chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site pain, Injection site urticaria, Pruritus
Clinical narrative: approximately 4 hours after injection pt states her entire left side of her body "went numb" and felt weak. Symptom lasted a few hours and resolved on its own. Pt then developed a rash to her bil arms, chest, and head starting about 6 hours after vaccination. Rash is painful and itchy. No history of rash in lifetime prior to this. 10 days later, pt still has pain and bruising at injection site.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Diarrhoea, Diplopia
Clinical narrative: Patient's message to me - The day after the shot (Friday), I started having severe stomach cramps, vomiting and diarrhea. I was shivering non stop. Then the scary part I had a sudden onset of weakness and actual paralysis. I literally couldn't move. I was laying on the bathroom floor in my own vomit. I couldn't lift my head or move my body. My heart was racing and I was SOB. This inability to move lasted about an hour.  The following day (Saturday), I experienced a severe HA, double vision, and had 5 episodes of pooping bright red blood with tissue and no stool. Sunday I developed hives and treated with Zyrtec and pepcid. I have had 2 more episodes of pooping bright blood last night and this AM. but now it has a lot of mucus.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Headache, Mucous stools, Palpitations, Paralysis
Clinical narrative: Patient's message to me - The day after the shot (Friday), I started having severe stomach cramps, vomiting and diarrhea. I was shivering non stop. Then the scary part I had a sudden onset of weakness and actual paralysis. I literally couldn't move. I was laying on the bathroom floor in my own vomit. I couldn't lift my head or move my body. My heart was racing and I was SOB. This inability to move lasted about an hour.  The following day (Saturday), I experienced a severe HA, double vision, and had 5 episodes of pooping bright red blood with tissue and no stool. Sunday I developed hives and treated with Zyrtec and pepcid. I have had 2 more episodes of pooping bright blood last night and this AM. but now it has a lot of mucus.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rectal haemorrhage, Urticaria, Vomiting
Clinical narrative: Patient's message to me - The day after the shot (Friday), I started having severe stomach cramps, vomiting and diarrhea. I was shivering non stop. Then the scary part I had a sudden onset of weakness and actual paralysis. I literally couldn't move. I was laying on the bathroom floor in my own vomit. I couldn't lift my head or move my body. My heart was racing and I was SOB. This inability to move lasted about an hour.  The following day (Saturday), I experienced a severe HA, double vision, and had 5 episodes of pooping bright red blood with tissue and no stool. Sunday I developed hives and treated with Zyrtec and pepcid. I have had 2 more episodes of pooping bright blood last night and this AM. but now it has a lot of mucus.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Pt reports swelling the day following the vaccine, pain that lasted for two weeks, and itchiness/redness that lasted for a month after the vaccine.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Vitiligo
Clinical narrative: Diagnosis of Vitaligo
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with covid
Age: 23.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: on mon i got 2 vax in my arm and have had a noticeable bump since then at site of HPV vaccine. woke up the morning after immunization to noticeable, very tender lump on arm.  yesterday upon discovery i had called the triage line associated with the clinic i went to and was told im good. i had noted a red circle around the spot last night, took pictures at that time. noted temperature increase in immediate area of swelling/redness.  this morning noting no red circle, less swelling, and no noticeable temperature difference in the immediate area.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with covid
Age: 68.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: The vaccine was discovered to be expired after administration. The date of expiration was 12/27/2023.  I consulted with the manufacturer, then the patient and the patients primary care physician were notified. Dr.'s office stated that they will evaluate the patients during his next visit in March.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: HOSPITALIZATION RELATED TO COVID-19 FOLLOWING COMPLETION OF PRIMARY VACCINE SERIES
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was 7 days expired at the time of administration. Patient did not have any adverse reactions. Parents were notified and declined to have the vaccine re-administered.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 RNA, SARS-CoV-2 test positive
Clinical narrative: HOSPITALIZATION RELATED TO COVID-19 FOLLOWING COMPLETION OF PRIMARY VACCINE SERIES
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pallor, Syncope
Clinical narrative: The patient had syncope and looked pale after the vaccination. The patient stayed around 15 minutes after the visit. We gave the immunizations with the patient laying back because this is a common side effect for this patient (according the patient and the mother) . We gave her small sips of water, an ice pack, and had her stay laying down checking on her every couple minutes. The provider also checked on her before she went home. The patient fully recovered within 15 minutes.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Medical assistant entered Infranrix as order. Provider mistakenly signed off on order. Provider realized mistake, and reentered and signed correct order (Boostrix). Infranrix was still given. Provider not aware of any adverse events. Provider has called and left a VM with parent.
