chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Mild injection site swelling; Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Headache and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity) and HEADACHE (Headache and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity) and HEADACHE (Headache and no interference with activity). At the time of the report, VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity) and HEADACHE (Headache and no interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: Mild fever (100.4 to 101.2 Degree F).         No concomitant medications were reported.  It was reported that patient had mild injection site swelling, mild fever (100.4-to-101.2-degree F), mild fatigue and no interference with activity, mild muscle pain and no interference with activity, Headache and no interference with activity anytime during the 2 days after the COVID-19 vaccination, which occurred on Sunday, 17-Dec-2023 and Monday, 18-Dec-2023.  No treatment medications were reported.  The Subject ID was reported as 5471161.  The Agency Subject ID was reported as 70626-54676.   This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:Patient 22
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Mild injection site swelling; Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Headache and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity) and HEADACHE (Headache and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity) and HEADACHE (Headache and no interference with activity). At the time of the report, VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity) and HEADACHE (Headache and no interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: Mild fever (100.4 to 101.2 Degree F).         No concomitant medications were reported.  It was reported that patient had mild injection site swelling, mild fever (100.4-to-101.2-degree F), mild fatigue and no interference with activity, mild muscle pain and no interference with activity, Headache and no interference with activity anytime during the 2 days after the COVID-19 vaccination, which occurred on Sunday, 17-Dec-2023 and Monday, 18-Dec-2023.  No treatment medications were reported.  The Subject ID was reported as 5471161.  The Agency Subject ID was reported as 70626-54676.   This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:Patient 22
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Pyrexia, Vaccination site erythema
Clinical narrative: Mild injection site redness; Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Moderate injection site swelling; Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Moderate injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)) and FATIGUE (Mild fatigue and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Moderate injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Mild muscle pain and no interference with activity). At the time of the report, VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Moderate injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Mild muscle pain and no interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: Mild fever (100.4 to 101.2 °F).          Concomitant medication not reported.   It was reported that the patient experienced the events anytime during the 2 days after the COVID-19 vaccination, which occurred on Sunday, Dec 17, 2023 and Monday, Dec 18, 2023.   Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild injection site redness; Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Moderate injection site swelling; Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Moderate injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)) and FATIGUE (Mild fatigue and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Moderate injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Mild muscle pain and no interference with activity). At the time of the report, VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Moderate injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Mild muscle pain and no interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: Mild fever (100.4 to 101.2 °F).          Concomitant medication not reported.   It was reported that the patient experienced the events anytime during the 2 days after the COVID-19 vaccination, which occurred on Sunday, Dec 17, 2023 and Monday, Dec 18, 2023.   Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:same reporter
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose abnormal, Headache, Somnolence
Clinical narrative: Sugar levels have not come down; headache and drowsiness have also been present since getting vaccinated; headache and drowsiness have also been present since getting vaccinated; This spontaneous case was reported by a patient and describes the occurrence of BLOOD GLUCOSE ABNORMAL (Sugar levels have not come down), SOMNOLENCE (headache and drowsiness have also been present since getting vaccinated) and HEADACHE (headache and drowsiness have also been present since getting vaccinated) in a 30-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030337) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 05-Jan-2024, the patient experienced BLOOD GLUCOSE ABNORMAL (Sugar levels have not come down), SOMNOLENCE (headache and drowsiness have also been present since getting vaccinated) and HEADACHE (headache and drowsiness have also been present since getting vaccinated). At the time of the report, BLOOD GLUCOSE ABNORMAL (Sugar levels have not come down), SOMNOLENCE (headache and drowsiness have also been present since getting vaccinated) and HEADACHE (headache and drowsiness have also been present since getting vaccinated) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: abnormal.         Concomitant medication was not provided. Treatment information was not reported.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2021 at 16:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "allergies with pistachios and cashews" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 28Dec2023 to 03Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Jan2021 as dose 1, single) and on 26Feb2021 as dose 2, single), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; HYDROCHLOROTHIAZIDE; SYMBICORT; ALBUTEROL HFA. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13Dec2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Negative; (Jan2024) Posititve. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 will be requested and submitted if and when received.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Systemic lupus erythematosus
