chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Condition aggravated, Depression, Fatigue, Malaise
Clinical narrative: I had just finished two months of 36 TMS treatments, for depression, and was no longer feeling depressed or tired... Until I received the COVID vaccine.  After that, my depression, fatigue, dysautonomia, and sleep issues quickly returned, and my chronic migraine worsened again. My TMS neurologist said the vaccine may have inflamed the lining of my brain, and recommended I return for 2 more months of TMS treatments, which I have just completed.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Sleep disorder
Clinical narrative: I had just finished two months of 36 TMS treatments, for depression, and was no longer feeling depressed or tired... Until I received the COVID vaccine.  After that, my depression, fatigue, dysautonomia, and sleep issues quickly returned, and my chronic migraine worsened again. My TMS neurologist said the vaccine may have inflamed the lining of my brain, and recommended I return for 2 more months of TMS treatments, which I have just completed.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Got the COVID shot with Pfizer, the Pfizer vaccine. Had symptoms of COVID/Had flu like symptoms and tested positive for Covid at the urgent care; Got the COVID shot with Pfizer, the Pfizer vaccine. Had symptoms of COVID/Had flu like symptoms and tested positive for Covid at the urgent care; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2024, outcome "unknown" and all described as "Got the COVID shot with Pfizer, the Pfizer vaccine. Had symptoms of COVID/Had flu like symptoms and tested positive for Covid at the urgent care". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Tested him with PCP (rapid test) and got the results in 10 minutes; Positive, notes: Tested positive for COVID at the urgent care. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 28Jun2024 to unknown date. Clinical course: Booster did not help.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: pentacel was administered with the DTap-IPV; however the lyophilized ACT-HIB was not administered with no adverse event; Initial information received on 25-Jun-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (health care professional).  This case involves an unknown age and unknown gender patient of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] was administered with the dtap-ipv; however the lyophilized act-hib was not administered with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (Powder and suspension for suspension for injection) (lot 4F1603A, Expiry date: 31-Jul-2026,  strength was unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunization) and pentacel was administered with the dtap-ipv; however the lyophilized act-hib was not administered with no adverse event (single component of a two-component product administered) (unknown latency).   Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to improperly administering the 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.  Batch/lot number requested, not available at the time of call. Caller refused follow-up.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was given PENTACEL but only administered the DTAP-IPV component with no reported adverse event; Initial information received on 27-Jun-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was given diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] but only administered the dtap-ipv 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 was given unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection (strength, lot number and expiry date not reported) via unknown route in unknown administration site for Immunization but only administered the dtap-ipv component with no reported adverse event (single component of a two-component product administered) (latency: same day). Information on the batch number was requested.  Reporter wants to get information if the dose was counted and if they can administer the ACTHIB component.   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: 1.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: administration of an expired PENTACEL product (with no reported adverse event); Initial information received on 27-Jun-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 1 years old male patient who was administered an expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] product (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 PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Immunisation.  On 26-Jun-2024, the patient received 0.5 ml TOTAL of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE  Powder and suspension for suspension for injection lot UJ957AB expiry date- 01-JUN-2024 via intramuscular route in the left thigh for immunization (strength unknown) (with no reported adverse event) (expired 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: 58.0
Sex: F
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: they administered a patient yf-vax im instead of subcutaneous with no reported adverse event; Initial information received on 28-Jun-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 58 years old female patient to whom administered YELLOW FEVER VACCINE - [YF-VAX] im instead of subcutaneous 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 suspect YELLOW FEVER VACCINE - Solution for injection lot UK050AA via intramuscular route in unknown administration site for immunization (strength, dose, expiry date unknown) instead of subcutaneous with no reported adverse event (incorrect route of product administration) (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.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not received yet; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-JUN-2024 The reporter stated that a patient presented to the pharmacy for the second Shingrix vaccination today.  Healthcare professional stated the patient received the first dose of Shingrix in 2021 (late dose). No further information is known such as DOB, initials, date of administration of first dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Dyspnoea, Rash, Rash pruritic