Age: 88.0
Sex: M
Vaccine: RSV
Symptoms: Cognitive disorder, Cough, Laboratory test normal, Magnetic resonance imaging head normal, Mental status changes
Clinical narrative: developed cough 3-4 days after vaccine and also change in mental status. has a noticable cognitive change and right hand tremor.  MRI brain and labs overall normal.
Age: 88.0
Sex: M
Vaccine: RSV
Symptoms: Tremor
Clinical narrative: developed cough 3-4 days after vaccine and also change in mental status. has a noticable cognitive change and right hand tremor.  MRI brain and labs overall normal.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Death
Clinical narrative: Patient expired 2/13/2024.
Age: 50.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect dose administered, Injection site erythema
Clinical narrative: Patient received 0.5 mL intradermally. Patient should have received 0.1 mL intradermally. Manufacturer was contacted; they advised that the patient should monitor for local and systemic side effects. Patient was notified on 2/14. Advised to monitor for Local Side Effects: Erythema, Pain, Edema, Pruritis, Hyperpigmentation, Induration and Systemic Side Effects: Fatigue, Headache, Myalgias, Nausea, Chills, Fever. Patient states minor redness around the site but other than that no additional symptoms.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 RNA, SARS-CoV-2 test positive
Clinical narrative: HOSPITALIZATION RELATED TO COVID-19 FOLLOWING COMPLETION OF PRIMARY VACCINE SERIES
Age: 85.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Woke up the next morning early with a headache, chills, and low fever.  Later in the morning after breakfast, I became a little nauseated.  Took a Tylenol, and laid down.  Later in the day, I started feeling better.  The next morning I was tired, but otherwise, I was okay.
Age: 1.5
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dtap/IPV  given prior authorised use date. 4years
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No reaction to the vaccine post administration. The vaccine that was administered expired 1 day prior to administration.
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Antimicrobial susceptibility test, Confusional state, Drug resistance, Dyskinesia, Dysuria
Clinical narrative: RESIDENT RECEIVED VACCINE W/ NO IMMEDIATE RXN.  PROGRESS NOTES STATE THE NEXT DAY, RESIDENT WAS BEING TESTED FOR UTI AFTER C/O DYSURIA.   DAY 2 S/P VACCINE, RESIDENT NOTED TO HAVE SEIZURE LIKE ACTIVITY LASTING 2-3 MINUTES WHILE PROVIDING CARE.  VS: 97.8-142-22-130/78-95% R/A.  STAFF DID REPORT RESIDENT POST ICTAL PERIOD OF CONFUSION, RESTLESSNESS AND GRABBING AT THE AIR THAT EVENTUALLY SUBSIDED.  WHEN REPORTED TO DOC, UA C&S WAS ORDERED AND RESIDENT STARTED EMPIRACALLY ON CIPRO.  RESIDENT HAD NO HX OF SEIZURES DESPITE HX OF UTI.  C&S SHOWED RESISTANCE TO CIPRO AND AMPICILLIN WAS ORDERED BUT THERE WAS NOT ANY FURTHER SEIZURE ACTIVITIY.  RESIDENT THEN CTB AFTER 5 DAYS OF TX WITH AMPICILLIN WITH VS NOTED TO BE WNL AND NO OTHER ABNORMAL EVENTS EXCEPT OFFERING FLUIDS.