Clinical narrative: Systemic lupus erythematosus (SLE); Significant diffuse hair loss; This is a spontaneous report received from a Physician.  A 10-year-old male patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) at the age of 10 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient was not diagnosed with COVID-19 prior the vaccination. The patient had no known allergies. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ALOPECIA (medically significant) with onset Nov2021, outcome "not recovered", described as "Significant diffuse hair loss"; SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "Systemic lupus erythematosus (SLE)". The event "significant diffuse hair loss" required physician office visit. The clinical course was reported as follows: The patient, healthy, on no medication received his second dose of his COVID vaccination, and then had significant diffuse hair loss without any improvement that has required multiple doctors' visits and attempts at treatment, including multiple topical agents and biologic therapies, without improvement and now requiring biologic therapy and concern for new onset systemic lupus erythematosus (SLE).  Therapeutic measures were taken as a result of alopecia.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: A possible contribution of suspect drug BNT162b2 (COMIRNATY) cannot be totally excluded for reported events given the compatible time association. Case will be reassessed should additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 20-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single at the age of 18 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2023) Positive; (01Jan2024) Negative; (06Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid Start Date: 26Dec2023, Stop Date: 31Dec2023. No known allergies.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 15:30 as dose 5 (booster), single (Lot number: GJ3277), in left arm and on 05Oct2023 at 15:30 as dose 6 (booster), single (Lot number: GK0923), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Sep2021 at 14:30 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 15Apr2022 at 15:30 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Jan2021 at 13:15 as dose 1, single (Lot number: EL3246), in left arm and on 06Feb2021 at 13:45 as dose 2, single (Lot number: EM9810), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Dec2023 at 08:30, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) decreased infection; (31Dec2023) Positive; (04Jan2024) Negative; (09Jan2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: The first onset of COVID; The first onset of COVID; Moderna ( Mar2021, Apr2021, Dec2021); BNT162B2 May2022; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Mar2021 as dose 1, single), in Apr2021 as dose 2, single), in Dec2021 as dose 3 (booster), single), in Oct2022 as dose 5 (booster), single) and in Nov2023 as dose 6 (booster), single) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID], start date: 01Dec2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset May2022, outcome "recovered", described as "Moderna ( Mar2021, Apr2021, Dec2021); BNT162B2 May2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Dec2023, outcome "recovered" and all described as "The first onset of COVID". The patient underwent the following laboratory tests and procedures: Body temperature: (11Dec2023) 101.6; SARS-CoV-2 test: (01Dec2023) Positive; (06Dec2023) Negative; (07Dec2023) Negative; (10Dec2023) Positive; (17Dec2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received nirmatrelvir, ritonavir (PAXLOVID) for COVID-19 treatment. That was 4 days after she had stopped taking Paxlovid and had already tested negative after the first onset of COVID on 01Dec2023. On 11Dec2023, fever (101.6) and all cold symptoms took until 15Dec2023 before she felt mostly good to normal. On 17Dec2023, she tested negative. That was the very first time for her that she had COVID. The patient was fully vaccinated.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: flu like symptoms; diaphoresis; chills; swelling at injection site; redness at injection site; Initial information was received on 09-Jan-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 34 years old male patient who experienced flu like symptoms, diaphoresis, chills, swelling at injection site and redness at injection site after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s),Concomitant medications and family history were not provided. The patient had no medical history, concomitant disease or risk factor.    On 05-Jan-2024, the patient received a unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine  (Suspension for injection) (lot U7948BA,strength, expiry date was unknown) via intramuscular route in unknown administration site for Got finger punctured with a drill bit.  On 06-JAN-2024 the patient developed flu like symptoms (influenza like illness), diaphoresis (hyperhidrosis), chills , swelling at injection site (vaccination site swelling) and redness at injection site (vaccination site erythema) (latency : 1 day) following the administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine.  There were no lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (flu like symptoms, chills, diaphoresis, swelling at injection site, redness at injection site).  At time of reporting, the outcome was Recovering / Resolving for all the events.
