chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Physician.  A 51-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Nov2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies: contrast dye" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Betadine, reaction(s): "Allergies: betadine". Vaccination history included: moderna (Dose Number: 3, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 04Jan2022, when the patient was 49-year-old, for Covid-19 Immunization; Covid-19 vaccine (Dose Number: 1, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose Number: 2, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 13Jan2024 to 18Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: 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 a Consumer or other non HCP.  An adult female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Single, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (Booster), Single, Unknown Manufacturer), for COVID-19 Immunization.The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (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: Negative; Positive, notes: positive test 4 days after negative test. Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from an Other HCP.  A 43-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 in which patient received Paxlovid on 15Jan2024.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I took two shots (Pfizer COVID-19 Vaccine); second time being diagnosed with COVID; I took two shots (Pfizer COVID-19 Vaccine); second time being diagnosed with COVID; I took two shots (Pfizer COVID-19 Vaccine); second time being diagnosed with COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 76-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "I took two shots (Pfizer COVID-19 Vaccine); second time being diagnosed with COVID". The event "i took two shots (pfizer covid-19 vaccine); second time being diagnosed with covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, disease recurrence. Additional information: patient stated that this is the first time she had that Paxlovid, because when she had COVID the very first time they did not give her that medication but this time that she had COVID the doctor gave it to her, and after the first time being prescribed with it did not go so well but this time, she stated the medication worked like a miracle and she was not sick as a drug and she was only diagnosed with a fever for only 2 nights while taking Paxlovid since being diagnosed last week. She wanted to go to the doctor because she got really high fever and she went in the morning to see the doctor and doctor said patient had COVID so, doctor gave her this prescription but she was really in owe of this medication because this medication is really help her a lot. It did like miracle because she did not get no more fever, her throat was not hurting and did not have any flame. This is her second time being diagnosed with COVID.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I have had all of the Pfizer vaccines (Pfizer COVID 19 Vaccine); also had COVID 4 times; I have had all of the Pfizer vaccines (Pfizer COVID 19 Vaccine); also had COVID 4 times; This is a spontaneous report received from a Nurse.  An 80-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PNEUMOCOCCAL VACCINE taken for immunisation as dose number unknown, single; RSV VACCINE taken for immunisation as dose number unknown, single. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN (had all of the Pfizer vaccines)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have had all of the Pfizer vaccines (Pfizer COVID 19 Vaccine); also had COVID 4 times". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Concern: Consumer stated, "I just need to tell you this, I have had all of the Pfizer vaccines (Pfizer COVID 19 Vaccine) that were available, I have also had COVID 4 times. I am just finishing my last bout with COVID and my last bout with Paxlovid.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Incorrect dose administered
Clinical narrative: I have had all of the Pfizer vaccines (Pfizer COVID 19 Vaccine); also had COVID 4 times; I have had all of the Pfizer vaccines (Pfizer COVID 19 Vaccine); also had COVID 4 times; This is a spontaneous report received from a Nurse.  An 80-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PNEUMOCOCCAL VACCINE taken for immunisation as dose number unknown, single; RSV VACCINE taken for immunisation as dose number unknown, single. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN (had all of the Pfizer vaccines)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have had all of the Pfizer vaccines (Pfizer COVID 19 Vaccine); also had COVID 4 times". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Concern: Consumer stated, "I just need to tell you this, I have had all of the Pfizer vaccines (Pfizer COVID 19 Vaccine) that were available, I have also had COVID 4 times. I am just finishing my last bout with COVID and my last bout with Paxlovid.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Body temperature decreased, Hunger, Illness