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Pathogen resistance, Postictal state, Proteus test positive, Restlessness, Seizure like phenomena
Clinical narrative: RESIDENT RECEIVED VACCINE W/ NO IMMEDIATE RXN.  PROGRESS NOTES STATE THE NEXT DAY, RESIDENT WAS BEING TESTED FOR UTI AFTER C/O DYSURIA.   DAY 2 S/P VACCINE, RESIDENT NOTED TO HAVE SEIZURE LIKE ACTIVITY LASTING 2-3 MINUTES WHILE PROVIDING CARE.  VS: 97.8-142-22-130/78-95% R/A.  STAFF DID REPORT RESIDENT POST ICTAL PERIOD OF CONFUSION, RESTLESSNESS AND GRABBING AT THE AIR THAT EVENTUALLY SUBSIDED.  WHEN REPORTED TO DOC, UA C&S WAS ORDERED AND RESIDENT STARTED EMPIRACALLY ON CIPRO.  RESIDENT HAD NO HX OF SEIZURES DESPITE HX OF UTI.  C&S SHOWED RESISTANCE TO CIPRO AND AMPICILLIN WAS ORDERED BUT THERE WAS NOT ANY FURTHER SEIZURE ACTIVITIY.  RESIDENT THEN CTB AFTER 5 DAYS OF TX WITH AMPICILLIN WITH VS NOTED TO BE WNL AND NO OTHER ABNORMAL EVENTS EXCEPT OFFERING FLUIDS.
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Urine analysis abnormal
Clinical narrative: RESIDENT RECEIVED VACCINE W/ NO IMMEDIATE RXN.  PROGRESS NOTES STATE THE NEXT DAY, RESIDENT WAS BEING TESTED FOR UTI AFTER C/O DYSURIA.   DAY 2 S/P VACCINE, RESIDENT NOTED TO HAVE SEIZURE LIKE ACTIVITY LASTING 2-3 MINUTES WHILE PROVIDING CARE.  VS: 97.8-142-22-130/78-95% R/A.  STAFF DID REPORT RESIDENT POST ICTAL PERIOD OF CONFUSION, RESTLESSNESS AND GRABBING AT THE AIR THAT EVENTUALLY SUBSIDED.  WHEN REPORTED TO DOC, UA C&S WAS ORDERED AND RESIDENT STARTED EMPIRACALLY ON CIPRO.  RESIDENT HAD NO HX OF SEIZURES DESPITE HX OF UTI.  C&S SHOWED RESISTANCE TO CIPRO AND AMPICILLIN WAS ORDERED BUT THERE WAS NOT ANY FURTHER SEIZURE ACTIVITIY.  RESIDENT THEN CTB AFTER 5 DAYS OF TX WITH AMPICILLIN WITH VS NOTED TO BE WNL AND NO OTHER ABNORMAL EVENTS EXCEPT OFFERING FLUIDS.
Age: 13.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Dyskinesia, Eye movement disorder, Throat tightness
Clinical narrative: After receiving vaccinations at 1135, patient's eyes rolled back in her head, bit down on a lollipop and started bilateral hand/feet jerking for about 2-3 seconds. Lollipop was removed from her mouth without incident. Patient's blood pressure was taken at 11:37 am and it was 84/64, HR:  88. Mother states patient did not eat anything today and denies any previous history of adverse reaction to vaccines. Patient was offered Gatorade from mother. Then patient states she felt tightness in her throat. At 11:39 10 ml of Benadryl was administered. At 11:47 patient denies any tightness in throat and blood pressure was retaken 104/72, HR 84. patient was observed till 12:05 for any further complication. Mother was advise. Mother was advised to report to ER for further evaluation. Mother voiced understanding per translator. Patient walked out of the clinic without assistance and in stable condition with parents.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 RNA, SARS-CoV-2 test positive
Clinical narrative: HOSPITALIZATION AND DEATH RELATED TO COVID-19 FOLLOWING COMPLETION OF PRIMARY VACCINE SERIES
Age: 1.5
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dtap/IPV given prior authorised use date 4 years.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site mass
Clinical narrative: Mom reported lump to injection site on right thigh.
