chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: administered after temperature excursions; no adverse event; This spontaneous report was received from Other Health Professional and refers to a currently 3-months-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # y003145, expiration date: 12-SEP-2026, administered for prophylaxis (strength, dose, dose number, frequency, scheme, anatomical location, and route of administration were not provided); and on an unknown date,  the patient started therapy with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 2052020, expiration date: 10-MAR-2026, administered orally for prophylaxis (strength, dose, dose number, frequency, and scheme were not provided); (Improper storage of product in use). The vaccine underwent a temperature excursion during 1h 30 m under 60 Fahrenheit Degrees. No previous temperature excursions.   No adverse event reported.   This case was previously reported as non-valid due to lack of individual patient identifiers, but upon follow-up information on 17-JAN-2025, was updated to valid.   This case was one of three from the same reporter. ; Sender's Comments:  US-009507513-2501USA004754:Original Case : 2501USA004754 US-009507513-2502USA000138:Original Case : 2501USA004754
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; Patient received the first dose on October 19, 2023 and the second dose in the series on 12/20/2024.; This spontaneous report was received from a registered pharmacist and refers to a 28-year-old male patient. No information regarding the patient's medical history, concurrent conditions, concomitant medication, drug reactions or allergies was provided.  On 19-OCT-2023, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (lot #, expiration date, route and site of administration were not reported) for prophylaxis.   On 20-DEC-2024, he received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (lot #, expiration date, route and site of administration were not reported) for prophylaxis (Inappropriate schedule of product administration). No additional adverse event was reported.
Age: 0.17
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: 2 month old patient was administered a dose of VARIVAX on 11/8/2024 "due to an error in their vaccine storage".; No additional AE; 2 month old patient was administered a dose of VARIVAX on 11/8/2024 "due to an error in their vaccine storage".; This spontaneous report was received from a physician assistant via an office manager and refers to a 2-month-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 08-NOV-2024 at the age of 2 months, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter, lot # Y011712 was confirmed to be valid, expiration date 02-JUL-2026 (route and site of administration were not provided) for prophylaxis, due to error in vaccine storage (Product administered to patient of inappropriate age, Product storage error). It was confirmed that the patient did not experience any medical concerns or symptoms. No additional adverse event reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure and shingles to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 19-JAN-2025 The reporter reported that did not stress at all was a way not to get them and no vaccines.  The number one cause of it everyone he/she know get the Shingrix shot and they got Shingles. Just like Covid vaccines all got Covid and it was bad Covid vaccine was to bring on the virus and did that makes no sense. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: got her 1st dose of Twinrix on 7/1/2024...she is scheduled coming today; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 01-JUL-2024, batch number:H7RF72 and expiry date:17-JAN-2026).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: got her 1st dose of Twinrix on 7/1/2024...she is scheduled coming today). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-JAN-2025 The reporter called to inform that they had a patient, she got her 1st dose of Twinrix on 7th January 2024 and she was scheduled coming at the time of reporting for the 2nd dose, she's long overdue. Did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Twinrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Havrix; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received HAV (Havrix) (batch number 55M72, expiry date 13-DEC-2024) for prophylaxis.   On 07-JAN-2025, the patient received the 1st dose of Havrix. On 07-JAN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: received an expired dose of Havrix). The outcome of the expired vaccine used 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: 07-JAN-2025 Reporter explained that a patient received an expired dose of Havrix on January 7th 2025 and vaccine was expired on December 13th 2024 which led to expired vaccine used. It was the first dose of a Hepatitis A vaccine for the patient.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Priorix intramuscular route instead of subcutaneous route; This non-serious case was reported by a nurse via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 48-year-old female patient who received MMR (Priorix) (batch number 342rc, expiry date 01-MAY-2025) for prophylaxis.   