chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. 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 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received bnt162b2 (BNT162B2 NOS), in Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "Drug Allergy: Clindamycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: positive at-home test. Therapeutic measure taken as a result of drug ineffective and covid-19 included Paxlovid from 17Sep2023 to 22Sep2023.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac discomfort, Chills, Cough, Headache, Heart rate increased
Clinical narrative: sick with chills, sweating, body aches, coughing and headache; sick with chills, sweating, body aches, coughing and headache; sick with chills, sweating, body aches, coughing and headache; sick with chills, sweating, body aches, coughing and headache; sick with chills, sweating, body aches, coughing and headache; I got zero REM sleep last night; Lowest HRV ever; highest resting heart rate ever; highest breathing rate ever; I am concerned your vaccine damaged my heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 24Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISCOMFORT (non-serious) with onset Sep2023, outcome "unknown", described as "I am concerned your vaccine damaged my heart"; HEART RATE VARIABILITY DECREASED (medically significant) with onset Sep2023, outcome "unknown", described as "Lowest HRV ever"; RESPIRATORY RATE INCREASED (medically significant) with onset Sep2023, outcome "unknown", described as "highest breathing rate ever"; HEART RATE INCREASED (medically significant) with onset Sep2023, outcome "unknown", described as "highest resting heart rate ever"; RAPID EYE MOVEMENTS SLEEP ABNORMAL (non-serious) with onset 24Sep2023, outcome "unknown", described as "I got zero REM sleep last night"; CHILLS (non-serious), HYPERHIDROSIS (non-serious), PAIN (non-serious), COUGH (non-serious), HEADACHE (non-serious) all with onset 24Sep2023, outcome "unknown" and all described as "sick with chills, sweating, body aches, coughing and headache". The patient underwent the following laboratory tests and procedures: Heart rate: (Sep2023) highest resting heart rate ever; Heart rate variability test: (Sep2023) lowest HRV ever; Respiratory rate: (Sep2023) highest breathing rate ever. Clinical course: It was reported that the patient was given with COVID vaccine yesterday (24Sep2023) and woke up in the middle of the night sick with chills, sweating, body aches, coughing and headache. Additionally, patient track all metrics and had the lowest HRV ever, highest resting heart rate ever, and highest breathing rate ever. Additionally, patient got zero REM sleep last night. Also, the first time ever. The patient was concerned that the vaccine damaged patient's heart.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate variability decreased, Heart rate variability test, Hyperhidrosis, Malaise, Pain
Clinical narrative: sick with chills, sweating, body aches, coughing and headache; sick with chills, sweating, body aches, coughing and headache; sick with chills, sweating, body aches, coughing and headache; sick with chills, sweating, body aches, coughing and headache; sick with chills, sweating, body aches, coughing and headache; I got zero REM sleep last night; Lowest HRV ever; highest resting heart rate ever; highest breathing rate ever; I am concerned your vaccine damaged my heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 24Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISCOMFORT (non-serious) with onset Sep2023, outcome "unknown", described as "I am concerned your vaccine damaged my heart"; HEART RATE VARIABILITY DECREASED (medically significant) with onset Sep2023, outcome "unknown", described as "Lowest HRV ever"; RESPIRATORY RATE INCREASED (medically significant) with onset Sep2023, outcome "unknown", described as "highest breathing rate ever"; HEART RATE INCREASED (medically significant) with onset Sep2023, outcome "unknown", described as "highest resting heart rate ever"; RAPID EYE MOVEMENTS SLEEP ABNORMAL (non-serious) with onset 24Sep2023, outcome "unknown", described as "I got zero REM sleep last night"; CHILLS (non-serious), HYPERHIDROSIS (non-serious), PAIN (non-serious), COUGH (non-serious), HEADACHE (non-serious) all with onset 24Sep2023, outcome "unknown" and all described as "sick with chills, sweating, body aches, coughing and headache". The patient underwent the following laboratory tests and procedures: Heart rate: (Sep2023) highest resting heart rate ever; Heart rate variability test: (Sep2023) lowest HRV ever; Respiratory rate: (Sep2023) highest breathing rate ever. Clinical course: It was reported that the patient was given with COVID vaccine yesterday (24Sep2023) and woke up in the middle of the night sick with chills, sweating, body aches, coughing and headache. Additionally, patient track all metrics and had the lowest HRV ever, highest resting heart rate ever, and highest breathing rate ever. Additionally, patient got zero REM sleep last night. Also, the first time ever. The patient was concerned that the vaccine damaged patient's heart.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Rapid eye movements sleep abnormal, Respiratory rate increased
