chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Nasal Swab/ Covid tested Positive; Nasal Swab/ Covid tested Positive; This is a spontaneous report received from a Consumer or other non HCP.  A 20-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2020 as dose 1, single (Batch/Lot number: unknown), in right arm and in May2020 as dose 2, single (Batch/Lot number: unknown) at the age of 16 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "mast cell activation syndrome" (unspecified if ongoing), notes: None other than the above mentioned mast cell activation syndrome. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Nasal Swab/ Covid tested Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Positive.  Clinical Course: Results of tests and procedures for investigation of the patient: Date: Nov2023; Test: Unknown home test Result Positive; Lab Notes Nasal Swab. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the patient within 2 weeks of vaccination. Prior to vaccination, the patient has not been diagnosed with COVID-19. Since the vaccination the patient has been tested for COVID-19. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: MMR
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: No additional AE. No PQC.; pediatric patient was only administered a portion of the recommended dosage of MMRII on 03/14/2024 due to the patient pulling away during administration.; This spontaneous report was received from a registered nurse referring to a pediatric (child) patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-MAR-2024, the patient was only administered a portion of the recommended dosage of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, dose number, lot number, expiration date, and route of administration were not provided) due to the patient pulling away during administration (Underdose). The vaccine was administered for prophylaxis.  No adverse events were reported.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No additional events; Patient was originally scheduled to receive their first doses of MMR-II and VARIVAX, but instead patient was given their first dose of MMR-II and their first dose of PROQUAD; Patient was originally scheduled to receive their first doses of MMR-II and VARIVAX, but instead patient was given their first dose of MMR-II and their first dose of PROQUAD; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On 22-MAR-2024, the patient was schedule to receive the first vaccination dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX), however, on that day, the patient was inadvertently vaccinated by a health professional (unspecified) instead with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter once, and with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter once (lot #, expiration date, route of administration and anatomical location were not provided for any of them) both for prophylaxis (wrong product administered) (extra dose administered). No additional events were reported (no adverse event).  Lot # is being requested and will be submitted if received.
Sex: M
Vaccine: HPV4
Symptoms: Blindness, Hyperhidrosis, Immediate post-injection reaction, Mydriasis, Pallor
Clinical narrative: Loss of vision; Ringing/static in ears; Dilated pupils; Sweating; Pale skin and lips,; Information has been received from a physician regarding a Company Representative on 05-APR-2024. This spontaneous report refers to a 12-years-old male patient of an unknown race.   The patient's concurrent conditions, concomitant medications and medical history were not reported.   On 05-Apr-2024, the patient was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (exact dose, units, strength, route of administration, lot # and expiration date was not reported).  On the same date (05-Apr-2024), the patient immediately reacted with: Ringing/static in ears (Tinnitus), Dilated pupils (Mydriasis), Sweating (Hyperhidrosis), Pale skin and lips (Pallor), and Loss of vision (Blindness). That day, the Symptoms resolved in less than 10 minutes.   The causal relationship between syncopal crisis (Syncope) and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.  Upon internal review the event Loss of vision (Blindness) was determined to be Medically Significant.