On 09-JAN-2025, the patient received Priorix (intramuscular). On 09-JAN-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix intramuscular route instead of subcutaneous route). The outcome of the subcutaneous injection formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-JAN-2025 The reporter reported that a staff member gave Priorix intramuscular route instead of subcutaneous route at the time of reporting, which led to subcutaneous injection formulation administered by other route. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: incomplete course of vaccination; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included brain injury. Previously administered products included Shingrix (Patient received first dose couple of years ago).   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: incomplete course of vaccination). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 09-JAN-2025 The patient received the first dose of Shingrix a couple of years ago, and not yet received the second dose, which led to incomplete course of vaccination.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: Incomplete dose/some came out of it; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 94SE2, expiry date 09-AUG-2026) for prophylaxis.   On 15-JAN-2025, the patient received the 1st dose of Shingrix. On 15-JAN-2025, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: Incomplete dose/some came out of it). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 15-JAN-2025 A pharmacy intern called to inform that a patient came for her 1st dose of the Shingrix vaccine and when it was being administered, there was an issue with the syringe, and some came out of it, which led to incomplete dose administered. According to the reported, that happened earlier that day. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: she administered the pentacel to a patient, but when she administered it, she only gave the diluent with no reported adverse event; Initial information received on 30-Jan-2025 regarding an unsolicited valid non-serious case received from a Other health professional.  This case involves, a 3 months old female patient who was administered the Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel], but when she administered it, she only gave the diluent 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 Hepatitis B Vaccine (HEP B VAX); Pneumococcal Vaccine and Rotavirus Vaccine for Immunization.  On 17-Jan-2025, the patient was administered 0.5 ml dose of the (Standard) Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (once) (lot UK022AA, expiry date: 30-Apr-2025) (unknown route) in the right thigh for immunization, but when she administered it, she only gave the diluent with no reported adverse event (single component of a two-component product administered) (latency-same day).  Reportedly, The MA (Medical Assistant) did not mix it with the compound. The patient didn't get that part of the vaccine.   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: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasal discomfort, Pain in extremity, Pyrexia, Rhinorrhoea, Skin warm
Clinical narrative: Arm remains extremely sore and hot to touch on Day 5. Started with  runny nose yesterday (day 4). Awoke a 2am this morning (day 5) with sneezing every few minutes. Inside nose/sinus is irritated with constant thin discharge from left nostril (clear, thin). Irregular low grade fever since late evening day 1. Symptoms ongoing.  Annoying but no life threat. Symptoms lasting longer than published information, with new ones presenting. Treating with Tylenol, advil, ice to site and rest.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Sneezing
Clinical narrative: Arm remains extremely sore and hot to touch on Day 5. Started with  runny nose yesterday (day 4). Awoke a 2am this morning (day 5) with sneezing every few minutes. Inside nose/sinus is irritated with constant thin discharge from left nostril (clear, thin). Irregular low grade fever since late evening day 1. Symptoms ongoing.  Annoying but no life threat. Symptoms lasting longer than published information, with new ones presenting. Treating with Tylenol, advil, ice to site and rest.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: the first made me feel sick for a few days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 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 sickness (Verbatim: the first made me feel sick for a few days). The outcome of the sickness was resolved.   The reporter considered the sickness to be related to Shingles vaccine.     The company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 18-JAN-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she just got his/her second vaccine yesterday (day before reporting). The reporter mentioned that first vaccine made him/her feel sick for a few days. The reporter hoping this one was not as bad but, he/she was sure the side effects were a drop in the bucket compared to shingles. The patient mentioned that the thought of getting shingles was terrifying.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema multiforme, Rash
Clinical narrative: Reported Symptoms: 1015218:ERYTHEMA MULTIFORME; 10037844:RASH;  Narrative: Other Relevant HX: Other:
