chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Taste disorder
Clinical narrative: WHEN I GET THE COVID VACCINES, THEY MAKE ME SICK; MESSES WITH MY TASTE BUDS; This is a spontaneous report received from a Nurse and a Consumer or other non HCP, Program ID.  A 65-year-old male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; tofacitinib citrate (XELJANZ), since 2018 (ongoing) (Lot number: GY2387) at 5 mg 2x/day. The patient's relevant medical history included: "Basal cell carcinoma of skin of left lower eyelid, including canthus" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Hypertensive heart disease without heart failure" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Rheumatoid arthritis " (unspecified if ongoing). Concomitant medication(s) included: AFLURIA QUAD; LISINOPRIL; PRAVASTATIN; LEVOTHYROXINE; VITAMIN D3; VITAMIN E [TOCOPHEROL]. The following information was reported: MALAISE(non-serious), outcome "unknown", described as "WHEN I GET THE COVID VACCINES, THEY MAKE ME SICK"; TASTE DISORDER (non-serious), outcome "unknown", described as "MESSES WITH MY TASTE BUDS". The action taken for tofacitinib citrate was dosage not changed.  Another reporter (Non-Health care professional) considered "when i get the covid vaccines, they make me sick" and "messes with my taste buds" as unrelated to tofacitinib citrate. Additional information: the patient stated that when he got the covid vaccines, they made him sick. He stated that he could win a hot pepper eating contest because the vaccine messed with his taste buds. The patient did not consider the events to be caused by tofacitinib citrate. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on a drug event temporal association and on the compatibility with the known adverse event profile of the suspect product, the company cannot completely exclude a reasonable possibility that the suspect BNT162b2 may have contributed to the onset of reported events.
Sex: U
Vaccine: RSV
Symptoms: Device breakage
Clinical narrative: Abrysvo, had a failure with one of the adapters caller was using, the luer lock mechanism cracked off, so couldn't use the product that caller was starting to reconstitute; The initial case was missing the following minimum criteria: no adverse event, product complaint only. Upon receipt of follow-up information on (12Dec2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from a Pharmacist from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM7644, Expiration Date: Jan2025) for immunisation, Device Lot Number: H739, Device Expiration Date: 01Apr2028. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown", described as "Abrysvo, had a failure with one of the adapters caller was using, the luer lock mechanism cracked off, so couldn't use the product that caller was starting to reconstitute".  Causality for "abrysvo, had a failure with one of the adapters caller was using, the luer lock mechanism cracked off, so couldn't use the product that caller was starting to reconstitute" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: NDC number of Abrysvo: 00069034405. NDC of Abrysvo vial adapter: 07290108240078. NDC of Abrysvo antigen vial: 00069020701. Abrysvo diluent syringe (NDC: 00069025001, Lot: HG1755, Expiry: May2025). Confirmed no patients involved with the Abrysvo that had the quality issue, once the luer lock mechanism fell off, quarantined the product and adapter and used a different Abrysvo vaccine. Total count size of 5, caller used the other 4 injections. Confirmed only 1 vaccine had the issue. Product looked normal until luer lock adapter fell off. When he tried to reconstitute the Luer lock adapter was broken and fell off, they could not use it. Patient received vaccine with another kit.