Sex: M
Vaccine: HPV4
Symptoms: Syncope, Tinnitus
Clinical narrative: Loss of vision; Ringing/static in ears; Dilated pupils; Sweating; Pale skin and lips,; Information has been received from a physician regarding a Company Representative on 05-APR-2024. This spontaneous report refers to a 12-years-old male patient of an unknown race.   The patient's concurrent conditions, concomitant medications and medical history were not reported.   On 05-Apr-2024, the patient was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (exact dose, units, strength, route of administration, lot # and expiration date was not reported).  On the same date (05-Apr-2024), the patient immediately reacted with: Ringing/static in ears (Tinnitus), Dilated pupils (Mydriasis), Sweating (Hyperhidrosis), Pale skin and lips (Pallor), and Loss of vision (Blindness). That day, the Symptoms resolved in less than 10 minutes.   The causal relationship between syncopal crisis (Syncope) and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.  Upon internal review the event Loss of vision (Blindness) was determined to be Medically Significant.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: experienced pain in the right shoulder so severe that he is currently unable to abduct it without pain.The HCP is classifying this as a significant incapacity as the patient is unable to move his arm in proper motions without any pain in his shoulder; experienced pain in the right shoulder so severe that he is currently unable to abduct it without pain.The HCP is classifying this as a significant incapacity as the patient is unable to move his arm in proper motions without any pain in his shoulder; This spontaneous report was received from a physician concerning to a 68-year-old male patient. The patient's medical history was not reported. Historical vaccination included pneumococcal vaccine. The patient's concurrent conditions included  diabetes,  hypertension, and arthritis. Concomitant medications included insulin glargine (LANTUS), exenatide (BYDUREON), famotidine (PEPCID), pantoprazole, metformin, amlodipine, atorvastatin calcium (LIPITOR) and gabapentin.   On 04-APR-2024, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 0.5ml/ series, lot #X018273, expiration date: 07-OCT-2024, administered in the right arm as active immunization for the prevention of pneumococcal disease by a health professional (strength, and route of administration were not provided) (the product was disposed of an is not available for retrieval).  One day later on 05-APR-2024, the patient experienced pain in the right shoulder so severe that he was currently unable to abduct it without pain, the physician was classifying this as a significant incapacity as the patient was unable to move his arm in proper motions without any pain in his shoulder (vaccination site pain) (injected limb mobility decreased). Moreover, they prescribed him medication such as ibuprofen, a muscle relaxer, and topical pain medicine that were given on 08-APR-2024, as well as rest. A blood work would follow (had not been conducted yet), they also stated this was the first time the patient has had vaccines in a long time. At the time of reporting, he had not recovered from the events.   The causal relationship between the events and the suspect vaccine was not provided. The physician considered the events of vaccination site pain and injected limb mobility decreased to have caused significant disability/incapacity.
Sex: F
Vaccine: MMR, SMALL
Symptoms: Vaccination failure
Clinical narrative: she herself has had the MMR and she has no immunity, stating the MMR vaccine did not take for her.; This spontaneous report was received from the female patient of unknown age who refers to herself.  The patient had two children and both of them had different fathers. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, lot #, expiry date, route and site of administration were not provided). Other suspect therapies included smallpox vaccine (strength, dose, lot #, route and site of administration were not reported).  The patient stated that she had no immunity, stating the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and smallpox vaccines did not take for her (vaccination failure).  The reporter considered vaccination failure to be related to suspect vaccines.  This is one of several reports received from the same reporter.  Lot # is being requested and will be submitted if received.; Sender's Comments:  US-009507513-2404USA000602:
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: received dose 3 of Shingrix/ extra dose; 2nd dose received late; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 81-year-old female patient who received Herpes zoster (Shingrix) (batch number L7445, expiry date 22-NOV-2025) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2020).   On 02-FEB-2024, the patient received the 3rd dose of Shingrix. In MAY-2021, the patient received the 2nd dose of Shingrix. In MAY-2021, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose received late). On 02-FEB-2024, the patient experienced extra dose administered (Verbatim: received dose 3 of Shingrix/ extra dose). The outcome of the extra dose administered and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt Date: 01-APR-2024 The registered pharmacist (RPH) reported that the patient received a 3rd dose of Shingrix vaccine which led to an extra dose administered. Th patient received the 2nd dose of Shingrix vaccine later than the recommended interval, which led to lengthening of the vaccination scheduled. No other information provided. The reporter consented to follow up.