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema multiforme, Injection site rash, Pruritus, Rash, Rash pruritic
Clinical narrative: Reported Symptoms: 10015218:ERYTHEMA MULTIFORME; 10023092:ITCHY RASH; 10037087:PRURITUS; 10037844:RASH; 10074684:RAISED RASH; 10080560:SKIN WEEPING; Narrative: Other Relevant HX: Other: RASH COVERED FROM INJECTION SITE DOWN TO WRIST. VERY ITCHY, RAISED, BUMPS; SOME WHEEPING WHERE BUMPS WERE SCRATCHED. LASTED APPROX 1 WEEK.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin weeping
Clinical narrative: Reported Symptoms: 10015218:ERYTHEMA MULTIFORME; 10023092:ITCHY RASH; 10037087:PRURITUS; 10037844:RASH; 10074684:RAISED RASH; 10080560:SKIN WEEPING; Narrative: Other Relevant HX: Other: RASH COVERED FROM INJECTION SITE DOWN TO WRIST. VERY ITCHY, RAISED, BUMPS; SOME WHEEPING WHERE BUMPS WERE SCRATCHED. LASTED APPROX 1 WEEK.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC20
Symptoms: Lip swelling
Clinical narrative: Reported Symptoms: 10024570:LIP SWELLING; Narrative: Other Relevant HX: Other: Lip Swelling
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Angioedema, Lip swelling
Clinical narrative: Reported Symptoms: 10002424:ANGIOEDEMA; 10024570:LIP SWELLING; Narrative: Other Relevant HX: Other: LIP SWELLING
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Angioedema, Cellulitis, Erythema multiforme, Myalgia, Oedema peripheral
Clinical narrative: Reported Symptoms: 10002424:ANGIOEDEMA; 10015218:ERYTHEMA MULTIFORME; 10034879:PHLEBITIS; 10037087:PRURITUS; 10037844:RASH;   Narrative: Patient had no complications after the vaccine was administered on 1/29/2018 and went home after. Patient then called the clinic, per telemedicine, that same day and reported he had developed increasing increasing generalized pain over his deltoid, triceps, bicep are with warmth and swelling. Patient came into the clinic 1/30/2018 and showed continuous edema in a rectangular area covering now all of his bicep and to a less extent triceps, with no local injection site that could be identified at that time, instead a generalized area of either cellulitis or phlebitis to be developed. No fever chills or other complaints from the patient. Other Relevant HX: Other:
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Phlebitis, Pruritus, Rash, Skin warm
Clinical narrative: Reported Symptoms: 10002424:ANGIOEDEMA; 10015218:ERYTHEMA MULTIFORME; 10034879:PHLEBITIS; 10037087:PRURITUS; 10037844:RASH;   Narrative: Patient had no complications after the vaccine was administered on 1/29/2018 and went home after. Patient then called the clinic, per telemedicine, that same day and reported he had developed increasing increasing generalized pain over his deltoid, triceps, bicep are with warmth and swelling. Patient came into the clinic 1/30/2018 and showed continuous edema in a rectangular area covering now all of his bicep and to a less extent triceps, with no local injection site that could be identified at that time, instead a generalized area of either cellulitis or phlebitis to be developed. No fever chills or other complaints from the patient. Other Relevant HX: Other:
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pruritus, Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: Approximately one hour after receiving the flu shot patient developed itchiness to body, and severe headache. Hands and feet very itchy. Patient went to ER for evaluation. Other Relevant HX: Other: RASH
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Reported Symptoms: 10064366: EXTRA DOSE ADMINISTERED; Narrative: Patient received first dose of COVID-19 Moderna vaccine on 02/26/2021, Patient received second dose of COVID-19 Moderna vaccine on 03/20/2021. Patient returned to clinic on 04/17/2021 to receive what he believed was his second dose of COVID-19 vaccine. A third dose of the two dose series was administered prior to the chart being reviewed for appropriateness. When asked for his vaccination card, Patient produced two cards indicating two doses on two different dates had been given as well. These dates were then confirmed through accurate reporting in the patient's chart. Other Relevant HX:  Other: Third dose of two dose series given
Age: 72.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: whole body rash with itching benadryl was helpful had itching with 2016 vaccine but no rash Other Relevant HX: Other:
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Tremor
Clinical narrative: Reported Symptoms: 10008531:CHILLS; 10040527:SHAKINESS; 10047862:WEAKNESS; Narrative: Other Relevant HX: Other: Shakes, chills, weakness
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Reported Symptoms: 10028411:MYALGIA; 10042674:SWELLING; Narrative: A: 72 y/o male develops mild cellulitis in the left deltoid a rea with redness, warm, firm and tenderness 4 x 4 cm, requires pain medication (Patient has tramadol that helps slightly) and antibiotic, need close follow up and return to clinic and also has an appointment on November 14, 2018. Pt states he still has some Tramadol left.  P: Keflex 1000 mg PO BID x 10 days, return to outpatient clinic if the conditions gets worse.  Other Relevant HX: Patient already had a prescription for tramadol for chronic back pain. Provided did not provide tramadol as a treatment drug, only the antibiotic. Just advised to take the tramadol as prescribed. Other: Swelling
