chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.92
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: administration of an adult dose of Havrix to 23 month-old patient; administration of an adult dose of Havrix to 23 month-old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 23-month-old female patient who received HAV (Havrix adult) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   On 08-JUL-2024, the patient received Havrix adult. On 08-JUL-2024, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: administration of an adult dose of Havrix to 23 month-old patient) and overdose (Verbatim: administration of an adult dose of Havrix to 23 month-old patient). The outcome of the adult product administered to child and overdose 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-JUL-2024 A nurse called to report the administration of an adult dose of Havrix to 23 month-old twin patients, which led to overdose and adult product administered to child. The HCP asked for guidance on this situation. Consented to follow up. The case is linked with US2024AMR085518, by same reporter; Sender's Comments:  US-GSK-US2024084967:Same reporter / different patient
Age: 1.92
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Havrix - Adult dose given to a child; Adult product administered to child; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 23-month-old female patient who received HAV (Havrix adult) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   On 08-JUL-2024, the patient received Havrix adult. On 08-JUL-2024, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: Havrix - Adult dose given to a child) and adult product administered to child (Verbatim: Adult product administered to child). The outcome of the overdose and adult product administered to child 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-JUL-2024 A nurse called to report the administration of an adult dose of Havrix to 23 month-old twin patients, which led to overdose and adult product administered to child. The HCP asked for guidance on this situation. Consented to follow up. The case is linked with US2024AMR085518, by same reporter; Sender's Comments:  US-GSK-US2024AMR085518:Same reporter / different patient
Sex: U
Vaccine: HIBV
Symptoms: Device connection issue, Needle issue, No adverse event, Product complaint
Clinical narrative: needle in the pediatric patient's arm; Needle detached from syringe hub/ very loose, turning freely; Product Complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental needle stick in a child patient who received Hib (Hiberix) (batch number 5347Z, expiry date 14-MAR-2026) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced accidental needle stick (Verbatim: needle in the pediatric patient's arm), syringe connection issue (Verbatim: Needle detached from syringe hub/ very loose, turning freely) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the accidental needle stick, syringe connection issue and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the accidental needle stick and syringe connection issue to be related to Hiberix.     It was unknown if the company considered the accidental needle stick and syringe connection issue to be related to Hiberix.   Additional Information: GSK receipt date: 08-JUL-2024 The health care professional (HCP) reported that they have had several Hiberix Syringe problems, four doses were wasted, the rest were usable.  One of the doses left the needle in the pediatric patient's arm. HCP stated that the was very loose, turning freely.  It would just pop off, losing the product during preparation and/or administration, usually when removing the cap. All suspect syringes have been discarded, therefore unable to be returned. The child was unharmed.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Underdose
Clinical narrative: the validity of a dose of Bexsero where only three fourth of the vaccine was administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number 2y393, expiry date 30-APR-2027) for prophylaxis.   On 21-JUN-2024, the patient received the 1st dose of Bexsero. On 21-JUN-2024, an unknown time after receiving Bexsero, the patient experienced incomplete dose administered (Verbatim: the validity of a dose of Bexsero where only three fourth of the vaccine was administered). The outcome of the incomplete dose administered 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-JUL-2024 A nurse called in to requested information about the validity of a dose of Bexsero where only three fourth of the vaccine was administered, which led to incomplete dose administered.  If there was any safety data available and how to proceed with the first dose of the series which would replace this one. They gave information about vaccines, event and patients.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Underdose; the 1st dose was a pediatric dose, due the patient was 19 YO at the moment; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 20-year-old female patient who received HBV (Engerix B pediatric) (batch number 32M5G, expiry date 14-SEP-2025) for prophylaxis.   On 06-JUL-2024, the patient received Engerix B pediatric. On 06-JUL-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Underdose) and adult use of a child product (Verbatim: the 1st dose was a pediatric dose, due the patient was 19 YO at the moment). The outcome of the underdose and adult use of a child product 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-JUL-2024 The patient over the weekend that were administrated the Engerix-B pediatric dose, that were over the age of 20, which led to overdose and adult use of child product.  The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up. The case is related to US2024084978, by same reporter.; Sender's Comments:  US-GSK-US2024084978:Same reporter/different patient