Age: 1.42
Sex: F
Vaccine: DTAPHEPBIP, HEP
Symptoms: Incorrect dose administered
Clinical narrative: patient whom received a dose of Pediarix and Engerix B at the same day/ Pediarix-extra dose of Hepatitis B; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 17-month-old female patient who received HBV (Engerix B) (batch number EM9E4, expiry date 17-FEB-2025) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number 77J49, expiry date 09-FEB-2026) for prophylaxis.   On 29-MAR-2024, the patient received Engerix B and Pediarix. On 29-MAR-2024, an unknown time after receiving Engerix B and Pediarix, the patient experienced overdose (Verbatim: patient whom received a dose of Pediarix and Engerix B at the same day/ Pediarix-extra dose of Hepatitis B). The outcome of the overdose 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: 01-APR-2024 The nurse called and asked for information about the patient who received a dose of Pediarix and Engerix B at the same day, which led to an overdose. The HCP (health care professional) asked for safety information regarding this case. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received first dose of Shingrix in March 2023 and the second dose was received on 01 April 2024; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2023).   On 01-APR-2024, the patient received the 2nd dose of Shingrix. On 01-APR-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received first dose of Shingrix in March 2023 and the second dose was received on 01 April 2024). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 02-APR-2024 The patient self-reported this case. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow-up.
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: patient got a second dose of Arexvy.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 77-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5X9JJ, expiry date 04-OCT-2025) for prophylaxis.   Concomitant products included RSV vaccine prot. subunit PreF3 (Arexvy).   On 01-APR-2024, the patient received the 2nd dose of Arexvy. On 01-APR-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: patient got a second dose of Arexvy.). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 04-APR-2024  Pharmacist stated she just found the error and has not yet informed the patient.  No further details provided. Pharmacist stated a patient got a second dose of Arexvy, which led to extra dose administered. Pharmacist granted permission for safety to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Hepatic failure, Psoriasis
Clinical narrative: LIVER SCN(LIVER FAILURE); psoriasis; This spontaneous report received from a consumer via a company representative concerned a 30 year old female. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were 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 Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient was diagnosed with psoriasis and liver (SCN) failure (Dose number in series 1), resulting for a need of liver transplant. The patient was looking for some information regarding reporting rates for the Covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the psoriasis and liver SCN(liver failure) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- Hepatic failure. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Pyrexia
Clinical narrative: 102 fever/The fever, was reported as 104F; This is a spontaneous report received from an Other HCP from medical information team and a sales representative.  A 2-month-old patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; diphtheria vaccine toxoid, hepatitis B vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (VAXELIS), as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 29Mar2024, outcome "recovered" (03Apr2024), described as "102 fever/The fever, was reported as 104F". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The 2-month-old was administered Prevnar 20 with Vaxelis (not Bexsero as initially reported). The fever, was reported as 104F and occurred the night (Friday, 29Mar2024) after being administered the two vaccines. On 03Apr2024 the fever has resolved.  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) will be requested and submitted if and when received.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment/COVID symptoms started 29Mar; COVID 19 Treatment/COVID symptoms started 29Mar; This is a spontaneous report received from a Consumer or other non HCP.  A 51-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1 (toppac); single (Lot number: HG4659) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Sleep Apnea" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: LORATADINE; FLUTICASONE. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Mar2024, outcome "not recovered" and all described as "COVID 19 Treatment/COVID symptoms started 29Mar". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: COVID symptoms started 29Mar. covid treatment with Paxlovid, Treatment start date was on 30Mar2024, Treatment stop date was on 03Apr2024. Patient had no known allergies. patient was also taking Loratadine and Fluticasone before he started taking Paxlovid.  No follow-up attempts are possible.