Age: 80.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Rash
Clinical narrative: rash
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, Death, SARS-CoV-2 RNA, SARS-CoV-2 test positive
Clinical narrative: DEATH RELATED TO COVID-19 FOLLOWING COMPLETION OF PRIMARY VACCINE SERIES
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Injection site reaction
Clinical narrative: site reaction
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 RNA, SARS-CoV-2 test positive
Clinical narrative: HOSPITALIZATION RELATED TO COVID-19 FOLLOWING COMPLETION OF PRIMARY VACCINE SERIES
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site reaction
Clinical narrative: site reaction
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cyanosis, Head injury, Pallor, Presyncope
Clinical narrative: -Incident today at the clinic as he was leaving, he bumped his head against glass door and had near syncope episode where he turned pale and lips turned blue. O2 levels 86%, BP 70s/50s. O2 supplement and tredenlenburg position helped symptoms. paramedics were called and he was taken to ER for further evaluation. (this is his 2nd time he had this same reaction after vaccinations, mom last recalled this happening at age 6 y.o) he also did not have anything to eat or drink today.  At about 12 pm
Age: 86.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Left arm redness approximately 3"x 3" in size (warm to the touch) distal to vaccination site which appeared 4 days after vaccination. Site of rash was just below deltoid muscle. Patient felt woozy the day of appearance of rash but claimed to be doing better today. Patient was  ambulatory and non-febrile with normal BP, pulse, oxygen saturation, Upon further questioning, the patient stated that she had similar rashes (self-resolving)  with other immunizations in the past. Recommended to patient to try Zyrtec 10mg QHS for 1 week and a cold compress on rash until resolution and that if anything got worse to follow up with us or PCP.
Age: 50.0
Sex: M
Vaccine: FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was given Fluad Quad instead of Fluarix Quad vaccine. No treatment was required. The patient did not experience any adverse effects from receiving the higher dose of flu vaccine.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Brain natriuretic peptide, Cough, Differential white blood cell count, Fatigue, Full blood count
Clinical narrative: Pt reports significant fatigue and malaise, ongoing as of 2/14/2024. Fever, 1/26/24-1/30/24.  Body aches, malaise, cough ~1 week following vaccine.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Influenza virus test, Laboratory test, Malaise, Pain, Pyrexia
Clinical narrative: Pt reports significant fatigue and malaise, ongoing as of 2/14/2024. Fever, 1/26/24-1/30/24.  Body aches, malaise, cough ~1 week following vaccine.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Respiratory syncytial virus test, SARS-CoV-2 test, Troponin, Urine analysis
Clinical narrative: Pt reports significant fatigue and malaise, ongoing as of 2/14/2024. Fever, 1/26/24-1/30/24.  Body aches, malaise, cough ~1 week following vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Nausea, Photophobia, Pyrexia
Clinical narrative: Nausea, vomiting, fever, chills, dizziness, weakness, light sensitivity. Was sick for 3 days from first shot 11/1/23, but reaction from second shot is much worse. Dr has prescribed Methylpred 4mg tabs
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Nausea, vomiting, fever, chills, dizziness, weakness, light sensitivity. Was sick for 3 days from first shot 11/1/23, but reaction from second shot is much worse. Dr has prescribed Methylpred 4mg tabs
Age: 67.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Culture positive, Injection site discolouration, Injection site erythema, Injection site infection, Injection site pain
Clinical narrative: 1 Hour after dose site very painful unable to lie on left arm.  2 days later  approximately 3inches around reddenrd , area appeared not warm to touch,  and  injection site red about dime size.  Site continued to be painful.  About 1 week later, the injection site became black, like eschar tissue, I covered it with collodial dressing .  went to pharmacy and showed them pictures of my left arm.  They said they would report it.  I have photos of the open sore.  It is now 2/14/24 and I still have the sore on my arm
Age: 67.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Injection site ulcer, Staphylococcal infection
Clinical narrative: 1 Hour after dose site very painful unable to lie on left arm.  2 days later  approximately 3inches around reddenrd , area appeared not warm to touch,  and  injection site red about dime size.  Site continued to be painful.  About 1 week later, the injection site became black, like eschar tissue, I covered it with collodial dressing .  went to pharmacy and showed them pictures of my left arm.  They said they would report it.  I have photos of the open sore.  It is now 2/14/24 and I still have the sore on my arm