Clinical narrative: sick with chills, sweating, body aches, coughing and headache; sick with chills, sweating, body aches, coughing and headache; sick with chills, sweating, body aches, coughing and headache; sick with chills, sweating, body aches, coughing and headache; sick with chills, sweating, body aches, coughing and headache; I got zero REM sleep last night; Lowest HRV ever; highest resting heart rate ever; highest breathing rate ever; I am concerned your vaccine damaged my heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 24Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISCOMFORT (non-serious) with onset Sep2023, outcome "unknown", described as "I am concerned your vaccine damaged my heart"; HEART RATE VARIABILITY DECREASED (medically significant) with onset Sep2023, outcome "unknown", described as "Lowest HRV ever"; RESPIRATORY RATE INCREASED (medically significant) with onset Sep2023, outcome "unknown", described as "highest breathing rate ever"; HEART RATE INCREASED (medically significant) with onset Sep2023, outcome "unknown", described as "highest resting heart rate ever"; RAPID EYE MOVEMENTS SLEEP ABNORMAL (non-serious) with onset 24Sep2023, outcome "unknown", described as "I got zero REM sleep last night"; CHILLS (non-serious), HYPERHIDROSIS (non-serious), PAIN (non-serious), COUGH (non-serious), HEADACHE (non-serious) all with onset 24Sep2023, outcome "unknown" and all described as "sick with chills, sweating, body aches, coughing and headache". The patient underwent the following laboratory tests and procedures: Heart rate: (Sep2023) highest resting heart rate ever; Heart rate variability test: (Sep2023) lowest HRV ever; Respiratory rate: (Sep2023) highest breathing rate ever. Clinical course: It was reported that the patient was given with COVID vaccine yesterday (24Sep2023) and woke up in the middle of the night sick with chills, sweating, body aches, coughing and headache. Additionally, patient track all metrics and had the lowest HRV ever, highest resting heart rate ever, and highest breathing rate ever. Additionally, patient got zero REM sleep last night. Also, the first time ever. The patient was concerned that the vaccine damaged patient's heart.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Abnormal dreams, Arthralgia, Arthropathy, Dysstasia, Fatigue
Clinical narrative: Hot, cold; EXTREME fatigue; joints on fire; knee caps tender to touch and painful; headache; strange dreams; inabilty to fully wake, unbalanced when standing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient. ~ A 69-year-old patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Aug2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Primary Immunization series complete), for COVID-19 immunization. The following information was reported: FEELING OF BODY TEMPERATURE CHANGE (non-serious), outcome "unknown", described as "Hot, cold"; FATIGUE (non-serious), outcome "unknown", described as "EXTREME fatigue"; ARTHROPATHY (non-serious), outcome "unknown", described as "joints on fire"; ARTHRALGIA (non-serious), outcome "unknown", described as "knee caps tender to touch and painful"; HEADACHE (non-serious), outcome "unknown"; ABNORMAL DREAMS (non-serious), outcome "unknown", described as "strange dreams"; DYSSTASIA (non-serious), outcome "unknown", described as "inabilty to fully wake, unbalanced when standing".  Additional information: the patient was vaccinated with the update COVID vaccine on 23Aug2023. The patient also have had all the Pfizer vaccines, but this one had the worst side effects. The patient is now 69 years old and thought the company may want to know for data. Hot, cold, EXTREME fatigue, joints on fire, knee caps tender to touch and painful, headache, strange dreams and inabilty to fully wake, unbalanced when standing.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache
Clinical narrative: Hot, cold; EXTREME fatigue; joints on fire; knee caps tender to touch and painful; headache; strange dreams; inabilty to fully wake, unbalanced when standing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient. ~ A 69-year-old patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Aug2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Primary Immunization series complete), for COVID-19 immunization. The following information was reported: FEELING OF BODY TEMPERATURE CHANGE (non-serious), outcome "unknown", described as "Hot, cold"; FATIGUE (non-serious), outcome "unknown", described as "EXTREME fatigue"; ARTHROPATHY (non-serious), outcome "unknown", described as "joints on fire"; ARTHRALGIA (non-serious), outcome "unknown", described as "knee caps tender to touch and painful"; HEADACHE (non-serious), outcome "unknown"; ABNORMAL DREAMS (non-serious), outcome "unknown", described as "strange dreams"; DYSSTASIA (non-serious), outcome "unknown", described as "inabilty to fully wake, unbalanced when standing".  Additional information: the patient was vaccinated with the update COVID vaccine on 23Aug2023. The patient also have had all the Pfizer vaccines, but this one had the worst side effects. The patient is now 69 years old and thought the company may want to know for data. Hot, cold, EXTREME fatigue, joints on fire, knee caps tender to touch and painful, headache, strange dreams and inabilty to fully wake, unbalanced when standing.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Lethargy