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: local site reaction of redness; local site reaction of warmth; local site reaction of tenderness; This is a spontaneous report received from a Nurse.  A female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Mar2024 as dose number unknown, single (Batch/Lot number: unknown), in left deltoid for immunisation. The patient's relevant medical history included: "Known sensitivity and history of reactions with other vaccines." (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset Apr2024, 6 days after the suspect product(s) administration, outcome "recovered" (08Apr2024), described as "local site reaction of redness"; VACCINATION SITE PAIN (non-serious) with onset Apr2024, 6 days after the suspect product(s) administration, outcome "recovered" (08Apr2024), described as "local site reaction of tenderness"; VACCINATION SITE WARMTH (non-serious) with onset Apr2024, 6 days after the suspect product(s) administration, outcome "recovered" (08Apr2024), described as "local site reaction of warmth". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site warmth, vaccination site pain.  Additional information: Patient presented 6 days post PCV20 vaccination with a local site reaction of redness, warmth, and tenderness. Patient denied fever, chills, or body aches. CBC was obtained and counts were normal. Cellulitis was ruled out. Site outlined and appeared less red and tender after 24 hours but encompassed a larger area of circumference.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Act-HIB was administered to a patient with no reported adverse event; Initial information received on 01-Apr-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Child of unknown gender who was administered expired HIB (PRP/T) Vaccine [ACT-HIB] 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 unknown dose of expired suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) with no reported adverse event (expired product administered) (latency: same day)  (lot number, expiry, strength not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  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: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram normal, Injection site paraesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Right sided chest pain that went away after a few months. Still experiencing Intermittent sharp tingling sensation that wraps down arm from injection site to pinky.. Worsens with weather changes and exercise. Arm strength has been noticeably weaker and not improving compared to left arm?s normal function.
Sex: F
Vaccine: VARZOS
Symptoms: Thrombocytopenia
Clinical narrative: Thrombocytopenia; This serious case was reported by a physician via call center representative and described the occurrence of thrombocytopenia in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced thrombocytopenia (Verbatim: Thrombocytopenia) (serious criteria GSK medically significant). The outcome of the thrombocytopenia was unknown.   The reporter considered the thrombocytopenia to be unrelated to Shingrix.   The company considered the thrombocytopenia to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 05-APR-2024 The physician mentioned that she wanted to report this as an adverse event since she believed there was no relation between the thrombocytopenia and Shingrix.   The healthcare professional did not provide the date of administration and other details since she had no access to the patient´s chart during the call. The healthcare professional just asked if there were previous reports of this thrombocytopenia after Shingrix vaccination.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: expired dose of daptacel was administered with no reported adverse event.; Initial information received on 08-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who was administered expired dose of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Apr-2024, the patient was administered expired 0.5 ml (dose 4) of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine (Suspension for injection) (lot C5980AB, expiry date: 06-Apr-2024, strength: standard, frequency: once) via intramuscular route in the thigh NOS (not otherwise specified) with no reported adverse event (expired product administered)( latency: same day) for Immunization.  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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Incorrect dose administered
Clinical narrative: Deathly sick after recieving too much Covid vaccine
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered
Clinical narrative: Patient given Priorix and Proquad during the same visit.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Injection site urticaria, Skin lesion, Urticaria
Clinical narrative: Patient woke up the following morning with Lesions, welt like, wheal/flare on   right arm, leg and buttocks  mother administerd benadryl po and they resolved,   Mother continued to administer benadryl q 6 hrs for the remainder of that day and they did not return
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis
Clinical narrative: Cellulitis of arm, left    -  Primary Absence of alarm findings on review of HPI and with PE. PE consistent with cellulitis. ATB therapy prescribed, reviewed follow-up precautions.     Relevant Medications   cephALEXin (KEFLEX) 500 MG capsule
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: It was noticed that this box of vaccine was expired after it has been administered.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: COVID 19 vaccine gave to patient on 4/11/24. Vaccine was expired (3/31/24). CMA who gave injection notified provider after injection was given. Provider notified patient. No adverse reaction was noted.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: nausea and vomiting and headache the next day. Received second dose of Bexsero in April and also had nausea, vomiting and headache the day after vaccination.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: vaccine was administered expired- exp date 3/25/24