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Reported Symptoms: 10028411:MYALGIA; 10042674:SWELLING; Narrative: A: 72 y/o male develops mild cellulitis in the left deltoid a rea with redness, warm, firm and tenderness 4 x 4 cm, requires pain medication (Patient has tramadol that helps slightly) and antibiotic, need close follow up and return to clinic and also has an appointment on November 14, 2018. Pt states he still has some Tramadol left.  P: Keflex 1000 mg PO BID x 10 days, return to outpatient clinic if the conditions gets worse.  Other Relevant HX: Patient already had a prescription for tramadol for chronic back pain. Provided did not provide tramadol as a treatment drug, only the antibiotic. Just advised to take the tramadol as prescribed. Other: Swelling
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Angioedema, Peripheral swelling
Clinical narrative: Reported Symptoms: 10002424:ANGIOEDEMA; 10002471:ANGIONEUROTIC EDEMA; 10042680:SWELLING ARM; Narrative: Other Relevant HX: Other: angioneurotic edema of larynx, swelling of arm
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Breakthrough COVID-19, Chest X-ray, Cough, Oropharyngeal pain
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATON; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084401:COVID-19 RESPIRATORY INFECTION;  Narrative: 86 YOM admitted through ED with complain of weakness, cough with congestion and throat pain. ED evaluation confirms COVID positive. Patient treated with remdesivir and discharged to home. Other relevant HX: HTN, Permanent A-Fib, recent CVA 5/24, T2DM, HF Other: Hospitalization for treatment of Covid infection s/p vaccination
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATON; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084401:COVID-19 RESPIRATORY INFECTION;  Narrative: 86 YOM admitted through ED with complain of weakness, cough with congestion and throat pain. ED evaluation confirms COVID positive. Patient treated with remdesivir and discharged to home. Other relevant HX: HTN, Permanent A-Fib, recent CVA 5/24, T2DM, HF Other: Hospitalization for treatment of Covid infection s/p vaccination
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Breakthrough COVID-19, Chest X-ray, Chills, Computerised tomogram abdomen
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084401:COVID-19 RESPIRATORY INFECTION;  Narrative: 39 YOM presented to the ED for evaluation of worsening epigastric pain with associated nausea, vomiting, and coffee-ground emesis that started 2 - 3 days ago. Initial incidental finding of Covid, but patient became symptomatic with bilateral wheezing, chills and cough on second day of hospitalization. Began treatment with remdesivir and dexamethasone. Patient discharged to continue treatment for mental health. Other Relevant HX: PMhx of bipolar disorder, alcohol use, substance use and homelessness Other: Hospitalization for treatment of Covid infection s/p vaccination
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Haematemesis, Nausea, SARS-CoV-2 test positive, Vomiting
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084401:COVID-19 RESPIRATORY INFECTION;  Narrative: 39 YOM presented to the ED for evaluation of worsening epigastric pain with associated nausea, vomiting, and coffee-ground emesis that started 2 - 3 days ago. Initial incidental finding of Covid, but patient became symptomatic with bilateral wheezing, chills and cough on second day of hospitalization. Began treatment with remdesivir and dexamethasone. Patient discharged to continue treatment for mental health. Other Relevant HX: PMhx of bipolar disorder, alcohol use, substance use and homelessness Other: Hospitalization for treatment of Covid infection s/p vaccination
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084401:COVID-19 RESPIRATORY INFECTION;  Narrative: 39 YOM presented to the ED for evaluation of worsening epigastric pain with associated nausea, vomiting, and coffee-ground emesis that started 2 - 3 days ago. Initial incidental finding of Covid, but patient became symptomatic with bilateral wheezing, chills and cough on second day of hospitalization. Began treatment with remdesivir and dexamethasone. Patient discharged to continue treatment for mental health. Other Relevant HX: PMhx of bipolar disorder, alcohol use, substance use and homelessness Other: Hospitalization for treatment of Covid infection s/p vaccination
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: Reported Symptoms: 10015150:ERYTHEMA; 10016357:FEELING OF WARMTH; 10037087:PRURITUS; Narrative: Patient is a 47 year old female who came to the clinic for follow-up for chronic conditions including but not limited to Environmental allergies, obesity, fatty liver, and hematuria. Patient received seasonal influenza vaccine during nurse visit and when being seen by provider complained of pruritis, erythema, and warmth to area. Provider diagnosed as mild allergic reaction to the vaccine and recommended IM injection of Benadryl which patient refused. Provider noted that symptoms were improved/resolved prior to patient leaving clinic and patient was counseled to take benadryl as needed or starting cetirizine for other environmental  allergies/rhinitis that they were being seen for. Other Relevant HX:  Other: PRURITIS; ERYTHEMA, WARMTH
