chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Exercise test, Magnetic resonance imaging heart, Myocarditis, Troponin
Clinical narrative: myocarditis; This is a literature report for the following literature source(s): "A report on short-term follow-up cardiac imaging and clinical outcomes of myocarditis after coronavirus disease 2019 vaccination".  A 12-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. 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. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovered". The patient underwent the following laboratory tests and procedures: C-reactive protein: elevated; Echocardiogram: left ventricular ejection fraction 64 percent, notes: no regional wall motion abnormality, normal diastolic function; left ventricular ejection fraction 65 percent, notes: no regional wall motion abnormality, normal diastolic function; Ejection fraction: 64 %; 65 %; Electrocardiogram: ST elevations in inferior leads, notes: on presentation; Resolved ST-T wave, notes: changes; Electrocardiogram ambulatory: Normal; Exercise test: Normal; Magnetic resonance imaging heart: edema patchy subepicardial late gadolinium, notes: enhancement; Small focal late gadolinium, notes: enhancement; Troponin: unknown results. Therapeutic measures were taken as a result of myocarditis.; Sender's Comments: Based on limited information in the case , a possible causal association between  the reported event Myocarditis and the suspect drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-PV202200088740 Same article/drug/event; Different patient;
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Echocardiogram, Ejection fraction, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: myocarditis; This is a literature report for the following literature source(s): "A report on short-term follow-up cardiac imaging and clinical outcomes of myocarditis after coronavirus disease 2019 vaccination". A 20-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose-1 SINGLE,), for Covid-19 Immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovered". The patient underwent the following laboratory tests and procedures: C-reactive protein: Elevated; Echocardiogram: LVEF 35%, moderate global hypokinesis of the left, notes: ventricle; NA, notes: Follow-up TTE, me- dian duration of fol- low-up 22 days (IQR, 18-38; Ejection fraction: 35 %, notes: In TTE On presentation; 45 %, notes: In CMR On presentation; 45 %, notes: In CMR  Follow-up; Electrocardiogram: Tall peaked symmetrical T waves, without QRS, notes: widening, P waves diminished; NA, notes: median duration of follow-up 159 days (IQR, 46-178); Electrocardiogram ambulatory: normal; Exercise test: normal; Magnetic resonance imaging heart: Global hypokinesis with LVEF 45%, edema, patchy, notes: subepicardial late gadolinium enhancement; Global hypokinesis with LVEF 45%, resolved edema,, notes: persistent slightly reduced late gadolinium enhancement. Follow-up CMR, median duration of follow up 117 days (IQR, 88-118; Troponin: unknown results. Therapeutic measures were taken as a result of myocarditis.; Sender's Comments: Based on limited information in the case , a possible causal association between  the reported event Myocarditis and the suspect drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-PV202200088740 Same article/drug/event; Different patient;
Sex: M
Vaccine: COVID19
Symptoms: Exercise test, Magnetic resonance imaging heart, Myocarditis, Troponin
Clinical narrative: myocarditis; This is a literature report for the following literature source(s): "A report on short-term follow-up cardiac imaging and clinical outcomes of myocarditis after coronavirus disease 2019 vaccination". A 20-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose-1 SINGLE,), for Covid-19 Immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovered". The patient underwent the following laboratory tests and procedures: C-reactive protein: Elevated; Echocardiogram: LVEF 35%, moderate global hypokinesis of the left, notes: ventricle; NA, notes: Follow-up TTE, me- dian duration of fol- low-up 22 days (IQR, 18-38; Ejection fraction: 35 %, notes: In TTE On presentation; 45 %, notes: In CMR On presentation; 45 %, notes: In CMR  Follow-up; Electrocardiogram: Tall peaked symmetrical T waves, without QRS, notes: widening, P waves diminished; NA, notes: median duration of follow-up 159 days (IQR, 46-178); Electrocardiogram ambulatory: normal; Exercise test: normal; Magnetic resonance imaging heart: Global hypokinesis with LVEF 45%, edema, patchy, notes: subepicardial late gadolinium enhancement; Global hypokinesis with LVEF 45%, resolved edema,, notes: persistent slightly reduced late gadolinium enhancement. Follow-up CMR, median duration of follow up 117 days (IQR, 88-118; Troponin: unknown results. Therapeutic measures were taken as a result of myocarditis.; Sender's Comments: Based on limited information in the case , a possible causal association between  the reported event Myocarditis and the suspect drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-PV202200088740 Same article/drug/event; Different patient;