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Blood test abnormal, Chills, Headache, Hypersensitivity, Lip swelling
Clinical narrative: Patient's mother called wanting information regarding vaccines given at 4/4/24 school clinic, as they were on the way to ER per their doctor's recommendation for illness. Per mom, patient developed fever, headache, and chills on Sunday April 7th. Then yesterday, April 9th, they noted body rash, that started on the face and chest, now spreading to her back, in addition to lip swelling. Patient's mother stated after calling the Doctor they were directed to the ER and were on their way at the time we spoke. After I verified the patient name, DOB, and parental name on file, I told patient's mother which vaccine was given (MenQuadfi) and the location (left deltoid). On 04/12/2024 at approx 9:35 AM, I spoke with patient's mom, to follow up on illness events that occurred earlier this week. She stats that in the ER patient was treated for an allergic reaction, though they were not able to conclude what from. She was treated with Epinephrine and patient's care was transferred from the Hospital ER to another specified ER. Patient's mother also states there were some irregularities to patient's blood work that were concerning but did not give specifics as to what. Mom states she personally didn't think the allergic reaction was from the vaccine, but they really didn't know. Patient's mother says patient's rash resolved while in the ER but started to come back yesterday.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Malaise, Pyrexia, Rash
Clinical narrative: Patient's mother called wanting information regarding vaccines given at 4/4/24 school clinic, as they were on the way to ER per their doctor's recommendation for illness. Per mom, patient developed fever, headache, and chills on Sunday April 7th. Then yesterday, April 9th, they noted body rash, that started on the face and chest, now spreading to her back, in addition to lip swelling. Patient's mother stated after calling the Doctor they were directed to the ER and were on their way at the time we spoke. After I verified the patient name, DOB, and parental name on file, I told patient's mother which vaccine was given (MenQuadfi) and the location (left deltoid). On 04/12/2024 at approx 9:35 AM, I spoke with patient's mom, to follow up on illness events that occurred earlier this week. She stats that in the ER patient was treated for an allergic reaction, though they were not able to conclude what from. She was treated with Epinephrine and patient's care was transferred from the Hospital ER to another specified ER. Patient's mother also states there were some irregularities to patient's blood work that were concerning but did not give specifics as to what. Mom states she personally didn't think the allergic reaction was from the vaccine, but they really didn't know. Patient's mother says patient's rash resolved while in the ER but started to come back yesterday.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Vaccination site pain
Clinical narrative: CHILD REPORTS VACCINE ADMINISTRATION SITE HAS BEEN HURS=TING SINCE DAY OF ADMINISTRATION.  ARM APPEARS TO BE RED AND SWOLLEN.  SWELLING AND TENDERNESS HAS SPREAD TO ELBOW.  CHILD ALSO STATES THAT ARM IS "ITCHY".
Age: 87.0
Sex: M
Vaccine: RSV
Symptoms: Apnoea, Death, Muscle rigidity, Seizure like phenomena, Tremor
Clinical narrative: Increased rigidity and tremors and then began to have seizure activity.  .. RResident physician notified.  Resident is Hospice due to dementia.  Continued on hospice care.  No seizure activity following initial 3 minutes .  Resident is DNR,  Resident with periods of apnea and then expired resident expired 4/11/24 at 15:14.  Resident physician, family and Medical Director notified.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Migraine, Postural orthostatic tachycardia syndrome, Tilt table test
Clinical narrative: POTS, chronic daily migraines
Age: 95.0
Sex: F
Vaccine: RSV
Symptoms: Blood glucose normal, Cold sweat, Dysarthria, Dysphagia, Facial paralysis
Clinical narrative: At 9 pm resident noted with eyes looking up and to the right, resident unable to focus her eyes resident noted with left side facial droop, resident noted to be trying to talk but speech is slurred, vs 134/82, 97.3, 88, 20, sp02=96%, resident noted to wet and clammy, bs=125, resident c/o back discomfort, unable to swallow any meds or fluids at this time, nurse supervisor made aware and in to assess.  Physician notified.
Age: 95.0
Sex: F
Vaccine: RSV
Symptoms: Gaze palsy, Musculoskeletal discomfort, Vision blurred
Clinical narrative: At 9 pm resident noted with eyes looking up and to the right, resident unable to focus her eyes resident noted with left side facial droop, resident noted to be trying to talk but speech is slurred, vs 134/82, 97.3, 88, 20, sp02=96%, resident noted to wet and clammy, bs=125, resident c/o back discomfort, unable to swallow any meds or fluids at this time, nurse supervisor made aware and in to assess.  Physician notified.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Enema administration, Intussusception
Clinical narrative: Pt seen in ED on 4/2/24 and diagnosed with intussusception reduced by air enema.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Syncope
Clinical narrative: Myocarditis, fainting
Age: 3.0
Sex: F
Vaccine: DTAP, DTPPVHBHPB, HEPA, MMR, PNC20, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: extra dose of DTaP given despite having Vaxelis administered. No noted adverse reactions.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Medical Assistant vaccinated/ administered wrong vaccine to patient. Patient vaccinated with DTAP- Infanrix instead of Hep A. No symptoms indicated at time of administration. Patient advised regards of error by provider.
