chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from an other HCP. A 62-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Sep2023 as dose 1, single (lot number unknown) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "celiac" (unspecified if ongoing); "sarcoidosis" (unspecified if ongoing); "low thyroid" (unspecified if ongoing); "allergies penicillin" (unspecified if ongoing); "allergies sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ibuprofen, reaction: "allergies". Vaccination history included: Covid-19 vaccine (dose 3 (booster), manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) 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 which included Paxlovid taken from 29Dec2023 to 02Jan2024.  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 known safety profile of the drug and temporal association, a causal relationship between suspect drug bnt162b2 omi xbb.1.5 and the reported events vaccination failure and covid 19 cannot be excluded.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, C-reactive protein increased, Poor quality product administered, Product administration error
Clinical narrative: CRP was 1.8 mg/dl which was elevated; 3 days after the refrigeration beyond use date/vaccine was not pulled in by the beyond use date (25Dec2023) and was given 3 days after (28Dec2023); 3 days after the refrigeration beyond use date/vaccine was not pulled in by the beyond use date (25Dec2023) and was given 3 days after (28Dec2023); This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 63-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Dec2023 as dose 1, 0.3 ml single (Lot number: HF9300, Expiration Date: Jan2025) at the age of 63 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 28Dec2023, outcome "unknown" and all described as "3 days after the refrigeration beyond use date/vaccine was not pulled in by the beyond use date (25Dec2023) and was given 3 days after (28Dec2023)"; C-REACTIVE PROTEIN INCREASED (non-serious), outcome "unknown", described as "CRP was 1.8 mg/dl which was elevated". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of c-reactive protein increased.  Additional information: NDC number of Covid-19 Vaccine is 0069-2362-10. Vaccination Facility Type is a family medicine doctor. The reporter mentioned patient used the 2023-2024 Comirnaty single dose vials 3 days after the refrigeration beyond use date. She wanted to know stability information. Reporter stated they had the Pfizer Covid-19 Vaccine in their office and they were not pulled in by the beyond use date (25Dec2023) and was given 3 days after (28Dec2023). The reporter asked if the patient need another one or are these valid vaccine since patient was given 3 days after. Reporter stated, for the patient, he had quite a few, have a PSA, a HIV, CMP, a C reactive protein, a CBC and a lipid. For all of them expect for the CBC there was one off the red blood cells were 4.35 -mcl and CRP was 1.8 mg/dl which was elevated.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400007800 same product and event, different patient;
Age: 54.0
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 54-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Celiac" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Gluten, reaction(s): "Allergy: gluten"; Codeine, reaction(s): "Allergy: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: treatment includes Paxlovid.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood cholesterol increased, Blood triglycerides, Blood triglycerides increased, Metabolic function test
Clinical narrative: his cholesterol (216 mg/dL) high; his triglycerides were both high; Caller mentioned they used the 2023-2024 Comirnaty single dose vials 2 and 3 days after the refrigeration beyond use date; Caller mentioned they used the 2023-2024 Comirnaty single dose vials 2 and 3 days after the refrigeration beyond use date; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 37-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Dec2023 as dose 1, 0.3 ml single (Lot number: HF9300, Expiration Date: Jan2025) at the age of 37 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 27Dec2023, outcome "unknown" and all described as "Caller mentioned they used the 2023-2024 Comirnaty single dose vials 2 and 3 days after the refrigeration beyond use date"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "his cholesterol (216 mg/dL) high"; BLOOD TRIGLYCERIDES INCREASED (non-serious), outcome "unknown", described as "his triglycerides were both high". Relevant laboratory tests and procedures are available in the appropriate section. Additional information:  They have the Pfizer Covid-19 Vaccine in their office and they were not pulled in by the beyond use date and the patient was given 2 days after. The beyond use date for both of those was December 25th 2023. The first patient it was given on 12/27 (December 27th 2023). For the first patient, he had a lipid panel and a basic metabolic panel. Well, his cholesterol (216 mg/dL) and his triglycerides were both high. The basic metabolic was fine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400007713 same product and event, different patient;