Sex: U
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: VISION PROBLEMS; This spontaneous report received from a patient via J&J managed social media site and 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 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 an unspecified date, the patient experienced vision problems  (Dose series:1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vision problems was not reported. This report was non-serious.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: local adverse event of swelling at the injection site of 5cm; local adverse event of redness at the injection site; This is a spontaneous report received from a Physician from a sales representative.  An infant patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "local adverse event of swelling at the injection site of 5cm"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "local adverse event of redness at the injection site".  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: pentacel was given to a patient without the hib component with no reported adverse event; Initial information received on 11-Jul-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient to whom DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was given to a patient without the hib component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Powder and suspension for suspension for injection lot UK036AB expiry-30-Jun-2025 via unknown route in unknown administration site for immunization (strength, dose unknown) without the hib component with no reported adverse event (single component of a two-component product administered) (latency same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 4th dose of daptacel was administered 2 weeks early from the recommended interval between doses 3 and 4 with no reported adverse event; Initial information received on 15-Jul-2024 regarding an unsolicited valid non-serious case received from a other health care professional.  This case involves a 5 years old female patient who was administered 4th dose of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] 2 weeks early from the recommended interval between doses 3 and 4 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (WISTAR RA 27/3) (MMR II) Hepatitis B Vaccine, Aesculus Hippocastanum (Varivax) and Polio Vaccine INACT (IPV) all for Prophylactic vaccination.  On 01-Feb-2023, the patient received dose 3 of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine (Suspension for injection) (lot number, expiry date and strength not reported) via unknown route in unknown administration site. On 08-Aug-2023 patient also received a dose 4 of vaccine 2 weeks early from the recommended interval between doses 3 and 4 with no reported adverse event (inappropriate schedule of product administration) (latency: same day) (lot number C6013AA) (expiry date: 05-Jul-2024) (strength: standard, frequency: once) via intramuscular route in the right arm for Immunisation.  Reportedly, the previous administration of DAPTACEL was administered on 01-Feb-2023. The next dose was administered on 08-Aug-2023, 5 months and 18 days from the previous dose instead of the recommended 6-month interval. Originally, the caller indicated that the dose administered on 08-Aug-2023 was the 2nd dose. However, after further discussion, it was determined that this actually the 4th dose.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: the patient is asymptomatic; HCP reported a 66 year old female received the GARDASIL9 vaccine on 07/03/2024.; This spontaneous report was received from a medical assistant and refers to a 66-year-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 03-JUL-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate age at vaccine administration ). The patient was asymptomatic (no adverse events were reported).  Lot # is being requested and will be submitted if received.
Age: 14.0
Sex: U
Vaccine: MEN
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: first dose on 7/27/2021 and is now 14 years old and received the 2nd dose on 7/9/2024 with no reported adverse event; Initial information received on 11-Jul-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 14 years old and unknown gender patient who got first dose on 7/27/2021 and is now 14 years old and received the 2nd dose on 7/9/2024 with no reported adverse event after receiving vaccine meningococcal A-C-Y-W135 (t conj) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Jul-2021, the patient received dose 1 of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection lot number not reported via unknown route in unknown administration site. On 09-Jul-2024 he/she also received a dose 2 of vaccine with an unknown batch number via unknown route in unknown administration site (strength and expiration date: not provided) for Immunisation (inappropriate schedule of product administration) (latency- 3 years 11 months and 13 days). Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Module of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 54.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Injection site is red and warm to touch, referred to PCP for evaluation for cellulitis.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: MMR - Reddened and hardened area around injection site.     Varicella - Reddened and hardened area around injection site.