Age: 7.0
Sex: M
Vaccine: FLUC3
Symptoms: Influenza, Influenza A virus test positive, Vaccination failure
Clinical narrative: Tested positive for Flu A; Tested positive for Flu A / LoE; This spontaneous case was received on 12-Dec-2023 from other non-health professional (reference number: SEQW23-04806) and concerned a 7-year-old, male patient.  The patient had no medical history and concomitant medication.  On 14-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, anatomical location: right deltoid; route of administration: not reported) for active immunization against influenza disease. The batch number reported was 944444 (reported batch number was identified by Seqirus to be correct batch number) and the expiry date was 22-May-2024.  On an unspecified date in Oct-2023, two weeks after receiving Flucelvax Quadrivalent, the patient had physical examination, and everything was fine.   On 10-Dec-2023, one month and 26 days after receiving Flucelvax Quadrivalent, the patient experienced flu A.   On 12-Dec-2023, the patient tested positive for flu. The flu was verified by nasal swab. Flu virus was type A.  On an unspecified date in Dec-2023, the patient started treatment with Tylenol (paracetamol) and Dimetapp (brompheniramine maleate, phenylephrine hydrochloride).  At the time of initial reporting, the patient had not recovered from the event of 'Influenza A virus infection'.  The reporter did not provide a causality assessment.  The events of 'Influenza A virus infection' and 'vaccination failure' were considered to be medically significant by a Physician within Department.  Case updated on 12-Jan-2024: Correction made to information received on 12-Dec-2023: Country field on General tab changed. No changes in the narrative.  Company comment: A 7-year-old male patient experienced influenza one month and 26 days following vaccination with Flucelvax Quadrivalent. In addition, patient was tested positive for flu verified with the nasal swab (influenza type A) (explicitly coded as: 'Vaccination failure'). Reportedly, patient had no medical history and wasn't using any concomitant medication. Causality for both reported events is assessed as possibly related, due to plausible temporal relationship.; Sender's Comments: A 7-year-old male patient experienced influenza one month and 26 days following vaccination with Flucelvax Quadrivalent. In addition, patient was tested positive for flu verified with the nasal swab (influenza type A) (explicitly coded as: 'Vaccination failure'). Reportedly, patient had no medical history and wasn't using any concomitant medication. Causality for both reported events is assessed as possibly related, due to plausible temporal relationship.
Sex: U
Vaccine: FLUX
Symptoms: Eczema, Rash
Clinical narrative: Eczema; Rash on my hands and feet; This spontaneous case was received on 05-Jan-2024 from other non-healthcare professional (consumer) via Communications (reference number: SEQW24-00074) and concerned a patient of unspecified age and gender.  The patient's concurrent conditions included egg allergy. The patient's concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with influenza vaccine (brand not specified; dose, route of administration, and anatomical location: not reported) for prevention of influenza virus. The batch number was not reported.  On an unspecified date, within 24 hours after receiving the influenza vaccine, the patient experienced a severe rash on hands and feet. The patient stated that they call it eczema, and the patient never had it until the shot, as reported.  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  This case was assessed as non-serious.  Company comment: A patient of unknown age and gender was vaccinated with influenza vaccine, on unknown day. Reportedly, within 24 hours following vaccination, patient complained of rash and eczema. Causality for both events is assessed as possibly related, due to chronological plausibility.; Sender's Comments: A patient of unknown age and gender was vaccinated with influenza vaccine, on unknown day. Reportedly, within 24 hours following vaccination, patient complained of rash and eczema. Causality for both events is assessed as possibly related, due to chronological plausibility.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 23 days beyond use date on product.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood culture negative, Blood lactic acid increased, Blood pressure decreased, Chest X-ray normal
Clinical narrative: tolerated shot well. at 130 am he got confused, weak, couldn't sit, turn in bed, no rigors. no n/v.  sx persisted 4-5 hours, he couldnt move and they called 911 after speaking to advice at about 5 am. he was given IV fluids for soft bp 90s systolic, k and mg repleted.  he felt better later in the day and was discharged from hospital  1/7/2024 around 7 pm.  neg bcx, cxr, covid screen, no change in chronic abn of head ct. he had sl elevated lactic acid and was treated for possible sepsis with ceftriaxone. no discharge abx recommended.  seen in usual post transplant office visit 1/1/2024.  doing okay.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head abnormal, Confusional state, Mobility decreased, SARS-CoV-2 test negative
Clinical narrative: tolerated shot well. at 130 am he got confused, weak, couldn't sit, turn in bed, no rigors. no n/v.  sx persisted 4-5 hours, he couldnt move and they called 911 after speaking to advice at about 5 am. he was given IV fluids for soft bp 90s systolic, k and mg repleted.  he felt better later in the day and was discharged from hospital  1/7/2024 around 7 pm.  neg bcx, cxr, covid screen, no change in chronic abn of head ct. he had sl elevated lactic acid and was treated for possible sepsis with ceftriaxone. no discharge abx recommended.  seen in usual post transplant office visit 1/1/2024.  doing okay.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine 21 DAYS beyond use date on product.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine beyond 23 days use date on product.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10days beyond use.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine 23 days beyond use date on product.