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error
Clinical narrative: his cholesterol (216 mg/dL) high; his triglycerides were both high; Caller mentioned they used the 2023-2024 Comirnaty single dose vials 2 and 3 days after the refrigeration beyond use date; Caller mentioned they used the 2023-2024 Comirnaty single dose vials 2 and 3 days after the refrigeration beyond use date; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 37-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Dec2023 as dose 1, 0.3 ml single (Lot number: HF9300, Expiration Date: Jan2025) at the age of 37 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 27Dec2023, outcome "unknown" and all described as "Caller mentioned they used the 2023-2024 Comirnaty single dose vials 2 and 3 days after the refrigeration beyond use date"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "his cholesterol (216 mg/dL) high"; BLOOD TRIGLYCERIDES INCREASED (non-serious), outcome "unknown", described as "his triglycerides were both high". Relevant laboratory tests and procedures are available in the appropriate section. Additional information:  They have the Pfizer Covid-19 Vaccine in their office and they were not pulled in by the beyond use date and the patient was given 2 days after. The beyond use date for both of those was December 25th 2023. The first patient it was given on 12/27 (December 27th 2023). For the first patient, he had a lipid panel and a basic metabolic panel. Well, his cholesterol (216 mg/dL) and his triglycerides were both high. The basic metabolic was fine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400007713 same product and event, different patient;
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial Fibrillation" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna (Dose 1), for COVID-19 immunization; Moderna (Dose 2), for COVID-19 immunization; Moderna (Dose 3), for COVID-19 immunization; Moderna (Dose 4), for COVID-19 immunization; Moderna (Dose 5), for COVID-19 immunization; Moderna (Dose 6), for COVID-19 immunization; Moderna (Dose 7), 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. Paxlovid was taken from 26Dec2024 to 31Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; 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)), on 08Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID, start date: 01Dec2023. 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 30Dec2023 to 03Jan2024.  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: M
Vaccine: COVID19, 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 53-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". 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.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 32.0
Sex: M
Vaccine: COVID19, 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 32-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 31Oct2023 as dose 1, single at the age of 32 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 4), as dose 1), as dose 2) and as dose 3). 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 Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible.
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 76-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Percocet, reaction(s): "Known allergies: Percocet". Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (Dose Number: 6, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right), administration date: 22May2023, when the patient was 75-year-old, for COVID-19 Immunization; BNT162b2;BNT162b2 omi ba.4-5 (Dose Number: 5, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 01Oct2022, when the patient was 74-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 4, Batch/Lot No: FJ4989, Location of injection: Arm Left), administration date: 14Apr2022, when the patient was 74-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: 301308A, Location of injection: Arm Left), administration date: 07Oct2021, when the patient was 73-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: ER8727, Location of injection: Arm Left), administration date: 25Mar2021, when the patient was 73-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Left), administration date: 04Mar2021, when the patient was 73-year-old, for COVID-19 Immunization. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, vaccination failure.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Chronic graft versus host disease oral, Condition aggravated
