chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood cholesterol increased, Blood triglycerides, Eosinophil count, Eosinophil count increased
Clinical narrative: CHOLESTEROL, TOTAL 209; LDL-CHOLESTEROL 124; NON HDL CHOLESTEROL 140; ABSOLUTE EOSINOPHILS 581; my cholesterol/ went to 160 /after taking COVID boosters; The initial case was missing the following minimum criteria: [Info not qualifying for AE reporting - All other sources] Upon receipt of follow-up information on [21Feb2024], this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP.  An 80-year-old female patient received BNT162b2 (COMIRNATY), on 11Apr2022 as dose 4 (booster), single (Lot number: FM9893) at the age of 79 years intramuscular, in left arm for covid-19 immunisation; omeprazole (PROTONIX [OMEPRAZOLE]), (ongoing)), oral for gastrooesophageal reflux disease. The patient's relevant medical history included: "hypertension", start date: 1998 (ongoing); "asthma", start date: 1990 (ongoing); "acid reflux", start date: 2003 (ongoing). Concomitant medication(s) included: LIVALO (ongoing); ADVAIR taken for asthma (ongoing); LOSARTAN taken for hypertension (ongoing); AMLODIPINE oral taken for hypertension (ongoing). Vaccination history included: bnt162b2 (dose 1, single lot number:maybe Eng202, intramuscular upper left arm, My be around 2pm), administration date: 26Feb2021, when the patient was 78-year-old, for COVID-19 immunisation; bnt162b2 (Dose 2, single lot number: ER8730, intramuscular upper left arm), administration date: 26Mar2021, when the patient was 78-year-old, for COVID-19 immunisation; bnt162b2 (Dose 3 (BOOSTER), single lot number: 301458A intramuscular upper left arm), administration date: 27Sep2021, when the patient was 79-year-old, for COVID-19 immunisation. The following information was reported: BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "CHOLESTEROL, TOTAL 209"; LOW DENSITY LIPOPROTEIN INCREASED (non-serious), outcome "unknown", described as "LDL-CHOLESTEROL 124"; NON-HIGH-DENSITY LIPOPROTEIN CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "NON HDL CHOLESTEROL 140"; EOSINOPHIL COUNT INCREASED (non-serious), outcome "unknown", described as "ABSOLUTE EOSINOPHILS 581"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "my cholesterol/ went to 160 /after taking COVID boosters". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: patient had been on and off statins for years. After rebound and high cholesterol, she went back on meds. She has taken Livalo 2 mg every day since Mar2022. Her Lipid profile improved greatly, all of her tests since then, 15Sep2022, 11Jan2023, 07Jul2023 all showed greatly improved lipid readings. Patient have also been exercising more and eating better.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Haematocrit, Haemoglobin, High density lipoprotein, Low density lipoprotein, Low density lipoprotein increased
Clinical narrative: CHOLESTEROL, TOTAL 209; LDL-CHOLESTEROL 124; NON HDL CHOLESTEROL 140; ABSOLUTE EOSINOPHILS 581; my cholesterol/ went to 160 /after taking COVID boosters; The initial case was missing the following minimum criteria: [Info not qualifying for AE reporting - All other sources] Upon receipt of follow-up information on [21Feb2024], this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP.  An 80-year-old female patient received BNT162b2 (COMIRNATY), on 11Apr2022 as dose 4 (booster), single (Lot number: FM9893) at the age of 79 years intramuscular, in left arm for covid-19 immunisation; omeprazole (PROTONIX [OMEPRAZOLE]), (ongoing)), oral for gastrooesophageal reflux disease. The patient's relevant medical history included: "hypertension", start date: 1998 (ongoing); "asthma", start date: 1990 (ongoing); "acid reflux", start date: 2003 (ongoing). Concomitant medication(s) included: LIVALO (ongoing); ADVAIR taken for asthma (ongoing); LOSARTAN taken for hypertension (ongoing); AMLODIPINE oral taken for hypertension (ongoing). Vaccination history included: bnt162b2 (dose 1, single lot number:maybe Eng202, intramuscular upper left arm, My be around 2pm), administration date: 26Feb2021, when the patient was 78-year-old, for COVID-19 immunisation; bnt162b2 (Dose 2, single lot number: ER8730, intramuscular upper left arm), administration date: 26Mar2021, when the patient was 78-year-old, for COVID-19 immunisation; bnt162b2 (Dose 3 (BOOSTER), single lot number: 301458A intramuscular upper left arm), administration date: 27Sep2021, when the patient was 79-year-old, for COVID-19 immunisation. The following information was reported: BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "CHOLESTEROL, TOTAL 209"; LOW DENSITY LIPOPROTEIN INCREASED (non-serious), outcome "unknown", described as "LDL-CHOLESTEROL 124"; NON-HIGH-DENSITY LIPOPROTEIN CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "NON HDL CHOLESTEROL 140"; EOSINOPHIL COUNT INCREASED (non-serious), outcome "unknown", described as "ABSOLUTE EOSINOPHILS 581"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "my cholesterol/ went to 160 /after taking COVID boosters". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: patient had been on and off statins for years. After rebound and high cholesterol, she went back on meds. She has taken Livalo 2 mg every day since Mar2022. Her Lipid profile improved greatly, all of her tests since then, 15Sep2022, 11Jan2023, 07Jul2023 all showed greatly improved lipid readings. Patient have also been exercising more and eating better.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphocyte count, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume
Clinical narrative: CHOLESTEROL, TOTAL 209; LDL-CHOLESTEROL 124; NON HDL CHOLESTEROL 140; ABSOLUTE EOSINOPHILS 581; my cholesterol/ went to 160 /after taking COVID boosters; The initial case was missing the following minimum criteria: [Info not qualifying for AE reporting - All other sources] Upon receipt of follow-up information on [21Feb2024], this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP.  An 80-year-old female patient received BNT162b2 (COMIRNATY), on 11Apr2022 as dose 4 (booster), single (Lot number: FM9893) at the age of 79 years intramuscular, in left arm for covid-19 immunisation; omeprazole (PROTONIX [OMEPRAZOLE]), (ongoing)), oral for gastrooesophageal reflux disease. The patient's relevant medical history included: "hypertension", start date: 1998 (ongoing); "asthma", start date: 1990 (ongoing); "acid reflux", start date: 2003 (ongoing). Concomitant medication(s) included: LIVALO (ongoing); ADVAIR taken for asthma (ongoing); LOSARTAN taken for hypertension (ongoing); AMLODIPINE oral taken for hypertension (ongoing). Vaccination history included: bnt162b2 (dose 1, single lot number:maybe Eng202, intramuscular upper left arm, My be around 2pm), administration date: 26Feb2021, when the patient was 78-year-old, for COVID-19 immunisation; bnt162b2 (Dose 2, single lot number: ER8730, intramuscular upper left arm), administration date: 26Mar2021, when the patient was 78-year-old, for COVID-19 immunisation; bnt162b2 (Dose 3 (BOOSTER), single lot number: 301458A intramuscular upper left arm), administration date: 27Sep2021, when the patient was 79-year-old, for COVID-19 immunisation. The following information was reported: BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "CHOLESTEROL, TOTAL 209"; LOW DENSITY LIPOPROTEIN INCREASED (non-serious), outcome "unknown", described as "LDL-CHOLESTEROL 124"; NON-HIGH-DENSITY LIPOPROTEIN CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "NON HDL CHOLESTEROL 140"; EOSINOPHIL COUNT INCREASED (non-serious), outcome "unknown", described as "ABSOLUTE EOSINOPHILS 581"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "my cholesterol/ went to 160 /after taking COVID boosters". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: patient had been on and off statins for years. After rebound and high cholesterol, she went back on meds. She has taken Livalo 2 mg every day since Mar2022. Her Lipid profile improved greatly, all of her tests since then, 15Sep2022, 11Jan2023, 07Jul2023 all showed greatly improved lipid readings. Patient have also been exercising more and eating better.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Monocyte count, Neutrophil count, Non-high-density lipoprotein cholesterol, Non-high-density lipoprotein cholesterol increased, Platelet count
Clinical narrative: CHOLESTEROL, TOTAL 209; LDL-CHOLESTEROL 124; NON HDL CHOLESTEROL 140; ABSOLUTE EOSINOPHILS 581; my cholesterol/ went to 160 /after taking COVID boosters; The initial case was missing the following minimum criteria: [Info not qualifying for AE reporting - All other sources] Upon receipt of follow-up information on [21Feb2024], this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP.  An 80-year-old female patient received BNT162b2 (COMIRNATY), on 11Apr2022 as dose 4 (booster), single (Lot number: FM9893) at the age of 79 years intramuscular, in left arm for covid-19 immunisation; omeprazole (PROTONIX [OMEPRAZOLE]), (ongoing)), oral for gastrooesophageal reflux disease. The patient's relevant medical history included: "hypertension", start date: 1998 (ongoing); "asthma", start date: 1990 (ongoing); "acid reflux", start date: 2003 (ongoing). Concomitant medication(s) included: LIVALO (ongoing); ADVAIR taken for asthma (ongoing); LOSARTAN taken for hypertension (ongoing); AMLODIPINE oral taken for hypertension (ongoing). Vaccination history included: bnt162b2 (dose 1, single lot number:maybe Eng202, intramuscular upper left arm, My be around 2pm), administration date: 26Feb2021, when the patient was 78-year-old, for COVID-19 immunisation; bnt162b2 (Dose 2, single lot number: ER8730, intramuscular upper left arm), administration