Clinical narrative: symptoms of memory loss.; shortness of breath; she has spots all over her body; She has them on her back and starting to itch like a regular rashes; This spontaneous case was reported by a patient family member or friend and describes the occurrence of AMNESIA (symptoms of memory loss.), DYSPNOEA (shortness of breath), RASH (she has spots all over her body) and RASH PRURITIC (She has them on her back and starting to itch like a regular rashes) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A, 032B21A and 03021B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AMNESIA (symptoms of memory loss.), DYSPNOEA (shortness of breath), RASH (she has spots all over her body) and RASH PRURITIC (She has them on her back and starting to itch like a regular rashes). At the time of the report, AMNESIA (symptoms of memory loss.), DYSPNOEA (shortness of breath), RASH (she has spots all over her body) and RASH PRURITIC (She has them on her back and starting to itch like a regular rashes) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-770532 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-770532:Same reporter, husband case
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: a patient recently received a COVID vaccine (unknown manufacturer) and now requires Paxlovid; a patient recently received a COVID vaccine (unknown manufacturer) and now requires Paxlovid; This is a spontaneous report received from a Pharmacist from medical information team.  A patient (age and gender not provided) received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "a patient recently received a COVID vaccine (unknown manufacturer) and now requires Paxlovid".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded.
Sex: U
Vaccine: COVID19
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: Chronic Inflammatory Demyelinating Polyneuropathy; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (medically significant), outcome "unknown", described as "Chronic Inflammatory Demyelinating Polyneuropathy".Clinical course: It was reported that the reporting patient met another person diagnosed with CIDP who said that their symptoms were noticed 2-3 months after vaccination, which the reporting patient worked back her timeline and discovered approximately the same timeline in symptoms to vaccination date.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400205229 same product/event, different patient/dose;
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Vertigo
Clinical narrative: Approximately a minute after receiving vaccine, donor stated she felt dizzy (room spinning). donor was assisted to bed and she laid down. Donor felt dizzy for approximately 3 minutes. Donor reported dizziness resolved after she laid down. donor was observed for the the remainder of the time. Donor denied dizziness retuning or any symptoms prior to leaving center.
Age: 1.08
Sex: M
Vaccine: PNC15
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of skin at the injection site. Parents contacted physician. Plan is to be seen by an allergist.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Injection site erythema
Clinical narrative: Nausea, fever, chills, severe aches and pains, extreme fatigue and weakness, nasal congestion, lack of appetite, unable to sleep first night following vaccine and then slept all day the next day.  Swelling, redness, a knot and the skin is hot at the injection site.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site swelling, Injection site warmth, Insomnia, Nasal congestion
Clinical narrative: Nausea, fever, chills, severe aches and pains, extreme fatigue and weakness, nasal congestion, lack of appetite, unable to sleep first night following vaccine and then slept all day the next day.  Swelling, redness, a knot and the skin is hot at the injection site.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia, Somnolence
Clinical narrative: Nausea, fever, chills, severe aches and pains, extreme fatigue and weakness, nasal congestion, lack of appetite, unable to sleep first night following vaccine and then slept all day the next day.  Swelling, redness, a knot and the skin is hot at the injection site.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Echocardiogram, Electrocardiogram, Heart rate irregular, Ventricular extrasystoles
Clinical narrative: Irregular heartbeat. Premature ventricular contractions. Been seeing a cardiologist since February of 2022. Now I take a beta blocker and magnesium oxide daily and I have annual visits to the cardiologist for checkups. PVCs have gotten worse over the years and need monitoring.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Headache, chills, severe pain, swelling and rash at injection site
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Arrhythmia, Atrial fibrillation, Cardiac failure congestive, Cardioversion
Clinical narrative: Two hours after the mRNA Covid shot I felt dizzy and sick at my stomach. I assumed that I would be better each day and didn't realize that this shot placed my heart in AFIB. Finally on 11/13/2022 I went to Urgent Care, and found that I was in congestive heart failure. I was sent to Hospital, where I was omitted for 2 days of testing. During this period I was informed that my heart was in AFIB and it was suggested that I find a cardiologist. I became a patient Dr of another Hospital. I received a cardioversion on 12/9/22 which lasted only 5 days. my heart then went into arrhythima and became normal on 12/28 2023 when iI received a flu shot!