Age: 6.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Angioedema, Face oedema, Injection site erythema, Injection site swelling, Laboratory test normal
Clinical narrative: Development of significant facial and lip angioedema with associated local erythema and swelling to vaccine sites with itching 30 hours after she received the vaccinations. Received benadryl, steroid shot and epinephrine in ED setting without any improvement. Swelling improved over 24 hours on its own.
Age: 63.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Fatigue, Feeling cold, Impaired work ability, Injection site cellulitis, Injection site infection
Clinical narrative: 63 Years old Female presents to clinic for injection site reaction.  Arm Pain and Tightness-  The chief complaint is localized pain and tightness in the arm following two vaccinations (pneumonia and tetanus) administered on Monday.   Post-Vaccination Symptoms-  The patient reports feeling sick for a day and a half after the vaccinations, with symptoms including feeling cold and fatigue. The patient slept for two hours in a chair and then went to bed, staying home from work the following day. The patient started feeling better by Wednesday afternoon.  Assessment/Plan      Cellulitis at injection site(Cellulitis, unspecified: L03.90)  Post-vaccination Reaction (Pneumonia and Tetanus Vaccines)   - Assessment: The patient presented with localized infection and discomfort at the injection site after receiving Pneumonia and Tetanus vaccines on Monday.  - Plan:    - Prescribe Amoxicillin 500 mg three times a day for 10 days.    - Advise the patient to apply heat/ice as needed.    - Instruct the patient to monitor the injection site and notify the clinic if there is no improvement by Monday.    - Report the adverse reaction to the vaccine injury place for further investigation.   Ordered:   Office Visit Level 3 Established 20-29 min 99213     Orders:   amoxicillin, 500 mg, = 1 cap, By mouth, TID, 10 Days, 30 cap, 0, 0, 04/22/24 11:16:00 CDT, Substitution Permitted, Pharmacy, 64, Height (inches) (Clinical), 04/12/24 10:59:00 CDT, in, 72.73, Weight (kg) (Clinical), 04/12/24 11:04:00 CDT, kg  This note was transcribed using a M Modal Fluency dictation program.  Due to this, despite review, note may contain grammatical errors, omissions, sound-a-like words, homonyms, or other idiosyncrasies that do not convey or communicate my full intent. Please feel free to contact me for any clarifications or questions.
Age: 63.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Injection site reaction, Malaise, Pain in extremity
Clinical narrative: 63 Years old Female presents to clinic for injection site reaction.  Arm Pain and Tightness-  The chief complaint is localized pain and tightness in the arm following two vaccinations (pneumonia and tetanus) administered on Monday.   Post-Vaccination Symptoms-  The patient reports feeling sick for a day and a half after the vaccinations, with symptoms including feeling cold and fatigue. The patient slept for two hours in a chair and then went to bed, staying home from work the following day. The patient started feeling better by Wednesday afternoon.  Assessment/Plan      Cellulitis at injection site(Cellulitis, unspecified: L03.90)  Post-vaccination Reaction (Pneumonia and Tetanus Vaccines)   - Assessment: The patient presented with localized infection and discomfort at the injection site after receiving Pneumonia and Tetanus vaccines on Monday.  - Plan:    - Prescribe Amoxicillin 500 mg three times a day for 10 days.    - Advise the patient to apply heat/ice as needed.    - Instruct the patient to monitor the injection site and notify the clinic if there is no improvement by Monday.    - Report the adverse reaction to the vaccine injury place for further investigation.   Ordered:   Office Visit Level 3 Established 20-29 min 99213     Orders:   amoxicillin, 500 mg, = 1 cap, By mouth, TID, 10 Days, 30 cap, 0, 0, 04/22/24 11:16:00 CDT, Substitution Permitted, Pharmacy, 64, Height (inches) (Clinical), 04/12/24 10:59:00 CDT, in, 72.73, Weight (kg) (Clinical), 04/12/24 11:04:00 CDT, kg  This note was transcribed using a M Modal Fluency dictation program.  Due to this, despite review, note may contain grammatical errors, omissions, sound-a-like words, homonyms, or other idiosyncrasies that do not convey or communicate my full intent. Please feel free to contact me for any clarifications or questions.