Age: 29.0
Sex: M
Vaccine: HEPA
Symptoms: Chills, Dizziness, Ear discomfort
Clinical narrative: PATIENT FILLED POP IN THE EAR AND FILLING DIZZI AND CHILL
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral, Arteriogram carotid, Balance disorder, Echocardiogram, Laboratory test
Clinical narrative: Patient received COVID vaccine booster 6/12/24 and on 6/21/24 began to have severe vertigo/disequilibrium.  Initially felt to have BPV, but did not respond to Epley and had disequilibrium no matter which direction moved her head. Was severe enough she had to go to hospital 6/21/24 and admitted 6/21/24 to 6/24/24 and had work up including carotid u/s. MRI and MRA of brain and neck, echo, monitoring, mx labs.  was discharged to SNF where she remained from 6/24/24 to 7/10/24.  hospital doctor suspected vestibulitis possibly due to COVID vaccine.  she is almost back to normal but still somewhat unsteady and had slow gradual improvement.  Unclear for certain that it was due to COVID vaccine, but possible and suspected
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging neck, Therapy non-responder, Ultrasound Doppler, Vertigo
Clinical narrative: Patient received COVID vaccine booster 6/12/24 and on 6/21/24 began to have severe vertigo/disequilibrium.  Initially felt to have BPV, but did not respond to Epley and had disequilibrium no matter which direction moved her head. Was severe enough she had to go to hospital 6/21/24 and admitted 6/21/24 to 6/24/24 and had work up including carotid u/s. MRI and MRA of brain and neck, echo, monitoring, mx labs.  was discharged to SNF where she remained from 6/24/24 to 7/10/24.  hospital doctor suspected vestibulitis possibly due to COVID vaccine.  she is almost back to normal but still somewhat unsteady and had slow gradual improvement.  Unclear for certain that it was due to COVID vaccine, but possible and suspected
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vestibulitis
Clinical narrative: Patient received COVID vaccine booster 6/12/24 and on 6/21/24 began to have severe vertigo/disequilibrium.  Initially felt to have BPV, but did not respond to Epley and had disequilibrium no matter which direction moved her head. Was severe enough she had to go to hospital 6/21/24 and admitted 6/21/24 to 6/24/24 and had work up including carotid u/s. MRI and MRA of brain and neck, echo, monitoring, mx labs.  was discharged to SNF where she remained from 6/24/24 to 7/10/24.  hospital doctor suspected vestibulitis possibly due to COVID vaccine.  she is almost back to normal but still somewhat unsteady and had slow gradual improvement.  Unclear for certain that it was due to COVID vaccine, but possible and suspected
Age: 29.0
Sex: F
Vaccine: PNC20
Symptoms: Allergy test, Contusion, Fall, Haemorrhage, Laboratory test
Clinical narrative: Patient had fainted and fell while walking out of the grocery store today. According to the Intern who administered the vaccine, as the patient walked into the vaccine room and sat down, patient looked nervous and scared chose to look away during the administration. Patient suffered from a bloody bruise on the side of forehead according to the employees. Paramedics were called and patient was attended to. Patient was sent to nearby hospital.
Age: 29.0
Sex: F
Vaccine: PNC20
Symptoms: Syncope
Clinical narrative: Patient had fainted and fell while walking out of the grocery store today. According to the Intern who administered the vaccine, as the patient walked into the vaccine room and sat down, patient looked nervous and scared chose to look away during the administration. Patient suffered from a bloody bruise on the side of forehead according to the employees. Paramedics were called and patient was attended to. Patient was sent to nearby hospital.