Sex: U
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: seven people who are vaccine injured permanently; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (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: INJURY (medically significant), outcome "unknown", described as "seven people who are vaccine injured permanently". The reporter stated it was mentioned not to take if you have a weakened immune system, well the bioweapon that forced everybody to get that would pretty much include most of the population, of not only country, but the world. Asked why wanted to wait 75 years before release the data on the covid-19 vaccine reporter know seven people who are vaccine injured permanently including a 17 year old boy who was the track star at his high school. 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-202300449689 same reporter/drug/event, different patient;US-PFIZER INC-202300451363 same reporter/drug/event, different patient;US-PFIZER INC-202300451361 same reporter/drug/event, different patient;US-PFIZER INC-202300451360 same reporter/drug/event, different patient;US-PFIZER INC-202300451362 same reporter/drug/event, different patient;US-PFIZER INC-202300451200 same reporter/drug/event, different patient;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, 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 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Lot number: FJ1620) for covid-19 immunisation; BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Lot number: EW0169) and in May2021 as dose 2, single (Lot number: EW0169) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (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 "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Postive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received PAXLOVID for treatment of COVID-19 from 20Nov2023 to 25Nov2023.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 73.0
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 74-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Htn" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "BPH" (unspecified if ongoing). The patient's concomitant medications were not reported. 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 (Paxlovid treatment start date: 09Dec2023, stop date: 14Dec2023) 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.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported events Vaccination failure, COVID-19 cannot be excluded
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 22Sep2023 at 16:00 as dose 1, single (Lot number: HG4628) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Nightshade vegetables" (unspecified if ongoing); "NET cancer stage 4 and Metastatic Melanoma in remission with immunotherapy" (unspecified if ongoing); "NET cancer stage 4 and Metastatic Melanoma in remission with immunotherapy" (unspecified if ongoing); "NET cancer stage 4 and Metastatic Melanoma in remission with immunotherapy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bee venom, reaction(s): "Known allergies: Bee Venom". Vaccination history included: BNT162b2 (DOSE 5 (BOOSTER), SINGLE, vaccine administration time=04:00 PM, vaccine lot number=GJ5342, vaccine location=Left arm), administration date: 16Sep2022, when the patient was 55-year-old, for COVID-19 immunization; moderna (DOSE 4 (BOOSTER), SINGLE, vaccine administration time=01:00 PM, vaccine lot number=059M21A,  vaccine location=Left arm), administration date: 15May2022, when the patient was 55-year-old, for COVID-19 immunization; moderna (DOSE 2, SINGLE, vaccine administration time=01:00 PM, vaccine lot number=018B21A, vaccine vaccine location=Left arm), administration date: 25Mar2021, when the patient was 54-year-old, for COVID-19 immunization; moderna (DOSE 1, SINGLE, vaccine administration time=01:00 PM, vaccine lot number=010A21A, vaccine location=Left arm), administration date: 25Feb2021, when the patient was 54-year-old, for COVID-19 immunization; Moderna (DOSE 3 (BOOSTER), SINGLE, vaccine administration date=15Nov2022 (as reported), vaccine administration time=01:00 PM, vaccine lot number=027H21B, vaccine location=Left arm), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Positive; (Dec2023) Positive, notes: Felt crumby, cough, phlegm, sneezing started back up and developed a temp again day 12 tested positive day 13. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course:  Paxlovid taken as treatment for event covid 19 start date=08Dec2023, treatment stop date=05Dec2023 (as reported). Adverse event: Felt sick tested positive. Started Paxlovid. In bed 8 days. Started feeling better.   The information on the batch/lot number for BNT162b2 omi xbb.1.5  will be requested and submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Blood immunoglobulin G, Myelin oligodendrocyte glycoprotein antibody-associated disease, Optic neuritis
Clinical narrative: diagnosed with bilateral optic neuritis secondary to myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD); diagnosed with bilateral optic neuritis secondary to myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD); This is a spontaneous report received from a Physician.  A 54-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history included: "Lynch syndrome" (unspecified if ongoing). There were no concomitant medications. The following information was reported: OPTIC NEURITIS (hospitalization, disability, medically significant), MYELIN OLIGODENDROCYTE GLYCOPROTEIN ANTIBODY-ASSOCIATED DISEASE (hospitalization, disability, medically significant) all with onset 01Dec2023, outcome "recovering" and all described as "diagnosed with bilateral optic neuritis secondary to myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD)". The patient was hospitalized for optic neuritis, myelin oligodendrocyte glycoprotein antibody-associated disease (hospitalization duration: 10 day(s)). The event "diagnosed with bilateral optic neuritis secondary to myelin oligodendrocyte glycoprotein antibody-associated disease (mogad)" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Antibody test: 1:1000, notes: very high; Blood immunoglobulin G: Positive, notes: bilateral optic neuritis secondary to myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). Therapeutic measures were taken as a result of optic neuritis, myelin oligodendrocyte glycoprotein antibody-associated disease. Clinical course: Otherwise healthy patient, 10 days after receiving COVID-19 vaccination developed eye pain and vision loss. Adverse event treatment reported as High dose IV steroids and 7 rounds of plasmapheresis. It was unknown if covid occurred prior vaccination and if covid tested post vaccination.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The events optic neuritis, and myelin oligodendrocyte glycoprotein antibody-associated disease are conservatively assessed as related to the suspect drug BNT162B2 OMI XBB.1.5 based on close temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. 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.