Age: 50.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reaction of patient observed. Patient was accidentally given hepatitis A vaccine instead of hepatitis B. Patient is immune to hep A based on titer lab results, so she did not need the hepatitis A vaccine.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Back pain, Fatigue
Clinical narrative: back pain, fatigue
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Cubital tunnel syndrome, Hypoaesthesia, Muscular weakness, Nerve injury, Pain in extremity
Clinical narrative: Both shots administered in left arms. First shot just some soreness?but second shot, the next morning I woke up and couldn?t feel my left pinky, and part of my ring finger?lost grip strength, and had pain/tingling  from my elbow to my fingers?was diagnosed as Cubital tunnel syndrome ulnar nerve damage
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Both shots administered in left arms. First shot just some soreness?but second shot, the next morning I woke up and couldn?t feel my left pinky, and part of my ring finger?lost grip strength, and had pain/tingling  from my elbow to my fingers?was diagnosed as Cubital tunnel syndrome ulnar nerve damage
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: upper left arm redness, swelling, hot to touch.. 5 inches in diameter
Age: 9.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Patient was given the Menveo 1 vial instead of getting th e 2-vial vaccine. Patient has no issues with the vaccine. Parents and provider were notified of error.  Vaccine does count and does not need to be repeated.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Fatigue, Nausea
Clinical narrative: Nausea, dizziness, weakness, exhaustion, loss of appetite. Arm pain. Duration of nausea and weakness approximately 24 hours. Some dizziness persists on 4/12/2024.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Nausea, dizziness, weakness, exhaustion, loss of appetite. Arm pain. Duration of nausea and weakness approximately 24 hours. Some dizziness persists on 4/12/2024.
Age: 19.0
Sex: F
Vaccine: HPV9, TD, HPV9, TD
Symptoms: Asthenia, Balance disorder, Dyspnoea, Lethargy
Clinical narrative: Patient feeling well before vaccinations. After vaccinations she became unsteady on her feet and weak. She later progressed to being lethargic. Vitals were taken. Clients initial set of vitals were, Blood Pressure: 124/94, Heart rate: 102 , and Pulse ox: 95%. RN provided cool compresses and called 911. After client took a heavy breath oxygen was provided via simple mask at a rate of 2.5 liters. Patient's pulse ox levels remained between 95% and 99%. First responders arrived gave report and transferred care. RN observed First Responders administer epinephrine and Benadryl. First responders reported clients vitals stable and transported patient to hospital.
Age: 19.0
Sex: F
Vaccine: HPV9, TD, HPV9, TD
Symptoms: Acute respiratory failure, Anaphylactic reaction, Anaphylaxis treatment, Angiogram pulmonary, Blood potassium decreased
Clinical narrative: Patient feeling well before vaccinations. After vaccinations she became unsteady on her feet and weak. She later progressed to being lethargic. Vitals were taken. Clients initial set of vitals were, Blood Pressure: 124/94, Heart rate: 102 , and Pulse ox: 95%. RN provided cool compresses and called 911. After client took a heavy breath oxygen was provided via simple mask at a rate of 2.5 liters. Patient's pulse ox levels remained between 95% and 99%. First responders arrived gave report and transferred care. RN observed First Responders administer epinephrine and Benadryl. First responders reported clients vitals stable and transported patient to hospital.