Age: 67.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Asthenia, Chills, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: 1 Hour after dose site very painful unable to lie on left arm.  2 days later  approximately 3inches around reddenrd , area appeared not warm to touch,  and  injection site red about dime size.  Site continued to be painful.  About 1 week later, the injection site became black, like eschar tissue, I covered it with collodial dressing .  went to pharmacy and showed them pictures of my left arm.  They said they would report it.  I have photos of the open sore.  It is now 2/14/24 and I still have the sore on my arm
Age: 67.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Lethargy, Pain, Paraesthesia, Pyrexia, Skin laceration
Clinical narrative: 1 Hour after dose site very painful unable to lie on left arm.  2 days later  approximately 3inches around reddenrd , area appeared not warm to touch,  and  injection site red about dime size.  Site continued to be painful.  About 1 week later, the injection site became black, like eschar tissue, I covered it with collodial dressing .  went to pharmacy and showed them pictures of my left arm.  They said they would report it.  I have photos of the open sore.  It is now 2/14/24 and I still have the sore on my arm
Age: 67.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Sleep disorder
Clinical narrative: 1 Hour after dose site very painful unable to lie on left arm.  2 days later  approximately 3inches around reddenrd , area appeared not warm to touch,  and  injection site red about dime size.  Site continued to be painful.  About 1 week later, the injection site became black, like eschar tissue, I covered it with collodial dressing .  went to pharmacy and showed them pictures of my left arm.  They said they would report it.  I have photos of the open sore.  It is now 2/14/24 and I still have the sore on my arm
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP, HIBV, HIBV, PNC20, PNC20, RV5, RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event at this time.  Vaccines given before  minimum due date.   Patient in primary care providers office.  She was examined and educated at that time by provider.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chest pain, Pain in extremity
Clinical narrative: intense pain in arm,shoulder,chest,legs and feet lasting several hours. started about 8 hours after vaccination.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, International normalised ratio normal, Pain in extremity, Tenderness, X-ray normal
Clinical narrative: Painful in shoulder area moving down the arm. Painful to touch. Tylenol, ice, heat. Went to the ED on 2/13/2024.  Treatment from ED ice and tylenol. If running a fever to return to ED.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Two days after my Covid vaccine dose, my muscles ached and felt extremely weak. This condition persisted and never subsided. To this day, I have constant soreness and weakness of my muscles throughout my body. For example, getting up after sitting for two minutes, I feel like I'm 90 years old.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Patient received injection on 2/12/24 to upper left thigh.  Pts mom reported on 2/14/24 that her left thigh area where she received the Infanrix (DTAP) vaccine was red and warm to the touch and she felt a knot under it.  The provider saw the pt and prescribed cefdinir and prenisolone to treat for cellulitis of the skin and a vaccine adverse reaction.  Pts twin sister received the same vaccines on 2/12/24 and experienced the same reaction to the DTAP vaccine.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE details available; not supported TE; This spontaneous report was received from a registered nurse practitioner (RNP) and referred to a patient of unknow age and gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On an unknown date, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #W028573, expiration date: 06-JAN-2025; lot #X014788, expiration date: 07-MAR-2025, both strength were not reported) experienced temperature excursion at -13.21 degree Celsius (C) for 0 hours 6 minutes and 44 seconds (product storage error). Previous temperature excursion showed 29 minutes at 8.07 C, 14 minutes at 8.07 C, 15 seconds at 8.08 C. On 12-JAN-2024, the patient was vaccinated with a single dose improper stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (0.5ml/once, health care professional [HCP] was unable to be sure which was administered to the patient. Lot #W028573, expiration date: 06-JAN-2025, lot #X014788, expiration date: 07-MAR-2025, strength, anatomical site of administration and route of administration were not provided) administered for prophylaxis. No further adverse event (AE) details available (no AE).  This is one of 9 reports received from the same reporter.