Sex: M
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: The consumer indicated that he was not given any information about how the vaccine should be transported or when it should be administered once out of refrigerator; This spontaneous report was received from a male patient of unknown age concerning to himself. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date around July 2023, the patient went to a store to get hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, lot #, expiration date, route of administration, anatomical location not provided); and he was handed the vaccine in a paper bag by the pharmacist. Then the patient would go to his health care professional (HCP) in order to be administered. The patient stated that he was not given any information about how the vaccine should be transported or when it should be administered once out of the refrigerator; only that he should put in the refrigerator as soon as he arrived home. He also reported that he was not told to keep out of the sun or if there was any protective covering on the vaccine.(product communication issue).  Moreover, the patient indicated that the vaccine was out of refrigerator for 15-20 minutes between the store and his house; and another 15 minutes between his house and the HCP. The patient went back to the store to complain and to get more information and he was told by the store that it was ok for the amount of time the vaccine was not refrigerated and the efficacy was not altered. Therefore, the patient proceeded to get the second and third vaccine from the store. The patient was inquiring if the vaccines would be effective or not. The dates of administration of any of the doses of the vaccine was unknown.
Age: 38.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse effects were reported; HCP called to report that an expired dose of MMR II was inadvertently administered to a patient on 7/12/2024. Expiration date of 5/25/2024.  Supported by post expiry memo.  See case 02634997.  No other adverse effects were reported. HCP refused to pr; This spontaneous report was received from a registered nurse referring to a 38-year-old male patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 12-JUL-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # w039699, expiration date 25-MAY-2024, 0.5 milliliter (route of administration not reported) for prophylaxis (expired product administered). No adverse event was reported.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Developed right elbow pain, lower arm pain. Experiencing pain when moving arm
Age: 80.0
Sex: M
Vaccine: PNC20
Symptoms: Cerebral ischaemia, Hemianopia homonymous, Ischaemic stroke, Occipital lobe stroke
Clinical narrative: Patient had the Prevnar20 vaccine on the 20th. Within 24 hours he presented to hospital with left homonymous hemianopsia related to focal ischemic stroke involving the right occipital region/right posterior cerebral artery. Uncertain whether this stroke is directly tied to Prevnar20 vaccine, but given proximity of its administration to his stroke we feel its wise to submit this information.
Age: 4.0
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Wrong patient received product
Clinical narrative: Patient came in for a well visit with her 12month old sister at the same time with the mom. Patient was due for priorix and varicella and her sister was due for hibrix, havrix, prevnar, Varivax, and Priorix. When i came to administer vaccines mom began having a conversation with me and i administered hibrix and havrix to patient before confirming i had the right patient.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Redness and irritation at injection site.
Age: 33.0
Sex: F
Vaccine: EBZR
Symptoms: Blood follicle stimulating hormone increased, Menopause, Oestradiol decreased
Clinical narrative: Pre menopause
Age: 1.58
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine product administered. No reported adverse outcomes/side effects.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood follicle stimulating hormone, Menopause, Oestradiol normal
Clinical narrative: pre menopause
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood follicle stimulating hormone, Menopause, Oestradiol normal
Clinical narrative: pre menopause
Age: 0.75
Sex: M
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A medical assistant failed to properly look at vaccines historical and gave both Vaxelis and Prevnar 20 when the patient was already up to date on vaccines and did not need the vaccines.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dyspnoea, Fatigue, Oxygen saturation decreased, Tachypnoea
Clinical narrative: Hospitalized 3/7/23-3/12/23 SOB, increased need for O2, fatigue, tachypneic, wheezing, dyspnea, a-fib,
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Hospitalized 3/7/23-3/12/23 SOB, increased need for O2, fatigue, tachypneic, wheezing, dyspnea, a-fib,