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Laboratory test
Clinical narrative: Two hours after the mRNA Covid shot I felt dizzy and sick at my stomach. I assumed that I would be better each day and didn't realize that this shot placed my heart in AFIB. Finally on 11/13/2022 I went to Urgent Care, and found that I was in congestive heart failure. I was sent to Hospital, where I was omitted for 2 days of testing. During this period I was informed that my heart was in AFIB and it was suggested that I find a cardiologist. I became a patient Dr of another Hospital. I received a cardioversion on 12/9/22 which lasted only 5 days. my heart then went into arrhythima and became normal on 12/28 2023 when iI received a flu shot!
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 85.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Pt stated that his arm has been in pain ever since he got the shingrix. He has been to the dr and received pain medication but the pain has persisted
Age: 85.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Pt stated that his arm has been in pain ever since he got the shingrix. He has been to the dr and received pain medication but the pain has persisted
Age: 36.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/PQC; 36-year-old was inadvertently administered PROQUAD; This spontaneous report was received from a nurse referring to a 36 year old patient (product administered to patient of inappropriate age) unknown gender. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 27-JUN-2024, the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # X000998, expiration date: 08-JUL-2024 (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis.   No adverse event reported.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report TE where product was administered to a patient.; This spontaneous report was received from a medical assistant concerning a 6 months-old female patient. Patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided.  On 20-JUN-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #X025233, expiration date: 03-JUL-2025, administered orally for prophylaxis (strength was not provided).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent a temperature excursion of 47.6 F for 54 minutes. There was no previous excursion.  No adverse events.
Sex: U
Vaccine: RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/no PQC reported; VAXELIS and ROTATEQ were administered to a patient after being involved in a temperature excursion.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.    On 01-JUL-2024, the patient was vaccinated with the first doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, orally, lot number X025246 with expiration date: 31-MAR-2025 that has been verified to be valid (strength, specific dosage, vaccination scheme and anatomical site of application were not provided) and with diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (V419) injection, lot number U7899AA with expiration date: 31-AUG-2026 that has been verified to be valid (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided) both of them administered for prophylaxis (product storage error).  On an unknown date, the vaccine had a temperature excursion of 47.48 F for 10 minutes, 0 seconds. No additional adverse events or product quality complaint were reported. No previous temperature excursion reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2407USA001274:
Age: 11.0
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event happened following vaccinations. Patient stayed approx. 30 mins after vaccines given.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: felt like crap; This non-serious case was reported by a consumer and described the occurrence of feeling abnormal in a 62-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling abnormal (Verbatim: felt like crap). The outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.     It was unknown if the company considered the feeling abnormal to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2024AMR082962   Additional Information: GSK Receipt Date: 27-JUN-2024 A reporter reported that a patient felt like shit after first dose.; Sender's Comments:  US-GSK-US2024AMR082962:same patient
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Neuropathy peripheral, Pain, Pruritus
Clinical narrative: Patient reports flu-like symptoms starting on day of vaccination. About 8 days post vaccine she reports she developed "painful hives" and was itchy all over. The injection site developed a red patch. Patient also reports she developed neuropathy of 2nd left toe (next to big toe). Patient states she has gotten better when I spoke to her on  7/3/2024.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient reports flu-like symptoms starting on day of vaccination. About 8 days post vaccine she reports she developed "painful hives" and was itchy all over. The injection site developed a red patch. Patient also reports she developed neuropathy of 2nd left toe (next to big toe). Patient states she has gotten better when I spoke to her on  7/3/2024.