Clinical narrative: I was sick; felt was very weak; felt like I have temperature but I only had a drop of temperature; I was hungry; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "sick". The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "I was sick"; ASTHENIA (non-serious), outcome "recovered", described as "felt was very weak"; BODY TEMPERATURE DECREASED (non-serious), outcome "recovered", described as "felt like I have temperature but I only had a drop of temperature"; HUNGER (non-serious), outcome "recovered", described as "I was hungry". Additional information: Patient had the very weird reaction for the last two shots of the vaccine for COVID and was worried. Thee first one, patient was sick for hours, the second time patient was sick for the whole day. Patient could not get off the bed and was wondering to take a third one or never. Vaccine name: patient was told that was the new, the last one was the newest. Patient felt very weak, the little sick. Patient felt like having temperature but only had a drop of temperature not that much but the whole day patient could not get up, patient was hungry. Patient did not do anything, it ruined the whole day. The next day, patient was totally okay.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "eczema" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL, start date: Jun2023. Past drug history included: Codeine, reaction(s): "Drug Allergy: Codeine". Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN, ), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was treated with PAXLOVID from 16Jan2024 to 21Jan2024.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 40-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer: Unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2; Manufacturer: Unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3 (booster); Manufacturer: Unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 4 (booster); Manufacturer: Unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 5 (booster); Manufacturer: Unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 6 (booster); Manufacturer: Unknown), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 22Jan2024 until 26Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: alopecia; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2 NOS), 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: ALOPECIA (non-serious), outcome "unknown".  Additional information. Patient is one of the students in the school district. She got alopecia from her COVID vaccines which she dutifully took because her Dad has cancer. Instead of being angry and taking legal action against Pfizer, she is changing lives by making other students who suffer from alopecia confident in their own skin. From what we understand she is 1 of 18 people that this has happened to.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400025594 same reporter/drug/event, different patient;US-PFIZER INC-202400029300 same reporter/drug/event, different patient;US-PFIZER INC-202400031339 same reporter/drug/event, different patient;US-PFIZER INC-202400031340 same reporter/drug/event, different patient;US-PFIZER INC-202400031341 same reporter/drug/event, different patient;US-PFIZER INC-202400031342 same reporter/drug/event, different patient;US-PFIZER INC-202400031343 same reporter/drug/event, different patient;US-PFIZER INC-202400031344 same reporter/drug/event, different patient;US-PFIZER INC-202400031345 same reporter/drug/event, different patient;US-PFIZER INC-202400031346 same reporter/drug/event, different patient;US-PFIZER INC-202400031347 same reporter/drug/event, different patient;US-PFIZER INC-202400031348 same reporter/drug/event, different patient;US-PFIZER INC-202400031349 same reporter/drug/event, different patient;US-PFIZER INC-202400031350 same reporter/drug/event, different patient;US-PFIZER INC-202400031351 same reporter/drug/event, different patient;US-PFIZER INC-202400031352 same reporter/drug/event, different patient;US-PFIZER INC-202400031353 same reporter/drug/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is currently her fifth time contracting COVID after taking all the Pfizer vaccinations and boosters; This is currently her fifth time contracting COVID after taking all the Pfizer vaccinations and boosters; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 70-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing); "COVID-19" (unspecified if ongoing); "COVID-19" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete, single), for COVID-19 Immunisation; Bnt162b2 (Dose number unknown (Booster), Single), for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "This is currently her fifth time contracting COVID after taking all the Pfizer vaccinations and boosters". Clinical Course: Patient stated that this was currently her fifth time contracting Covid after taking all the Pfizer vaccinations and boosters and she did not state if she previously took Paxlovid.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: severe case of urticaria; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2024NVX-US-000000183 (Novavax).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 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: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: URTICARIA (non-serious), outcome "recovered", described as "severe case of urticaria".  Additional information: It was reported that the patient had a severe case of urticaria for 2 days.  The lot number for BNT162b2, BNT162b2 omi ba.4-5, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-758915 (Moderna).  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number unknown. Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization. The following information was reported: DEATH (death, medically significant), outcome "fatal". The patient date of death was 01Jan1990. The reported cause of death was unknown. It was not reported if an autopsy was performed. Caller indicated that covid vaccine killed got Pfizer vaccine first booster shot and died. After getting dose, started freaking out, caregiver offered to call # but didn't feel like was necessary walked in and died in front of date of death unknown, unknown if autopsy done. Was described as being for age.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Reported Cause(s) of Death: Death
