/12 so parents started treating with cetirizine & benadryl. Had a headache and possibly vomiting around 7/9. She began having a circumoral rash around 7/15 or 7/18 and parents went to urgent care on 7/21, was prescribed bactrim for the rash, and had two doses that night and the morning of 7/22 at about 10 am. She began having a blotchy rash on the hands around 11 am so parents presented to the emergency department thinking there was a reaction to the bactrim. From the time they left their house, patient was able to walk with slightly ataxic gait, and upon presentation to nearby ER (within approx 15 minutes), patient was unable to walk at all. She continued to have rapid ascending paralysis up to the upper arms. In the ER patient did have vomiting with the hand rash and was treated for anaphylaxis (benadryl, intramuscular epinephrine). Admitted to PICU and received IVIG x2 doses and now on high dose steroids. Has also been on antibiotics since 7/22 - 7/25 at time of filling the form. Developed fevers 2 days after IVIG treatments and has thick secretions/congestion. Her neurologic exam from 7/22 - 7/25 has stayed stable (complete weakness of lower extremities without any movement, no reflexes of lower extremities or upper extremities, and poor coordination of upper arms but can flex biceps and very subtly lift arm off the bed).
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given a vaccine on 7/24/23 that expired on 6/3/23.  No adverse reactions reported by parent. GSK was contacted and said that CDC recommends re-vaccination.  Patient's mom was contacted on 7/25/23 and she said that she and his dad will decide whether to revaccinate.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Cold sweat, Pallor, Urine analysis
Clinical narrative: Patient received Bexerso, dose #2 in office today.  Patient left exam room and walked to front desk.  Patient noticed her feet feeling clammy and she was having difficulty seeing when she told her mom and her sister she was having trouble standing.  Patient sat in chair in waiting room and LPN called for help.  Patient pulse was 60 and she was pale and clammy.  MD came to assess patient.  Dstick was obtained per order and was 88.  Patient was able to stand and pivot to wheelchair and was brought back to patient room.  Patient BP was 78/58 upon arriving to patient room.  Patient laid down on exam table with legs elevated and drank sips of of water and ate an ice pop. Patient noticeably less pale and verbally stating she feels much closer to her normal self.  Patient drank full cup of water and BP was 88/64.
Age: 32.0
Sex: F
Vaccine: UNK, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: a small patch of redness in the site of injection, no pain just warm feeling
Age: 32.0
Sex: F
Vaccine: UNK, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: a small patch of redness in the site of injection, no pain just warm feeling
Age: 32.0
Sex: F
Vaccine: UNK, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red raised bump in area where the injection was located. No itchiness unless I touch it. There's a slight warmth to touch.
Age: 32.0
Sex: F
Vaccine: UNK, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red raised bump in area where the injection was located. No itchiness unless I touch it. There's a slight warmth to touch.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: PT WAS GIVEN HIGHER DOSE . HE IS 19 YEARS OLD BUT RECEIVED 20+ DOSE.
Sex: F
Vaccine: MEN
Symptoms: Injury, Loss of personal independence in daily activities, Vaccination complication
Clinical narrative: within 2 days was hospitalized & has since had to take a medical leave to deal with her vax injuries; since had to take a medical leave to deal with her vax injuries; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination complication in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, 2 days after receiving Meningococcal B vaccine, the patient experienced vaccination complication (Verbatim: within 2 days was hospitalized & has since had to take a medical leave to deal with her vax injuries) (serious criteria hospitalization) and activities of daily living impaired (Verbatim: since had to take a medical leave to deal with her vax injuries). The outcome of the vaccination complication and activities of daily living impaired were not reported.   It was unknown if the reporter considered the vaccination complication and activities of daily living impaired to be related to Meningococcal B vaccine.   It was unknown if the company considered the vaccination complication and activities of daily living impaired to be related to Meningococcal B vaccine.   Additional Information: GSK Receipt Date: 18-JUL-2023 This case was reported by a patient's parent via interactive digital media. The patient received MenB vaccine. The patient needed it to form at her university and within 2 days was hospitalized and had since had to take a medical leave to deal with her vaccine injuries.  The reporter stated that he/she had been always been provac and nor more. The reporter further stated that not to take it.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Have took the flu shots and still got the flu 4 or 5 times/Suspected vaccination failure; Have took the flu shots and still got; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced vaccination failure (Verbatim: Have took the flu shots and still got the flu 4 or 5 times/Suspected vaccination failure) (serious criteria GSK medically significant) and influenza (Verbatim: Have took the flu shots and still got). The outcome of the vaccination failure was unknown and the outcome of the influenza was not reported.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu vaccine.     It was unknown if the company considered the vaccination failure and influenza to be related to Flu vaccine.   Linked case(s) involving the same patient:  US2023AMR089591   Additional Information: GSK Receipt Date: 20-JUN-2023 This case was reported by consumer via interactive digital media. The reporter reported that he or she received the flu shots, but still got the flu 4 or 5 times. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting. The case had been link to the case US2023AMR089591 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2023AMR089591:Same patient
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination faliure/ was vaccinated but still got the shingles; was vaccinated but still got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 67-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination faliure/ was vaccinated but still got the shingles) (serious criteria GSK medically significant) and shingles (Verbatim: was vaccinated but still got the shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-Jul-2023 The case was received from the patient via interactive digital media. The patient was vaccinated but still got the shingles. The patient stated that it seems like a lighter case. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I got the shots years ago and I now have shingles/Suspected Vaccination Failure; now have shingles; still hurts like heck; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got the shots years ago and I now have shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: now have shingles) and pain (Verbatim: still hurts like heck). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-JUL-2023 This case was reported by a patient via interactive digital media. The patient got the shingles shots years ago and he/she now had shingles. The reporter stated that it might be and it was not full force but it still hurt like heck. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had 2 shots and still break out/ Suspected vaccination faliure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had 2 shots and still break out/ Suspected vaccination faliure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 22-JUL-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received two doses of Shingles vaccine and still experienced break out. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: some body aches; Arm hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced general body pain (Verbatim: some body aches) and pain in arm (Verbatim: Arm hurt). The outcome of the general body pain and pain in arm were not reported.   It was unknown if the reporter considered the general body pain and pain in arm to be related to Shingles vaccine.  It was unknown if the company considered the general body pain and pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-JUL-2023 This case was reported by a patient via interactive digital media. The patient just received his/her shingles injection.  The patient's arm hurt a bit and some body aches but he/she would take that over the shingles pain. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Paraesthesia, Rash
Clinical narrative: Shingles; Rash; Severe pain; Tingling; Burning; Vomiting; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 3 months after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles), rash (Verbatim: Rash), pain (Verbatim: Severe pain), tingling (Verbatim: Tingling), burning sensation (Verbatim: Burning) and vomiting (Verbatim: Vomiting). The outcome of the shingles, rash, pain, tingling, burning sensation and vomiting were not reported.   It was unknown if the reporter considered the shingles, rash, pain, tingling, burning sensation and vomiting to be related to Shingles vaccine.     It was unknown if the company considered the shingles, rash, pain, tingling, burning sensation and vomiting to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-JUL-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and 3 months later experienced rash, severe pain, burning, tingling and his or her pain was so bad as he or she was vomiting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Shingles; Rash; Severe pain; Tingling; Burning; Vomiting; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 3 months after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles), rash (Verbatim: Rash), pain (Verbatim: Severe pain), tingling (Verbatim: Tingling), burning sensation (Verbatim: Burning) and vomiting (Verbatim: Vomiting). The outcome of the shingles, rash, pain, tingling, burning sensation and vomiting were not reported.   It was unknown if the reporter considered the shingles, rash, pain, tingling, burning sensation and vomiting to be related to Shingles vaccine.     It was unknown if the company considered the shingles, rash, pain, tingling, burning sensation and vomiting to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-JUL-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and 3 months later experienced rash, severe pain, burning, tingling and his or her pain was so bad as he or she was vomiting. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Dtap vaccine +  mild reaction (rash).; This non-serious case was reported by a physician via call center representative and described the occurrence of rash in a 73-year-old female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced rash (Verbatim: Dtap vaccine +  mild reaction (rash).). The outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Tdap Vaccine.     It was unknown if the company considered the rash to be related to Tdap Vaccine.   Additional Information: GSK receipt date 18 Jul 2023: The patient needs Boostrix. The patient was administered TDaP in 2007 and had a mild reaction (rash).   The reporter would like to know whether or not it would be safe to administer Boostrix to her. The reporter consented to follow up.
Age: 30.0
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Unapproved Age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 30-year-old female patient who received Men B NVS (Bexsero) (batch number 5YP3L, expiry date 18-OCT-2023) for prophylaxis.   On 18-JUL-2023, the patient received Bexsero. On 18-JUL-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Unapproved Age). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-JUL-2023 The reporter stated that local state requirements indicate that adults aged 30 and under should receive meningococcal B vaccination for entering higher education facilities. The reporter reported that clinic administered a dose of Bexsero to the reporting day, to a 30-year-old patient. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up. The reporter reported that the 30 years old patient administered Bexsero vaccine, which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: Expired Rotarix (lyo) was administered to patient on 14JUL2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a male patient who received Rota (Rotarix lyophilized formulation) (batch number G973H, expiry date 01-JUL-2023) for prophylaxis.   On 14-JUL-2023, the patient received Rotarix lyophilized formulation. On 14-JUL-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced expired vaccine used (Verbatim: Expired Rotarix (lyo) was administered to patient on 14JUL2023). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 18 Jul 2023: The HCP reported that Expired Rotarix (lyo) was administered to patient which led to expired vaccine used. The reporter consented to follow up.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired dose of boostrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 28-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number HF2YA, expiry date 15-JUL-2023) for prophylaxis.   On 18-JUL-2023, the patient received Boostrix. On 18-JUL-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Expired dose of boostrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 18-JUL-2023 A nurse reported that she administered an expired dose of Boostrix to a patient on 18 July 2023, which led to expired vaccine used.  At the time of reporting, repeat dose had not been administered.  The vaccine administration facility was the same as primary reporter The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Longer than recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 49-year-old female patient who received HAB (Twinrix) (batch number X239D, expiry date 22-SEP-2023) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 30th September 2022, batch number: X239d, expiry date 22 September 2023).   On 31-MAR-2023, the patient received the 2nd dose of Twinrix. On 31-MAR-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Longer than recommended interval). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 19 Jul 2023 The pharmacist called in to report that a patient was looking to receive the 3rd dose of Twinrix but there was a 6 month period between dose 1 and 2. They provided information about event, vaccine and patient.  Follow-up was accepted. The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter. The patient looking to receive the 3rd dose of Twinrix but there was a 6 month period between dose 1 and 2, which led to drug dose administration interval too long.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Longer than Recommended Interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Longer than Recommended Interval). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 19-JUL-2023 The patient received a dose of Engerix B later than the recommended interval, which led to lengthening of the vaccine schedule. The reporter consented to follow up.