date: 26Mar2021, when the patient was 78-year-old, for COVID-19 immunisation; bnt162b2 (Dose 3 (BOOSTER), single lot number: 301458A intramuscular upper left arm), administration date: 27Sep2021, when the patient was 79-year-old, for COVID-19 immunisation. The following information was reported: BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "CHOLESTEROL, TOTAL 209"; LOW DENSITY LIPOPROTEIN INCREASED (non-serious), outcome "unknown", described as "LDL-CHOLESTEROL 124"; NON-HIGH-DENSITY LIPOPROTEIN CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "NON HDL CHOLESTEROL 140"; EOSINOPHIL COUNT INCREASED (non-serious), outcome "unknown", described as "ABSOLUTE EOSINOPHILS 581"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "my cholesterol/ went to 160 /after taking COVID boosters". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: patient had been on and off statins for years. After rebound and high cholesterol, she went back on meds. She has taken Livalo 2 mg every day since Mar2022. Her Lipid profile improved greatly, all of her tests since then, 15Sep2022, 11Jan2023, 07Jul2023 all showed greatly improved lipid readings. Patient have also been exercising more and eating better.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell count, Red cell distribution width, Total cholesterol/HDL ratio, White blood cell count
Clinical narrative: CHOLESTEROL, TOTAL 209; LDL-CHOLESTEROL 124; NON HDL CHOLESTEROL 140; ABSOLUTE EOSINOPHILS 581; my cholesterol/ went to 160 /after taking COVID boosters; The initial case was missing the following minimum criteria: [Info not qualifying for AE reporting - All other sources] Upon receipt of follow-up information on [21Feb2024], this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP.  An 80-year-old female patient received BNT162b2 (COMIRNATY), on 11Apr2022 as dose 4 (booster), single (Lot number: FM9893) at the age of 79 years intramuscular, in left arm for covid-19 immunisation; omeprazole (PROTONIX [OMEPRAZOLE]), (ongoing)), oral for gastrooesophageal reflux disease. The patient's relevant medical history included: "hypertension", start date: 1998 (ongoing); "asthma", start date: 1990 (ongoing); "acid reflux", start date: 2003 (ongoing). Concomitant medication(s) included: LIVALO (ongoing); ADVAIR taken for asthma (ongoing); LOSARTAN taken for hypertension (ongoing); AMLODIPINE oral taken for hypertension (ongoing). Vaccination history included: bnt162b2 (dose 1, single lot number:maybe Eng202, intramuscular upper left arm, My be around 2pm), administration date: 26Feb2021, when the patient was 78-year-old, for COVID-19 immunisation; bnt162b2 (Dose 2, single lot number: ER8730, intramuscular upper left arm), administration date: 26Mar2021, when the patient was 78-year-old, for COVID-19 immunisation; bnt162b2 (Dose 3 (BOOSTER), single lot number: 301458A intramuscular upper left arm), administration date: 27Sep2021, when the patient was 79-year-old, for COVID-19 immunisation. The following information was reported: BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "CHOLESTEROL, TOTAL 209"; LOW DENSITY LIPOPROTEIN INCREASED (non-serious), outcome "unknown", described as "LDL-CHOLESTEROL 124"; NON-HIGH-DENSITY LIPOPROTEIN CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "NON HDL CHOLESTEROL 140"; EOSINOPHIL COUNT INCREASED (non-serious), outcome "unknown", described as "ABSOLUTE EOSINOPHILS 581"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "my cholesterol/ went to 160 /after taking COVID boosters". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: patient had been on and off statins for years. After rebound and high cholesterol, she went back on meds. She has taken Livalo 2 mg every day since Mar2022. Her Lipid profile improved greatly, all of her tests since then, 15Sep2022, 11Jan2023, 07Jul2023 all showed greatly improved lipid readings. Patient have also been exercising more and eating better.
Sex: U
Vaccine: RSV
Symptoms: Product container issue
Clinical narrative: Defected; top was twisted a little too hard and then the vial broke; Defected; top was twisted a little too hard and then the vial broke; The initial case was missing the following minimum criteria: No Adverse Effect. Upon receipt of follow-up information on (15Feb2024), 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: HN3801) for immunisation, Device Lot Number: H758, Device Expiration Date: 01May2028. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), DEVICE DEFECTIVE (non-serious), outcome "unknown" and all described as "Defected; top was twisted a little too hard and then the vial broke".  Causality for "defected; top was twisted a little too hard and then the vial broke" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Joint range of motion decreased, Myalgia, Pain in extremity