Sex: U
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: seven people who are vaccine injured permanently; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (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: INJURY (medically significant), outcome "unknown", described as "seven people who are vaccine injured permanently". The reporter stated it was mentioned not to take if you have a weakened immune system, well the bioweapon that forced everybody to get that would pretty much include most of the population, of not only country, but the world. Asked why wanted to wait 75 years before release the data on the covid-19 vaccine reporter know seven people who are vaccine injured permanently including a 17 year old boy who was the track star at his high school. 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-202300449688 same reporter/drug/event, different patient;US-PFIZER INC-202300449689 same reporter/drug/event, different patient;
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia, Peripheral swelling, Thrombosis
Clinical narrative: it was like blood clotted in his arms and hands; muscle pain in the arms, shoulders and hands; numbness in his hands and frequent swelling as a result of the vaccination; numbness in his hands and frequent swelling as a result of the vaccination; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "it was like blood clotted in his arms and hands"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain in the arms, shoulders and hands"; HYPOAESTHESIA (non-serious), PERIPHERAL SWELLING (non-serious), outcome "unknown" and all described as "numbness in his hands and frequent swelling as a result of the vaccination". Therapeutic measures were not taken as a result of thrombosis, myalgia, hypoaesthesia, peripheral swelling. Clinical course: Patient did not have any known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300450904 same reporter/patient, different dose/events;
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia, Peripheral swelling, Thrombosis
Clinical narrative: it was like blood clotted in his arms and hands; Muscle pain in the arms, shoulders and hands; numbness in his hands and frequent swelling as a result of the vaccination; numbness in his hands and frequent swelling as a result of the vaccination; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "numbness in his hands and frequent swelling as a result of the vaccination", "muscle pain in the arms, shoulders and hands", "numbness in his hands and frequent swelling as a result of the vaccination", "it was like blood clotted in his arms and hands". The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "it was like blood clotted in his arms and hands"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain in the arms, shoulders and hands"; HYPOAESTHESIA (non-serious), PERIPHERAL SWELLING (non-serious), outcome "unknown" and all described as "numbness in his hands and frequent swelling as a result of the vaccination". Therapeutic measures were not taken as a result of thrombosis, myalgia, hypoaesthesia, peripheral swelling. Clinical course: Patient had muscle pain in his arms, shoulders and hands, numbness in hands and frequent swelling as a result of the vaccination, it was like blood clotted in his arms and hands since he received 4 doses, two in each arm. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had COVID and COVID tested prior vaccination.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300450904 Same patient/vaccine, different dose/events (LOE);
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 62 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Oct2023 as dose 6 (booster), single (Lot number: 208F23A), in left 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's relevant medical history included: "Sulfa: Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Oct2023, outcome "recovered"; DRUG INEFFECTIVE (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: (unspecified date) Positive; (Dec2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient took Paxlovid from 07Dec2023 to 12Dec2023. Covid symptoms came back 2 days after end of Paxlovid course. 2 days after testing negative
Sex: U
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: seven people who are vaccine injured permanently; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJURY (medically significant), outcome "unknown", described as "seven people who are vaccine injured permanently". The reporter stated it was mentioned not to take if you have a weakened immune system, well the bioweapon that forced everybody to get that would pretty much include most of the population, of not only specific country, but the world. Asked why wanted to wait 75 years before release the data on the covid-19 vaccine reporter know seven people who are vaccine injured permanently including a 17 year old boy who was the track star at his high school. 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-202300449688 same reporter/drug/event, different patient;US-PFIZER INC-202300449689 same reporter/drug/event, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: seven people who are vaccine injured permanently; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJURY (medically significant), outcome "unknown", described as "seven people who are vaccine injured permanently". The reporter stated it was mentioned not to take if you have a weakened immune system, well the bioweapon that forced everybody to get that would pretty much include most of the population, of the world. Asked why wanted to wait 75 years before release the data on the covid-19 vaccine reporter know seven people who are vaccine injured permanently including a 17 year old boy who was the track star at his high school. 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-202300449688 same reporter/drug/event, different patient;US-PFIZER INC-202300449689 same reporter/drug/event, different patient;
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 Consumer or other non HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Jan2016, stop date: 19Dec2023. Vaccination history included: Bnt162b2 (DOSE 5 (BOOSTER), SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. 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.  Clinical course: COVID 19 Treatment- Paxlovid. Treatment start date: 11Dec2023. Treatment stop date: 15Dec2023. Vaccine administration date: Nov2023. Vaccine administration time: 08:00 AM.  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.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: who has been in and out of hospital with high blood pressure; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 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: HYPERTENSION (hospitalization) with onset 2023, outcome "unknown", described as "who has been in and out of hospital with high blood pressure". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: high. Clinical course: Reporter stated, she had one another friend who had been in and out of hospital with high blood pressure after receiving pfizer covid vaccine as well.  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-202300450897 same reporter/product, different AE/patient;US-PFIZER INC-202300451540 same reporter/product, different AE/patient;
Age: 61.0
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 61-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 at 19:30 as dose 1, single (Lot number: HD9835) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 06Oct2023; ATENOLOL, start date: 09Oct2023. Past drug history included: Amoxicillin, reaction(s): "Allergy". 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; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot number: GJ3275, Anatomical location: Left 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 12Dec2023 to 14Dec2023.