Clinical narrative: stroke symptoms; lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke symptoms"; LETHARGY (non-serious), outcome "unknown". Clinical course: Patient had been experiencing side effects including but not limited to stroke symptoms and lethargy since patient received the first COVID vaccine.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001165 (RA).  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick".  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Cervix disorder, Intermenstrual bleeding
Clinical narrative: Break through bleeding; bleeding in between periods; Biopsied and found mRNA in the cervical tissue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001181 (Novavax).  A female patient received bnt162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERMENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "Break through bleeding; bleeding in between periods"; CERVIX DISORDER (non-serious), outcome "unknown", described as "Biopsied and found mRNA in the cervical tissue". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: Cardiac arrhythmias; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001179 (Novavax).  A female patient in her 40's received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARRHYTHMIA (medically significant), outcome "unknown", described as "Cardiac arrhythmias".  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Dyslexia, Investigation
Clinical narrative: dyslexia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received bnt162b2 (BNT162B2 NOS), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSLEXIA (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller mentioned that she took the Pfizer COVID19 vaccine last year. The caller said that she was negative now and that she will go to her sister-in-law's birthday party. The caller would like to know if she can get the vaccine, and she wants to know if the vaccine was effective. caller said that she had dyslexia and that she took the Pfizer vaccine  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Maternal exposure during pregnancy, No adverse event
Clinical narrative: maternal vaccine exposure with no reported adverse event; Initial information received on 21-Sep-2023 (with live follow up CSD:22-SEP-2023 processed together) regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 30 years old female patient who was pregnant and exposed to influenza quadrival A-B vaccine [Fluzone Quadrivalent] with no reported adverse event.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported maternal vaccine exposure with no reported adverse event occurred at 19 weeks of pregnancy and the patient was exposed to influenza quadrival A-B vaccine at 19 weeks of pregnancy, during second pregnancy trimester for influenza quadrival A-B vaccine.  The date of last menstrual period was reported as 09-May-2023. The estimated due date is 13-Feb-2024. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On 14-Sep-2023, the patient received a dose 1 of suspect influenza quadrival A-B vaccine Suspension for injection (lot UT80404A) (with an unknown strength, expiry date, dosage) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation).  On 14-SEP-2023 the patient had maternal vaccine exposure with no reported adverse event (exposure during pregnancy) (latency-same day) following the administration of influenza quadrival A-B vaccine.  Relevant prenatal testing was not reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event  Additionally, at time of reporting, the pregnancy is still ongoing.
Age: 78.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: arm is a little sore from the flu vaccine; Initial information received on 15-Sep-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case is linked to case 2023SA226846(CLUSTER).  This case involves a 78 years old female patient who experienced arm is a little sore from the flu vaccine after receiving Influenza Vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (with an unknown expiry date, lot number and strength) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date, the patient developed an event of arm is a little sore from the flu vaccine (pain in extremity) (unknown latency).  It is unknown if the patient experienced any additional symptoms/events  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event arm is a little sore from the flu vaccine.