Sex: U
Vaccine: PNC20
Symptoms: Liquid product physical issue
Clinical narrative: something floating in it. Caller didn't feel comfortable administering this product; This is a spontaneous report received from an Other HCP from product quality group.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: HE6172, Expiration Date: 28Feb2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "something floating in it. Caller didn't feel comfortable administering this product".  The reporter considered "something floating in it. caller didn't feel comfortable administering this product" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "something floating in it. caller didn't feel comfortable administering this product" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).  Additional information: Caller has prefilled syringe of Prevnar 20 and saw something floating in it. Tried to shake it up to distribute and it never did. Caller didn't feel comfortable administering this product. Wants replacement.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: I experienced parosmia - a cigarette-like burning smell that dissipated after about three weeks.; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): US-MODERNATX-MOC20231212000102 (Moderna).  A 47-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAROSMIA (non-serious) with onset 01Oct2023, outcome "not recovered", described as "I experienced parosmia - a cigarette-like burning smell that dissipated after about three weeks.".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Discomfort, Hernia, Pain, Swelling
Clinical narrative: a little hernia; swelling; cough; pain; Some discomfort; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HERNIA (non-serious), outcome "unknown", described as "a little hernia"; SWELLING (non-serious), outcome "unknown"; COUGH (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown"; DISCOMFORT (non-serious), outcome "unknown", described as "Some discomfort".  Additional information: In a recorded HCP-Pt interaction from Jan2024, the patient was experiencing hernia symptoms after taking the COVID vaccine. The patient has some swelling, cough, pain, and discomfort. The doctor stated that the patient could have a little hernia or something, seems like.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood cholesterol increased, Blood triglycerides, Blood triglycerides increased, Cataract
Clinical narrative: cataracts; high cholesterol; depression; shortness of breath; cough; triglycerides and my cholesterol were a little high; I'm a little down; allergies; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient received BNT162b2 (BNT162B2 NOS), 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: CATARACT (medically significant), outcome "not recovered", described as "cataracts"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "not recovered", described as "high cholesterol"; DEPRESSION (non-serious), outcome "not recovered"; DYSPNOEA (non-serious), outcome "not recovered", described as "shortness of breath"; COUGH (non-serious), outcome "recovering"; BLOOD TRIGLYCERIDES INCREASED (non-serious), outcome "unknown", described as "triglycerides and my cholesterol were a little high"; DEPRESSED MOOD (non-serious), outcome "unknown", described as "I'm a little down"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergies". The patient underwent the following laboratory tests and procedures: Blood cholesterol: little high; Blood triglycerides: little high.  clinical course: In this recorded HCP-PT interaction from Jan2024, PT is experiencing high cholesterol, cataracts, depression, shortness of breath, and cough after taking COVID vaccine. Patient stated that, my triglycerides and my cholesterol were a little high. Every May I go to the eye doctor, she told me last May, my cataracts aren't bad enough to do anything, come back next year and see if they're changed. patient can see fine. Patient was little down. I don't know what to do with himself. No palpitations, shortness of breath. Sometimes running up and down the steps. Patient came home with allergies and have been coughing and thought it was allergies because that's what it felt like, but it's much better but it's not a hundred percent gone.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Depressed mood, Depression, Dyspnoea, Hypersensitivity
Clinical narrative: cataracts; high cholesterol; depression; shortness of breath; cough; triglycerides and my cholesterol were a little high; I'm a little down; allergies; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient received BNT162b2 (BNT162B2 NOS), 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: CATARACT (medically significant), outcome "not recovered", described as "cataracts"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "not recovered", described as "high cholesterol"; DEPRESSION (non-serious), outcome "not recovered"; DYSPNOEA (non-serious), outcome "not recovered", described as "shortness of breath"; COUGH (non-serious), outcome "recovering"; BLOOD TRIGLYCERIDES INCREASED (non-serious), outcome "unknown", described as "triglycerides and my cholesterol were a little high"; DEPRESSED MOOD (non-serious), outcome "unknown", described as "I'm a little down"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergies". The patient underwent the following laboratory tests and procedures: Blood cholesterol: little high; Blood triglycerides: little high.  clinical course: In this recorded HCP-PT interaction from Jan2024, PT is experiencing high cholesterol, cataracts, depression, shortness of breath, and cough after taking COVID vaccine. Patient stated that, my triglycerides and my cholesterol were a little high. Every May I go to the eye doctor, she told me last May, my cataracts aren't bad enough to do anything, come back next year and see if they're changed. patient can see fine. Patient was little down. I don't know what to do with himself. No palpitations, shortness of breath. Sometimes running up and down the steps. Patient came home with allergies and have been coughing and thought it was allergies because that's what it felt like, but it's much better but it's not a hundred percent gone.