chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain and soreness an inch below the injection site. Worse pain than typical for patient with vaccines. Two days after injection, redness developed in the area of pain and soreness. Pain lasted about a week. Redness lasted about 3 days.
Age: 46.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong patient received product
Clinical narrative: MA had another MA verify that the MA was giving the right Imms and we went through all of out steps to make sure that the IMMS that were ordered were correct and that everything was good to go. MA went into the wrong room and gave the IMMS to this pt, which Shingrix was not ordered for this person. MA did speak with her Doctor and he did call the pt and let him know what had happened. Extra training was provided and was told to always ask name and dob before doing anything to a pt.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram normal, Electrocardiogram ambulatory normal, Heart rate increased, Hypotension, Palpitations
Clinical narrative: Hypotension with Tachycardia:  HR 58 bpm today.  Orthostatic VS essentially positive today with sitting BP 100/58 and standing BP 88/58 off midodrine this morning.  At home, low BP and fast HR.  + palpitations since Covid 12/2022, she had her 2nd Moderna Covid vaccination at Pharmacy 2 months prior to Covid infection.  Works as an EMT and pharmacy tech.  Negative OSA test.  Holter and Echo 2/2024 normal.  On diltiazem and midodrine.  Overall fair controlled.      -I suspect this is POTS due to negative work up with worsening vasomotor sx.      -Educated pt on increasing fluids and salt      -Continue Liquid IV, salt chews      -Will try metoprolol 25 mg BID PRN for HR persistently >100 bpm in place of the diltiazem       -Continue midodrine 10 mg TID PRN for low BP.  I advised pt to monitor her BP at home as she increases her salt and fluid intake as this may allow us to use a lower dose of the midodrine and we want to avoid the hypertensive effect of midodrine.  Pt aware of not taking midodrine past 6 pm in order to avoid supine HTN.       -An excuse for work was given to patient today       -As her sx started after COVID infection s/p initial 2 step COVID-19 Moderna vaccination, I suspect this could be an adverse effect of vaccination with infection shortly afterwards which has been noted in a study in     Due to complex issues I spent at least 34 minutes on this visit, including but not limited to face-to-face counseling, review of prior OV notes, review of prior testing and labs, charting and coordination of care.      Return in about 3 months (around 9/11/2024).   Patient was advised to call with any questions or concerns. If symptoms worsen patient was advised to follow up in our office or the Emergency Dept. Benefits, risks, contraindications, and complications of recommended treatments were explained the patient understands and agrees to proceed with plan.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Postural orthostatic tachycardia syndrome, Sleep study normal, Tachycardia
Clinical narrative: Hypotension with Tachycardia:  HR 58 bpm today.  Orthostatic VS essentially positive today with sitting BP 100/58 and standing BP 88/58 off midodrine this morning.  At home, low BP and fast HR.  + palpitations since Covid 12/2022, she had her 2nd Moderna Covid vaccination at Pharmacy 2 months prior to Covid infection.  Works as an EMT and pharmacy tech.  Negative OSA test.  Holter and Echo 2/2024 normal.  On diltiazem and midodrine.  Overall fair controlled.      -I suspect this is POTS due to negative work up with worsening vasomotor sx.      -Educated pt on increasing fluids and salt      -Continue Liquid IV, salt chews      -Will try metoprolol 25 mg BID PRN for HR persistently >100 bpm in place of the diltiazem       -Continue midodrine 10 mg TID PRN for low BP.  I advised pt to monitor her BP at home as she increases her salt and fluid intake as this may allow us to use a lower dose of the midodrine and we want to avoid the hypertensive effect of midodrine.  Pt aware of not taking midodrine past 6 pm in order to avoid supine HTN.       -An excuse for work was given to patient today       -As her sx started after COVID infection s/p initial 2 step COVID-19 Moderna vaccination, I suspect this could be an adverse effect of vaccination with infection shortly afterwards which has been noted in a study in     Due to complex issues I spent at least 34 minutes on this visit, including but not limited to face-to-face counseling, review of prior OV notes, review of prior testing and labs, charting and coordination of care.      Return in about 3 months (around 9/11/2024).   Patient was advised to call with any questions or concerns. If symptoms worsen patient was advised to follow up in our office or the Emergency Dept. Benefits, risks, contraindications, and complications of recommended treatments were explained the patient understands and agrees to proceed with plan.