Clinical narrative: is pain on the right arm; muscle pain; a limited movement/grabbing strength and range of motion, is all compromised; a limited movement/grabbing strength and range of motion, is all compromised; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Dose number unknown, manufacturer unknown), administration date: 15Apr2022, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "is pain on the right arm"; MYALGIA (medically significant), outcome "unknown", described as "muscle pain"; JOINT RANGE OF MOTION DECREASED (medically significant), ASTHENIA (medically significant), outcome "unknown" and all described as "a limited movement/grabbing strength and range of motion, is all compromised". Therapeutic measures were taken as a result of pain in extremity, myalgia, joint range of motion decreased, asthenia. The patient specified that he couldn't pick up stuff. He didn't have the strength and if he did pick it up, trying to move it in different directions was a problem. He didn't have that strength. Treatment: the patient stated he had one doctor give him a Cortisone shot in other arms to see if that would help and it did not.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, Dementia Alzheimer's type, Vertigo
Clinical narrative: ongoing advancement to alhizmer; vertigo symptoms; brain fog; 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 02Nov2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Gallbladder removal", start date: 11Feb2021, stop date: 11Feb2021; "COVID-19", start date: 20Sep2023 (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA taken for influenza immunisation, on 10Oct2023 as dose number unknown, single. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot number: EN6206, At time: 15:00, Anatomical location: Arm Left), administration date: 06Mar2021, when the patient was 64-year-old, for COVID-19 immunization, reaction(s): "Taste rubber/vanilla milk", "Vertigo prone sleeping", "prone sleeping", "High blood pressure", "Left arm sore"; BNT162b2 (DOSE 2, SINGLE, Batch/Lot number: ER8732   , Anatomical location: Arm Left), administration date: 27Mar2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: BRAIN FOG (non-serious) with onset 03Jan2024 at 22:30, outcome "not recovered"; DEMENTIA ALZHEIMER'S TYPE (medically significant) with onset 03Jan2024 at 22:30, outcome "not recovered", described as "ongoing advancement to alhizmer"; VERTIGO (non-serious) with onset 03Jan2024 at 22:30, outcome "not recovered", described as "vertigo symptoms". Therapeutic measures were not taken as a result of dementia alzheimer's type, vertigo, brain fog. Clinical course: It was reported that patient had vertigo symptoms also some brain fog also seem to have ongoing advancement to alhizmer some pressure towards upper and frontal lobes increase vertigo during high-end sexual activity. 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: Linked Report(s) : US-PFIZER INC-2021337249 Same patient/drug, different event/dose;
Sex: U
Vaccine: RSV
Symptoms: Device connection issue, Device leakage
Clinical narrative: The adapter broke, the threads were not good and fluid leakage occurred when reconstituting dose; The adapter broke, the threads were not good and fluid leakage occurred when reconstituting dose; This is a spontaneous report received from a Pharmacist from a sales representative.  A 20-day-old patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Feb2024 as dose number unknown, single (Lot number: HM0167) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), DEVICE LEAKAGE (non-serious) all with onset 2024, outcome "unknown" and all described as "The adapter broke, the threads were not good and fluid leakage occurred when reconstituting dose". Therapeutic measures were not taken as a result of device breakage, device leakage.  The reporter considered "the adapter broke, the threads were not good and fluid leakage occurred when reconstituting dose" not related to rsv vaccine prot.subunit pref 2v. Causality for "the adapter broke, the threads were not good and fluid leakage occurred when reconstituting dose" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  No follow-up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had 2 Pfizer COVID vaccines but still got COVID; had 2 Pfizer COVID vaccines but still got COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An elderly female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergic to egg" (unspecified if ongoing), notes: carries Epipen. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "had 2 Pfizer COVID vaccines but still got COVID". Clinical course: Caller also mentioned that she had 2 Pfizer COVID vaccines but still got COVID. Caller stated that she hadn't eaten egg in the past years which as she assumed may cause the allergy to be less severe. Caller was over 65. The doctor said that the patient was healthy.  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-202400049860 Same patient/product, different dose/events;