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness
Clinical narrative: Reported Symptoms: 10012727:DIARRHEA; 10016379:FELT FAINT; Narrative: Other Relevant HX: Other: FEELING FAINT; DIARRHEA
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Reported Symptoms: 10033446:PAIN IN LEG; Narrative: Other relevant HX: PAIN IN LEG
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Reported Symptoms: 10002218:ANAPHYLAXIS; Narrative: Other Relevant HX: Other: ANAPHYLAXIS
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: Reported Symptoms: 10047340:VERTIGO; 10047700:VOMITING; Narrative: Other Relevant: HX: VERTIGO
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, Chest X-ray, Computerised tomogram abdomen, Computerised tomogram thorax, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATON; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084401:COVID-19 RESPIRATORY INFECTION; Narrative: 68 year old male with PMH of ESRD s/p renal transplant in 2005 on MM, tacrolimus, and daily prednisone admitted for acute covid infection w/o hypoxia. Patient with sepsis by SIRS criteria, likely secondary to acute covid infection per 8/7/24 hospitalist note. Given the risk of progression/severe disease in chronically immunosuppressed patient, patient was started on empiric remdesivir. Patient discharged home after completing 5 days of IV antiviral. Other Relevant HX: PMH significant for Afib, DM2, HTN, hyperlipidemia, HFpEF, gout, BPH, IDA, and CKD s/p kidney transplant in 2008 on immunosuppression Other: Hospitalization for treatment of Covid infection s/p vaccination
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Sepsis, Systemic inflammatory response syndrome
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATON; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084401:COVID-19 RESPIRATORY INFECTION; Narrative: 68 year old male with PMH of ESRD s/p renal transplant in 2005 on MM, tacrolimus, and daily prednisone admitted for acute covid infection w/o hypoxia. Patient with sepsis by SIRS criteria, likely secondary to acute covid infection per 8/7/24 hospitalist note. Given the risk of progression/severe disease in chronically immunosuppressed patient, patient was started on empiric remdesivir. Patient discharged home after completing 5 days of IV antiviral. Other Relevant HX: PMH significant for Afib, DM2, HTN, hyperlipidemia, HFpEF, gout, BPH, IDA, and CKD s/p kidney transplant in 2008 on immunosuppression Other: Hospitalization for treatment of Covid infection s/p vaccination
Age: 69.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Breakthrough COVID-19, Chest X-ray normal, Computerised tomogram thorax normal, Dyspnoea, Hypoxia
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084401:COVID-19 RESPIRATORY INFECTION; Narrative: Patient is a 71 year old MALE with PMH of recent CAP PNA treated with inpatient stay and antibiotics presented to ED from assisted care facility for 4-5 days of increasing work of breathing, SOB, and wheezing. Patient found to be Covid positive and hypoxic to the mid 80s. H&P from 8/9/24 expressed concern for potential undiagnosed COPD based on extensive tobacco use history. Patient treated with remdesivir and dexamethasone and discharged back to assisted living facility. Other Relevant HX: PMH of recent CAP PNA treated with inpatient stay and antibiotics, persistent leukocytosis, mechanical aortic valve, mitral valve stenosis, HTN, HLD, renal cysts, BPH, GERD, CKDstage 3, Ulcerative colitis, and paroxysmal a-fib with extensive tobacco use history, concern for COPD. Other: Hospitalization for treatment of Covid infection s/p vaccination
Age: 69.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: SARS-CoV-2 test positive, Scan with contrast normal, Wheezing
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084401:COVID-19 RESPIRATORY INFECTION; Narrative: Patient is a 71 year old MALE with PMH of recent CAP PNA treated with inpatient stay and antibiotics presented to ED from assisted care facility for 4-5 days of increasing work of breathing, SOB, and wheezing. Patient found to be Covid positive and hypoxic to the mid 80s. H&P from 8/9/24 expressed concern for potential undiagnosed COPD based on extensive tobacco use history. Patient treated with remdesivir and dexamethasone and discharged back to assisted living facility. Other Relevant HX: PMH of recent CAP PNA treated with inpatient stay and antibiotics, persistent leukocytosis, mechanical aortic valve, mitral valve stenosis, HTN, HLD, renal cysts, BPH, GERD, CKDstage 3, Ulcerative colitis, and paroxysmal a-fib with extensive tobacco use history, concern for COPD. Other: Hospitalization for treatment of Covid infection s/p vaccination
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood gases abnormal, Breakthrough COVID-19, COVID-19 pneumonia, Computerised tomogram thorax, Dyspnoea
