chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Lipoma, Magnetic resonance imaging
Clinical narrative: I have a large lipoma removed from my deltoid muscle at about the place where we injected the vaccine/ benign lipoma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received bnt162b2 (BNT162B2), on 13May2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 70 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension. Concomitant medication(s) included: LISINOPRIL taken for hypertension. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Lot number: EN5318), administration date: 29Jan2021, when the patient was 69-year-old, for COVID-19 immunisation, reaction(s): "Lipoma"; bnt162b2 (DOSE 2, SINGLE, Lot number: EN6200), administration date: 19Feb2021, when the patient was 69-year-old, for COVID-19 immunisation, reaction(s): "Lipoma"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: FF2590), administration date: 10Nov2021, when the patient was 70-year-old, for COVID-19 immunisation, reaction(s): "Lipoma". The following information was reported: LIPOMA (medically significant), outcome "unknown", described as "I have a large lipoma removed from my deltoid muscle at about the place where we injected the vaccine/ benign lipoma". The patient underwent the following laboratory tests and procedures: Biopsy: came up benign, notes: Biopsy which came up benign; Magnetic resonance imaging: large lipoma, notes: I have a large lipoma removed from my deltoid muscle at about the place where we injected the vaccine and the location can be confirmed through an MRI. Therapeutic measures were taken as a result of lipoma. Clinical course: Patient had a large lipoma removed from his deltoid muscle at about the place where injected the vaccine and the location could be confirmed through an MRI that was made and then the surgeon had a record and the biopsy which came up benign. So, those two three documentations about that item and he did not know if it was the problem with the vaccine or if it just happened but it was curious that it was all on the same area. The vaccine was injected all on the right deltoid, all the same and the lipoma was in that area also and the surgeon could explain that better than patient could certainly. But he was curious if they were related, he did not know but it was a record saying, he did not know why. However, was there any relationship in time and also in location. All of the vaccine that he received, were Pfizer's. Treatment: Consumer stated, "No, just removal. He mentioned again, they do had the documentation of the MRI and the surgeons report, and the biopsy and he did not know if any parts of it remained. So, it could be tested for something other than what she was looking for.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300354231 Same patient and product, Different dose and events;
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 51 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: ER8729), on 27Apr2021 as dose 2, single (Lot number: EW0171), on 11Nov2021 as dose 3 (booster), single (Lot number: FH8028) and on 11Apr2022 as dose 4 (booster), single (Lot number: FK9729) for covid-19 immunisation. The patient's relevant medical history included: "AHCM heart condition (apical hypertrophic cardiomyopathy)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (Nov2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Nov2023) Negative, notes: tested negative 25Nov - 01Dec. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 20Nov2023 to 24Nov2023. Clinical Course: Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 11Mar2021 at 12:00 as dose 1, single (Lot number: EN6119), in left arm and on 05Apr2021 at 12:00 as dose 2, single (Lot number: ER8730) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid with start date as 02Dec2023.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 as dose 1, single (Lot number: HH7595) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "Known allergies: narcotics (e.g., vicodin, codeine)" (unspecified if ongoing). The patient's concomitant medications were not reported. 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; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (Dose 5 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (Dose 6 (BOOSTER), SINGLE, 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 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The patient received Paxlovid as COVID 19 Treatment from 20Nov2023 to 25Nov2023.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Jan2023 as dose 5 (booster), single (Lot number: GJ5342), in left arm and on 31Aug2023 at 14:30 as dose 6 (booster), single (Lot number: GK0928) at the age of 70 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 17Mar2021 as dose 2, single (Lot number: EN6203), in left arm, on 17Nov2021 as dose 3 (booster), single (Lot number: FG3527) and on 12Jun2022 as dose 4 (booster), single (Lot number: FM0173), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "glaucoma" (unspecified if ongoing); "Known allergies: Psyllium Husk" (unspecified if ongoing); "Known allergies: Polycillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Nov2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Nov2023) positive, notes: (very dark line). Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 19Nov2023 to 24Nov2023.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Feeling abnormal, Palpitations