Sex: U
Vaccine: FLU4
Symptoms: Accidental exposure to product, Device leakage, No adverse event
Clinical narrative: the liquid starts leaking where the needle is attached and onto the patient's shoulder as they try to push down the plunger with no reported adverse event; Initial information received on 21-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient for whom reporter reported, the liquid starts leaking where the needle is attached and onto the patient's shoulder as they try to push down the plunger with no reported adverse event while receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Sep-2023, the patient received a dose of suspect influenza quadrival A-B high dose HV vaccine (lot UT8072AA, expiry date- 30-JUN-2024) (with an unknown strength, formulation, dosage)  via unknown route in unknown administration site for Immunization.  On 21-SEP-2023 the reporter reported that the liquid starts leaking where the needle is attached and onto the patient's shoulder as they try to push down the plunger with no reported adverse event (accidental exposure to product) (latency- same day) following the administration of influenza quadrival A-B high dose HV vaccine.  Reportedly, Pharmacist is reporting a recurring issue with FLUZONE HD QIV administration. They report that after the needle is attached to the pen tip, it doesn't seem to have a good seal and the liquid starts leaking where the needle is attached and onto the patient's shoulder as they try to push down the plunger.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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: 82.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of FLUZONE HD QIV was administered to a patient/dose expired on 30JUN2023 with no reported adverse event; Initial information was received on 22-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 82 years old male patient who received expired dose of influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT] was administered to a patient/dose expired on 30jun2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 21-Sep-2023, the patient received a dose of 0.7 ml of suspect influenza quadrival a-b high dose hv vaccine (lot UJ882AB, Expiry date : 30-Jun-2023, frequency : once, formulation, strength was unknown) via unknown route in the right deltoid for Influenza and Immunization and expired dose of fluzone hd qiv was administered to a patient/dose expired on 30jun2023 with no reported adverse event (expired product administered) (latency : same day).  Action taken with QUADRIVALENT influenza vaccine (Fluzone HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown for the event expired dose of fluzone hd qiv was administered to a patient/dose expired on 30jun2023 with no reported adverse event.  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: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site discolouration, Injection site rash, Injection site swelling, Peripheral swelling, Rash erythematous
Clinical narrative: Itchy red rash, warm and swollen arm, raised white bumps in rash at injection site
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash pruritic, Skin warm
Clinical narrative: Itchy red rash, warm and swollen arm, raised white bumps in rash at injection site
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Injection site pain
Clinical narrative: some injection site pain; fatigue; Initial information received on 22-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case is linked to case 2023SA294491(CLUSTER).  This case involves 64 years female patient who had some injection site pain and fatigue after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength, dosage, expiry date, lot number- not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation). Information on the batch number was requested.  On an unknown date, (unknown latency), the patient developed some injection site pain (vaccination site pain) and fatigue following the administration of influenza vaccine. Caller did not specify which flu vaccines she received in the past.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for both the events.
Sex: F
Vaccine: FLU4
Symptoms: Immunisation reaction
Clinical narrative: she did have a reaction to it years ago; Initial information received on 22-Sep-2023 regarding an unsolicited valid non-serious case received from a Patient.  This case involves a 76 years old female patient and she did have a reaction to it years ago while receiving vaccine influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza Quadrival A-B High Dose HV Vaccine formulation, strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date she did have a reaction to it years ago (immunisation reaction) (unknown latency) following the administration of Influenza Quadrival A-B High Dose HV Vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event she did have a reaction to it years ago.  At time of reporting, the outcome was Unknown for the event she did have a reaction to it years ago.
Age: 61.0
Sex: F
Vaccine: FLU4, FLUR3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: caller says that fluzone hd was given to patient instead of flublok with no reported adverse event; Initial information was received on 22-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA294386(CLUSTER).  This case involves 61 years old female patient who reported that caller says that influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT] was given to patient instead of influenza quadrivalent recombinant vaccine [Flublok] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 21-Sep-2023, the patient received a dose of 0.7 ml of suspect influenza quadrival a-b high dose hv vaccine (lot UT8104BA, Expiry date : 30-Jun-2024, Frequency : once, formulation, strength was unknown) via intramuscular route in the left arm for Immunization and influenza quadrivalent recombinant vaccine (dosage, formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization).  . On 21-Sep-2023 the patient reported that caller says that fluzone hd was given to patient instead of flublok with no reported adverse event (wrong product administered) (latency : same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event caller says that fluzone hd was given to patient instead of flublok with no reported adverse event.  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: 60.0