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084401:COVID-19 RESPIRATORY INFECTION; Narrative: 67 y/o male who presented to the ED on 8/17/24 w/ shortness of breath, malaise, and headache of one day's duration and was found to have COVID pneumonia. His ABG O2 on initial presentation was 58 and he was initially requiring O2 in order to maintain his oxygen saturations. He was admitted for management of his suspected COVID pneumonia. Patient discharged to home after completing treatment with remdesivir. Other Relevant HX: PMHx of T2DM w/ diabetic nephropathy, HTN, HLD, PTSD, GERD, OSA, and osteoarthritis of the knees s/p left TKA on 6/24/24 Other: Hospitalization for treatment of Covid infection s/p vaccination
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Malaise, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084401:COVID-19 RESPIRATORY INFECTION; Narrative: 67 y/o male who presented to the ED on 8/17/24 w/ shortness of breath, malaise, and headache of one day's duration and was found to have COVID pneumonia. His ABG O2 on initial presentation was 58 and he was initially requiring O2 in order to maintain his oxygen saturations. He was admitted for management of his suspected COVID pneumonia. Patient discharged to home after completing treatment with remdesivir. Other Relevant HX: PMHx of T2DM w/ diabetic nephropathy, HTN, HLD, PTSD, GERD, OSA, and osteoarthritis of the knees s/p left TKA on 6/24/24 Other: Hospitalization for treatment of Covid infection s/p vaccination
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, COVID-19 pneumonia, SARS-CoV-2 test positive, Treatment noncompliance
Clinical narrative: Reported Symptoms: 10067923:VACCINE BREAKTHROUGH INFECTION; Narrative: Patient was living independently for approximately one month following being a resident at a long term facility. Patient received two doses of the Moderna Covid-19 vaccine (12/29/2020 & 01/26/2021). On 09/28/2021 patient presented to an emergency department at a different facility where he tested positive for the COVID-19 infection. Patient had stopped taking all his home medications (including but limited to carbidopa/levodopa, quetiapine and ropinirole) without tapering or under the advisement of a physician due to his caretaker also being sick with the infection. Patient was transferred to the local facility for quarantine and supportive care. All medications were re-initiated. The COVID-19 pneumonia infection did not require any treatment. Patient had no where to discharge to until 10/14/2021 when he returned back to the long term care facility he had lived at previously. Other Relevant HX: Past medical history relevant for: T2DM, deep brain stimulation, GERD, parkinsonism, anxiety disorder, hyperlipidemia Other: COVID-19 Breakthrough Infection
Age: 97.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Anuria, Blood glucose increased, Blood lactic acid increased, Blood pressure decreased
Clinical narrative: Reported Symptoms: 10011906:DEATH; 10067923:VACCINE BREAKTHROUGH INFECTION; Narrative: patient living at home with wife and had four daughters as caretakers. Patient received two doses of Moderna COVID-19 vaccine (01/13/2021 & 02/10/2021). At presentation to emergency department (10/03/2021), patient had elevated heart rate, elevated blood sugars, appeared short of breath, not eating and requiring 6L of oxygen. COVID-19 test came back positive, along with elevated troponin, elevated lactate and worsening kidney function from baseline. Patient's kidney function did not support treatment with remdesivir, was was treated solely with dexamethasone. Patient's oxygen needs continued to escalate, blood pressure dropped, and was anuria throughout his stay in the hospital prior to expiring 10/05/2021. Other Relevant HX: Problem list significant for: CKD stage 4, T2DM, HTN, Troponin positive on admission for non-STMI Acute hypoxemia Other: COVID-19 Breakthrough Infection
Age: 97.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, Death, Decreased appetite, Dyspnoea, Heart rate increased
Clinical narrative: Reported Symptoms: 10011906:DEATH; 10067923:VACCINE BREAKTHROUGH INFECTION; Narrative: patient living at home with wife and had four daughters as caretakers. Patient received two doses of Moderna COVID-19 vaccine (01/13/2021 & 02/10/2021). At presentation to emergency department (10/03/2021), patient had elevated heart rate, elevated blood sugars, appeared short of breath, not eating and requiring 6L of oxygen. COVID-19 test came back positive, along with elevated troponin, elevated lactate and worsening kidney function from baseline. Patient's kidney function did not support treatment with remdesivir, was was treated solely with dexamethasone. Patient's oxygen needs continued to escalate, blood pressure dropped, and was anuria throughout his stay in the hospital prior to expiring 10/05/2021. Other Relevant HX: Problem list significant for: CKD stage 4, T2DM, HTN, Troponin positive on admission for non-STMI Acute hypoxemia Other: COVID-19 Breakthrough Infection
Age: 97.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Renal impairment, SARS-CoV-2 test positive, Troponin increased