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Echocardiogram, Ejection fraction, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: myocarditis; This is a literature report.  A 16-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose-1, SINGLE, UNKNOWN MANUFACTURER), for Covid-19  immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant), 1 day after the suspect product(s) administration, outcome "recovered". The patient underwent the following laboratory tests and procedures: C-reactive protein: Elevated; Echocardiogram: LVEF 66%, no RWMA, normal diastolic function, notes: On presentation; LVEF 69%, no RWMA, abnormal tissue Doppler, notes: suggestive of diastolic dysfunction (Follow-up); Ejection fraction: 66 %, notes: On presentation; 69 %, notes: Follow-up; Electrocardiogram: sinus tachycardia, notes: On presentation; Sinus arrhythmia, notes: Follow-up; Electrocardiogram ambulatory: Normal; Exercise test: Normal; Magnetic resonance imaging heart: NA, notes: On presentation; Absence of acute edema. Focal subepicardial late, notes: gadolinium enhancement. Imaging suggestive of history of acute myocarditis (follow-up); Troponin: unknown results. Therapeutic measures were taken as a result of myocarditis.; Sender's Comments: Based on limited information in the case , a possible causal association between  the reported event Myocarditis and the suspect drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-PV202200088740 Same article/drug/event; Different patient;
Sex: M
Vaccine: COVID19
Symptoms: Exercise test, Magnetic resonance imaging heart, Myocarditis, Troponin
Clinical narrative: myocarditis; This is a literature report.  A 16-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose-1, SINGLE, UNKNOWN MANUFACTURER), for Covid-19  immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant), 1 day after the suspect product(s) administration, outcome "recovered". The patient underwent the following laboratory tests and procedures: C-reactive protein: Elevated; Echocardiogram: LVEF 66%, no RWMA, normal diastolic function, notes: On presentation; LVEF 69%, no RWMA, abnormal tissue Doppler, notes: suggestive of diastolic dysfunction (Follow-up); Ejection fraction: 66 %, notes: On presentation; 69 %, notes: Follow-up; Electrocardiogram: sinus tachycardia, notes: On presentation; Sinus arrhythmia, notes: Follow-up; Electrocardiogram ambulatory: Normal; Exercise test: Normal; Magnetic resonance imaging heart: NA, notes: On presentation; Absence of acute edema. Focal subepicardial late, notes: gadolinium enhancement. Imaging suggestive of history of acute myocarditis (follow-up); Troponin: unknown results. Therapeutic measures were taken as a result of myocarditis.; Sender's Comments: Based on limited information in the case , a possible causal association between  the reported event Myocarditis and the suspect drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-PV202200088740 Same article/drug/event; Different patient;
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt very tired the next day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 90-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "arthritic knees" (unspecified if ongoing), notes: has arthritic knees not she does not have good bones.; "she does not have good bones" (unspecified if ongoing), notes: has arthritic knees not she does not have good bones. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "felt very tired the next day". Additional information: The caller mentioned she was 90 years old and has arthritic knees and she does not have good bones. She also mentioned that with her previous doses she felt very tired the next day and asked what was going on with the fatigue. She mentioned that it was concerning, but that probably apart from being more tired that she has been with the previous vaccination, caller suspects she will not suffer from anything unusual, and that she will make an appointment to receive the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201253856 same patient/ drug/ event, different dose number;US-PFIZER INC-202201253858 same patient/ drug/ event, different dose number;US-PFIZER INC-202201253857 same patient/ drug/ event, different dose number;
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Fatigue, Headache
Clinical narrative: Aches/Pain; Has 99.9F temperature; A lot of chills; Bad headache; Exhausted; Does not feel good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Single), for COVID-19 immunization; Bnt162b2 (Dose: 2, Single), for COVID-19 immunization; Bnt162b2 (Dose: 3 (Booster), Single), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Aches/Pain"; BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "Has 99.9F temperature"; CHILLS (non-serious), outcome "unknown", described as "A lot of chills"; HEADACHE (non-serious), outcome "unknown", described as "Bad headache"; FATIGUE (non-serious), outcome "unknown", described as "Exhausted"; MALAISE (non-serious), outcome "unknown", described as "Does not feel good". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient was asking if it is normal to experience symptoms on the first day and how long these symptoms will last. Patient stated that she never had reactions with the Pfizer COVID vaccines before. She also stated that she had reactions with the Pfizer COVID vaccine bivalent as her 4th shot/dose. Patient mentioned that she had a lot of chills, bad headache, aches and pain, exhausted and does not feel good, and had 99.9F temperature. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: Aches/Pain; Has 99.9F temperature; A lot of chills; Bad headache; Exhausted; Does not feel good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Single), for COVID-19 immunization; Bnt162b2 (Dose: 2, Single), for COVID-19 immunization; Bnt162b2 (Dose: 3 (Booster), Single), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Aches/Pain"; BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "Has 99.9F temperature"; CHILLS (non-serious), outcome "unknown", described as "A lot of chills"; HEADACHE (non-serious), outcome "unknown", described as "Bad headache"; FATIGUE (non-serious), outcome "unknown", described as "Exhausted"; MALAISE (non-serious), outcome "unknown", described as "Does not feel good". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient was asking if it is normal to experience symptoms on the first day and how long these symptoms will last. Patient stated that she never had reactions with the Pfizer COVID vaccines before. She also stated that she had reactions with the Pfizer COVID vaccine bivalent as her 4th shot/dose. Patient mentioned that she had a lot of chills, bad headache, aches and pain, exhausted and does not feel good, and had 99.9F temperature. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain, Wrong product administered
Clinical narrative: Severe pain in left and right hip joints; Severe soreness in left and right thigh muscles that extended down to back of knees; Severe soreness in left and right thigh muscles that extended down to back of knees; Wrong vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 16:15 as dose 1 (bivalent), single (Lot number: GJ6739) at the age of 80 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "slow urine flow" (unspecified if ongoing); "sluggish stool" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESYLATE. Past drug history included: Known allergies: statin medications, reaction(s): "known allergies: Statin medications". The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 06Oct2022, outcome "unknown", described as "Wrong vaccine administered"; ARTHRALGIA (non-serious) with onset 11Oct2022, outcome "not recovered", described as "Severe pain in left and right hip joints"; MYALGIA (non-serious), PAIN (non-serious) all with onset 11Oct2022, outcome "not recovered" and all described as "Severe soreness in left and right thigh muscles that extended down to back of knees". Therapeutic measures were taken as a result of arthralgia, myalgia, pain.  Additional information: The patient did not receive any other vaccine within four weeks. The patient did not have Covid prior to vaccination and the patient was not tested with Covid post vaccination. AE treatment: Extra Strength Pain Reliever Acetaminophen 500 mg.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient experienced moderate arm pain, which by 27 hours post-dose had reduced to mild arm pain.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 11-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 at 15:30 as dose 4 (booster), single (Lot number: GK1657) at the age of 11 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Eczema" (unspecified if ongoing). Concomitant medication(s) included: QUADRIVALENT INFLUENZA VACCINE taken for immunisation, on 24Sep2022 as dose 1, single. 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: PAIN IN EXTREMITY (non-serious) with onset 23Oct2022, outcome "recovering", described as "Patient experienced moderate arm pain, which by 27 hours post-dose had reduced to mild arm pain.".  Additional information: Reporter was Pfizer employee. Dose was received more than 3. Product: COVID 19 [Brand: Pfizer-BioNTech COVID-19 Vaccine, Is bivalent: True]. Facility type vaccine was Pharmacy or Drug Store. If other vaccine in four weeks: Yes. Other vaccine 4weeks product was Quadrivalent Influenza Vaccine [Other vaccine 4weeks lot number: unknown, Other vaccine 4weeks dose number: 1]. Other medications in two weeks was Daily multivitamins. The vaccine recipient reported to me roughly 27 hours post-vaccination that the morning after the vaccine, he experienced moderate arm pain, which by 27 hours post-dose had reduced to mild arm pain. No other AEs were reported. If covid prior vaccination, was provided as No. If covid tested post vaccination, was provided as No. Known allergies: NKA.  No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Extra dose administered, Headache, Vaccination site pain