Sex: M
Vaccine: FLU4, FLUR3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: FLUZONE HD was given instead of FLUBLOK with no reported adverse event; Initial information received on 22-Sep-2023 regarding an unsolicited valid non-serious case received from an Other health professional.  This case is linked to case 2023SA294371(CLUSTER).  This case involves a 60 years old male patient who experienced influenza quadrival A-B high dose hv vaccine [Fluzone high-dose quadrivalent] was given instead of influenza quadrivalent recombinant vaccine [Flublok] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 20V (CRM197) (prevnar 20) for Immunisation.  On 22-Sep-2023, the patient received 0.7 ml dose of suspect influenza quadrival a-b high dose hv vaccine (lot UT8104BA and expiration date- 31-Jun-2024) via intramuscular route in the left arm (strength: not provided) for Immunisation and received a dose of suspect influenza quadrivalent recombinant vaccine lot number not reported via unknown route in unknown administration site (dose, route, formulation, strength, lot/batch number and expiration date: not provided) for immunization (wrong product administered)  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Pain in extremity, Rash macular
Clinical narrative: then developed a large, blotchy, diffuse, pink area at the injection site that lasted a couple of days/area was about 1 x 5 x 3 inches; the next day his arm was sore; then developed a large, blotchy, diffuse, pink area at the injection site that lasted a couple of days/area was about 1 x 5 x 3 inches; Initial information received on 22-Sep-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case is linked to cases 2023SA294438(CLUSTER) and 2023SA293461(CLUSTER).  This case involves an unknown age male patient who developed a large, blotchy, diffuse, pink area at the injection site that lasted a couple of days/area was about 1 x 5 x 3 inches, the next day his arm was sore after receiving vaccine influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Sep-2023, the patient received a dose 0.7 ml of suspect Influenza Quadrival A-B High Dose HV Vaccine formulation, strength, expiry date: not reported lot U8084BA via unknown route in unknown administration site for immunization.  On 09-SEP-2023 the patient developed then developed a large, blotchy, diffuse, pink area at the injection site that lasted a couple of days/area was about 1 x 5 x 3 inches (rash macular) (vaccination site erythema) and the next day his arm was sore (pain in extremity) 1 day following the administration of Influenza Quadrival A-B High Dose HV Vaccine.  Reportedly, The caller received Fluzone High Dose QIV on 08Sep2023. This was the second year that he has received the high dose vaccine. Last year he did not have any reactions. After his flu vaccine last year, he received a Covid-19 bivalent shot by Moderna. He got a very bright red reaction to that vaccine. It was quite demarcated, almost like a tattoo. He was so concerned about the reaction to that Covid shot that he went to an urgent care. A nurse practitioner thought it might be cellulitis. She drew a circle around it and told him to seek medical help if the area moved outside the circle. It did not get bigger and went away on its own. After the Covid shot, he received a pneumonia shot. He said, "I had a little reaction to the pneumonia shot", but did not elaborate. Most recently, after the Fluzone High Dose QIV on 08Sept2023, the next day his arm was sore. He then developed a large, blotchy, diffuse, pink area at the injection site that lasted a couple of days. The area was about 1 x 5 x 3 inches. This reaction was not as obvious as the reaction he had to the Covid shot. The redness was lighter and more blotchy.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event Rash macular, was Unknown for the event Pain in extremity and was Recovered / Resolved on an unknown date for the event Vaccination site erythema.
Age: 1.58
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired ACT-HIB was administered to a patient with no reported adverse event; Initial information received on 22-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves 19 months old female patient who was administered expired haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for Immunisation.  On 15-Sep-2023, the patient received a standard expired dose 4 of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection at a dose of 0.5 ml total (lot UJ798AB, expiry date- 11-SEP-2023) via intramuscular route in the right thigh for Immunization with no reported adverse event (expired product administered) (latency- same day).  Caller asks if the efficacy of ACT-HIB is diminished after 11Sep2023, of if it is still good for a certain amount of time after the expiration date?   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site vesicles
Clinical narrative: developed a 1.5cm blister at the site of injection; Initial information was received on 22-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 4 years old and unknown gender patient who developed a 1.5cm blister at the site of injection after receiving diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine (Suspension for injection) (lot U7656AA, Expiry date : 08-Mar-2025,strength was unknown) via unknown route in unknown administration site for Prophylactic vaccination (Immunization).  On an unknown date the patient developed a 1.5cm blister at the site of injection (vaccination site vesicles) (latency : 1 day) following the administration of diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS and ipv VACCINE (Quadracel) was not applicable.  It was not reported if the patient received a corrective treatment for the event (developed a 1.5cm blister at the site of injection).  At time of reporting, the outcome was Unknown for the event developed a 1.5cm blister at the site of injection.