Clinical narrative: oral cGVHD flare; oral cGVHD flare; This is a literature report.  A 73-year-old male received allogeneic HCT for acute lymphocytic leukemia in March 2019. He developed GVHD 1 year later with skin, liver, and oral involvement. He had symptoms of dry mouth, sensitive buccal mucosa and tongue, and reduced taste. Patient's oral sensitivity and loss of taste affected eating. In May2020, he developed classical oral lichenoid changes with extensive striations, severe erythema on the buccalmucosa and lateral border of the tongue, soft palate and attached gingiva and ulcers on hard palatal gingiva in the molar regions. Initial oral treatment with budesonide and doxepin rinses for pain was provided. At follow-up in June 2020, he was much improved without pain and ate well. Besides dry mouth, all oral changes due to cGVHD resolved. He remained on stable doses of ibrutinib, tacrolimus, and low-dose prednisone. He received Pfizer (BNT162b2) 2 doses, 3 weeks apart in May2021. Two weeks after the last dose, he presented with oral pain and skin rash. No other triggers were identified. When seen, exfoliative dermatitis of the hands which had followed vaccination was reported improving. Oral tissues were moist with saliva. However, extensive striae and severe erythema was present on the right buccalmucosa with plaque-like changes and striations, on the left striations, 3 mm ulceration and severe erythema and ulceration on the palatal gingiva of the upper bicuspid areas were seen. Oral symptoms had been in remission for 9 months prior to recurrence. Budesonide rinse was resumed, and patient started on ruxolitinib and extracorporeal photopheresis. Symptoms improved after 2 months of treatment.; Sender's Comments: Based on the limited information available in the case, the relationship between the events Chronic graft versus host disease oral , Condition aggravated and the suspect drug cannot be excluded. 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.,Linked Report(s) : US-PFIZER INC-PV202400003533 Same suspect/article and diiferent patient/event;
Sex: M
Vaccine: COVID19
Symptoms: Chronic graft versus host disease oral, Condition aggravated
Clinical narrative: status of oral cGVHD flare was seen/These findings were much more prominent than oral findings seen in November 2020; status of oral cGVHD flare was seen/These findings were much more prominent than oral findings seen in November 2020; This is a literature report for the following literature source(s).  A 58-year-old male was referred for management of oral cGVHD. He completed HCT in 2004 for chronic myelogenous leukemia. He had cGVHD with dry mouth, increased dental caries, and oral sensitivity affecting diet. When seen in December 2018 for oral changes, he was off all systemic immunosuppressive therapy. He had extensive lichenoid striations involving the buccal mucosa and tongue with plaque-like changes on the lateral borders of the tongue with isolated moderate to severe erythema. He was prescribed topical vitamin A, cevimeline, and fluconazole due to culture-confirmed candidiasis. At follow-up, he had marked improvement with normal volume of saliva, reduction in erythema, and plaque-like changes. Following improvement, regular follow-up was conducted on a 6-month basis, and he maintained minimal lichenoid changes without erythema, normal saliva, and resolution of clinical candidiasis. After 6 months, fluconazole was discontinued. He was diagnosed in December 2020 with COVID-19 with severe flu-like and respiratory symptoms but avoided hospital admission and recovered after 3 weeks. He then received Pfizer (BNT162b2) vaccines, the first dose in March and second dose in April 2021. He experienced mild fatigue, muscle and joint pain, and low-grade fever that he stated resolved in 8 h. He then became aware of increased thickness of white changes on the left side of the tongue. In July 2021, oral findings included lichenoid striations, patchy moderate erythema, but increased plaque-like changes on the left lateral tongue, involving the entire lateral border with mild thickness, and palatal gingiva in the upper molar regions. These findings were much more prominent than oral findings seen in November 2020. Local therapy with increased vitamin A, cevimeline, a cholinergic agonist, resuming fluconazole and beginning turmeric was recommended. Oral symptoms resolved but mild change oral lesions persisted. At 1 month post vaccination, the status of oral cGVHD flare was seen.; Sender's Comments: Based on the limited information available in the case, the relationship between the events Chronic graft versus host disease oral , Condition aggravated and the suspect drug cannot be excluded. 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.,Linked Report(s) : US-PFIZER INC-PV202400003533 Same article/drug and different patient /event;
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, single at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was vaccinated at 13:00. Tested positive for Covid. Completed 5-day course of Paxlovid from 30Dec2023 to 04Jan2024.   No follow-up attempts are possible.