Clinical narrative: Reported Symptoms: 10011906:DEATH; 10067923:VACCINE BREAKTHROUGH INFECTION; Narrative: patient living at home with wife and had four daughters as caretakers. Patient received two doses of Moderna COVID-19 vaccine (01/13/2021 & 02/10/2021). At presentation to emergency department (10/03/2021), patient had elevated heart rate, elevated blood sugars, appeared short of breath, not eating and requiring 6L of oxygen. COVID-19 test came back positive, along with elevated troponin, elevated lactate and worsening kidney function from baseline. Patient's kidney function did not support treatment with remdesivir, was was treated solely with dexamethasone. Patient's oxygen needs continued to escalate, blood pressure dropped, and was anuria throughout his stay in the hospital prior to expiring 10/05/2021. Other Relevant HX: Problem list significant for: CKD stage 4, T2DM, HTN, Troponin positive on admission for non-STMI Acute hypoxemia Other: COVID-19 Breakthrough Infection
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Breakthrough COVID-19, Condition aggravated, Cough, Death
Clinical narrative: Reported Symptoms: 10011906:DEATH; 10067923:VACCINE BREAKTHROUGH INFECTION; Narrative: Patient who lives in an assisted living facility received two COVID-19 immunizations (05/06/2021 & 06/10/2021). Patient has a medical history significant for COPD, OSA, pulmonary hypertension, and hypoxia requiring 3-4L of oxygen at baseline. While at home, patient developed a cough and shortness of breath. Caregiver administered an at-home COVID test on 09/24/2021. His condition worsened, and was escorted the emergency department on 10/01/2021 where diagnosis of COVID was confirmed with a PCR test. Patient was admitted to floor with hypoxemic respiratory failure and started on IV dexamethasone and CA-pneumonia antibiotics. Remdesivir and baricitinib were added to his treatment regimen as well. Patient returned to baseline oxygen needs and was discharged back to the assisted living home. Primary care notes indicate continued worsening condition over the next weeks. Patient presented back to the ED 10/22/2021 for increasing hypoxia (oxygen requirements up to 6L/min), weakness and dyspnea. Patient was admitted to the floor, and expired a few hours after admission. Other Relevant HX: Lives in assisted living facility on 3-4L oxygen at baseline Problem list significant for: COPD, hypoxia, pulmonary hypertension, OSA Other: Breakthrough COVID-19 infection
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoxia, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10011906:DEATH; 10067923:VACCINE BREAKTHROUGH INFECTION; Narrative: Patient who lives in an assisted living facility received two COVID-19 immunizations (05/06/2021 & 06/10/2021). Patient has a medical history significant for COPD, OSA, pulmonary hypertension, and hypoxia requiring 3-4L of oxygen at baseline. While at home, patient developed a cough and shortness of breath. Caregiver administered an at-home COVID test on 09/24/2021. His condition worsened, and was escorted the emergency department on 10/01/2021 where diagnosis of COVID was confirmed with a PCR test. Patient was admitted to floor with hypoxemic respiratory failure and started on IV dexamethasone and CA-pneumonia antibiotics. Remdesivir and baricitinib were added to his treatment regimen as well. Patient returned to baseline oxygen needs and was discharged back to the assisted living home. Primary care notes indicate continued worsening condition over the next weeks. Patient presented back to the ED 10/22/2021 for increasing hypoxia (oxygen requirements up to 6L/min), weakness and dyspnea. Patient was admitted to the floor, and expired a few hours after admission. Other Relevant HX: Lives in assisted living facility on 3-4L oxygen at baseline Problem list significant for: COPD, hypoxia, pulmonary hypertension, OSA Other: Breakthrough COVID-19 infection
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Breakthrough COVID-19, Fall, Respiratory depression
Clinical narrative: Reported Symptoms: 10038678:RESPIRATORY DEPRESSION; 10067923:VACCINE BREAKTHROUGH INFECTION; Narrative: Patient received two doses of Pfizer COVID-19 vaccine (01/27/2021 & 02/19/2021). On 09/20/2021 patient presented to the ED for chief complain of back pain due to frequent falls. Patient was sent home with Tylenol and cyclobenzaprine. A COVID-19 sample was taken at this time. Patient presented to the ED again on 09/24/2021 with a chief complain of weakness. Labs were reviewed, patient was COVID positive. Patient was admitted, received a four day course of dexamethasone 6mg daily, 2L of oxygen and was empirically treated with ceftriaxone 2g. Patient returned to baseline and was discharged 10/01/2021. Other Relevant HX: Pfizer COVID-19 vaccine dose #1 (01/27/2021) Pfizer COVID-19 vaccine dose #2 (02/19/2021) Problem list significant for: CHF, COPD, CAD, OSA, HTN, obesity Other: Breakthrough COVID-19 infection