Age: 60.0
Sex: U
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: They intended to use FLUBLOK but instead gave the High Dose to someone that was 60  with no reported adverse event; They intended to use FLUBLOK but instead gave the High Dose to someone that was 60  with no reported adverse event; Initial information received on 22-Sep-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 60 years old and unknown gender patient and reporter reported they intended to use Influenza Quadrivalent Recombinant Vaccine [Flublok Qiv]  but instead gave the Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] to someone that was 60  with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (with an unknown strength,formulation, expiry date and lot number) via unknown route in unknown administration site for immunization.  On an unknown date, the reporter reported they intended to use Influenza Quadrivalent Recombinant Vaccine [Flublok Qiv]  but instead gave the Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] to someone that was 60  with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency: same day).  It was reported, Good afternoon, I was calling to report a (unintelligible) incident. I had a customer reach out to me about giving the wrong flu product to a customer. They intended to use FLUBLOK but instead gave the High Dose to someone that was 60 and I was just calling to report that. I am the staff on the account. Feel free to give me a call back if you have any questions. I believe the physician called in to report it as well. I think it should already be in the system but just wanted to get this reported. Please let me know if you need anything else.   Action taken: not applicable.  Outcome: Unknown for the reported events  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: 2.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site rash, Irritability, Muscle twitching
Clinical narrative: rash on the right thigh, pink, about 4cm in diameter.  that occurred immediately and the patient was given benadryl and that went away after about 2 hours.  That afternoon and evening (about 3-4 hours later) she became irritable, had a fever, and had twitching of her muscles every 30-60 seconds which lasted about 10 hours.  her irritability and fever lasted longer (about 24 hours post vaccination).  most of the symptoms were gone by about 30 hours post-vaccination
Age: 2.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: rash on the right thigh, pink, about 4cm in diameter.  that occurred immediately and the patient was given benadryl and that went away after about 2 hours.  That afternoon and evening (about 3-4 hours later) she became irritable, had a fever, and had twitching of her muscles every 30-60 seconds which lasted about 10 hours.  her irritability and fever lasted longer (about 24 hours post vaccination).  most of the symptoms were gone by about 30 hours post-vaccination
Age: 55.0
Sex: M
Vaccine: FLUR4
Symptoms: Chest pain, Dizziness, Electrocardiogram normal, Feeling abnormal, Laboratory test normal
Clinical narrative: after getting flublok, patient did not feel good, chest pain and arm pain , dizziness so he went to ER that night. They did ECG and other tests but all came normal.
Age: 55.0
Sex: M
Vaccine: FLUR4
Symptoms: Pain in extremity
Clinical narrative: after getting flublok, patient did not feel good, chest pain and arm pain , dizziness so he went to ER that night. They did ECG and other tests but all came normal.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Skin warm
Clinical narrative: Rash on back of left thigh that looks like crusted dots Started with one; now have 5. Itchy when they come in Then burn and warm to the touch
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Flushing, Pharyngeal swelling
Clinical narrative: On 9/28/2023, at approxmately 10:00 am, the patient was given a Covid-19 Comirnaty immunization, NDC #00069-2362-01, Lot #HD9835, anticipated expiraton date 11/29/2023. The patient reported no prior history of allergies or allergic reactions and a past history of Covid-19 immunizations. At approximately 10:02 am, the patient sat down abruptly in a nearby chair and appeared visibly flushed. The patient self-reported a momentary inability to breath (due to swollen throat), shortness of breath, abrupt sensation of heart, and chest pain/tightness. 911 was called and an epi-pen retreived; the patient was not given an epi-pen due to stating that they now had no difficulty breathing. The pharmacist stayed with the patient until the EMTs arrived. The patient was later observed leaving the store under her own power. When contacted at approximately 3:00 PM on 9/28/2023, the patient reported a full recovery and no need for a hospital visit etc.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: On 9/28/2023, at approxmately 10:00 am, the patient was given a Covid-19 Comirnaty immunization, NDC #00069-2362-01, Lot #HD9835, anticipated expiraton date 11/29/2023. The patient reported no prior history of allergies or allergic reactions and a past history of Covid-19 immunizations. At approximately 10:02 am, the patient sat down abruptly in a nearby chair and appeared visibly flushed. The patient self-reported a momentary inability to breath (due to swollen throat), shortness of breath, abrupt sensation of heart, and chest pain/tightness. 911 was called and an epi-pen retreived; the patient was not given an epi-pen due to stating that they now had no difficulty breathing. The pharmacist stayed with the patient until the EMTs arrived. The patient was later observed leaving the store under her own power. When contacted at approximately 3:00 PM on 9/28/2023, the patient reported a full recovery and no need for a hospital visit etc.
Age: 64.0
Sex: F
Vaccine: FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event, wrong dose was given
Age: 51.0
Sex: F
Vaccine: FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event, wrong dose given to patient
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Gave patient the high dose flu shot and she is not 65+ No adverse reactions