Age: 72.0
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 73-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 72 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Meniere's disease" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulpha" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Benadryl, reaction(s): "Allergy". Vaccination history included: COVID-19 vaccine (DOSE 3 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; COVID-19 vaccine (PRIMARY IMUUNIZATION SERIES COMPLETED, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2023) Positive; (08Jan2024) Positive. Therapeutic measures were taken as a result of Vaccination failure, COVID-19 including Paxlovid from 27Dec2023 to 01Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: 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 70-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MOUNJARO. 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 20Dec2023 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I experienced rebound; I experienced rebound; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 69-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 31Oct2023 as dose 1, single (Lot number: HG5967) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Systemic Lupus Erythematosus" (unspecified if ongoing); "Vestibular Migraine" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE, start date: Jun2020. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Vaccine lot number: GH9702, Vaccine location: Right arm), administration date: 02Nov2022, when the patient was 68-year-old, for COVID-19 immunization; moderna COVID-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Vaccine location: Right arm), administration date: 02Nov2021, when the patient was 67-year-old, for COVID-19 immunization; moderna COVID-19 vaccine (DOSE 2, SINGLE, Vaccine lot number: 006B21A, Vaccine location: Left arm), administration date: 24Mar2021, when the patient was 66-year-old, for COVID-19 immunization; moderna COVID-19 vaccine (DOSE 1, SINGLE, Vaccine lot number: 001A21A, Vaccine location: Right arm), administration date: 24Feb2021, when the patient was 66-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, latency 7 days 23 hrs 30 min after the suspect product(s) administration, outcome "recovered" (01Jan2024) and all described as "I experienced rebound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (31Dec2023) negative; (01Jan2024) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received.
Sex: M
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 54-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 4 (Booster), 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 1, Single, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  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, SARS-CoV-2 test
Clinical narrative: Infected with COVID; Infected with COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 35-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Jan2024, outcome "recovering" and all described as "Infected with COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "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 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: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, SARS-CoV-2 test
Clinical narrative: Approx. 1 week post vaccination, I noticed start of considerable hair loss . This lasted about 1 month and has now only small amount of continued loss.; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 at 12:00 as dose 1, single (Lot number: HD9835) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "PCN allergy" (unspecified if ongoing); "MS allergy" (unspecified if ongoing). Concomitant medication(s) included: CELEBREX. 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, manufacturer unknown), for COVID-19 immunisation. The following information was reported: ALOPECIA (non-serious) with onset 30Oct2023, outcome "recovering", described as "Approx. 1 week post vaccination, I noticed start of considerable hair loss . This lasted about 1 month and has now only small amount of continued loss.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of alopecia.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: got symptoms postiive test 02Jan2024; got symptoms postiive test 02Jan2024; This is a spontaneous report received from a Nurse from product quality group. A 29-year-old female patient (unknown if pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Nov2023 as dose 1, single (Lot number: HF9275) at the age of 29 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications which include unspecified Sequiris vaccine on 09Nov2023 with lot number of 944457 and vaccination location of right deltoid. 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 30Dec2023, outcome "recovering" and all described as "got symptoms postiive test 02Jan2024". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jan2024) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: The patient's signs and symptom may have started on 30Dec2023 (early or late moderate; cannot be confirmed) which included Fatigue, runny nose, sneezing, mild cough, mild fever, sore throat.   No follow-up attempts are possible.; Sender's Comments: Based on available information, a lack of efficacy (Vaccination failure and COVID-19) with the suspect vaccine BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 51-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Dec2023 at 16:00 as dose 1, single (Batch/Lot number: unknown), 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 Complete, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (Booster), Single, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 4 (Booster), Single, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was treated with nirmatrelvir, ritonavir (PAXLOVID) from 29Dec2023 to 03Jan2024. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 treatment/positive COVID test; COVID 19 treatment/positive COVID test; 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 16Nov2023 as dose 1, single (batch/lot number: unknown) at the age of 71 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "sulfa allergies" (unspecified if ongoing); "TIA" (unspecified if ongoing); "squamous and basal cell cancers" (unspecified if ongoing), notes: removed 2018; "squamous and basal cell cancers" (unspecified if ongoing), notes: removed 2018. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction: "allergies". Vaccination history included: Moderna (dose 5, location of injection arm left), administration date: 16Nov2023, when the patient was 71-year-old, for COVID-19 immunization; Moderna (dose 4, location of injection arm left), administration date: 04May2022, when the patient was 70-year-old, for COVID-19 immunization; Moderna (dose 3, location of injection arm left), administration date: 27Oct2021, when the patient was 69-year-old, for COVID-19 immunization; Moderna (dose 2, location of injection arm left), administration date: 12Mar2021, when the patient was 68-year-old, for COVID-19 immunization; Moderna (dose 1, location of injection arm left), administration date: 10Feb2021, when the patient was 68-year-old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Dec2023, outcome "recovering" and all described as "COVID 19 treatment/positive COVID test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Dec2023) positive; (02Jan2024) negative; (04Jan2024) negative; (05Jan2024) positive; (09Jan2024) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 27Dec2023 to 31Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from a Nurse.  A 40-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 at 10:00 as dose 1, single (Lot number: HG4677) at the age of 40 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Vaccine brand: Pfizer / BioNTech, time: 11:00 AM,lot number: GH9693, dose number: 4; location: Right arm,), administration date: 21Sep2022, when the patient was 39-year-old, for Covid-19 immunization; BNT162b2 (Vaccine brand: Pfizer / BioNTech, time: 12:15 PM, lot number: FF8841, dose number: 3, location: Right arm), administration date: 05Oct2021, when the patient was 38-year-old, for Covid-19 immunization; BNT162b2 (Vaccine brand: Pfizer / BioNTech, time: 11:00 AM, lot number: EL3249, dose number: 2, location: Right arm), administration date: 12Jan2021, when the patient was 37-year-old, for Covid-19 immunization; BNT162b2 (Vaccine brand: Pfizer / BioNTech, time: 01:00 PM, lot number: EK5730, dose number: 1, location: Right arm), administration date: 22Dec2020, when the patient was 37-year-old, for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 22Dec2023, outcome "not recovered", COVID-19 (medically significant) with onset 22Dec2023, outcome "not recovered" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (22Dec2023) Positive, notes: day 0 of Paxlovid; (unspecified date) Positive, notes: I tested positive for 6 days with rebound; (unspecified date) Positive, notes: I tested positive for 6 days with rebound; (unspecified date) Positive, notes: I tested positive for 6 days with rebound; (unspecified date) Positive, notes: I tested positive for 6 days with rebound; (26Dec2023) Negative, notes: started testing negative on day 4; (31Dec2023) Positive, notes: positive again with return of symptoms on day 9. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had no known allergies. Patient started Paxlovid on 22Dec2023 at day 0, started testing negative on day 4, then positive again with return of symptoms on day 9. Symptoms with rebound were more significant than initial infection. Patient then tested positive for 6 days with rebound.  No follow-up attempts are possible.; 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.
Age: 72.0
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 72-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "RA" (unspecified if ongoing); "Sleep Apnea" (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 "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound of Covid infection after 7 days negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical details: Patient received Paxlovid for COVID-19 Treatment from 21Dec2023 to 26Dec2023. On 07Jan2024 rebound of Covid infection after 7 days negative.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: 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 38-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: symptoms returned and test was 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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 65-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Lot number: HD9835) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sleep apnea" (unspecified if ongoing); "heart: SVD (Small Vessel Disease)" (unspecified if ongoing), notes: heart: SVD (Small Vessel Disease); "Atrial fibrillation" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 4, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 5, Unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Dec2023) Positive, notes: Paxlovid taken with very mild symptoms, the day after a positive home test; (30Dec2023) Negative, notes: Negative test results on 4 days after treatment began. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 63.0
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 from product quality group.  A 63-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Lot number: Hd9876) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Was prescribed Paxlovid and was tested negative; Positive, notes: But was tested positive 6 days later. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible.