chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: He still has shoulder pain on the same spot where he got the injection; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (He still has shoulder pain on the same spot where he got the injection) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 29-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced ARTHRALGIA (He still has shoulder pain on the same spot where he got the injection). At the time of the report, ARTHRALGIA (He still has shoulder pain on the same spot where he got the injection) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported. The suspect product dosage text was reported as unknown. No treatment medication was reported.   Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This spontaneous case was reported by a patient and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient did not received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Lupus-like syndrome. Concomitant products included PREDNISONE for Lupus-like syndrome.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that patient lips were swelled, lips were numb and tingly, throat itchy and swelling. Patient had a Johnson and Johnson vaccine in OCT2021. No other vaccines in 4 weeks prior No treatment medication was reported. Company comment: This spontaneous case concerns a 59-year-old female patient, with no relevant medical history reported, who experienced the unexpected and serious (medically significant) event of ANAPHYLACTIC REACTION, after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine) vaccine. Since the exact event´s onset date was not reported, latency could not be properly assessed. She experienced swelling, numb and tingly of lips and itchy throat. No treatment medication was reported but she was taking prednisone for her lupus at the time. No information disclosed about diagnostic tests performed or treatments received. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: COVID-19, Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: tested for COVID and I tested positive; Running nose; Light grade fever; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 19Dec2023 at 15:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 78 years intramuscular, in left arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN; EZETIMIBE; CIALIS; METOPROLOL; LOSARTAN; ELIQUIS. The patient also took other concomitant therapy. The following information was reported: PYREXIA (non-serious) with onset 20Dec2023, outcome "recovering", described as "Light grade fever"; RHINORRHOEA (non-serious) with onset 20Dec2023, outcome "recovering", described as "Running nose"; COVID-19 (non-serious) with onset 20Dec2023, outcome "recovering", described as "tested for COVID and I tested positive". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19, rhinorrhoea, pyrexia.  Additional information: Patient stated, "I had a COVID Vaccine (Later clarified as Pfizer COVID-19 Vaccine) on last Tuesday afternoon along with a RSV vaccine (Later clarified as RSV Abrysvo) like the 2 shots. And Wednesday evening I started having some symptoms you know kind of like running nose and light grade fever and they were kind of like COVID symptoms and, so they continued the next day a little bit and yesterday I went ahead and tested for COVID and I tested positive and I had your COVID shots all along the way I mean from the very beginning every time available for a booster I had one and I had one in even last October and then this most recent one again on Tuesday and I did not know if it was my testing positive was a possible response to the vaccine or if I actually have the COVID virus." Patient have taken some Flonase, Mucinex, Afrin as Treatment for the events.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  will be requested and submitted if and when received.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain barre syndrome; This is a spontaneous report received from a Pharmacist from a sales representative.  A 76-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 29Dec2023 as dose number unknown, single (Lot number: HF5021) at the age of 76 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant) with onset 29Dec2023, outcome "unknown", described as "Guillain barre syndrome". It was unknown if therapeutic measures were taken as a result of guillain-barre syndrome.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  will be requested and submitted if and when received.; Sender's Comments: Guillain barre syndrome occurred on the same day with the administration of ABRYSVO.  The event most likely represents a coincidental medical condition.  More information such as medical history, concomitant medication and diagnostic workups including infectious panel, immunological markers neurological examinations are needed to identify the alternative etiology for the occurrence.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test