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: covid; covid; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "covid". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: has not started taking PAXLOVID; has not started taking PAXLOVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 76-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "has not started taking PAXLOVID".  Additional information: Patient stated, "I got the Pfizer shot" and opted in to be contacted in the future regarding this. Patient has not started taking PAXLOVID.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient had gotten both the moderna and pfizer vaccine shots (total of 5)/ Paxlovid; Patient had gotten both the moderna and pfizer vaccine shots (total of 5)/ Paxlovid; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient had gotten both the moderna and pfizer vaccine shots (total of 5)/ Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The patient caregiver stated 'Patient had gotten bother the moderna and Pfizer vaccine shots (Total of 5)'.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was given with FLUZONE QIV NP 3 months ago and it was overlooked so the patient received another dose of FLUZONE QIV NP recently, with no reported adverse event; Initial information received on 25-Jan-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old female patient was given with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] 3 months ago and it was overlooked so the patient received another dose of fluzone qiv np recently, 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 MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI) for Prophylactic vaccination.  On 22-Jan-2024, the patient received a dose of 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE (Suspension for injection) lot U8202CA, Expiry date: 30-Jun-2024, strength was unknown via intramuscular route in the left deltoid for influenza and patient was given with fluzone qiv np 3 months ago and it was overlooked so the patient received another dose of fluzone qiv np recently, with no reported adverse event (inappropriate schedule of product administration) (latency : same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.67
Sex: M
Vaccine: IPV, TDAP
Symptoms: Product storage error
Clinical narrative: temperature excursion that lasted 43 hours and 35 minutes/ Have products been administered post excursion: YES With no reported adverse event; Initial information received from Regulatory Authority on 25-Jan-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 8 months old male patient and reporter reported temperature excursion for diphtheria-2/tetanus/5 ac pertussis vaccine [adacel] and poliomyelitis vaccine (inactivated) [ipol] that lasted 43 hours and 35 minutes/ have products been administered post excursion: yes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Jan-2024, the patient received 0.5 ml (Dose 2) of suspect IPV (VERO) Suspension for injection (lot number: W1B511M) (Expiry date: 08-Sep-2025) via intramuscular route in the left thigh for immunization.  On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number:  U7905AA) (Expiry date: 03-Oct-2025) via unknown route in unknown administration site for immunsiation.  On 19-Jan-2024,  the reporter reported temperature excursion for diphtheria-2/tetanus/5 ac pertussis vaccine [adacel] and poliomyelitis vaccine (inactivated) [ipol] that lasted 43 hours and 35 minutes/ have products been administered post excursion: yes with no reported adverse event (poor quality product administered) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: TENIVAC which already expired 24SEP2023 was administered with no reported adverse event; Initial information was received on 26-Jan-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and gender patient to whom diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] which already expired 24 sep 2023 was administered 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 diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Suspension for injection) (lot U7183AA, expiry date: 24-Sep-2024, unknown strength) via unknown route in unknown administration site for Immunisation and Tenivac which already expired 24 sep 2023 was administered with no reported adverse event (expired product administered) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 6.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Max/low temperature reached: 9.3 C for 13 mins 10 C for 10 C was administered to patient with no reported adverse event; Initial information was received from Regulatory Authority on 29-Jan-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 years old female patient to whom max/low temperature reached: 9.3 c for 13 mins 10 c for 10 c was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Dec-2023, the patient received a 0.5 ml, once dose of suspect IPV (VERO) (Suspension for injection) (lot W1B511M, expiry date: 25-Sep-2025, Strength: standard) via intramuscular route in the left deltoid for Immunisation and max/low temperature reached: 9.3 c for 13 mins 10 c for 10 c was administered to patients with no reported adverse event (poor quality product administered) (Latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: administered IPOL that had Max/low temperature reached: 9.3 C for 13 mins 10 C for 10 C with no adverse event; Initial information received on 29-Jan-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 11 years old male (4th patient) patient who was administered IPV (VERO) [IPOL] that had max/low temperature reached: 9.3 c for 13 mins 10 c for 10 c with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Prophylactic vaccination; DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Prophylactic vaccination; and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination.  