Age: 13.0
Sex: M
Vaccine: HEP, MMR, MNQ, TDAP, VARCEL
Symptoms: Anxiety, Dizziness, Immediate post-injection reaction, Loss of consciousness, Nausea
Clinical narrative: Patient was extremely anxious and had to be reminded to breathe throughout vaccine administration. After vaccines were administered, he briefly lost consciousness (less than 10 seconds)  and while he was being reclined in the exam chair, with legs elevated, he regained consciousness and was alert and orientated. A cold compress was applied to his neck and a fan utilized for comfort. He was able to answer questions. He stated he became light-headed and nauseated during the vaccine administration. He was able to consume juice and crackers without issue. Patient was observed for over 30 minutes. BP and pulse within normal limits. He denied light-headedness, nausea or any other symptoms. He was escorted to check out with his parents and he was able to ambulate independently. He voiced no complaints and was utilizing his phone.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Pt woke up the morning after with hives that covered his abdomen and complaining of chest muscle pain.  Mom gave oral and topical Benadryl and Tylenol. Symptoms slowly went away and by the 2nd morning he had no symptoms.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Apathy, Asthenia, Decreased appetite, Diarrhoea
Clinical narrative: On April 17, 2021 I lost my appetite!  By the time I got to City (this is where I go every 3 months for cancer scans), around the first of May I had lost 53 pounds.  My gut has pain all day, the pain is like a headache in my gut.  When I force food gut pain turns into a migraine.  Sometimes so bad I have to lay down in fetal position for 30 min to get it to ease up. No vomiting till 2 weeks ago.  I have diarrhea more often than not.  No energy, no motivation and really feel bad all the time!
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gastrointestinal tube insertion, Laboratory test, Migraine, Scan
Clinical narrative: On April 17, 2021 I lost my appetite!  By the time I got to City (this is where I go every 3 months for cancer scans), around the first of May I had lost 53 pounds.  My gut has pain all day, the pain is like a headache in my gut.  When I force food gut pain turns into a migraine.  Sometimes so bad I have to lay down in fetal position for 30 min to get it to ease up. No vomiting till 2 weeks ago.  I have diarrhea more often than not.  No energy, no motivation and really feel bad all the time!
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: On April 17, 2021 I lost my appetite!  By the time I got to City (this is where I go every 3 months for cancer scans), around the first of May I had lost 53 pounds.  My gut has pain all day, the pain is like a headache in my gut.  When I force food gut pain turns into a migraine.  Sometimes so bad I have to lay down in fetal position for 30 min to get it to ease up. No vomiting till 2 weeks ago.  I have diarrhea more often than not.  No energy, no motivation and really feel bad all the time!
Age: 7.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: MMRV was given instead of Varicella
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: na
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Felt dizzy 1 hour after vaccine was given. Fever began about 2 hours after vaccine given at a temperature of 100.  Highest temperature of 101.4. Redness around injection site and pain that spread to opposite side. Vaccine given 6/10, still experiencing symptoms today (6/13). Redness and pain still present. As of 6/13 no more fever.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Hyperhidrosis, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: The donor advised that after she had gotten home, she began experiencing itching, rash, swelling, aching around the injection site and general feverish, sweaty and fatigue.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: The donor advised that after she had gotten home, she began experiencing itching, rash, swelling, aching around the injection site and general feverish, sweaty and fatigue.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Antinuclear antibody, C-reactive protein, Full blood count, Limb mass, Magnetic resonance imaging joint
Clinical narrative: Patient received Bexsero #1 on her well checkup . Mother returned to clinic on 06/10/2024 stating patient experienced left arm pain after vaccination and then later developed a bump and decrease ROM .
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Mobility decreased, Pain in extremity, Red blood cell sedimentation rate
Clinical narrative: Patient received Bexsero #1 on her well checkup . Mother returned to clinic on 06/10/2024 stating patient experienced left arm pain after vaccination and then later developed a bump and decrease ROM .