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site bruising, Injection site cellulitis, Injection site erythema, Injection site rash, Injection site vesicles
Clinical narrative: Patient seen here at the clinic this morning 7/19/24. Mom noticed raised red blistered area with some bruising  on outer part of left arm this morning 7/19/24 when patient woke up, left arm was not red and blistered when patient went to bed 7/18/24 per mom. diagnosed as cellulitis of left upper limb. given Rx for antibiotics, Keflex 250mg/5ml oral suspension to take twice daily for 7 days and Rx for Zovirax 5% topical ointment to apply to rash daily for 7 days.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pain, Skin mass, Skin warm
Clinical narrative: Per mom patient has a lump bigger than a quarter size its red and hot to touch and local pain
Age: 0.33
Sex: M
Vaccine: PNC20
Symptoms: Breath holding, Lethargy, Pallor
Clinical narrative: After the PCV20 vaccine was given, the baby had a pale face, was holding his breath, and was lethargic. He was stimulated by blowing into his face, calling out to him, and lightly tapping him. He was fine after a few seconds. Mother reports this also happened during his first set of immunizations, but not sure which vaccine did it. Mother informed us that she wanted to know which vaccine could have caused the reaction. Our MA gave Pentacel first , baby had no reaction.  After the PCV was given the baby had the reaction described above. We told mother to separate the PCV from other vaccines for future vaccines.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: New patient came in for a new patient 12 year well child exam and has a language barrier, speaks language. No immunization records were provided, and I verbally told my coworker to grab a 12+ Moderna out of the freezer and when she was getting the hearing and vision of patient, she heard me asking the interpreter if the patient has had an 11-year set of immunizations. My coworker administered the 6?11-month Moderna instead of the 12+. There were no adverse reactions prior to leaving office.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Herpes zoster, Neuralgia, Pain, Sensitive skin
Clinical narrative: Pt had Zoster sin herpete as evidenced by neuropathic burning pain and sensitivity across his right flank and torso arising after 1 day of lower thoracic pain, corresponding to T10.  He was examined on day 7 of symptoms, at which time it had started to improve.  Sensitivity did not cross midline.  No corresponding rash was present.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Injection site hypoaesthesia, Injection site pain
Clinical narrative: patient states experienced pain at injection site and then numbness at injection site
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Approx 1 week after injection I had significant pain and limited mobility in my arm from the elbow to the shoulder. Especially when my elbow is bent going into the shoulder and joint area.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Redness on arm started Wednesday, July 17, 2024 in the evening. July 18, 2024, redness worsened and was warm to the touch. July 19, 2024, redness is more pronounced, raised, hot to the touch and itching. Employee has used cold compresses and over the counter Benadryl in the evening to attempt relief with little success.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Chest discomfort, Joint stiffness
Clinical narrative: Patient reported feeling occasional "chest tightening like a squeezing sensation, that sometimes radiates to my right shoulder that started a day after I got the vaccine. It comes and goes but is not constant, but it does happen multiple times a day randomly.". Patient told to go to Urgent care and set an appointment with their Primary Care provider.
Age: 34.0
Sex: F
Vaccine: RAB
Symptoms: Blood glucose normal, Chills, Dizziness, Feeling abnormal, Paraesthesia
Clinical narrative: Patient describes feeling "a bit loopy, and the slightest bit dizzy and like not here if that makes sense" Patient taken to a room and placed on an exam table with feet up and able to recline. Vital signs, and sugar levels were taken and all normal. After 30 minutes patient reports feeling chills all over and "waves of tingles". 9-1-1 alerted and patient taken to emergency department.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Hypoaesthesia, Magnetic resonance imaging, Myalgia, Paraesthesia
Clinical narrative: Patient claims the vaccine was administered in the bicep muscle and not the shoulder muscle.  Pt complains of numbness/tingling in the fingers on the left arm, ongoing shoulder and bicep pain. The patient first sought medical treatment at urgent care in January 2024.  She was then referred to neurologist who completed x-ray, ultrasound, and MRI.  Per patient was not given any diagnoses regarding the incident.  Unknown treatments the patients has tried.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administered at inappropriate site, Ultrasound scan, X-ray