Clinical narrative: lost sense of smell and taste; lost sense of smell and taste; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose number unknown (booster), single (Lot number: GJ3275) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Renal cell carcinoma" (unspecified if ongoing), notes: (Kidney removed); "Kidney removed" (not ongoing), notes: Kidney removed; "Allergies" (unspecified if ongoing), notes: Known allergies. Concomitant medication(s) included: METFORMIN; GLIPIZIDE; LISINOPRIL; PRILOSEC [OMEPRAZOLE]; MONTELUKAST. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunisation. The following information was reported: AGEUSIA (disability), ANOSMIA (disability) all with onset 29Oct2022, outcome "not recovered" and all described as "lost sense of smell and taste". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jan2023) Negative. Therapeutic measures were not taken as a result of ageusia, anosmia. Clinical course: 2 - 4 days after the Pfizer booster vaccine, she lost her sense of smell and taste. To date, 28Dec2023, her sense of smell and taste has not returned.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Copd" (ongoing). The patient took concomitant medications, reported as: There is other medication in 2weeks. The following information was reported: VACCINATION FAILURE (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 vaccination failure, covid-19. The patient received Paxlovid from 21Dec2023 to 25Dec2023 for COVID 19 Treatment. No adverse event reported.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Investigation, Menstruation irregular
Clinical narrative: abnormally heavy periods. Bleeding so bad that requires help to the bathroom; Each period is 10 days and comes every 10 days; This is a spontaneous report received from a Consumer or other non HCP.  A 16-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 at 12:00 as dose 1, single (Lot number: Ew0151) at the age of 16 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 21Apr2021, outcome "not recovered", described as "Each period is 10 days and comes every 10 days"; HEAVY MENSTRUAL BLEEDING (medically significant) with onset 21Apr2021, outcome "not recovered", described as "abnormally heavy periods. Bleeding so bad that requires help to the bathroom". The events "abnormally heavy periods. bleeding so bad that requires help to the bathroom" and "each period is 10 days and comes every 10 days" required physician office visit. The patient underwent the following laboratory tests and procedures: Tests: cannot find a cause. Therapeutic measures were not taken as a result of heavy menstrual bleeding, menstruation irregular. Clinical course: Patient got vaccinated back in 2021 and still had abnormally heavy periods. Each period was 10 days and came every 10 days. Doctors and many tests could not find a cause or what had caused that prolonged set of issues. Bleeding so bad that required help to the bathroom. Happened right after getting first dose of vaccine. There was no other vaccine in four weeks or other medications in two weeks. There was no covid prior vaccination or was not covid tested post vaccination. Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200586172 Same patient, same product (Dose 3, Booster), different events;
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Heart disease" (unspecified if ongoing). The patient's concomitant medications were not reported. 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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" (Dec2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 20Dec2023 to 24Dec2023. Clinical course: Patient had no known allergies.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Coronary artery thrombosis, Syncope
Clinical narrative: blood clot in his heart; collapsed/ Syncope; This is a spontaneous report received from an Other HCP.  A male patient received BNT162b2 omi xbb.1.5 (COVID-19 VACCINE OMI XBB.1.5 - MANUFACTURER UNKNOWN), 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: CORONARY ARTERY THROMBOSIS (medically significant), outcome "unknown", described as "blood clot in his heart"; SYNCOPE (medically significant), outcome "unknown", described as "collapsed/ Syncope". The events "blood clot in his heart" and "collapsed/ syncope" required emergency room visit. Clinical course: There was a young man playing another team and he collapsed with a blood clot in his heart. He had COVID vaccine. She didn't know anything more about that.  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: Linked Report(s) : US-PFIZER INC-202300457549 same reporter, different patient/event;
Age: 63.0
Sex: F
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 Nurse.  A 64-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing); "B12 deficiency" (unspecified if ongoing); "D deficiency" (unspecified if ongoing); "ADD (Attention deficit disorder)" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL] oral; VITAMIN B-12 oral; BIOTIN oral; BUPROPION oral; TYLENOL oral; IBUPROFEN oral. 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; Covid-19 vaccine (Dose 3 (Booster); Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 4 (Booster); Manufacturer unknown), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid treatment from 20Dec2023 to 24Dec2023.  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: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162b2 omi xbb.1.5 administration.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other: Moderna; Vaccine Dose number: 4; Vaccine brand: Pfizer/BioNTech, Vaccine Dose number: 5; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old male patient received BNT162b2 (BNT162B2 NOS), on 21Oct2022 at 13:00 as dose 5 (booster), single (Lot number: Clam6) at the age of 69 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Feb2021 at 09:45 as dose 1, single (Lot number: 039K20A), in right arm, on 05Mar2021 at 10:00 as dose 2, single (Lot number: 026A21A), in right arm, on 28Oct2021 at 09:00 as dose 3 (booster), single (Lot number: 076C21A), in left arm and on 12May2022 at 13:00 as dose 4 (booster), single (Lot number: 057M21), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Oct2022 at 13:00, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine Dose number: 4; Vaccine brand: Pfizer/BioNTech, Vaccine Dose number: 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 15Dec2023 to 21Dec2023. Clinical course: Patient had no known allergies.