Age: 15.0
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the pt was vaccinated with 1st dose of VAQTA on 22-OCT-2013, and with 2nd dose on 23-MAR-2018; This spontaneous report has been received from an other health care professional via immunization record from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (# 2310USA002275), concerning a 15-year-old patient. The patient's historical vaccine included: unspecified diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP) vaccine, unspecified hepatitis B vaccine (manufacturer unknown), unspecified Haemophilus B conjugate vaccine (manufacturer unknown), unspecified measles (+) mumps (+) rubella (MMR) vaccine (manufacturer unknown), unspecified pneumococcal conjugate PCV 7 vaccine, unspecified polio vaccine inact (IPV) vaccine, and unspecified varicella vaccine (manufacturer unknown). Her concomitant vaccines included unspecified varicella vaccine (manufacturer unknown), unspecified diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) vaccine, and unspecified meningococcal vaccine polysaccharide vaccine. There was no information about the patient's concurrent conditions, or medical history provided.  On 22-OCT-2013, the patient was vaccinated with the 1st dose of unspecified hepatitis A vaccine (manufacturer unknown). On 23-MAR-2018, patient received 2nd dose of unspecified hepatitis A vaccine (manufacturer unknown) (LLT: Inappropriate schedule of vaccine administered). The patient's other vaccines included unspecified HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), unspecified influenza, seasonal vaccine, unspecified meningococcal B, recombinant vaccine, unspecified meningococcal vaccine polysaccharide vaccine, and unspecified influenza quadrivalent vaccine.    This is one of 5 reports created for the same patient.; Sender's Comments:  US-009507513-2310USA002275: US-009507513-2311USA006377: US-009507513-2311USA006630: US-009507513-2311USA005952:
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, Speech disorder developmental
Clinical narrative: received his first dose of PROQUAD at 12 months and his second dose at 18 months of age; She mentioned that her son is speech delayed and was questioning if the immunization schedule could; This spontaneous report was received from the patient's mother concerning a male child patient. Patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided.  On an unknown date (also reported as at 12 months), the patient was vaccinated with the first dose of with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). On an unknown date (also reported as at 18 months), the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, expiration date: 07-MAR-2022, administered for prophylaxis (strength, dose, frequency, lot #, route of administration and anatomical location were not provided for both doses) (Inappropriate age at vaccine administration).   On 28-JUL-2021, the patient's speech was delayed and the mother of the patient was questioning if the immunization schedule could have caused the speech delay. The outcome of the event was not provided.  Causal relationship between measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and the event was not provided.
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Jynneos vaccine was administered to two patients after beyond use date (BUD) passed; Case reference number US-BN-2024-000054 is a spontaneous case report initially received from a nurse via Health Authority (reference number: USBAV24-0079) on 12-Jan-2024 and concerns two patients of unspecified age and gender.  The patients' relevant medical history and concomitant medications were not provided.  On unspecified date, reported as on Wednesday, the first patient was vaccinated with a dose of Jynneos vaccine (batch number: FDP000016) after beyond use date (BUD) which was on 10-Jan-2024, at an unknown dose, route, or site of administration for an unknown indication (explicitly coded as 'expired vaccine used').   On unspecified date, reported as today, the second patient was vaccinated with a dose of Jynneos vaccine (batch number: FDP000016) after beyond use date (BUD) which was on 10-Jan-2024, at an unknown dose, route, or site of administration for an unknown indication (explicitly coded as 'expired vaccine used').  At the time of initial report, it was unknown if the patients experienced any adverse events due to Jynneos vaccine.  No further information provided.; Reporter's Comments: Two patients of unspecified age and gender were vaccinated with a dose of Jynneos vaccine for an unknown indication, after beyond use date (BUD), which is considered as expired vaccine used. It was unknown if the patients experienced any adverse events due to Jynneos vaccine. Expired product administered is considered as listed per company convention. The patients' relevant medical history and concomitant medications were not provided. Expired product administered has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: Two patients of unspecified age and gender were vaccinated with a dose of Jynneos vaccine for an unknown indication, after beyond use date (BUD), which is considered as expired vaccine used. It was unknown if the patients experienced any adverse events due to Jynneos vaccine. Expired product administered is considered as listed per company convention. The patients' relevant medical history and concomitant medications were not provided. Expired product administered has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: RVX
Symptoms: Oedema
Clinical narrative: Body swelled with water; This non-serious case was reported by a consumer and described the occurrence of edema in a 77-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concomitant products included aripiprazole (Abilify), clonazepam (Klonopin), semaglutide (Ozempic) and insulin detemir (Levemir).   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced edema (Verbatim: Body swelled with water). The outcome of the edema was not resolved.   It was unknown if the reporter considered the edema to be related to RSV vaccine.     It was unknown if the company considered the edema to be related to RSV vaccine.   Additional Information: GSK Receipt date: 08-FEB-2024 The patient received a dose of RSV and had body swelled with water. The symptoms were not treated. The reporter requesting consent to follow up.
Age: 4.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Urticaria
Clinical narrative: Developed very large hives; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of hives in a 4-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced hives (Verbatim: Developed very large hives). The outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Kinrix and Kinrix Pre-Filled Syringe Device.     It was unknown if the company considered the hives to be related to Kinrix and Kinrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-FEB-2024 The nurse reported that after receiving Kinrix vaccine patient developed very large hives. The reporter consented to follow-up.