Clinical narrative: Patient claims the vaccine was administered in the bicep muscle and not the shoulder muscle.  Pt complains of numbness/tingling in the fingers on the left arm, ongoing shoulder and bicep pain. The patient first sought medical treatment at urgent care in January 2024.  She was then referred to neurologist who completed x-ray, ultrasound, and MRI.  Per patient was not given any diagnoses regarding the incident.  Unknown treatments the patients has tried.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired spikevax given on 7/17/2024  date expired on 6/16/2024
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Laboratory test normal, Pain in extremity, Paraesthesia
Clinical narrative: Extreme peripheral neurology with tingling and pain in legs and arms. Symptoms began roughly 4 hours after shot. Could not stand and was very weak and had to lay in bed for 2 days.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: One hour after vaccine administration the patient developed pain and swelling associated with itching at the site of vaccine administration. Patient was evaluated 48 hours after vaccine administration and was noted to have a rash of 4x4.5 inches, raised edematous, tender indurated and with erythema at the site of injections. The patient developed large local reaction following the administration of the above two vaccine in the right deltoid region. No other systemic signs or symptoms were noted. Treatment: Oral Prednisolone, Naprosyn, Hydroxyzine and topical betamethasone. vitals stable at the time of discharge.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site rash, Injection site swelling, Local reaction
Clinical narrative: One hour after vaccine administration the patient developed pain and swelling associated with itching at the site of vaccine administration. Patient was evaluated 48 hours after vaccine administration and was noted to have a rash of 4x4.5 inches, raised edematous, tender indurated and with erythema at the site of injections. The patient developed large local reaction following the administration of the above two vaccine in the right deltoid region. No other systemic signs or symptoms were noted. Treatment: Oral Prednisolone, Naprosyn, Hydroxyzine and topical betamethasone. vitals stable at the time of discharge.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Head injury, Syncope
Clinical narrative: Patient given Tdap, Hpv and MCV. Patient waiting for vaccine records when she had an episode of syncope while sitting on the treatment table.Patient hit back of head on the wall and was assisted by staff  lying position by staff with legs up. Nurse assist called overhead. MD and LVN RN and MA came to assist. Ice pack placed. Patient was alert and oriented within minutes. Monitored for 30 minutes and MD assess patient. RTC reviewed with mother and patient, verbalize understanding and follow up appointment made with PCP.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Injection site pruritus, Urticaria
Clinical narrative: Immediately following injection, pt felt injection site was itchy. 5 minutes post injection, hives broke out from shoulder down to wrist.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Herpes zoster
Clinical narrative: PATIENT STATED SHE GOT POSSILBLY GOT  SHINGLES FROM AREXVY  PER DOCTOR
Age: 0.33
Sex: F
Vaccine: HPV9, PNC20, RV5
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: wrong vaccine given, informed doctor, patient case sent to RN, called CDC and was informed that because of the child's age that the baby won't have a reaction.
Age: 0.42
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Child was given 2 doses of Vaxelis and Rotarix, instead of one dose of Vaxelis one dose of PCV15 and one dose of Rotarix.  No immediate or ongoing problems noted at this time.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Syringe issue, Underdose
Clinical narrative: Administered Vaccine (Kinrix Lot #:3RT93 EXP: 04/03/2026 NDC: 58160-812-43) Into left thigh after cleanning. Vaccine solution squirted out side of needle hub onto patients parent's neck. Pt did not receive full or half dose. Called Pharmacist. Pharmacist said to administer another dose. Patient is returning in 2 weeks to get Kinrix dose.
Age: 43.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red swollen skin surrounding the site of injection with c/o warmth to injection site and itching. Systemic Fever and chills.
Age: 43.0
Sex: F
Vaccine: PNC20
Symptoms: Pyrexia
Clinical narrative: Red swollen skin surrounding the site of injection with c/o warmth to injection site and itching. Systemic Fever and chills.