Age: 40.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Product storage error
Clinical narrative: Patient was administered covid vaccine 23 days beyond use date on product..
Age: 40.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Expired product administered
Clinical narrative: Patient was administered covid vaccine 23 days beyond use date on product..
Age: 40.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Product storage error
Clinical narrative: Patient was administered the Covid Vaccine 17 days beyond use date on product.
Age: 40.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Expired product administered
Clinical narrative: Patient was administered the Covid Vaccine 17 days beyond use date on product.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine 21 DAYS beyond use date on product.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine 21 days beyond use date on product.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10 days beyond use.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine 23 day beyond use date on product.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Pt called today 1/12/24 stating that she had a large lump where she was vaccinated. about 2 inches wide. hot the touch, a little itchy and red. Not to painful, no bruising.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 21 days beyond use date on product.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10 days beyond use.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 23 days beyond use date on product.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 21 DAYS beyond use date on product.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 21 days  beyond use date on product.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine 23 days beyond use date on product.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10 days beyond use.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 21 days beyond use date on product.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine 23 days beyond use date on product.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10days beyond use.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 21 DAYS beyond use date on product.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10 days beyond use.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 23 days beyond use date on product.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine 21 days beyond use date on product.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10days beyond use.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine 21 days beyond use date on product.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10 days beyond use.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine 23 days beyond use date on product.
Age: 5.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: At 24 hrs after the Immunization his arm from joint to joint, shoulder to elbow was red and swollen, hurt some, normal mobility and they came to our ED and he got Benadryl from mother of patient. She gave it again 6 hrs later and the redness subsided and swelling still prominent. Today 3 days later arm no longer red but is mildly swollen from joint to joint and erythema present 17 sm vertically from shoulder to elbow with swelling circumferential 2 cm larger than non affected arm.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10 days beyond use.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 21 DAYS beyond use date on product.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Electric shock sensation, Herpes zoster, Rash
Clinical narrative: Shingles outbreak within 12 hours of second shot.  Nerve ?zapping? and outbreak of rash.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10 days beyond use.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 23 days beyond use date on product.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10 days beyond use.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10days beyond use.
Age: 58.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Neurological symptom
Clinical narrative: Patient developed signs of stroke, was treated while hospitalized, and has since recovered
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10days beyond use.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine 6 days beyond use date on product.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10 days beyond use.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10days beyond use.
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Abdominal pain upper, Flatulence, Pruritus, Rash, Rash erythematous
Clinical narrative: Severe gas and stomach pain followed an hour later by itching and red rash from neck to knees
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10 days beyond use.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 6 days beyond use date on product.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10 days beyond use.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10 days beyond use.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10 days beyond use.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Blood glucose increased
Clinical narrative: THE ADVERSE EVENT OCCURED STARTING THE NEXT DAY.  PT STARTING EXPERIENCING UNCONTROLLED HIGH GLUCOSE READINGS VIA HER CGM. SHE TESTED VIA FINGER STICK TO VERIFY AND IT WAS ELEVATED.  PT HAS HAD ELEVATED GLUCOSE LEVELS SINCE HER VACCINATION IN NOVEMBER OF 2023.  SHE STATES SHE HAS HAD TO INCREASE HER INSULIN DOSES SUBSTANTIALLY TO GET HER GLUCOSE READINGS BELOW THE "200 MARK". NO NEW MEDS STARTED AND NO NEW ILLNESS OR DX FROM A MD.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10 days beyond use.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine 6 days beyond use date on product.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10 days beyond use.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10 days beyond use.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine 6 days beyond use date on product.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10 days beyond use.