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 Nurse.  A 46-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) for covid-19 immunisation. The patient had no relevant medical history. 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 30Nov2023 to 05Dec2023. 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: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded.
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.  An adult male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, single (Lot number: HG4629) for covid-19 immunisation, Device Lot Number: HG4629. The patient's relevant medical history included: "prostate cancer" (unspecified if ongoing); "hypercholesterolemia" (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; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 5 (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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 08Dec2023 to 12Dec2023.  No follow-up attempts are possible.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 34-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 34 years, in left 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: 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 06Dec2023 to10Dec2023. 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: 68.0
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 68-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. 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 with paxlovid from 07Dec2023 to 11Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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 Consumer or other non HCP.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Aug2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "COPD" (unspecified if ongoing); "sclerosis cholangitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: treatment of Covid-19; (Dec2023) Negative, notes: Had 2 negative covid-19 tests after 4 days after paxlovid. 12 days after I tested positive again; (Dec2023) Negative, notes: Had 2 negative covid-19 tests after 4 days after paxlovid. 12 days after I tested positive again; (Dec2023) Positive, notes: Had 2 negative covid-19 tests after 4 days after paxlovid. 12 days after I tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the patient received other vaccination and medication (Ursodiol, amlodipine, Zetia, novolog )in two weeks. Paxlovid was taken as treatment for COVID-19 from 03Dec2023 to 07Dec2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild pain in the location of shot during 6-7 weeks.; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old male patient received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 24Oct2023 at 13:00 as dose 1, single (Lot number: HF9275) at the age of 55 years other, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE. 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, Manufacturer  Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4, Manufacturer  Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 5, Manufacturer  Unknown), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03Nov2023 at 12:00, outcome "not recovered", described as "Mild pain in the location of shot during 6-7 weeks.". Therapeutic measures were taken as a result of vaccination site pain.  Additional information: The patient received hot compress as treatment. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination patient has not  been tested for COVID-19.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Cough, Investigation, SARS-CoV-2 test, Sinusitis
Clinical narrative: sinus infection; his face started swelling up yesterday; has problems with taste, when he eats hes not tasting his food; cough; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 65-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "stomach " (unspecified if ongoing); "myasthenia gravis" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Moderna covid-19 vaccine (dose 1, single), administration date: 2020, for COVID-19 Immunization; Moderna covid-19 vaccine (dose 2, single), administration date: 2021, for COVID-19 Immunization. The following information was reported: COUGH (non-serious) with onset Dec2023, outcome "unknown"; AGEUSIA (non-serious) with onset 19Dec2023, outcome "not recovered", described as "has problems with taste, when he eats hes not tasting his food"; SWELLING FACE (non-serious) with onset 19Dec2023, outcome "not recovered", described as "his face started swelling up yesterday"; SINUSITIS (non-serious), outcome "unknown", described as "sinus infection". The events "his face started swelling up yesterday", "has problems with taste, when he eats hes not tasting his food" and "sinus infection" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of swelling face, ageusia, sinusitis.  Additional information: The reporter took the patient to the doctor yesterday who gave him antibiotics (amoxicillin 125mg; taking twice a day) and steroids (methylprednisolone 4mg; taking 6 tablets then 5, 4, 3, 2, then 1).