Age: 36.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event occurred.  This was a vaccine administration error.  A pediatric/adolescent dose of HepA vaccine was inadvertently given instead of an adult dose.  No adverse outcomes. A second dose of pediatric HepA was administered approx 10 minutes after first, to equal an adult dose (per doctor recommendations).
Age: 0.83
Sex: F
Vaccine: VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received a Varivax for traveling outside the country prior to 1 year of age.
Age: 28.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event occurred.  This was a vaccine administration error.  A pediatric/adolescent dose of HepA vaccine was inadvertently given instead of an adult dose.  No adverse outcomes. A second dose of pediatric HepA was administered approx 10 minutes after first, to equal an adult dose (per doctor recommendations).
Age: 2.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Pt was administered MenQuadfi instead of the Pneumococcal vaccine.  Dr., Medical Director was notified. MD stated this will not harm the child. Dr. stated it is alright to proceed and give the Pneumoccal vaccine. The parent was informed that the vaccine was given out of series and it would not cause any harm.  The parent wanted to proceed and have the child receive the Pneumococcal vaccine.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Electric shock sensation, Musculoskeletal disorder, Paraesthesia, Peripheral swelling
Clinical narrative: 1/17/23 vaccine given, 1/17/23 at 3 pm adverse reaction started - rash, arm swollen. 1/30/23 - prednisone. 2/3/23 - started benadryl. 2/20/23 - saw Dr. 2/21/23 - started pregabalin but stopped as it made her sicker. 3/6/23 - started with FNP. Symptoms included: itching, swollen arm, legs didn't work, blurred vision, joint pain, tingling from left to right chest, couldn't swish water in mouth, ears ringing, electrical feelings in all nerves. Still dealing with adverse effects.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Tinnitus, Vision blurred
Clinical narrative: 1/17/23 vaccine given, 1/17/23 at 3 pm adverse reaction started - rash, arm swollen. 1/30/23 - prednisone. 2/3/23 - started benadryl. 2/20/23 - saw Dr. 2/21/23 - started pregabalin but stopped as it made her sicker. 3/6/23 - started with FNP. Symptoms included: itching, swollen arm, legs didn't work, blurred vision, joint pain, tingling from left to right chest, couldn't swish water in mouth, ears ringing, electrical feelings in all nerves. Still dealing with adverse effects.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site rash
Clinical narrative: Rash in arm below injection site  Chills, Tiredness, headache
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Pt developed significant blood in stool and continued to  have bloody stools for 10 days.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Contraindication to vaccination
Clinical narrative: This is an Admin Error ( patient should have received live virus vaccine 12 months post-chemotherapy)
Age: 18.0
Sex: F
Vaccine: YF
Symptoms: Rash, Urticaria
Clinical narrative: patient developed hive-form rash to all extremities one day after receiving yellow fever vaccine. was seen in medical clinic on 7/5/2024, at which time hive-form rash persists
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given beyond BUD Covid Spikevax vaccine. No adverse symptoms observed.
Age: 90.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: just started to sweat and get light headed
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: After receiving the covid vaccine on 6/26/24, two days later patient started having  a fever and she has red circular patches where covid vaccine was given. She came in today; patches are starting to get better.