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10038678:RESPIRATORY DEPRESSION; 10067923:VACCINE BREAKTHROUGH INFECTION; Narrative: Patient received two doses of Pfizer COVID-19 vaccine (01/27/2021 & 02/19/2021). On 09/20/2021 patient presented to the ED for chief complain of back pain due to frequent falls. Patient was sent home with Tylenol and cyclobenzaprine. A COVID-19 sample was taken at this time. Patient presented to the ED again on 09/24/2021 with a chief complain of weakness. Labs were reviewed, patient was COVID positive. Patient was admitted, received a four day course of dexamethasone 6mg daily, 2L of oxygen and was empirically treated with ceftriaxone 2g. Patient returned to baseline and was discharged 10/01/2021. Other Relevant HX: Pfizer COVID-19 vaccine dose #1 (01/27/2021) Pfizer COVID-19 vaccine dose #2 (02/19/2021) Problem list significant for: CHF, COPD, CAD, OSA, HTN, obesity Other: Breakthrough COVID-19 infection
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Computerised tomogram thorax abnormal, Cough, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10084401:COVID-19 RESPIRATORY INFECTION;  Narrative: Vaccinated patient (received both doses of Pfizer COVID vaccine 1/2021) was a resident of an assisted living facility that experienced a COVID-19 outbreak. He tested positive for COVID on 9/15/21, and noted increased oxygen requirements (2L at baseline up to 5L), along with cough (no fever or other symptoms reported). Admitted to the medical facility and treated with dexamethasone 6mg daily.  Repeated COVID testing on 9/21/21 also positive). Chest CT was consistent w/ COVID-19 pneumonia. He improved to baseline and was discharged back to the assisted living facility. Dates of admission 9/21-9/27/21. Other Relevant HX: Problem list includes hypertension, diabetes, dyspnea Other: COVID-19  infection
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Reported Symptoms: 10063978: WRONG VACCINE ADMINISTERED;  Narrative: On 04/10/2021 Patient was administered one dose of the Janssen COVID-19 Vaccine. Patient returned on 05/08/2021 requesting his second dose. Moderna COVID-19 vaccine was then administered. The individual administering the vaccine did not review the chart prior to injection. The chart accurately showed the patient received Janssen the month prior, thus a second dose of any COVID-19 vaccine would have been inappropriate.  Other Relevant HX:  Other: Dose of Moderna COVID-19 vaccine given following a dose of Janssen COVID-19 vaccine
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Reported Symptoms: 10042772:SYNCOPE; Narrative: Other Relevant HX:
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Reported Symptoms: 10011232:COUGHING; Narrative: Other relevant H: COUGH
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Reported Symptoms: 10058327:EXPIRED DRUG USED; 10081576:PRODUCT ADMINISTRATION ERROR; Narrative: Vaccine administration errors, not associated with an adverse event. On 4/26/2024, nurse administered covid-19 vaccine past the expiration/beyond use date. Covid-19 vaccine beyond use date was labeled as 4/24/2024, but was administered on 4/26/2024. No adverse effect to report. Other Relevant HX:  Other: Dose administered past the expiration/beyond-use date
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Coronary artery bypass, Cough, Dyspnoea, Hyperhidrosis
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10042772:SYNCOPE; 10043088:TACHYPNEA; Narrative: Patient received Moderna COVID booster (monovalent) as he was due at PCP office. Several hours later her reported to the ED. This was the providers report: "This 65 yr. old male presents with a history of shortness of breath, sudden onset 1 hours ago, associated with cough, and diaphoresis, patient thought it was pneumonia and came in. he had his Covid 19 booster earlier today. Otherwise well prior to onset, he relates simialr symptoms when 'I had my heart attack'. Was treated at Medical Center.' -Patient found to have STEMI and transferred to hospital where CABG x 3 was performed. Other Relevant HX: Other:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Tachypnoea
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10042772:SYNCOPE; 10043088:TACHYPNEA; Narrative: Patient received Moderna COVID booster (monovalent) as he was due at PCP office. Several hours later her reported to the ED. This was the providers report: "This 65 yr. old male presents with a history of shortness of breath, sudden onset 1 hours ago, associated with cough, and diaphoresis, patient thought it was pneumonia and came in. he had his Covid 19 booster earlier today. Otherwise well prior to onset, he relates simialr symptoms when 'I had my heart attack'. Was treated at Medical Center.' -Patient found to have STEMI and transferred to hospital where CABG x 3 was performed. Other Relevant HX: Other:
Age: 11.0
Sex: F
Vaccine: COVID19, HPV9, MNQ, TDAP
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: Patient left office with only sore arms which is typical for post injection administration. No other adverse reactions were noted. Patient was administered COVID Pfizer for the age group of 12+ instead of 5-11 years. Grandmother accompanied patient to her wellness exam on 1/31/2025. Consent was obtained from mother via phone while in office. Dose does not need to be repeated. System accepted the dose for COVID for the season.
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Fatigue, Headache, Tinnitus
Clinical narrative: arm redness 2-3'', fatigue, headache, tinnitus for 6 days