On 08-Dec-2023, the patient received a dose of suspect IPV (VERO) Suspension for injection (lot W1B511M, Expiry date: 08-Sep-2025 with unknown strength) via intramuscular route in the left deltoid as immunization that had max/low temperature reached: 9.3 c for 13 mins 10 c for 10 c with no adverse event (poor quality product administered) (Latency: same day).  It was reported "the punctured IPOL previously was administered to 50 patients. Product/s: Punctured IPOL Reason: Unknown Human error? Unknown Administered? Yes, it was administered to 50 patients."   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 and Regulatory Authority 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: 9.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: it was administered to 50 patients with no reported adverse event; Punctured IPOL 9.3 C for 13 mins 10 C for 10 C, with no reported adverse event; Initial information was received from Regulatory Authority on 29-Jan-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 9 years old male patient who reported that it was administered to 50 patients with no reported adverse event and punctured IPV (VERO) [IMOVAX POLIO] 9.3 c for 13 mins 10 c for 10 c, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine; and Influenza Vaccine for Immunisation.  On 14-Dec-2023, the patient received a dose of 0.5 ml of suspect IPV (VERO) (Suspension for injection) lot W1C751M , Expiry date:18-Nov-2025, strength was unknown via intramuscular route in the left deltoid for Immunization and it was administered to 50 patients with no reported adverse event (poor quality product administered) and punctured ipol 9.3 c for 13 mins 10 c for 10 c, with no reported adverse event (product storage error) (latency : same day).  Reportedly "As stated above Human error? Unknown Administered? Yes, it was administered to 50 patients. Does extended stability data cover the excursion? No Nurse verbally consented for a follow up in case Safety team wants additional information. See Transfer Screen for the details of patient 10. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data. This situation is pre-assessed as a medication error/an inappropriate use due to administration of punctured IPOL that is not suitable for use."   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: 8.0
Sex: F
Vaccine: IPV
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Max/low temperature reached: 9.3 C for 13 mins/punctured IPOL was administered to patient with no reported adverse event; Max/low temperature reached: 9.3 C for 13 mins/punctured IPOL was administered to patient with no reported adverse event; Initial information received on 29-Jan-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 8 years old female patient who administered punctured IPV (VERO) [IMOVAX POLIO] which was exposed to max/low temperature reached: 9.3 celsius for 13 minutes  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination.  On 15-Dec-2023, the patient administered 0.5 ml of punctured IPV (VERO) (lot W1C751M , expiry date: 18-Nov-2025, Strength = standard, Frequency = once) via intramuscular route in the left deltoid as immunization and it was exposed to max/low temperature reached: 9.3 celsius for 13 minutes (poor quality product administered) (product storage error) (Latency: same day).  The human error reported was unknown.   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: 18.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: the punctured IPOL she reported previously was administered (with no reported adverse event); Initial information was received from Regulatory Authority on 29-Jan-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 years old female patient who the punctured IPV (VERO) [IMOVAX POLIO] she reported previously was administered (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B Vaccine; MENINGOCOCCAL Vaccine A/C/Y/W CONJ (TET TOX) (MENQUADFI); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and Varicella Zoster Vaccine (Varicella Vaccine) for Prophylactic vaccination.  On 20-Dec-2023, the patient received a  dose of 0.5 ml of suspect IPV (VERO) (Suspension for injection) lot W1C751M , Expiry date:18-Nov-2025, strength was unknown via intramuscular route in the left deltoid for Immunization and the punctured ipol she reported previously was administered (with no reported adverse event) (poor quality product administered) (latency: same day).  Reportedly "Reason: Unknown Max/low temperature reached: 9.3 C for 13 mins 10 C for 10 C Duration: As stated above Human error? Unknown Administered? Yes, it was administered to 50 patients. Does extended stability data cover the excursion? No Nurse verbally consented for a follow up in case Safety team wants additional information. See Transfer Screen for the details of patient 16. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data. This situation is pre-assessed as a medication error/an inappropriate use due to administration of punctured IPOL that is not suitable for use."  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.