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Patient received DTAP instead of TDAP dose.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Pt. was given first inj. in left arm, tolerated well. Pt. was given second inj, in right arm. Pt. was talking did fine after one to two minutes started to lay back on exam table. I asked if pt. was OK, her eyes were open, but pt. did not respond. Pt. had bilateral leg, arm, hand shaking/contorting. Yelled for front desk to get provider, grabbed vitals machine, started to obtain vitals. LPN entered room with NP. Elevated pt.'s feet, put cool rag on forehead. PCP entered the room, started assessing pt. stepped out of room, pt. was fully alert and oriented. PCP asked to monitor pt. every 5 minutes for 15 minutes. After first five minutes, came in for ten minute vitals, pt. was still alert, and PCP was doing head to toe assessment. Obtained another set of vitals after five minutes, pt. was cleared to leave with mother, per PCP. No medications given.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Headache, Loss of consciousness, Posture abnormal, Syncope
Clinical narrative: pt was administered boostrix first on left arm, and varivax on right arm at 9:40am.  around 9:45am, pt experienced syncope. pt slumped down from standing to sitting position.  Pt had normal breathing but blacked out of about 1 minute.  Pt did not have any injuries, and did not hit his head.  I had pt lying down supine on a sheet on the floor for about 10 minutes.  Pt said he was feeling fine, but had a mild headache.  Pt was able to stand up and then sit down.  Pt's mother and I were there the whole time to monitor the pt.  After sitting down for 5 minutes, pt was feeling fine.  Pt was given bottle water and drank about 3/4 of it.  Pt looked fine with no injuries.  I had pt and pt mom stay in the vicinity for 15 more minutes just in case, and pt was feeling fine.  Pt went home with pt mother.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose normal, Vomiting
Clinical narrative: Patient was given 11-year vaccinations which included Boostrix, Gardasil, and Menveo. The patient was then asked to wait 15 minutes after administration to leave. At the 10-minute mark the patient's parent comes out to let us know that the patient was vomiting. Vital signs and blood sugar was obtained at this time. Patient stated that he did eat breakfast. All vital signs and sugar were within normal range.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient fainted shortly after receiving HPV vaccine.
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Erythema, swelling  x 2-3 days with persistent itching and erythematous patch at site of infection on day 6 although swelling now decreased with cold compresses
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Pt experienced red, raised itchy bumps down entire left forearm. She claimed the rash was persisting for over 2 weeks since date of vaccination (Date of shot:5/29/24, she presented to the pharmacy on 6/13/24). She claimed she had been using Calamine lotion to treat the bumps. I recommended she use PO Benadryl 25mg capsules QD for now until she could follow up with a PCP, especially since her occupation is a Nanny and would be in contact with an 8-month old infant.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Bradycardia, Syncope
Clinical narrative: Patient experienced syncope shortly after vaccination administration, experied vasovagal syncope x2 with bradycardia
Age: 0.5
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine expired on 06/08/2024, given after expiration date.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling cold, Headache, Impaired work ability, Pyrexia, Sleep disorder
Clinical narrative: From around 8:00pm Tuesday, a headache started building. I became cold with a mild fever overnight and the headache grew worse. I didn't sleep much. Around 6:30am Wednesday, I vomited about 5 times. I still had a headache and was cold. At 9:00, I wanted to brush my teeth, but vomited in the sink 4-5 times. I ate only soup Wednesday, at night. Tylenol seemed to help the headache some. I felt a little headache Wednesday night and wanted to go to work today, but woke up with an intensified headache. I took 2 Tylenol around 7am and felt better by noon, but now I am wiped out.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: From around 8:00pm Tuesday, a headache started building. I became cold with a mild fever overnight and the headache grew worse. I didn't sleep much. Around 6:30am Wednesday, I vomited about 5 times. I still had a headache and was cold. At 9:00, I wanted to brush my teeth, but vomited in the sink 4-5 times. I ate only soup Wednesday, at night. Tylenol seemed to help the headache some. I felt a little headache Wednesday night and wanted to go to work today, but woke up with an intensified headache. I took 2 Tylenol around 7am and felt better by noon, but now I am wiped out.