Age: 1.08
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pediarix was inadvertently given as 4th dose of DTaP.  Client was due for DTaP and HepB and appropriate intervals were met from previous doses.  Client is following an alternate vaccine schedule and mom requested Pediarix.  Nurse should have been more careful to note that Pediarix should not be given as 4th dose of DTaP.  Client had no adverse effects.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Hypersensitivity, Pain, Pyrexia, Radiculopathy
Clinical narrative: At 16hr: nerve irritation, primarily in back. At 24hr: full body nerve irritation and hypersensitivity. At 36hr: fever of 101.3 with body aches and headache. Used Motrin for fever control. Rest until better
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warmth noted to right upper arm, 1 day after administration of the vaccines.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Feeling hot, Peripheral coldness, Vomiting
Clinical narrative: AFTER VACCINE WAS GIVEN, SHE WAS ASKED TO STAY 15-20 MIN.TO SEE ANY REACTION.  ABOUT 10 MIN AFTER THE VACCINE, CX COMPLAINED DIZZINESS, HOT BUT COLD EXTREMITIES.  SHE WAS ASKED TO SIT DOWN STILL WITH HER HEAD PUT DOWN.  SHE VOMITED.  WE CALLED HER MOM REGARDING HER SITUATION AND CONTINUE MONITORED HER . AFTER THREW UP, SHE SAID SHE FELT MUCH BETTER.  WE OFFERED HER WATER AND A RICE CRACKER.  AS HER MOM ARRIVED ABOUT 20 MIN LATER, SHE FELT ALMOST BETTER. I TOLD HER MOM KEPT OBSERVE HER TO SEE ANY OTHER REACTION DEVELOP AND GO ER IF SEVERE.  I FOLLOWED UP WITH HER AFTER COUPLE HOURS AFTER SHE GOT HOME AND SHE SAID SHE IS COMPLETELY FINE
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Dyspnoea, Hypoaesthesia, Injection site pain, Malaise, Nausea
Clinical narrative: Patient reported 4 hours after injection her arm became sore and numb, the numbness traveled down to her hand. She states she felt sick, short of breath, and nausea/vomiting. Went to the ER and her O2 level was checked and it was normal and sent her home. As of today 7/5/24 she feels completely better, just sore at injection site.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Patient reported 4 hours after injection her arm became sore and numb, the numbness traveled down to her hand. She states she felt sick, short of breath, and nausea/vomiting. Went to the ER and her O2 level was checked and it was normal and sent her home. As of today 7/5/24 she feels completely better, just sore at injection site.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Fall, Unresponsive to stimuli
Clinical narrative: PATIENT WAS SEATED WHILE BEING VACCINATED AT APPROXIMATELY 1620 WITH ABOVE VACCINES. PATIENT STOOD UP AND WAS STANDING FOR APPROXIMATELY 3-5 MINUTES WHILE HIS SIBLING WAS BEING VACCINATED. PATIENT THEN FELL TO THE FLOOR PER MOM AND SHE YELLED OUT "HELP".  PATIENT WAS BREATHING BUT UNRESPONSIVE FOR APPROXIMATELY 30 SECONDS. DR AND 911 WERE CALLED. IMMUNIZATION STAFF MONITORED PATIENT UNTIL RESPONSE TEAM ARRIVED. PATEINT WAS THEN TRANSPORTED TO NEARBY HOSPITAL.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergic respiratory symptom, Dysphagia, Epistaxis, Eye pruritus, Nasopharyngitis
Clinical narrative: Had expected  arm aches - no big deal;  However, experienced cold/allergy symptoms day after shot, July 3.  runny nose, itchy eyes, took diphenhydramineon .  On July 4 -Thursday late afternoon, evening and July 5 (Friday) encountered inflamed tonsils, difficulty swallowing, will go to ER if symptoms don?t pass.  Also, had bloody nose Friday morning waking up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rhinorrhoea, Tonsillar inflammation
Clinical narrative: Had expected  arm aches - no big deal;  However, experienced cold/allergy symptoms day after shot, July 3.  runny nose, itchy eyes, took diphenhydramineon .  On July 4 -Thursday late afternoon, evening and July 5 (Friday) encountered inflamed tonsils, difficulty swallowing, will go to ER if symptoms don?t pass.  Also, had bloody nose Friday morning waking up.