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 Physician.  A 70-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hay fever / related allergies" (unspecified if ongoing); "Hypertension very well controlled for 14 years on Rx." (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN/HCTZ, start date: 01Feb2007; SIMVASTATIN, start date: 04Sep2013, stop date: 18Dec2023. 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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, 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 20Dec2023 to 24Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the given information and known safety profile , the possible contributory role of the suspect for the events vaccination failure and covid-19 cannot be completely excluded.
Age: 57.0
Sex: F
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 57-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Fibrimyalgia" (unspecified if ongoing); "hashimotos" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "Known allergies: Many antibiotics, codeine, cymbalta" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: Sep2009; NORCO, start date: Jun2010; OMEPRAZOLE, start date: Sep2022; WELLBUTRIN, start date: Sep2023, stop date: 16Dec2023. 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; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunization; Moderna (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 16Dec2023 to 21Dec2023  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 52.0
Sex: F
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 52-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, in left arm 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 19Dec2023 to 24Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; she also got COVID in Jun and got COVID again on Christmas day; she also got COVID in Jun and got COVID again on Christmas day; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), 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 included: "diabetic" (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 Jun2023, outcome "unknown" and all described as "she also got COVID in Jun and got COVID again on Christmas day"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Caller stated last fall she was scheduled to have a shot (the COVID-19 vaccine), and when she got there, they gave her Pfizer and said they could not give her Moderna which she got every other time. She got the Pfizer COVID-19 shot. She also got COVID in Jun and got COVID again on Christmas day. She had a medication called Paxlovid. Caller stated the package she had last Jun came with 30 pills (3 in the morning and 3 at night), but the box she got a few days ago came with 20 pills (only 2 each time). Caller stated she was diabetic and had no renal impairment. Caller stated there was no basis for the decision for getting the lower dosage. She was 3 days through Paxlovid and had 2 days left. Caller stated she still had a lot of symptoms, she was stuffy, coughing but the fevers broke after 2 days.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400000317 Same patient/same product, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 48-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: "known allergies: Tetracycline" (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 Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 15Dec2023 to 19Dec2023.  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: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Known allergies: Penicillin" (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 Dec2023, outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 19Dec2023 to 23Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 52.0
Sex: F
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 52-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 13:30 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient's 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; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures (Paxlovid treatment start date: 19Dec2023, stop date: 23Dec2023) were taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Physician.  A 69-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 at 13:15 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "meningioma" (unspecified if ongoing); "Allergy: Cashews, pistachios" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Alendronate, reaction(s): "Known allergies: Alendronate"; Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Sulfamethoxazole-trimethaprin, reaction(s): "Known allergies: Sulfamethoxazole-Trimethaprin"; Clindamycin, reaction(s): "Known allergies: Clindamycin"; Levoxacin, reaction(s): "Known allergies: levoxacin". Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (Batch/Lot No: Unknown. Misplaced/discarded , Location of injection: Arm Left , Vaccine Administration Time: 03:45 PM), administration date: 16Sep2022, when the patient was 68-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Treatment is Paxlovid from 23Dec2023 to 28Dec2023.   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: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162b2 omi xbb.1.5 administration.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 48-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (ongoing), notes: (under Tx (treatment)). The patient's concomitant medications were not reported. 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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 includes Paxlovid from 23Dec2023 to 28Dec2023. Clinical course: Patient had no known allergies.  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: A causal relationship to the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded for event vaccination failure. This case will be reassessed upon receipt of additional information.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2021 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "pre diabetes" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "obesity" (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 Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 16Dec2023 to 20Dec2023. Clinical Course: Patient had no known allergies.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 70-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE, Anatomical location: Right arm), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 20Dec2023 to 25Dec2023. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 71.0