Age: 12.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered COVID vaccine vial was administered one week after the beyond use date. Our site received Comirnaty lot HD9876 on 10/2/23- past 10 weeks after the beyond use date. No adverse events occurred. Follow-up of patient clear.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: PATIENT NOTICED BUMPS ON BACK, THOUGHT WAS ACNE, PICKED A FEW AND THEN REALIZED WHOLE BACK WAS COVERED IN HIVES NOT LONG AFTER, HIVES APPEARED ON FRONT TORSO AS WELL. HIVES DID NOT HURT OR ITCH
Age: 62.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: was informed that patient wanted RSV vaccine. Did not query the  vaccines prior to given. patient went to outsode pharmacy and requested information. received a call on 7-19-2024 that patient had received the vaccine in 2023. after query I was able to pull the outside vaccine into the system.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Dysphagia, Pharyngeal swelling
Clinical narrative: could not swallow, throat swollen,
Age: 28.0
Sex: F
Vaccine: HPV9
Symptoms: Lip swelling, Pruritus, Skin irritation
Clinical narrative: patient states that around midnight (7/18/24). patient felt general itchiness with increased irritation on palms of both hands and soles of both feet. Shortly after that lips starting swelling. patient still with same symptoms in morning
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Client did not have any adverse events after incorrect vaccine was administered
Age: 18.0
Sex: M
Vaccine: HEPA, MMR, PNC20
Symptoms: Cold sweat, Fall, Injection site discomfort, Loss of consciousness, Pallor
Clinical narrative: After administering subq MMR vaccine patient stated that he really felt the medication go in. Few seconds later he said "wow" and starting to fall over. Patient turned pale, clammy. unresponsive a few seconds after that and woke up.
Age: 18.0
Sex: M
Vaccine: HEPA, MMR, PNC20
Symptoms: Unresponsive to stimuli
Clinical narrative: After administering subq MMR vaccine patient stated that he really felt the medication go in. Few seconds later he said "wow" and starting to fall over. Patient turned pale, clammy. unresponsive a few seconds after that and woke up.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Pharyngeal swelling, Rash, Urticaria
Clinical narrative: Patient is experiences raised bumps all over the body (hives) accompanied by minor swelling of the throat. Symptoms started approximately a day after administration of the shot and as of 7/19, symptoms have abided some but are still bothersome.  Tx: She was advised to take cetirizine in the morning and diphenhydramine in the evening as needed. Additionally, she was advised to topically apply hydrocortisone over the affected areas twice daily and topical lidocaine 4% as needed for itching and irritation.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nodule, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: PATIENT HAS KNOT IN LEFT ARM, REDNESS, SWELLING, PAIN, AND ITCHING , SYMTOMS STARTING ONE DAY AFTER AND SYMPTOMS CONTINUING FOR 4 DAYS AFTER VACCINATION
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site urticaria
Clinical narrative: Patient devloped 2cm area of hives, 1cm adjacent to injection site under latex free bandage within 5 mins of injection. patient given oral benadryl after provider looked at site. pt had no troubles breathing or facial swelling. bandaids were also removed.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Disability, Fatigue, Headache, Immediate post-injection reaction, Impaired work ability
Clinical narrative: Severe nausea, fatigue and headache starting immediately after receipt. Symptoms lasted until 7/3/24 and resulted in missed work time. Disability marked below due to inability to work. No permanent damage.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea
Clinical narrative: Severe nausea, fatigue and headache starting immediately after receipt. Symptoms lasted until 7/3/24 and resulted in missed work time. Disability marked below due to inability to work. No permanent damage.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Brain fog, Diabetes mellitus, Dyspnoea, Fatigue
Clinical narrative: Fever, can't take full breath, muscle pain, fatigue, gastric issues, myocarditis, brain fog, no smell, seizure, diabetes, on going hospital visits for 4 years, many specialists, many drugs and supplements
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Myalgia, Myocarditis, Pyrexia, Seizure
Clinical narrative: Fever, can't take full breath, muscle pain, fatigue, gastric issues, myocarditis, brain fog, no smell, seizure, diabetes, on going hospital visits for 4 years, many specialists, many drugs and supplements
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Crying
Clinical narrative: 3/15/24-sole vaccine given-cried for 3d, fever initially.  Hx from family 7/18/24:  Patient's cries started ~3 hours post Injection, increasing in severity gradually until peak at 24hrs with no decline post injection. At ~50 hrs, gradually decline until cessation at ~72 hours post injection. The only breaks were when the poor babe was so tired she fell asleep but woke up crying. It was awful. Slight fever (99 degrees F) was observed on day 1 (~12 hours post injection) and subsided following Tylenol (she was given 1.25mL per the dosing chart you provided us that day). It did not help other than lowering her fever.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Drug ineffective