Age: 54.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Rash, Rash macular, Swelling
Clinical narrative: Patient reported 30 minutes after immunization administration she noticed a rash and swelling on left side of neck. Patient administered ice and diphenhydramine herself, did not seek care. Patient states swelling resolved, some "splotchiness" was visible for another 3-4 hours. Denies difficulty breathing.
Age: 40.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site mass
Clinical narrative: Patient has small lump on deltoid at injection site. No redness or signs of infection.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site vesicles, Injection site warmth
Clinical narrative: Left leg: large erythematous, edematous, warm, slightly firm area extending to both sides of thigh around injection site, many blisters of varying sizes containing clear fluid from 9 o'clock to 2 o'clock on erythematous area, no pain with palpation, good mobility of leg; Right leg: quarter-size slightly warm erythematous area around injection site on thigh, no swelling.  She was seen on 7/3 and received Quadracel in her left thigh and Engerix B in her right thigh. Patient has not had the Quadracel vaccine before.        On 7/4 family noticed redness at the injection site that has progressively gotten worse.        Mom took Patient to UC yesterday and were told that it was a vaccine reaction and to put a cold compress on it.        Symptoms continued to worsen overnight (see pictures in chart) and now has very large, warm red area with blisters on left thigh around injection site. Mom does note there has been some improvement from the last picture that was sent to the present time.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No adverse event; vaccine administration error; client received MenA component only due to improper product mixing.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Patient returned to clinic today 7/5/2024 with Redness and swelling to the Left Deltoid. Noticeable bruise.  Patient has used cold packs but concerned with the swelling.  Client informed to administer Benadryl and continue to use icepacks every couple of hours for swelling.  Client informed that if swelling and redness continue to progress instead of decreasing they need to seek medical attention.  No difficulty breathing noted.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: LOCAL NUMBNESS IN THE LEFT RING AND PINKY FINGERS
Age: 65.0
Sex: M
Vaccine: PNC20, RSV
Symptoms: Albumin CSF abnormal, Antinuclear antibody negative, Asthenia, Bladder catheterisation, CSF cell count normal
Clinical narrative: Patient went to ER after developing lower extremity weakness 3 days after vaccines were given.  he was admitted  to hospital and work up was done. Discharge Diagnoses (Problems): 1. AIDP (acute inflammatory demyelinating polyneuropathy), 04/27/2024 2. Lower extremity paralysis, 04/27/2024  3. Urinary incontinence, 04/27/2024  4. Leg numbness, 04/27/2024  5. COPD (chronic obstructive pulmonary disease), 04/27/2024  Discharge Disposition  MRU inpatient rehab  Hospital Course :   65-year-old male with past medical history significant for depression, anxiety, Lumbar spinal stenosis s/p L4-5, L5-S1 fusion, chronic pain/pain management, left leg and bottom of left foot numbness, chronic right hip pain/OA, COPD, Insomnia, and HLD presented to ED with worsening bilateral leg numbness/weakness ascending up to abdomen. Patient has chronic left leg numbness due to spinal surgery he was getting progressively more weak associated with numbness which brought him to the hospital. Patient had received RSV and Prevnar 20 a week ago.  MRI brain was unremarkable. Patient had LP.  CSF studies consistent with cytoalbuminic dissociation with normal cell count.  Evaluated by Neurology, on IVIG day 4/5.  EMG c/w AIDP. IV steroids discontinued given that after discussion with two radiologists, there is no evidence of spinal cord compression. To check vital capacity and NIF every 8-12 hours. VC 21.65, NF -50. Telemetry due to risk of dysautonomia. Plasmapheresis deferred.  #AIDP  -Likely due to vaccine induced AIDP than Guillain-Barre syndrome  -Initially treated with Solu-Medrol and IVIG.   -Solu-Medrol discontinued as there is no evidence of spinal cord compression -Neurology followed.  Negative RPR, HIV, HTLV, Cx.  ANA, rheumatoid factor negative.  -s/p Day 5/5 IVIG ending 5/1/24   #Urinary incontinence    -Secondary to above continue Foley catheter #COPD (chronic obstructive pulmonary disease)    -Continued home medications while inpatient #Hyperlipemia     -Continued home medications while inpatient #Lumbar spondylosis #Insomnia  -Resumed trazodone while inpatient #Vitamin B12 deficiency    -s/p inpatient IM replete. Consider outpatient oral vit B12 #constipation, due to decreased ambulation and loss of feeling to push stool  -increased BM regimen with minor BM on 5/2  -KUB with normal gas pattern #depression and anxiety; adjustment disorder  -patient requested Cymbalta 30mg, started 5/3 evening  -prn xanax   Discharge to MRU   Per Neurology: MRI brain with no acute findings.  MRI cervical spine with multilevel disc bulg. No spinal cord changes or significant narrowing. Discussed with radiologist.  MRI of the thoracic and T-spine with and without contrast reported as unremarkable for spinal cord changes or significant narrowing. Discussed with radiologist.  CSF studies consistent with cytoalbuminic dissociation, protein 261 with normal white blood cell.  Elevated RBC is most likely traumatic in nature.  EMG RLE consistent with AIDP.
Age: 65.0
Sex: M
Vaccine: PNC20, RSV
Symptoms: CSF protein increased, CSF red blood cell count positive, CSF test abnormal, CSF white blood cell count negative, Cardiac telemetry
Clinical narrative: Patient went to ER after developing lower extremity weakness 3 days after vaccines were given.  he was admitted  to hospital and work up was done. Discharge Diagnoses (Problems): 1. AIDP (acute inflammatory demyelinating polyneuropathy), 04/27/2024 2. Lower extremity paralysis, 04/27/2024  3. Urinary incontinence, 04/27/2024  4. Leg numbness, 04/27/2024  5. COPD (chronic obstructive pulmonary disease), 04/27/2024  Discharge Disposition  MRU inpatient rehab  Hospital Course :   65-year-old male with past medical history significant for depression, anxiety, Lumbar spinal stenosis s/p L4-5, L5-S1 fusion, chronic pain/pain management, left leg and bottom of left foot numbness, chronic right hip pain/OA, COPD, Insomnia, and HLD presented to ED with worsening bilateral leg numbness/weakness ascending up to abdomen. Patient has chronic left leg numbness due to spinal surgery he was getting progressively more weak associated with numbness which brought him to the hospital. Patient had received RSV and Prevnar 20 a week ago.  MRI brain was unremarkable. Patient had LP.  CSF studies consistent with cytoalbuminic dissociation with normal cell count.  Evaluated by Neurology, on IVIG day 4/5.  EMG c/w AIDP. IV steroids discontinued given that after discussion with two radiologists, there is no evidence of spinal cord compression. To check vital capacity and NIF every 8-12 hours. VC 21.65, NF -50. Telemetry due to risk of dysautonomia. Plasmapheresis deferred.  #AIDP  -Likely due to vaccine induced AIDP than Guillain-Barre syndrome  -Initially treated with Solu-Medrol and IVIG.   -Solu-Medrol discontinued as there is no evidence of spinal cord compression -Neurology followed.  Negative RPR, HIV, HTLV, Cx.  ANA, rheumatoid factor negative.  -s/p Day 5/5 IVIG ending 5/1/24   #Urinary incontinence    -Secondary to above continue Foley catheter #COPD (chronic obstructive pulmonary disease)    -Continued home medications while inpatient #Hyperlipemia     -Continued home medications while inpatient #Lumbar spondylosis #Insomnia  -Resumed trazodone while inpatient #Vitamin B12 deficiency    -s/p inpatient IM replete. Consider outpatient oral vit B12 #constipation, due to decreased ambulation and loss of feeling to push stool  -increased BM regimen with minor BM on 5/2  -KUB with normal gas pattern #depression and anxiety; adjustment disorder  -patient requested Cymbalta 30mg, started 5/3 evening  -prn xanax   Discharge to MRU   Per Neurology: MRI brain with no acute findings.  MRI cervical spine with multilevel disc bulg. No spinal cord changes or significant narrowing. Discussed with radiologist.  MRI of the thoracic and T-spine with and without contrast reported as unremarkable for spinal cord changes or significant narrowing. Discussed with radiologist.  CSF studies consistent with cytoalbuminic dissociation, protein 261 with normal white blood cell.  Elevated RBC is most likely traumatic in nature.  EMG RLE consistent with AIDP.