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Insomnia, Malaise, Migraine
Clinical narrative: tired; migraine; stomach was upset; lack of sleep; felt crappy; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of tiredness in a 46-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 05-FEB-2024, the patient received Shingles vaccine. On 06-FEB-2024, 1 days after receiving Shingles vaccine, the patient experienced tiredness (Verbatim: tired), migraine (Verbatim: migraine), upset stomach (Verbatim: stomach was upset) and feeling abnormal (Verbatim: felt crappy). In FEB-2024, the patient experienced sleep loss (Verbatim: lack of sleep). The outcome of the tiredness, migraine, upset stomach and sleep loss were not reported and the outcome of the feeling abnormal was resolved (duration 1 day).   It was unknown if the reporter considered the tiredness, migraine, upset stomach, feeling abnormal and sleep loss to be related to Shingles vaccine.     It was unknown if the company considered the tiredness, migraine, upset stomach, feeling abnormal and sleep loss to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-FEB-2024 It was reported that patient recently have the Shingles vaccine on Monday on 5th February 2024 and the next day she felt crappy for a day. The patient reported that Tuesday was horrible, tired and had a migraine. The patient ended up having to take a nap during the day, which she had to do since her diagnosis of MS. She did have a lack of sleep the night prior, and her stomach was upset after her lunch, which may have contributed.
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Multiple sclerosis
Clinical narrative: tired; migraine; stomach was upset; lack of sleep; felt crappy; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of tiredness in a 46-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 05-FEB-2024, the patient received Shingles vaccine. On 06-FEB-2024, 1 days after receiving Shingles vaccine, the patient experienced tiredness (Verbatim: tired), migraine (Verbatim: migraine), upset stomach (Verbatim: stomach was upset) and feeling abnormal (Verbatim: felt crappy). In FEB-2024, the patient experienced sleep loss (Verbatim: lack of sleep). The outcome of the tiredness, migraine, upset stomach and sleep loss were not reported and the outcome of the feeling abnormal was resolved (duration 1 day).   It was unknown if the reporter considered the tiredness, migraine, upset stomach, feeling abnormal and sleep loss to be related to Shingles vaccine.     It was unknown if the company considered the tiredness, migraine, upset stomach, feeling abnormal and sleep loss to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-FEB-2024 It was reported that patient recently have the Shingles vaccine on Monday on 5th February 2024 and the next day she felt crappy for a day. The patient reported that Tuesday was horrible, tired and had a migraine. The patient ended up having to take a nap during the day, which she had to do since her diagnosis of MS. She did have a lack of sleep the night prior, and her stomach was upset after her lunch, which may have contributed.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 4-month-old was administered an injection for Kinrix vaccine; 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 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   On 22-JAN-2024, the patient received Kinrix (lt. vastus lateralis). On 22-JAN-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a 4-month-old was administered an injection for Kinrix vaccine). 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: 06-FEB-2024 The reporter was an Healthcare professional/Licensed practice nurse. Healthcare professional reported an adverse event for Kinrix vaccine. Healthcare professional reported that a 4-month-old infant was administered an injection for Kinrix vaccine, which led to Inappropriate age at vaccine administration. No additional events were reported for this patient. The reporter consented to follow up. Healthcare professional reported an adverse event for Out of age range. Healthcare professional consent to follow up.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2 days early and called asking if it could be administered early; 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 22-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B adult (received 1st dose on 19th August 2023).   On 15-DEC-2023, the patient received the 2nd dose of Engerix B adult. On 15-DEC-2023, an unknown time after receiving Engerix B adult, the patient experienced drug dose administration interval too long (Verbatim: 2 days early and called asking if it could be administered early). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 06-FEB-2024 The pharmacist had a patient waiting to get the 3rd dose of Engerix-B and had come 1 week and 2 days early and called asking if it could be administered early.  When asked, pharmacist stated 1st dose and 2nd dose (administered at a different store).  The patient was in today for her third dose.   No 3rd dose administered at the time of call. The patient received 2nd dose after the schedule time, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix before recommended 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 18-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   On 06-FEB-2024, the patient received Kinrix. On 06-FEB-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix before recommended 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: 06-FEB-2024 Nurse called to report Kinrix was administered to an 18-month-old patient, before the recommended age, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: U