Age: 49.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: There has been no adverse reaction to the administration of this vaccine.  The Pt wanted an MMR & Varicella vaccination.  This nurse merely attempted to be efficient and give one vaccination versus two.  There is nothing showing any contraindications against this vaccine versus two separate  vaccinations of MMR & Varicella.  A fellow nurse sought information online and discovered ProQuad is recommended for 12 and under.  There was nothing printed on the packaging to indicate this prior to administration, ergo no way for this nurse to know that.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Nausea, Paraesthesia, Pharyngeal paraesthesia
Clinical narrative: Patient disclosed symptoms within 10min of vaccine administration. Symptoms described as light headedness/dizziness leading to a pounding headache that remained constant, nausea lasting approx. 25min., face/throat tingling denies any respiratory complications lasting approx. 20min., emesis approx. <2mL of pure phlegm. Initial vitals B/P 151/98 98pulse done at 12:23pm, upon release vitals B/P 132/78  86 pulse at 1:30pm. Donor did rest in office under my supervision for >30min, symptoms resolved with the exception of the pounding headache sent patient home with daughter, educated on importance of seeking medical attention if symptoms return or worsen, educated on importance of hydration status post nausea episode. Voiced Understanding.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Patient disclosed symptoms within 10min of vaccine administration. Symptoms described as light headedness/dizziness leading to a pounding headache that remained constant, nausea lasting approx. 25min., face/throat tingling denies any respiratory complications lasting approx. 20min., emesis approx. <2mL of pure phlegm. Initial vitals B/P 151/98 98pulse done at 12:23pm, upon release vitals B/P 132/78  86 pulse at 1:30pm. Donor did rest in office under my supervision for >30min, symptoms resolved with the exception of the pounding headache sent patient home with daughter, educated on importance of seeking medical attention if symptoms return or worsen, educated on importance of hydration status post nausea episode. Voiced Understanding.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient is still having arm pain
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: Pt received third dose of Bexsero. A second dose of Bexsero was administered at an outside facility and was not updated in the EHR.
Age: 44.0
Sex: M
Vaccine: DTAP
Symptoms: Pain in jaw
Clinical narrative: Extreme jaw pain left side. I went to the dentist and he found nothing that would be causing me pain to my jaw muscles.
Age: 10.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HPV9
Symptoms: Feeling hot, Headache, Pain, Pyrexia
Clinical narrative: He is very hot with a high fever. He has a very bad headache and just lays down. He has pain in his whole body.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: I was asked if we had covid vaccine available to give to this child I had pediatric covid vaccine for ages 12 and up.  When verifying her age  i miss calculated by 3 months and she was technically 11yrs and 9 months old when Vaccine was given.  The patient has not had any adverse reaction or event at this time. The error was caught when vaccine documentation was taking place.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Nausea
Clinical narrative: patient said that she has been nauseous
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Insomnia, Irritability, Rash, Rash vesicular
Clinical narrative: MOM REPORTS THAT CHILD WAS FUSSY AND DID NOT WANT TO SLEEP THE NIGHT BEFORE AND WHEN CHILD WOKE UP THE NEXT MORNING A RASH WAS AROUND LEFT EYE AND THEN SPREAD ACROSS FACE, EARS AND WAS ALSO ON TRUNK AREA.  MOM ALSO REPORTS THAT THE RASH ALSO APPEARS SLIGHTLY BLISTERY AT TIMES.
Sex: U
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 24.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: This specific Menveo dose has a MenA Lyophilized Conjugate Component which was not administered with the vaccine. Patient has been called and informed. Going to consult with the provider on next steps
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pediarix (DTaP-HepB-IPV) ordered by MD. Kinrix (DTaP-IPV) inadvertently administered instead to patient. Mother notified of vaccine administered. Infant has been doing well following vaccination with no reported new issues.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient was advised to sit and wait by NP and RN but patient stated she was fine and was okay leave clinic. Patient went to front desk for checkout and had vaso vagal episode with syncope. NP and RN supervised patient who was moved to room, BP monitored, snack/juice provided, and patient recovered within 5-10 minutes. Patient told NP after recovery that she did not eat anything for lunch.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: in error patient given 2 doses of DTaP and IPV.  developed left leg pain .  no swelling at injection site
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Headache, Heart rate increased, Laboratory test
Clinical narrative: Bad headaches for several months. Primary problem was that I developed afib. I have always been in great shape, and my resting heart rate would normally be at about 60. Over the fall months, my heart rate continued to increase until January of '22, when I was having resting heart rates of 120, with spikes up to 180.