Age: 65.0
Sex: M
Vaccine: PNC20, RSV
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Constipation, Culture negative, Diplegia
Clinical narrative: Patient went to ER after developing lower extremity weakness 3 days after vaccines were given.  he was admitted  to hospital and work up was done. Discharge Diagnoses (Problems): 1. AIDP (acute inflammatory demyelinating polyneuropathy), 04/27/2024 2. Lower extremity paralysis, 04/27/2024  3. Urinary incontinence, 04/27/2024  4. Leg numbness, 04/27/2024  5. COPD (chronic obstructive pulmonary disease), 04/27/2024  Discharge Disposition  MRU inpatient rehab  Hospital Course :   65-year-old male with past medical history significant for depression, anxiety, Lumbar spinal stenosis s/p L4-5, L5-S1 fusion, chronic pain/pain management, left leg and bottom of left foot numbness, chronic right hip pain/OA, COPD, Insomnia, and HLD presented to ED with worsening bilateral leg numbness/weakness ascending up to abdomen. Patient has chronic left leg numbness due to spinal surgery he was getting progressively more weak associated with numbness which brought him to the hospital. Patient had received RSV and Prevnar 20 a week ago.  MRI brain was unremarkable. Patient had LP.  CSF studies consistent with cytoalbuminic dissociation with normal cell count.  Evaluated by Neurology, on IVIG day 4/5.  EMG c/w AIDP. IV steroids discontinued given that after discussion with two radiologists, there is no evidence of spinal cord compression. To check vital capacity and NIF every 8-12 hours. VC 21.65, NF -50. Telemetry due to risk of dysautonomia. Plasmapheresis deferred.  #AIDP  -Likely due to vaccine induced AIDP than Guillain-Barre syndrome  -Initially treated with Solu-Medrol and IVIG.   -Solu-Medrol discontinued as there is no evidence of spinal cord compression -Neurology followed.  Negative RPR, HIV, HTLV, Cx.  ANA, rheumatoid factor negative.  -s/p Day 5/5 IVIG ending 5/1/24   #Urinary incontinence    -Secondary to above continue Foley catheter #COPD (chronic obstructive pulmonary disease)    -Continued home medications while inpatient #Hyperlipemia     -Continued home medications while inpatient #Lumbar spondylosis #Insomnia  -Resumed trazodone while inpatient #Vitamin B12 deficiency    -s/p inpatient IM replete. Consider outpatient oral vit B12 #constipation, due to decreased ambulation and loss of feeling to push stool  -increased BM regimen with minor BM on 5/2  -KUB with normal gas pattern #depression and anxiety; adjustment disorder  -patient requested Cymbalta 30mg, started 5/3 evening  -prn xanax   Discharge to MRU   Per Neurology: MRI brain with no acute findings.  MRI cervical spine with multilevel disc bulg. No spinal cord changes or significant narrowing. Discussed with radiologist.  MRI of the thoracic and T-spine with and without contrast reported as unremarkable for spinal cord changes or significant narrowing. Discussed with radiologist.  CSF studies consistent with cytoalbuminic dissociation, protein 261 with normal white blood cell.  Elevated RBC is most likely traumatic in nature.  EMG RLE consistent with AIDP.