Age: 38.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Product storage error
Clinical narrative: None stated.
Age: 38.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Expired product administered
Clinical narrative: None stated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10 days beyond use.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine beyond use date on product. 10 days beyond use.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Patient was administered the Covid Vaccine 17 days beyond use date on product.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 6 days beyond use date on product.
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Patient was administered the Covid Vaccine 17 days beyond use date on product
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 6 days beyond use date on product.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid vaccine 6 days beyond use date on product.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Patient was administered the Covid Vaccine 17 Days beyond use date on product
Age: 19.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Patient was administered the Covid Vaccine 17 days beyond use date on product
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 6 days beyond use date on product.
Age: 51.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Patient was administered the Covid Vaccine 17 days beyond use date on product
Age: 73.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Patient was administered the Covid Vaccine 17 Days beyond use date on product
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Patient was administered the Covid Vaccine 17 Days beyond the use date on product
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Patient was administered the Covid Vaccine 17 days beyond use date on the product
Age: 46.0
Sex: F
Vaccine: FLU4, HEP
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site swelling, Local reaction
Clinical narrative: In the course of less than 1 minute after vaccination patient developed a 'bump' at each injection site on her right arm. The bump, per my professional experience, seemed larger than normal. I gave two IMZs, Engrex-B and Fluzone Quad, to a 46 year old woman. Both shots were administered in her deltoid muscle of her right arm. Immediately after administrating the vaccines, the patient had 2 'large bumps', localized reactions at the injection site. Each bump was, in my professional experience, not typical due to their size and elevation. I gave patient a cold ice pack and 10 mLs of liquid Benadryl 12.5 mg/5 mL (total 25 mg).  Patient reported no pain or discomfort. She reported no shortness of breath or difficulty breathing. She reported not being light headed or dizzy. I discussed with patient and patient representative about signs of allergic reaction. I told them to notify me if any thing changed, such as shortness of breath or difficulty breathing.  I had patient stay in pharmacy for 30 minutes (recommendation is 15-30 minutes) to monitor for anaphylaxis. I checked in with the patient every 5ish minutes. I checked in on patient 3 to 4 times while she waited in the IMZ booth.  At 5:24 pm I searched for resources in regards to the localized swelling. Patient left the pharmacy at 6 pm. Before leaving, I checked patient's blood pressure, it was 128/80. I checked the 'bumps' the swelling had decreased where it was barely noticeable with some bruising.   Patient has an appointment with her provider on Tuesday (1/16/2024).
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Client presented to pop up event requesting flu vaccination 1/8/24 . When documenting administration it was discovered client had already recieved flu vaccination this season with Fluzone October 17 2023
Age: 61.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Left shoulder pain started at time of vaccine and had persisted until next visit 1/12/2024
Age: 35.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Feeling cold, Headache, Injection site pain, Night sweats, Vertigo
Clinical narrative: Ache in arm at site, within a few hours, lasted for ~1 day; headache of some kind (felt like what you get after spinning around in a chair - like the inside of your skull has more inertia than usual and would keep traveling in the direction you turn your head) started some time that night, maybe 5? hours later,  lasted ~1 day; night sweats heavyer than usual, that night and the next; feeling of coldness especially in feet, that night and the next;
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Patient broke out in hives that were widespread.
Age: 17.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Pallor, Visual impairment
Clinical narrative: Patient stated prior to giving shots that he has past medical history of fainting with vaccine administration. Gave patient both shots in right deltoid normally, patient's mother stated that he was looking paler than normal. After a few minutes of sitting, patient noted that he was having trouble seeing, at which point I had the patient lay down on the floor and elevated his feet. Patient continued to talk and had consistent pulse during this time. After ~5 minutes, patient regained vision and he stayed laying down for another 10 minutes before moving to a chair, and after 10 minutes he was ok to walk around the store.
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Pain, Swelling
Clinical narrative: Redness at injection site, pain and swelling
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Muscle spasms, Pain
Clinical narrative: 105.7 to 104.3 degree fever, severe headache, chills, uncontrollable shivers, weaknessmuscle spasms and pain for 2 days
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 105.7 to 104.3 degree fever, severe headache, chills, uncontrollable shivers, weaknessmuscle spasms and pain for 2 days
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Tinnitus
Clinical narrative: Tinnitus