Age: 52.0
Sex: F
Vaccine: FLU4, HEP, TDAP
Symptoms: Pulse absent, Respiratory arrest, Unresponsive to stimuli
Clinical narrative: Patient was given flu vaccine at 9:43 AM. Other nurse administered other vaccines (Tdap, Hep B) afterwards. Patient was found unresponsive with no chest movements or pulse in restroom at 2:45 PM. EMS called.
Age: 52.0
Sex: F
Vaccine: FLU4, HEP, TDAP
Symptoms: Death, Prone position, Pulse absent, Respiratory arrest, Resuscitation
Clinical narrative: Patient was given flu vaccine at 9:43 AM. Other nurse administered other vaccines (Tdap, Hep B) afterwards. Patient was found unresponsive with no chest movements or pulse in restroom at 2:45 PM. EMS called.
Age: 52.0
Sex: F
Vaccine: FLU4, HEP, TDAP
Symptoms: Pulse absent, Respiratory arrest, Unresponsive to stimuli
Clinical narrative: Patient received Tdap and Hep B at 11:28am on 06/13/24 with no sign or symptoms of any reaction to vaccine.  Patient was ambulatory and alert.   Patient was later reported laying prone on floor in clinic restroom.  Upon arrival no pulse, no chest movement  was detected and CPR was started.  EMS was called and shortly after their arrival the patient was pronounced deceased.  Police arrived took over care until Medical Examiner arrived to remove patient body from clinic.
Age: 52.0
Sex: F
Vaccine: FLU4, HEP, TDAP
Symptoms: Death, Prone position, Pulse absent, Respiratory arrest, Resuscitation
Clinical narrative: Patient received Tdap and Hep B at 11:28am on 06/13/24 with no sign or symptoms of any reaction to vaccine.  Patient was ambulatory and alert.   Patient was later reported laying prone on floor in clinic restroom.  Upon arrival no pulse, no chest movement  was detected and CPR was started.  EMS was called and shortly after their arrival the patient was pronounced deceased.  Police arrived took over care until Medical Examiner arrived to remove patient body from clinic.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Contusion, Dizziness, Fall, Lip injury, Skin abrasion
Clinical narrative: At approximately 10:15 pt had syncopal episode about 5-10 minutes after receiving HPV vaccine. Pt was out in the lobby with MOC and MOC was paying for visit. Pts syncopal episode and fall was unwitnessed. RN was alerted by clerical staff member when the staff member and MOC heard pt land on the ground. Clerical staff yelled for this RN and  NP. Pt was found face first on ground. RN and NP assessed pt and saw no emergent needs. Pt was able to roll over unassisted. Pt had minor swelling, bruising, and  slight abrasions to the left side oh his face as well as a laceration on the inside of his lip. Pt said he remembered the fall. MOC was unsure if pt lost consciousness, pt did not think he did. Pt was still feeling dizzy and was given Gatorade and cookies while remaining of the floor in a self supported sitting position. At 10:20 pts BP was 80/50. At this point pt felt he could walk, and was accompanied by this RN and MOC to exam room where pt laid on table and continued to drink Gatorade. At 10:30 pts BP was 100/63, HR 75, and O2 96. Pt was no longer feeling dizzy and was able to walk without assistance. Pt was instructed on what to do if he ever felt dizzy again, and to alert all future medical provides that he had a syncopal episode after a vaccination.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Swelling face, Syncope
Clinical narrative: At approximately 10:15 pt had syncopal episode about 5-10 minutes after receiving HPV vaccine. Pt was out in the lobby with MOC and MOC was paying for visit. Pts syncopal episode and fall was unwitnessed. RN was alerted by clerical staff member when the staff member and MOC heard pt land on the ground. Clerical staff yelled for this RN and  NP. Pt was found face first on ground. RN and NP assessed pt and saw no emergent needs. Pt was able to roll over unassisted. Pt had minor swelling, bruising, and  slight abrasions to the left side oh his face as well as a laceration on the inside of his lip. Pt said he remembered the fall. MOC was unsure if pt lost consciousness, pt did not think he did. Pt was still feeling dizzy and was given Gatorade and cookies while remaining of the floor in a self supported sitting position. At 10:20 pts BP was 80/50. At this point pt felt he could walk, and was accompanied by this RN and MOC to exam room where pt laid on table and continued to drink Gatorade. At 10:30 pts BP was 100/63, HR 75, and O2 96. Pt was no longer feeling dizzy and was able to walk without assistance. Pt was instructed on what to do if he ever felt dizzy again, and to alert all future medical provides that he had a syncopal episode after a vaccination.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Nurse reported patient was accidently administered an expired dose of MMR II on May 31, 2024.; This spontaneous report was received from a nurse, referring to a 1-year-old male patient.  The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On 31-MAY-2024, the patient was accidently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection, lot #W035197, expiration date: 24-MAY-2024, administered for prophylaxis by health professional (strength, dose, and route of administration were not provided) (expired product administered). No additional adverse event (AE) was reported (no adverse event).