Clinical narrative: zero energy or motivation to my heart feeling like it was racing or chest pains; felt like shit for a month; chest pains; zero energy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jan2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "massotosis" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: CHEST PAIN (non-serious) with onset 2023, outcome "unknown", described as "chest pains"; FEELING ABNORMAL (non-serious) with onset 2023, outcome "recovered" (2023), described as "felt horrible for a month"; ASTHENIA (non-serious) with onset 2023, outcome "unknown", described as "zero energy"; PALPITATIONS (non-serious) with onset 2023, outcome "unknown", described as "zero energy or motivation to my heart feeling like it was racing or chest pains".  Additional Information: Patient got covid vaccination on Sunday at (Withheld). One no the after covid traveled (Withheld) to (Withheld) on 06Feb2023 tested positive after second booster first week of Jan. Generally felt horrible for a month, zero energy or motivation to his heart feeling like it was racing or chest pains. Patient had massotosis and there was not any assistance here false sense of security. Patient got aware of those adverse events on 30Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300197284 same patient/product, different dose (LOE)/event;US-PFIZER INC-PV202300197257 different patient, same product, different events;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Cardiac assistance device user, Drug ineffective, Suspected COVID-19
Clinical narrative: got COVID in Jan and this process start all over again with a COVID; got COVID in Jan and this process start all over again with a COVID; having effects to the body including a pacemaker; 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 number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got COVID in Jan and this process start all over again with a COVID"; CARDIAC ASSISTANCE DEVICE USER (medically significant), outcome "unknown", described as "having effects to the body including a pacemaker". Clinical course: The patient had been having many health issues for the last couple of years since the patient got the shot (Pfizer COVID-19 Vaccine) and then the patient worked on reversing them and reign over them but the patient hadn't and then the patient got COVID in Jan and this process start all over again with a COVID. The patient started having effects to the body including a pacemaker.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Blood pressure measurement, Blood test, Discomfort
Clinical narrative: got COVID in Jan and this process start all over again with a COVID; got COVID in Jan and this process start all over again with a COVID; having effects to the body including a pacemaker; 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 number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got COVID in Jan and this process start all over again with a COVID"; CARDIAC ASSISTANCE DEVICE USER (medically significant), outcome "unknown", described as "having effects to the body including a pacemaker". Clinical course: The patient had been having many health issues for the last couple of years since the patient got the shot (Pfizer COVID-19 Vaccine) and then the patient worked on reversing them and reign over them but the patient hadn't and then the patient got COVID in Jan and this process start all over again with a COVID. The patient started having effects to the body including a pacemaker.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Encephalopathy, Exercise tolerance decreased, Fatigue, Headache
Clinical narrative: got COVID in Jan and this process start all over again with a COVID; got COVID in Jan and this process start all over again with a COVID; having effects to the body including a pacemaker; 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 number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got COVID in Jan and this process start all over again with a COVID"; CARDIAC ASSISTANCE DEVICE USER (medically significant), outcome "unknown", described as "having effects to the body including a pacemaker". Clinical course: The patient had been having many health issues for the last couple of years since the patient got the shot (Pfizer COVID-19 Vaccine) and then the patient worked on reversing them and reign over them but the patient hadn't and then the patient got COVID in Jan and this process start all over again with a COVID. The patient started having effects to the body including a pacemaker.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate decreased, Hypotension, Inappropriate schedule of product administration, Magnetic resonance imaging