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: sinus infection; his face started swelling up yesterday; has problems with taste, when he eats hes not tasting his food; cough; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 65-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "stomach " (unspecified if ongoing); "myasthenia gravis" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Moderna covid-19 vaccine (dose 1, single), administration date: 2020, for COVID-19 Immunization; Moderna covid-19 vaccine (dose 2, single), administration date: 2021, for COVID-19 Immunization. The following information was reported: COUGH (non-serious) with onset Dec2023, outcome "unknown"; AGEUSIA (non-serious) with onset 19Dec2023, outcome "not recovered", described as "has problems with taste, when he eats hes not tasting his food"; SWELLING FACE (non-serious) with onset 19Dec2023, outcome "not recovered", described as "his face started swelling up yesterday"; SINUSITIS (non-serious), outcome "unknown", described as "sinus infection". The events "his face started swelling up yesterday", "has problems with taste, when he eats hes not tasting his food" and "sinus infection" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of swelling face, ageusia, sinusitis.  Additional information: The reporter took the patient to the doctor yesterday who gave him antibiotics (amoxicillin 125mg; taking twice a day) and steroids (methylprednisolone 4mg; taking 6 tablets then 5, 4, 3, 2, then 1).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 64.0
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 64-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Environmental allergies" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO, stop date: 10Dec2023; SIMVASTATIN, stop date: 10Dec2023. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), 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: 11Dec2023, stop date: 15Dec2023) 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: 17.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID. Her only symptom is a mild sore throat; tested positive for COVID. Her only symptom is a mild sore throat; This is a spontaneous report received from a Consumer or other non HCP.  A 17-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 17 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Possible allergy to some antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Batch/lot number: GJ2524, Route of Administration: Intramuscular, Anatomical Location: Arm Left, At: 15:30), administration date: 10Sep2022, when the patient was 16-year-old, for COVID-19 immunisation, reaction(s): "Fatigue", "mild muscle aches"; 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Dec2023, outcome "recovering" and all described as "tested positive for COVID. Her only symptom is a mild sore throat". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Dec2023) Positive, notes: Nasal Swab, flowflex. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: Reporter stated that they tested (name withheld) and (name withheld) tested positive for COVID. Her only symptom was a mild sore throat. No COVID prior vaccination. COVID tested post vaccination: Yes.  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-202201157237 Same patient, different vaccine and different event.;
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Dec2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfa drugs, reaction(s): "Allergy". The following information was reported: COVID-19 (non-serious), outcome "unknown", described as "COVID 19".  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Rash, Skin irritation
Clinical narrative: random patches of a rash; patches of dry and sometimes irritated skin; patches of dry and sometimes irritated skin; This is a spontaneous report received from a consumer. An elderly female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (lot number unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart problems" (unspecified if ongoing); "respiratory problems" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "random patches of a rash"; DRY SKIN (non-serious), SKIN IRRITATION (non-serious), outcome "unknown" and all described as "patches of dry and sometimes irritated skin".  Additional Information: The patient called about the Covid vaccines and boosters. The patient stated she is getting ready to take the current booster. She stated that in the past, she has usually had an onset a day to two days after she has had the shot, of random patches of a rash, but no raised bumps, just some patches of dry and sometimes irritated skin, but not bumps. It usually lasts a week to 10 days. She is wondering what that was indicative of or what she can do and; if this was a common side effect. She has not reported her previous side effects to Pfizer directly. She added that she has had a lot of health problems this past fall so she is late on getting to the booster, but it is coming into the days where people are going to be off.  She was wondering if it will get worse with repeated shots or if there was any way to prevent it or have it become less of a problem. She is currently 75 (age).  Batch/lot number is not provided.
Sex: F
Vaccine: UNK
Symptoms: Chronic spontaneous urticaria, Condition aggravated
Clinical narrative: The HCP suspects non-response to Xolair due to Covid-19 vaccination; had a flare up after Covid-19 vaccination; This is a spontaneous report received from a Physician. Other Case identifier(s): NUS2023US226727, NUS2023US226695.  A 50-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; omalizumab (XOLAIR) for chronic spontaneous urticaria. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INTERACTION (non-serious), outcome "unknown", described as "The HCP suspects non-response to Xolair due to Covid-19 vaccination"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "had a flare up after Covid-19 vaccination". The action taken for omalizumab was unknown.  Additional information: The patient was well controlled on omalizumab (XOLAIR) for 10 years, had a flare up after Covid-19 vaccination, and omalizumab (XOLAIR) injection no longer worked to control.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 has been requested and will be submitted if and when received.