Age: 19.0
Sex: F
Vaccine: HPV9, TD, HPV9, TD
Symptoms: Chest X-ray, Computerised tomogram head, Endotracheal intubation, Fall, Hypoxia
Clinical narrative: Patient feeling well before vaccinations. After vaccinations she became unsteady on her feet and weak. She later progressed to being lethargic. Vitals were taken. Clients initial set of vitals were, Blood Pressure: 124/94, Heart rate: 102 , and Pulse ox: 95%. RN provided cool compresses and called 911. After client took a heavy breath oxygen was provided via simple mask at a rate of 2.5 liters. Patient's pulse ox levels remained between 95% and 99%. First responders arrived gave report and transferred care. RN observed First Responders administer epinephrine and Benadryl. First responders reported clients vitals stable and transported patient to hospital.
Age: 19.0
Sex: F
Vaccine: HPV9, TD, HPV9, TD
Symptoms: Lymphocyte count increased, Monocyte count increased, Respiratory arrest
Clinical narrative: Patient feeling well before vaccinations. After vaccinations she became unsteady on her feet and weak. She later progressed to being lethargic. Vitals were taken. Clients initial set of vitals were, Blood Pressure: 124/94, Heart rate: 102 , and Pulse ox: 95%. RN provided cool compresses and called 911. After client took a heavy breath oxygen was provided via simple mask at a rate of 2.5 liters. Patient's pulse ox levels remained between 95% and 99%. First responders arrived gave report and transferred care. RN observed First Responders administer epinephrine and Benadryl. First responders reported clients vitals stable and transported patient to hospital.
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Patient reports redness, swelling, and itching 7 days after receiving vaccination.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Fall
Clinical narrative: The patient declined to sit for a few minutes after vaccination and proceeded to leave.  She departed the clinic and was approximately halfway down the hall to the exit of the building when her mother reported that she said that she felt dizzy and immediately fell to the floor.  On staff arrival, she was alert and oriented and reported that she had caught her lip during the fall but there was no outward appearance of injury.  The offer of medical intervention was declined, and the patient was able to get up independently with standby assistance only.  She was assisted to their vehicle by wheelchair.  A follow up call was placed on 4/12/2024 and the mother reported that she was fine and was at school.
Age: 1.5
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Vaccine that was given was 11 days past expiration date. Mother was notified that the vaccine that was given had been expired. Provider was notified as well. Patient will need to get another dose as this is not considered a valid dose and Mother is aware. There were no signs and symptoms from the date of vaccination until today 04/12/2024
Age: 15.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Head injury, Syncope
Clinical narrative: Translation used, Patient had received vaccine, patient was walking toward the door to exit the clinic, patient had syncope episode and hit her head on light switch, mom caught patient. Vital signs were taken WNL, EMS was called, EMS arrived, vital signs were taken WNL, EMS assessed patient, offered for patient to be transported to the hospital, parent and patient declined transportation to ED for further evaluation, Parent wanted to watch patient at home.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC15, VARCEL
Symptoms: Cough, Feeling hot, Insomnia, Poor feeding infant, Rash
Clinical narrative: Mom states on 4/10/24, child developed cough and felt very hot; no thermometer to take temperature; on 4/11/24, she developed a pruiritic, pink, raised papular rash to trunk of body and forehead and did not sleep last night and won't take bottle but will breastfeed. No signs or redness or edema to vaccine sites. Skin cool and dry today and child smiling. Called pediatrician and informed they could not work child in today and wanted mom to take her to ER or urgent care. Provided mom contact information for Urgent Care and she states she is going there when she leaves here.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC15, VARCEL
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Mom states on 4/10/24, child developed cough and felt very hot; no thermometer to take temperature; on 4/11/24, she developed a pruiritic, pink, raised papular rash to trunk of body and forehead and did not sleep last night and won't take bottle but will breastfeed. No signs or redness or edema to vaccine sites. Skin cool and dry today and child smiling. Called pediatrician and informed they could not work child in today and wanted mom to take her to ER or urgent care. Provided mom contact information for Urgent Care and she states she is going there when she leaves here.