Age: 11.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse side effects were reported.; HCP called to report that MMR II was administered on 6/10/2024 after the expiration date of 6/3/2024.; This spontaneous report was received from a medical assistant and referred to an 11-year-old patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 10-JUN-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHA) injection, lot #X005838, expiration date: 03-JUN-2024, administered for prophylaxis (strength, exact dose, anatomical location and route of administration were not provided) (Expired product administered). Product was supported by post expiry memo. Consent to contact was yes. No adverse side effects were reported. No additional information available at this time. No additional adverse even (AE) (No adverse event).
Sex: U
Vaccine: RV5, UNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AEs were reported; Nurse reported that a patient received the third dose of VAXELIS and ROTATEQ earlier than recommended.  The patient received first doses of both vaccines on 2/1/2024 VAXELIS (u7776aa) ROTATEQ (x010219), second doses on 3/22/2024 VAXELIS (u7767ba) ROT; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 01-FEB-2024, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot number x010219, expiration date 14-DEC-2024, oral (dose not reported) and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid(VAXELIS) lot number u7776aa (dose, route of administration and expiration date not reported). On 22-MAR-2024, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot number x021032, expiration date 09-MAR-2025, oral (dose not reported) and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid(VAXELIS) lot number u7767ba (dose, route of administration and expiration date not reported), and on 09-APR-2024, the patient received the third dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot number x023405, expiration date 26-JUN-2025, oral (dose not reported) and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid(VAXELIS) lot number u7801aa (dose, route of administration and expiration date not reported) all doses for prophylaxis (inappropriate schedule of product administration). No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse called and reported vaccine with temperature excursion had been administered.  Nurse granted permission to follow up.  No additional AE/no PQC.            ?    Names of vaccines involved (including lot/exp): PROQUAD LOT: X022919 Initial Expi; This spontaneous report was received from licensed practice nurse 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 an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) subcutaneous injection, administered for prophylaxis (lot #X022919 has been verified to be valid, expiry date reported and established as 12-MAR-2025) (strength, dose, anatomical location, and route of administration were not provided). The administered dose of the vaccine was stored at a temperature of 6 up to 14 /9.5 degrees Fahrenheit (F), during a time frame of 9 minutes. There was a previous temperature excursion reported as: 47 F for 4 hours.  There was no adverse effect reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse called and reported vaccine with temperature excursion had been administered on 06/05/2024.  No side effects or symptoms reported.   Nurse granted permission to follow up.  No additional AE/no PQC.            ?    Names of vaccines involved; This spontaneous report was received from nurse and refers to a patient of unknonw age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-JUN-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, unk, lot #X022919, expiration date: 12-MAR-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion in 6 degree Farenheit up to 14 degree Farenheit (9.5 degree Farenheit) for 9 minutes (Product storage error)). This vaccine underwent previous excursion in 47 degree Farenheit to 77 degree Farenheit (66 degree Farenheit) for 4 hours. No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pyrexia, Vaccination failure
Clinical narrative: Suspected vaccination failure / been vaccinated but think I got it anyway; Been vaccinated but think I got it anyway. Under breasts.; Fever; Blisters; 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.   The patient's past medical history included chickenpox (Had chickenpox severely at 12 years).   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 failure / been vaccinated but think I got it anyway) (serious criteria GSK medically significant), shingles (Verbatim: Been vaccinated but think I got it anyway. Under breasts.), fever (Verbatim: Fever) and blister (Verbatim: Blisters). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the fever and blister were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, fever and blister to be related to Shingles vaccine.   The company considered the vaccination failure to be related to Shingles vaccine. It was unknown if the company considered the shingles, fever and blister to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-JUN-2024 This case was reported by a patient via interactive digital media. The patient had been vaccinated but thought he/she got them anyway, under breasts.  No documents. Used alcohol to clear it up but never really went away. The patient got fever and blisters. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingles vaccine.