Clinical narrative: potential lack of effect related to GARDASIL 9; No adverse event; This spontaneous report was received from a Nurse Practitioner (N.P) concerning a 33-year-old female patient with Crohn's disease.  The patient's pertinent concurrent conditions, medical history, historical drugs, drug allergies and concomitant medications were not reported.  On an unknown date (when the patient was 18 years old), the patient was vaccinated with a complete doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route, lot# and the expiration date were not reported) for prophylaxis.    Caller was a N.P who was requesting information on whether a patient with Crohn's disease that completed a series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) when she was 18 should be revaccinated now at the age of 33. During the call, the healthcare provider stated this patient had received repeat doses of other vaccines due to having Chron's disease. As they cannot confirm whether these repeat vaccines were MSD vaccines. During the conversation she indicated she thought there might be a decline in hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) titers due to the patient having Crohn's disease and would like to proceed with revaccination but stated she was not going to draw titers. AE was being filed at this time for potential lack of effect related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as well (labelled drug-disease interaction issue). Healthcare provider did not wish to provide any additional details related to this AE. No additional AE details available. No additional AE reported.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AEs were reported; Pharmacist reported that a patient received GARDASIL 9 doses 2 days apart.  The first dose was given on 6/20/2024 and the second dose was given on 6/22/2024.  The first and the second doses had the same lot and expiry.   No additional AEs were report; This spontaneous report was received from a pharmacist concerning a patient of unknown age. The patient's pertinent concurrent conditions, medical history, historical drugs, drug allergies and concomitant medications were not reported.     On 20-JUN-2024, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1965079, expiration date: 01-FEB-2026 (dose and route were not reported) for prophylaxis. On 22-JUN-2024, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1965079, expiration date: 01-FEB-2026 (dose and route were not reported) for prophylaxis. (Inappropriate schedule of product administration)  No additional AEs were reported, no further information provided (No adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Expired vaccine used; This spontaneous report was received from a consumer, concerning a patient of unknown age and gender. No information was provided regarding the patient's relevant medical history, concomitant medications, and drug reactions or allergies.  On 01-JUL-2024, the patient was inadvertently administered an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) (lot # X005838 has been verified to be a valid lot number, expiration date reported and upon internal review was established as 03-JUN-2024), as prophylaxis (dose, route of administration, anatomical location and vaccination scheme were not reported) (expired product administered). No adverse events were reported.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC; Vaccine administered after being improperly stored; This spontaneous report was received from a Medical Assistant concerning a 12-year-old female patient.   The patient's pertinent concurrent conditions, medical history, historical drugs, drug allergies and concomitant medications were not reported.    On 26-JUN-2024, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(route was not reported) lot # 1965079,expiration date: 01-FEB-2026, 0.5 milliliter for prophylaxis.    The Medical Assistant called to report a temperature excursion where the vaccine was administered to the patient (product storage error). The TE was 47.6 F for 0 hours and 54 Minutes and 0 Seconds. No previous temperature excursion. No additional AE/PQC (No adverse event). ; Sender's Comments:  US-009507513-2407USA001607:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: HCP called and reported an adult patient who received their first dose of GARDASIL 9 about one year ago and received their second dose of GARDASIL 9 on 07JUL2024.; No additional AE/PQC.; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown gender (age was not provided).  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On an unspecified date in 2023 (reported as about one year ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, exact dose, lot #, expiry date, and route of administration were not provided) administered for prophylaxis.  On 07-JUL-2023, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, exact dose, lot #, expiry date, and route of administration were not provided) administered for prophylaxis (Inappropriate schedule of product administration). Limited patient demographics provided. Operator of device was reported as health professional. No additional details were known by reporter. No additional adverse event or product quality complaint.  Lot # is being requested and will be submitted if received.