Sex: F
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 Nurse.  A 72-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 15:45 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's 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; Covid-19 vaccine (Dose 3 (Booster), Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 4 (Booster), Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 5 (Booster), Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 6 (Booster), Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, 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 23Dec2023 to 26Dec2023.  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: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162b2 omi xbb.1.5 administration.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Physician.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Jun2023 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "Allergies: IV Dye" (unspecified if ongoing); "Gerd" (unspecified if ongoing); "CAD" (unspecified if ongoing); "TBI" (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 Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 20Dec2023 to 25Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 in this patient cannot be completely excluded.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Oct2023 at 20:15 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mood Disorder" (unspecified if ongoing); "GERD" (unspecified if ongoing); "GAD" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN, start date: 01Jun2021, stop date: 20Dec2023; VASCEPA, start date: 02Jan2018; DEXLANSOPRAZOLE, start date: 06Mar2020; TRINTELLIX, start date: 04Feb2016; TRAZODONE, start date: 03Jun2019. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative, notes: Symptoms returned and after testing negative 3 times, I tested positive once again; (unspecified date) negative, notes: Symptoms returned and after testing negative 3 times, I tested positive once again; (unspecified date) negative, notes: Symptoms returned and after testing negative 3 times, I tested positive once again; (Dec2023) Positive, notes: Symptoms returned and after testing negative 3 times, I tested positive once again; (Dec2023) Positive, notes: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information : The patient received the vaccine. Other medication in 2 weeks were Pravastatin, Vascepa, dexlansoprazole, Trintellix and Trazodone. The patient received paxlovid since 20Dec2023 till 26Dec2023 for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Physician.  A 69-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipudemia" (unspecified if ongoing); "s/p mitral repair" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures included Paxlovid from 23Dec2023 to 27Dec2023 were taken as a result of vaccination failure, covid-19.  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: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162b2 omi xbb.1.5 administration.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Nov2023 at 11:30 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. He did not have other medical history and known allergies. Concomitant medication(s) included: CRESTOR, start date: 07Nov2023, stop date: 18Dec2023.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Dec2023, outcome "recovered" (Dec2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Negative; (Dec2023) Negative; (19Dec2023) Positive. Therapeutic measures including Paxlovid were taken as a result of vaccination failure, covid-19 from 19Dec2023 to 23Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergy. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 21Dec2023 to 25Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "auto immune disorder- mixed connective tissue disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), administration date: 05Oct2022, when the patient was 56-year-old, for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series completed, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Having completed a course of Paxlovid after testing positive for Covid; Negative, notes: I tested negative for three days. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid treatment on 21Dec2023 to Dec2023. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jul2022 as dose 5 (booster), single (Lot number: FP7135) at the age of 52 years, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4 (booster), single) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Dec2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 20Dec2023 to 25Dec2023.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid rebound; Covid rebound; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "dyslipidemia" (unspecified if ongoing); "transverse mylelitis", start date: Mar2017 (unspecified if ongoing), notes: history of transverse mylelitis Mar2017; "neurogenic bowel" (unspecified if ongoing); "cervical radiculopathy" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "basal cell carcinoma on face" (unspecified if ongoing); "concussion", start date: 1998 (unspecified if ongoing), notes: history of concussion 1998; "fatty liver" (unspecified if ongoing); "prediabetic" (unspecified if ongoing); "cataracts" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Jan2000, stop date: Dec2023. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE; Manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Dec2023, outcome "unknown" and all described as "Covid rebound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Dec2023) Positive; (28Dec2023) Positive; (29Dec2023) Positive; (30Dec2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos" (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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.