Age: 68.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Previous adult dose was administered; pedictric dose was administered; This non-serious case was reported by a pharmacist via patient support programs and described the occurrence of adult use of a child product in a 68-year-old male patient who received HBV (Engerix B pediatric) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B).   On 11-JAN-2024, the patient received the 2nd dose of Engerix B pediatric. On 11-JAN-2024, an unknown time after receiving Engerix B pediatric and ENGERIX B, the patient experienced adult use of a child product (Verbatim: Previous adult dose was administered) and underdose (Verbatim: pedictric dose was administered). The outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt Date: 05-JUN-2024 Pharmacy called to inquire of what dosage to provide patient with after injecting the patient with an adult dose in December 2023 and current dosage (pediatric) was given in January of 2024 which led to adult use of a child product and underdose. Pharmacy was inquiring of the proper dosage to administer to patient after administering two previous doses.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Loss of personal independence in daily activities, Pain in extremity, Rash erythematous
Clinical narrative: might be shingles; soreness of injected arm; itchy red spots; she has blisters on her left arm that are itchy; rash on left arm/on her wrist she has itchy red spots/rash; She can't wear a watch or a bracelet; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chicken pox as a child). Previously administered products included Influenza vaccine with an associated reaction of illness (received on an unknown date). Family history included shingles (Family history of shingles- (Two sisters got shingles, one recently and the patient recently spent time with her)).   On an unknown date, the patient received the 1st dose of Shingrix (right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: might be shingles), pain in arm (Verbatim: soreness of injected arm), itchy rash (Verbatim: itchy red spots), blister (Verbatim: she has blisters on her left arm that are itchy), red rash (Verbatim: rash on left arm/on her wrist she has itchy red spots/rash) and activities of daily living impaired (Verbatim: She can't wear a watch or a bracelet). The outcome of the shingles, pain in arm, itchy rash, blister, red rash and activities of daily living impaired were not resolved.   It was unknown if the reporter considered the shingles, itchy rash, blister, red rash and activities of daily living impaired to be related to Shingrix. The reporter considered the pain in arm to be related to Shingrix.   It was unknown if the company considered the shingles, itchy rash, blister, red rash and activities of daily living impaired to be related to Shingrix. The company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-JUN-2024 The reporter was the patient. She received 1st dose of Shingrix on a couple of weeks ago. The vaccine was given in her right arm. Her right arm (the injected arm) was still sore. She reported that she had blisters on her left arm that were itchy. She said that some of them were starting to dry up. She mentioned that on her wrist she has itchy red spots/rash. She could not wear a watch or a bracelet due to the watch/bracelet irritating the itchy area. (The caller was concerned that this might be shingles). Reporter got an inbound call, and their conversation was cut short. The patient did not got the opportunity to collect the exact date of the Shingrix vaccine, the lot number, or location of where she received the vaccine. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: might be shingles; soreness of injected arm; itchy red spots; she has blisters on her left arm that are itchy; rash on left arm/on her wrist she has itchy red spots/rash; She can't wear a watch or a bracelet; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chicken pox as a child). Previously administered products included Influenza vaccine with an associated reaction of illness (received on an unknown date). Family history included shingles (Family history of shingles- (Two sisters got shingles, one recently and the patient recently spent time with her)).   On an unknown date, the patient received the 1st dose of Shingrix (right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: might be shingles), pain in arm (Verbatim: soreness of injected arm), itchy rash (Verbatim: itchy red spots), blister (Verbatim: she has blisters on her left arm that are itchy), red rash (Verbatim: rash on left arm/on her wrist she has itchy red spots/rash) and activities of daily living impaired (Verbatim: She can't wear a watch or a bracelet). The outcome of the shingles, pain in arm, itchy rash, blister, red rash and activities of daily living impaired were not resolved.   It was unknown if the reporter considered the shingles, itchy rash, blister, red rash and activities of daily living impaired to be related to Shingrix. The reporter considered the pain in arm to be related to Shingrix.   It was unknown if the company considered the shingles, itchy rash, blister, red rash and activities of daily living impaired to be related to Shingrix. The company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-JUN-2024 The reporter was the patient. She received 1st dose of Shingrix on a couple of weeks ago. The vaccine was given in her right arm. Her right arm (the injected arm) was still sore. She reported that she had blisters on her left arm that were itchy. She said that some of them were starting to dry up. She mentioned that on her wrist she has itchy red spots/rash. She could not wear a watch or a bracelet due to the watch/bracelet irritating the itchy area. (The caller was concerned that this might be shingles). Reporter got an inbound call, and their conversation was cut short. The patient did not got the opportunity to collect the exact date of the Shingrix vaccine, the lot number, or location of where she received the vaccine. The reporter consented to follow up.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient receive Kinrix while being only two years old; Kinrix would be their third IPV and Dtap dose; 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 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   On 10-MAY-2024, the patient received Kinrix. On 10-MAY-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient receive Kinrix while being only two years old) and inappropriate schedule of vaccine administered (Verbatim: Kinrix would be their third IPV and Dtap dose). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were 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: 03-JUN-2024 The patient received Kinrix while being only two years old and reporter wish to know how to proceed, which led to inappropriate age at vaccine administration.  During the call they also mentioned that this would be their 5th IPV and Dtap dose but then walked back that statement stating that it would be their third IPV and Dtap dose, which led to inappropriate schedule of vaccine administered. Clarification was solicited but it was not able to be provided. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: accidentally gave a 3 year old a tdap instead of the dtap; supposed to receive 4th dose of dtap (infanrix) but instead received Tdap (boostrix); This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number DD7F7, expiry date 06-DEC-2025) for prophylaxis.   On an unknown date, the patient received the 1st dose of Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: accidentally gave a 3 year old a tdap instead of the dtap) and wrong vaccine administered (Verbatim: supposed to receive 4th dose of dtap (infanrix) but instead received Tdap (boostrix)). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were 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: 04-JUN-2024 Medical Assistant called reported patient was supposed to receive 4th dose of dtap (infanrix) but instead received Tdap (boostrix) which was accidentally given to a 3-year-old. They were instructed to call to determine if the child needs to be revaccinated or was there any possible problem that the child might have because she was too young to have the tdap.
Age: 2.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 2-years-old patient accidentally received a dose of Boostrix; product administered at wrong age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 2-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 57CP2, expiry date 11-JAN-2026) for prophylaxis.   Previously administered products included DTAP (received three previous doses of DTAP vaccine on an unknown date).   On 04-JUN-2024, the patient received the 4th dose of Boostrix. On 04-JUN-2024, an unknown time after receiving Boostrix, the patient experienced accidental underdose (Verbatim: 2-years-old patient accidentally received a dose of Boostrix) and inappropriate age at vaccine administration (Verbatim: product administered at wrong age). The outcome of the accidental underdose and inappropriate age at vaccine administration were 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: 04-JUN-2024 The medical assistant called in to report that a 2-years-old patient accidentally received a dose of Boostrix on the day of reporting, which led to an accidental underdose and inappropriate age at vaccine administration. During the call the healthcare professional initially mentioned that the patient only had two doses of DTAP vaccine but then verified that it was in fact three previous doses of DTAP received by the patient. The vaccine administration facility was the same as primary reporter. The reporter consented the follow up.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Heart rate increased, Myalgia
Clinical narrative: Rapid heart beating; shivering; Tiredness; weakness; muscle pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of heartbeats increased in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 25-MAR-2024, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced heartbeats increased (Verbatim: Rapid heart beating), shivering (Verbatim: shivering), tiredness (Verbatim: Tiredness), weakness (Verbatim: weakness) and muscle pain (Verbatim: muscle pain). The outcome of the heartbeats increased, shivering, tiredness, weakness and muscle pain were resolved.   It was unknown if the reporter considered the heartbeats increased, shivering, tiredness, weakness and muscle pain to be related to Shingrix.     It was unknown if the company considered the heartbeats increased, shivering, tiredness, weakness and muscle pain to be related to Shingrix.   Additional Information: GSK receipt date: 04-JUN-2024 The reporter was a patient and reported that he received both doses of Shingrix and after second dose he had muscle pain, weakness, tiredness, shivering, and rapid heart beating. Patient reports that the heart was beating faster than normal. Lot and expiration days were unknown. Patient reports that all symptoms subsided in 24. The reporter consented to follow-up.