Age: 46.0
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 46-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 at 17:00 as dose 1, single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 11Feb2024 to 15Feb2024.  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: 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 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 64 years, 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, as dose 4 (booster), single and as dose 5 (booster), single for covid-19 immunisation. The patient's relevant medical history included: "Essential thrombocytosis" (unspecified if ongoing); "Known allergies: Lactose" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYUREA, start date: Feb2019. 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 included Paxlovid from 10Feb2024 to 14Feb2024. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
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 45-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. 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 Feb2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 14Feb2024 to 18Feb2024. Clinical course: The patient did not received other medication in 2 weeks.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstruation delayed, Stress
Clinical narrative: Every time I vaccinated, my cycle is severly delayed with weeks of cramping; Every time I vaccinated, my cycle is severly delayed with weeks of cramping; stress; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 03Mar2022 as dose 4, single (Lot number: FK9896) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 04Mar2021, when the patient was 49-year-old, for COVID-19 immunisation, reaction(s): "menstrual cycle delay", "menstrual cramps"; BNT162b2 (DOSE 2, SINGLE), administration date: 25Mar2021, when the patient was 49-year-old, for COVID-19 immunisation, reaction(s): "menstrual cycle delay", "menstrual cramps"; BNT162b2 (DOSE 3, SINGLE), administration date: 16Oct2021, when the patient was 50-year-old, for COVID-19 immunisation, reaction(s): "menstrual cycle delay", "menstrual cramps". The following information was reported: MENSTRUATION DELAYED (non-serious), DYSMENORRHOEA (non-serious), outcome "unknown" and all described as "Every time I vaccinated, my cycle is severly delayed with weeks of cramping"; STRESS (non-serious), outcome "unknown". Therapeutic measures were taken as a result of menstruation delayed, dysmenorrhoea. Additional information: It was reported that patient took zero medication. Her period was on time and normal until she received vaccination. Patient reported that every time she vaccinated, her cycle is severely delayed with weeks of cramping.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: all of the symptoms of CV19/ totally positive; all of the symptoms of CV19/ totally positive; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "seasonal flus" (unspecified if ongoing), notes: In ages past (I am now 77 years) I have experienced seasonal flus usually in January or Feb. 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 "recovering" and all described as "all of the symptoms of CV19/ totally positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) totally positive, notes: I did do the home-test for Corona four days into the misery-totally positive.  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-PV202400025603 same patient, different dose/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: all of the symptoms of CV19/ totally positive; all of the symptoms of CV19/ totally positive; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "seasonal flus" (unspecified if ongoing), notes: In ages past (I am now 77 years) I have experienced seasonal flus usually in January or Feb. 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 "recovering" and all described as "all of the symptoms of CV19/ totally positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) totally positive, notes: I did do the home-test for Corona four days into the misery-totally positive.  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-PV202400025603 same patient, different dose/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: fell quite ill; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Seasonal flus" (unspecified if ongoing), notes: have experienced seasonal flus usually in January or February. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: 2021, for COVID-19 Immunization. The following information was reported: ILLNESS (medically significant) with onset 2021, outcome "unknown", described as "fell quite ill". Clinical course: Early in 2021, the patient received two injections of the vaccine for Corona Virus, (known as COVID virus) on two different visits to her local "Community pharmacy". Needless to say, she received no aftereffects. Then, she went to the "lambs-to-the-slaughter", so to speak and was convinced of the necessity of receiving a 'booster injection' which she described as "for what many of us believed would be complete immunity from the deadly virus". Within about eight days of receiving the booster injection in Oct2021, she fell quite ill. To say the least, until Dec2023 was still ill and too frequency bed-bound for days at a time.   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-202400048994 Same patient, different dose/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: fell quite ill; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Seasonal flus" (unspecified if ongoing), notes: have experienced seasonal flus usually in January or February. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: 2021, for COVID-19 Immunization. The following information was reported: ILLNESS (medically significant) with onset 2021, outcome "unknown", described as "fell quite ill". Clinical course: Early in 2021, the patient received two injections of the vaccine for Corona Virus, (known as COVID virus) on two different visits to her local "Community pharmacy". Needless to say, she received no aftereffects. Then, she went to the "lambs-to-the-slaughter", so to speak and was convinced of the necessity of receiving a 'booster injection' which she described as "for what many of us believed would be complete immunity from the deadly virus". Within about eight days of receiving the booster injection in Oct2021, she fell quite ill. To say the least, until Dec2023 was still ill and too frequency bed-bound for days at a time.   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-202400048994 Same patient, different dose/event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in right arm 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 4 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer Unknown, Primary immunization completed), 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". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid from 12Feb2024 to 16Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  An 80-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown), in left arm 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. Vaccination history included: Moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Moderna covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Moderna covid-19 vaccine (DOSE 1, SINGLE), 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. Clinical course: The patient has no known allergy. Patient received Paxlovid as treatment from 07Feb2024 to 11Feb2024.  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: Pain
Clinical narrative: had some local pain with all vaccines and boosters; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3302) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "had some local pain with all vaccines and boosters".  No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400009954 Same patient, different vaccine dose and different event;
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain
Clinical narrative: 2nd Date 07Feb2021/1st date 27Jan2021; had some local pain with all vaccines and boosters; This is a spontaneous report received from a Consumer or other non HCP.  An adult patient received BNT162b2 (BNT162B2), on 07Feb2021 as dose 2, single (Lot number: EN6201) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, intramuscular, left deltoid, EL3302), administration date: 27Jan2021, for Covid-19 immunisation, reaction(s): "local pain with all vaccines and boosters". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 07Feb2021, outcome "unknown", described as "2nd Date 07Feb2021/1st date 27Jan2021"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "had some local pain with all vaccines and boosters". Additional information: It was not unexpected as the patient had some local pain with all vaccines and boosters.   No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400009954 Same patient, different vaccine dose and different event;
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: had some local pain with all vaccines and boosters; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Lot number: 301358A) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, intramuscular, left deltoid, EL3302), administration date: 27Jan2021, for COVID-19immunisation, reaction(s): "local pain with allvaccines and boosters"; BNT162b2 (Dose 2, intramuscular, left deltoid, EN6201), administration date: 07Feb2021, for COVID-19immunisation, reaction(s): "local pain with allvaccines and boosters". The following information was reported: PAIN (non-serious), outcome "unknown", described as "had some local pain with all vaccines and boosters".  No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400009954 Same patient, different vaccine dose and different event;
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 43-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1 (toppac), single (Lot number: HG4677) at the age of 43 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; 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 Feb2024, outcome "recovered" (20Feb2024) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Feb2024) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19 starting on 14Feb2024 until 18Feb2024.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; Dose #1: Pfizer/ Dose #2: Pfizer/ Dose #3: Pfizer/ Dose #4: Moderna/ Dose #5: Pfizer/ Dose #6: Moderna.; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Oct2022 as dose 5 (booster), single (Lot number: pfrgj5342) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: pfrep7534), in left arm, on 24Mar2021 as dose 2, single (Lot number: pfrep7534), in left arm and on 25Sep2021 as dose 3 (booster), single (Lot number: pfrff2588), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29May2022 as dose 4 (booster), single (Lot number: mod054a22a), in left arm and on 27Oct2023 as dose 6 (booster), single (Lot number: mod8058492), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HypoThyroid" (unspecified if ongoing); "Known allergies: Topical antibiotic ointment: Poly/Neosporin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29May2022, outcome "unknown", described as "Dose #1: Pfizer/ Dose #2: Pfizer/ Dose #3: Pfizer/ Dose #4: Moderna/ Dose #5: Pfizer/ Dose #6: Moderna."; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Jan2024, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Concomitant medication(s) included: LEXAPRO, start date: 01Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received PAXLOVID as COVID-19 treatment from 09Feb2024 to 13Feb2024.  The lot number for BNT162b2 omi xbb.1.5, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400048856 Same patient, different drug and event;
Age: 47.0
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 47-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Oct2023 as dose 1, single (batch/lot number: HF9299) at the age of 47 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "migraines" (unspecified if ongoing); "allergies gluten" (unspecified if ongoing); "PMS" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 3, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 4, 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 "treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 15Feb2024 to 15Feb2024
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: actually got my first case of COVID about 3 months later; actually got my first case of COVID about 3 months later; This is a spontaneous report received from a Consumer or other non HCP.  An 86-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Jun2023 as dose 6 (booster), single (Lot number: GJ3268) at the age of 85 years intramuscular, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FJ9943) and as dose 5 (booster), single (Lot number: FJ9943) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Lot number: 939903), as dose 2, single (Lot number: 013M20A) and in 2021 as dose 1, single (Lot number: 025L20A) for covid-19 immunisation. The patient's relevant medical history included: "chronic lung issues" (unspecified if ongoing); "chronic heart issues" (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 "unknown" and all described as "actually got my first case of COVID about 3 months later".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400049745 Same reporter, Patient / Different AE, Vaccine Dose;
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Post-acute COVID-19 syndrome
Clinical narrative: actually got my first case of COVID about 3 months later; actually got my first case of COVID about 3 months later; This is a spontaneous report received from a Consumer or other non HCP.  An 86-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Jun2023 as dose 6 (booster), single (Lot number: GJ3268) at the age of 85 years intramuscular, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FJ9943) and as dose 5 (booster), single (Lot number: FJ9943) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Lot number: 939903), as dose 2, single (Lot number: 013M20A) and in 2021 as dose 1, single (Lot number: 025L20A) for covid-19 immunisation. The patient's relevant medical history included: "chronic lung issues" (unspecified if ongoing); "chronic heart issues" (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 "unknown" and all described as "actually got my first case of COVID about 3 months later".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400049745 Same reporter, Patient / Different AE, Vaccine Dose;