Clinical narrative: got COVID in Jan and this process start all over again with a COVID; got COVID in Jan and this process start all over again with a COVID; having effects to the body including a pacemaker; 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 number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got COVID in Jan and this process start all over again with a COVID"; CARDIAC ASSISTANCE DEVICE USER (medically significant), outcome "unknown", described as "having effects to the body including a pacemaker". Clinical course: The patient had been having many health issues for the last couple of years since the patient got the shot (Pfizer COVID-19 Vaccine) and then the patient worked on reversing them and reign over them but the patient hadn't and then the patient got COVID in Jan and this process start all over again with a COVID. The patient started having effects to the body including a pacemaker.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Movement disorder, Myalgia, Pain, Sensation of blood flow, Weight
Clinical narrative: got COVID in Jan and this process start all over again with a COVID; got COVID in Jan and this process start all over again with a COVID; having effects to the body including a pacemaker; 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 number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got COVID in Jan and this process start all over again with a COVID"; CARDIAC ASSISTANCE DEVICE USER (medically significant), outcome "unknown", described as "having effects to the body including a pacemaker". Clinical course: The patient had been having many health issues for the last couple of years since the patient got the shot (Pfizer COVID-19 Vaccine) and then the patient worked on reversing them and reign over them but the patient hadn't and then the patient got COVID in Jan and this process start all over again with a COVID. The patient started having effects to the body including a pacemaker.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: got COVID in Jan and this process start all over again with a COVID; got COVID in Jan and this process start all over again with a COVID; having effects to the body including a pacemaker; 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 number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got COVID in Jan and this process start all over again with a COVID"; CARDIAC ASSISTANCE DEVICE USER (medically significant), outcome "unknown", described as "having effects to the body including a pacemaker". Clinical course: The patient had been having many health issues for the last couple of years since the patient got the shot (Pfizer COVID-19 Vaccine) and then the patient worked on reversing them and reign over them but the patient hadn't and then the patient got COVID in Jan and this process start all over again with a COVID. The patient started having effects to the body including a pacemaker.  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: Chills, Illness, Pyrexia
Clinical narrative: Fever; Chills; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), 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. Vaccination history included: Comirnaty (dose number unknown, single), for COVID-19 immunisation, reaction(s): "chills", "sick", "fever". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown"; ILLNESS (non-serious), outcome "unknown", described as "sick".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300434157 same patient/drug/AEs, different dose;
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: persistent insomnia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Dec2023 as dose 1, single (Lot number: MG4633) at the age of 25 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PMDD" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Asthma primary" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ibuprofen, reaction(s): "Allergy"; Haldol, reaction(s): "Allergy". The following information was reported: INSOMNIA (non-serious) with onset 04Dec2023, outcome "unknown", described as "persistent insomnia". Therapeutic measures were taken as a result of insomnia. Additional information: treatment received Ambien CR medication and Benadryl.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neuralgic amyotrophy
Clinical narrative: I was diagnosed today with Parsonage-Turner syndrome; Right shoulder pain; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 66-year-old male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 28Nov2023 at 08:00 as dose 1, single (Lot number: HF9300) at the age of 66 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hypercholesterolaemia" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; ASPIRIN [ACETYLSALICYLIC ACID]; ELIQUIS; PREVACID; OMEGA-3 FATTY ACIDS; METOPROLOL; VITAMIN D3; REPATHA; HYDROCHLOROTHIAZIDE LOSARTAN. Vaccination history included: Moderna covid-19 vaccine (Dose 1, single, lot number 031M20A, expiration date 05Aug2021, NDC# 80777-0273-99), administration date: 23Feb2021, when the patient was 63-year-old, for COVID-19 immunisation; Moderna covid-19 vaccine (Dose 2, single, lot number 025A21A, expiration date 24Aug2021, NDC# 80777-0273-99), administration date: 23Mar2021, when the patient was 63-year-old, for COVID-19 immunisation; Moderna covid-19 vaccine (Dose 3 (booster), single, lot number 061E21A), administration date: 04Nov2021, when the patient was 64-year-old, for COVID-19 immunisation; Moderna covid-19 vaccine (Dose 4 (booster), single, lot number 022J22A), administration date: 06Apr2022, when the patient was 64-year-old, for COVID-19 immunisation; Moderna covid-19 vaccine (Dose 5 (booster), single, lot number 055F22B), administration date: 29Sep2022, when the patient was 65-year-old, for COVID-19 immunisation. The following information was reported: ARTHRALGIA (non-serious) with onset 29Nov2023, outcome "not recovered", described as "Right shoulder pain"; NEURALGIC AMYOTROPHY (non-serious) with onset 04Dec2023, outcome "not recovered", described as "I was diagnosed today with Parsonage-Turner syndrome". Therapeutic measures were taken as a result of neuralgic amyotrophy, arthralgia.  Additional information: The patient stated that he was diagnosed on 04Dec2023 with Parsonage-Turner syndrome, so it's an immune related inflammatory brachial plexus. The patient stated also that he had the immunization on November28th. On November 29th, he developed right shoulder pain. The injection was in left arm. He started having pain in right shoulder on Wednesday November 29th. The pain has been persistent and on 04Dec2023 he was diagnosed with Parsonage-Turner syndrome. The shoulder pain was persistent, he had not recovered at the time of this report. The patient was treated with Prednisone. It was a tapering dose. He started at 50 milligrams daily to the tapered over the following weeks down to zero.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: I have lost my smell; I have lost my smell, taste; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient received bnt162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: ENJ201) at the age of 79 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANOSMIA (non-serious), outcome "not recovered", described as "I have lost my smell"; AGEUSIA (non-serious), outcome "not recovered", described as "I have lost my smell, taste".
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Condition aggravated, Klebsiella infection, Pseudomonas infection, Respiratory disorder, Sputum culture
Clinical narrative: fainted; Sputum cultures showed klebsiella and Pseudomonas; Sputum cultures showed klebsiella and Pseudomonas; This illness did not respond to treatment, only got worse; have been sick with resp problems; 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 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 25Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization; Bnt162b2 (Dose 2, single), for COVID-19 immunization; Bnt162b2 (Dose 3 (booster), single), for COVID-19 immunization; Bnt162b2 (Dose 4 (booster), single), for COVID-19 immunization. The following information was reported: RESPIRATORY DISORDER (medically significant) with onset 27Nov2023, outcome "not recovered", described as "have been sick with resp problems"; SYNCOPE (hospitalization, medically significant), outcome "unknown", described as "fainted"; PSEUDOMONAS INFECTION (medically significant), KLEBSIELLA INFECTION (medically significant), outcome "unknown" and all described as "Sputum cultures showed klebsiella and Pseudomonas"; CONDITION AGGRAVATED (medically significant), outcome "not recovered", described as "This illness did not respond to treatment, only got worse". The patient was hospitalized for syncope (start date: 17Nov2023, discharge date: 23Nov2023, hospitalization duration: 7 day(s)). The patient underwent the following laboratory tests and procedures: Sputum culture: Sputum cultures showed Klebsiella and Pseudomonas. Therapeutic measures were taken as a result of klebsiella infection, respiratory disorder, condition aggravated.  Clinical course: On 25Sep went to (Company name withheld), got the latest (5th) Pfizer and Flu vaccine at the same time. Saw pulmonologist on 26Sep, everything was fine. On 27Nov came down with resp symptoms. Patient have been sick with resp problems since, went through three rounds of treatment by pulmonologist, including antibiotics and Prednisone, this illness did not respond to treatment, only got worse. Sputum cultures showed klebsiella and Pseudomonas. Finally patient fainted while shopping and ended up in the. Hospital on 17Nov. D/C 23.  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, FLUX
Symptoms: Syncope
Clinical narrative: fainted; Sputum cultures showed klebsiella and Pseudomonas; Sputum cultures showed klebsiella and Pseudomonas; This illness did not respond to treatment, only got worse; have been sick with resp problems; 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 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 25Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization; Bnt162b2 (Dose 2, single), for COVID-19 immunization; Bnt162b2 (Dose 3 (booster), single), for COVID-19 immunization; Bnt162b2 (Dose 4 (booster), single), for COVID-19 immunization. The following information was reported: RESPIRATORY DISORDER (medically significant) with onset 27Nov2023, outcome "not recovered", described as "have been sick with resp problems"; SYNCOPE (hospitalization, medically significant), outcome "unknown", described as "fainted"; PSEUDOMONAS INFECTION (medically significant), KLEBSIELLA INFECTION (medically significant), outcome "unknown" and all described as "Sputum cultures showed klebsiella and Pseudomonas"; CONDITION AGGRAVATED (medically significant), outcome "not recovered", described as "This illness did not respond to treatment, only got worse". The patient was hospitalized for syncope (start date: 17Nov2023, discharge date: 23Nov2023, hospitalization duration: 7 day(s)). The patient underwent the following laboratory tests and procedures: Sputum culture: Sputum cultures showed Klebsiella and Pseudomonas. Therapeutic measures were taken as a result of klebsiella infection, respiratory disorder, condition aggravated.  Clinical course: On 25Sep went to (Company name withheld), got the latest (5th) Pfizer and Flu vaccine at the same time. Saw pulmonologist on 26Sep, everything was fine. On 27Nov came down with resp symptoms. Patient have been sick with resp problems since, went through three rounds of treatment by pulmonologist, including antibiotics and Prednisone, this illness did not respond to treatment, only got worse. Sputum cultures showed klebsiella and Pseudomonas. Finally patient fainted while shopping and ended up in the. Hospital on 17Nov. D/C 23.  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: Antibody test, Inclusion body myositis
Clinical narrative: I test positive for the CN1A antibody (Inclusion Body Myositis).; 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), in Jan2022 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: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunisation. The following information was reported: INCLUSION BODY MYOSITIS (medically significant) with onset Jan2022, 24 hrs after the suspect product(s) administration, outcome "unknown", described as "I test positive for the CN1A antibody (Inclusion Body Myositis)." The patient underwent the following laboratory tests and procedures: Antibody test: (Jan2022) Positive. Clinical course: Patient had the Covid Booster shot on Jan2022 within 24 hours patient had severe reaction not the typically reaction most people experience. Patient knew he/she was in trouble. It inflamed all his/her muscles. Patient tested positive for the CN1A antibody (Inclusion Body Myositis). This was a rare inflammatory, neurodegenerative condition with no cure or treatment. Patient never had COVID and said the vaccine/booster was not necessary for healthy people.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she tested positive; she tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  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 (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: Wednesday morning she tested negative; positive, notes: Thursday afternoon, she tested positive. Clinical course: They got their covid vaccinations on Sunday at (Withheld). On Tuesday his wife was not feeling well. Wednesday morning she tested negative. But this afternoon, Thursday afternoon, she tested positive.  No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300429534 different patient, same product, different events;US-PFIZER INC-PV202300197284 different patient, same product, different events;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jan2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "massotosis" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive. Clinical Course: One no the after covid traveled (Withheld) to (Withheld) on 06Feb2023 tested positive after second booster first week of jan.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300429534 same patient, different dose and event;US-PFIZER INC-PV202300197257 different patient, same product, different events;
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: she is fighting a cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  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: Comirnaty (Dose 1), for covid-19 immunization; Comirnaty (Dose 2), for covid-19 immunization. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "she is fighting a cold".
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Malaise
Clinical narrative: joint pain; DIDN'T FEEL WELL; Initial information received on 27-Nov-2023 regarding an unsolicited valid non-serious case received from a Patient.  This case is linked to case 2023SA372578(CLUSTER).  This case involves Adult female patient who experienced joint pain and didn't feel well after receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Dust allergy, Grass allergy, Birch pollen allergy and Fruit allergy (HAZELNUT, APPLE, MELON).  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, strength, form, dose, expiry date not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed joint pain (arthralgia) and didn't feel well (malaise) (unknown latency) following the administration of Influenza Vaccine.  It was reported "patient wanted to know if she can get covid booster while on dupixent. she mentioned she didn't feel well for a couple weeks after getting flu shot and doesn't want to deal with that again."  Action taken: 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 the events.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: given fluzone high dose out of indication 64 years old by mistake of provider with no reported adverse event; Initial information received on 29-Nov-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 64 years old male patient who was given influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] out of indication by mistake of provider 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 influenza quadrival A-B high dose HV vaccine (formulation: Suspension for injection in pre-filled syringe) (strength; lot number; expiry date not reported) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation). Information regarding batch number will be requested in this case.  On an unknown date 64 years old male patient was given influenza quadrival A-B high dose HV vaccine out of indication by mistake of provider with no reported adverse event (product administered to patient of inappropriate age) (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.  Was the company suspect product inappropriately used as per local Marketing authorization? Yes Is it intentional No Therapeutic Purpose Unknown At the initiative of: Unknown
Sex: F
Vaccine: FLUX
Symptoms: Fatigue
Clinical narrative: was tired after flu shot; Initial information received on 06-Nov-2023 regarding an unsolicited valid non-serious courtesy case received from a consumer/non-hcp.  This case involves an unknown age female patient (170 cm and 49.9 kg) who was tired after receiving influenza vaccine.  At the time of the event, the patient had ongoing Cancer. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included lenvatinib mesilate (Lenvima); pembrolizumab (Keytruda); apixaban (Eliquis); levofloxacin (Lovenox [Levofloxacin]); famotidine (Pepcidin); fluconazole (Diflucan); Nystatin; vitamins NOS (Multivitamin [Vitamins NOS]); and elasomeran (Moderna COVID-19 Vaccine) for Prophylactic vaccination.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation; strength; lot number; expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). There will be no information regarding batch number in this case.  On an unknown date the patient was tired after influenza vaccine (fatigue) (unknown latency).  It was reported, "patient says she knows Lenvima can lower her immune system but asking if the days she does infusion of Keytruda along with Lenvima could it even make it lower and ask if we have any suggestions on what she could do to help with it. ; I advised yes, the chemo drugs can lower blood counts. patient said they did. I said in addition, body is busy fighting cancer. best is to protect herself/use extra precautions to avoid getting sick. she said after last infusion, got a cold. could have been from lower blood counts and she said maybe someone there was sick. advised her to maybe wear a mask for a few days after her infusion and always wash hands/sanitizer, avoid transfer to face. can boost vit C for a couple days before infusion (she mentioned cont'd: orange juice or can take tabs). she also got the covid booster and flu shot. she mentioned she is on lovenox and has noticed bloody nose when blow nose. mentioned she is more tired after her infusion and was tired after flu shot. she asked if she got vit D levels taken, should she take a supplement if they are low. i said i would recommend it, yes, if low.; outcome: unk. patient re-reported: reports blood clot in june, blood in urine and kidney stones. doctor aware. currently taking lovenox to dissolve clot and may be possibly switching to eliquis and wanted to know about possible drug interactions with lenvima and keytruda. advised per clin pharm, no interactions with lovenox or eliquis and lenvima and keytruda. explained lenvima, keytruda and lovenox can all cause blood in urine. explained lovenox is more effective at dissoloving clots, while eliquis prevents future clots. explained lovenox can also be uesed as prevention."  Action taken was 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.
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: that they have given a patient with a double dose of the FLUZONE HD QIV with no reported adverse event; Initial information received on 28-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient and reporter reported that they have given a patient with a double dose of the Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] 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 formulation, strength, expiry date and lot number) via unknown route in unknown administration site for influenza immunization.  On an unknown date, reporter reported that they have given a patient with a double dose of the Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event (extra dose administered) (latency: same day).  It was reported, Physician Assistant calls in to inform that they have given a patient with a double dose of the FLUZONE HD QIV. They are asking if there are side effects for the overdose. This situation is pre-assessed as a medication error/an inappropriate use due to administering an extra dose of the vaccine. AE reporting was not utilized during the call as caller only expressed her frustrations over Sanofi not having further recommendations for this case. No further information were collected.  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.