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose on June 30th 2023 and 3rd dose on Aug 3rd 2023; first dose of Twinrix on Jan 3rd 2023, 2nd dose on June 30th 2023; 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 HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 03 January 2023).   On 03-AUG-2023, the patient received the 3rd dose of Twinrix. On 30-JUN-2023, the patient received the 2nd dose of Twinrix. On 30-JUN-2023, not applicable after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: first dose of Twinrix on Jan 3rd 2023, 2nd dose on June 30th 2023 ). On 03-AUG-2023, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose on June 30th 2023 and 3rd dose on Aug 3rd 2023). The outcome of the drug dose administration interval too long and drug dose administration interval too short 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: 07-FEB-2024 The pharmacist had a patient who got first dose of Twinrix on January 3rd 2023, 2nd dose on June 30th 2023 and 3rd dose on August 3rd 2023.  The reporter asked the interval between 2nd and 3rd dose ok, was a 4th dose recommended. The patient received 2nd dose after 5 months, which led lengthening of vaccination schedule. The patient received 3rd dose less than 2 months after 2nd dose, which led to shortening of vaccination schedule.  The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: half or 1/4 of the dose went in the patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) (batch number E9KH7, expiry date 22-NOV-2025) for prophylaxis.   On 07-FEB-2024, the patient received Shingrix (right arm). On 07-FEB-2024, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: half or 1/4 of the dose went in the patient). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 07-FEB-2024 Registered pharmacist reported they were administering a Shingrix dose to a patient and the patient pulled away while pushing the plunger. The reporter stated that about half or 1/4 of the dose went in the patient, which led to incomplete dose administered.  The pharmacist inquired how to proceed. The reporter declined to provide patient details. The reporter did not consent to follow-up.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: inadvertently administered a Priorix dose to a patient via Intramuscularly route instead of Subcutaneously, today on 2/8/24.; This non-serious case was reported by a nurse via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 38-year-old female patient who received MMR (Priorix) (batch number 75S93, expiry date 11-MAY-2024) for prophylaxis.   On 08-FEB-2024, the patient received Priorix (intramuscular, left deltoid). On 08-FEB-2024, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: inadvertently administered a Priorix dose to a patient via Intramuscularly route instead of Subcutaneously, today on 2/8/24.). The outcome of the subcutaneous injection formulation administered by other route 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: 08-FEB-2024 The reporter inquired any side effects or any reactions to look for or what to do. The reporter reported an Medical Assistant inadvertently administered a Priorix dose to a patient via Intramuscularly route instead of Subcutaneously at the time of reporting, which led to subcutaneous injection formulation administered by other route. The patient was administered in the left deltoid. The reporter did not consent to follow-up.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: never got the rest of the doses; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (On 3rd March 2023, received first dose).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: never got the rest of the doses). The outcome of the incomplete course of vaccination 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: 08-FEB-2024 The reporter reported that the patient got one dose of Twinrix and never got the rest of the doses. Reporter asked did they restart and how to space it. The reporter consented to follow-up. Till the time of reporting patient did not receive the rest of doses of Twinrix, which led to incomplete course of vaccination.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: overdose; 19 year old female was administered an adult dose of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B adult) (batch number 7MH25, expiry date 07-DEC-2025) for prophylaxis.   On 08-FEB-2024, the patient received Engerix B adult. On 08-FEB-2024, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: overdose) and inappropriate age at vaccine administration (Verbatim: 19 year old female was administered an adult dose of Engerix-B). The outcome of the overdose 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: 08-FEB-2024 Medical Assistant reported a 19-year-old patient was administered an adult dose of Engerix-B, which led to overdose and inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the second dose was administered today 2/9/2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 09-FEB-2024, the patient received the 2nd dose of Shingrix. On 09-FEB-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: the second dose was administered today 2/9/2024). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 09-FEB-2024 Medical Assistant called to see guidance on a patient who received Shingrix first dose in DEC-2023 and the second dose was administered today on 09-FEB-2024. Healthcare professional stated that the Doctor have just said that everything was okay as long as they have 4 weeks in between. The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix, earlier than the recommended interval, which led to shortening of vaccination schedule.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2024, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced tested positive for covid (Dose number in series 1). Laboratory data included: COVID-19 virus test positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid was not reported. This report was non-serious.