Clinical narrative: Headache; Chills; Sore in both arms; Received two doses at once; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 14-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose number unknown (booster), single (Lot number: GH9693) at the age of 14 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: coviD-19 vaccine (States that her daughter had a booster, 21Jan2022. This was the first of the Bivalent Booster.), administration date: 21Jan2022, when the patient was 13-year-old, for Covid-19 Immunization; Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 Immunization. The following information was reported: EXTRA DOSE ADMINISTERED (non-serious) with onset 22Oct2022, outcome "unknown", described as "Received two doses at once"; HEADACHE (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Sore in both arms".  Additional information: It was reported that the patient received two doses of the Pfizer BioNTech Covid 19 Bivalent Vaccine instead of one dose. The patient's physician said to just watch for tachycardia or other symptoms. The patient had a headache and some chills, she was better on 24Oct2022, just sore in both arms.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt very tired the next day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 90-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "arthritic knees not she does not have good bones" (unspecified if ongoing), notes: arthritic knees not she does not have good bones. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization, reaction(s): "she felt very tired the next day"; Bnt162b2 (Dose: 2), for COVID-19 Immunization, reaction(s): "she felt very tired the next day". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "felt very tired the next day".  Additional Information: Patient had not taken the bivalent vaccine and wants to know if there will be any reactions. She already got the first 3 shots and what she was concerned about as the fact that it said bivalent. She asked if she could be irritated by receiving the 4th dose with the bivalent. She also mentioned that with her previous doses she felt very tired the next day, and asked, what was going on with the fatigue. She asked if she could be fatigue with the new bivalent. She mentioned that it was concerning, but that probably apart from being more tired that she had been with the previous vaccination. Patient suspect that she will not suffer from anything unusual, and that she will make an appointment to receive the vaccine. The patient was asking do the Bivalent vaccine have some sort of extra adjunct material to make it stronger? or why is it called bivalent. The patient also asked if there was something different in the new vaccine compared to the first three doses that she received. The patient received 4 shots of COVID 19 vaccines at the moment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201253451 same patient/ drug/ event, different dose number;
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: "ADHD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Eczema" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; ADDERALL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received COVID-19 Treatment with anti-viral Paxlovid from 22Oct2022.   Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cataract, Diabetes mellitus, Hypertension, Immunisation reaction
Clinical narrative: cataract in eye; bad reaction to covid-19 vaccine; Diabetes; Liver issues; High blood pressure; Calcification in lungs; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4419006-00.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 24Aug2021 as dose 1, single (Batch/Lot number: unknown) and on 22Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 57 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY CALCIFICATION (non-serious) with onset 01Oct2021, outcome "unknown", described as "Calcification in lungs"; DIABETES MELLITUS (medically significant) with onset 01Oct2021, outcome "unknown", described as "Diabetes"; HYPERTENSION (non-serious) with onset 01Oct2021, outcome "unknown", described as "High blood pressure"; LIVER DISORDER (non-serious) with onset 01Oct2021, outcome "unknown", described as "Liver issues"; CATARACT (medically significant), outcome "unknown", described as "cataract in eye"; IMMUNISATION REACTION (non-serious), outcome "unknown", described as "bad reaction to covid-19 vaccine". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (01Oct2021) High. The action taken for adalimumab was dosage not changed.  Clinical course: It was unknown if patient was enrolled in covid-19-vaccine trial.  The reporter's assessment of the causal relationship of "cataract in eye", "diabetes", "liver issues", "high blood pressure", "calcification in lungs" and "bad reaction to covid-19 vaccine" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, the causal relationship of "cataract in eye", "diabetes", "liver issues", "high blood pressure", "calcification in lungs" and "bad reaction to covid-19 vaccine" with the suspect product(s) BNT162b2 cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Liver disorder, Pulmonary calcification
Clinical narrative: cataract in eye; bad reaction to covid-19 vaccine; Diabetes; Liver issues; High blood pressure; Calcification in lungs; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4419006-00.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 24Aug2021 as dose 1, single (Batch/Lot number: unknown) and on 22Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 57 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY CALCIFICATION (non-serious) with onset 01Oct2021, outcome "unknown", described as "Calcification in lungs"; DIABETES MELLITUS (medically significant) with onset 01Oct2021, outcome "unknown", described as "Diabetes"; HYPERTENSION (non-serious) with onset 01Oct2021, outcome "unknown", described as "High blood pressure"; LIVER DISORDER (non-serious) with onset 01Oct2021, outcome "unknown", described as "Liver issues"; CATARACT (medically significant), outcome "unknown", described as "cataract in eye"; IMMUNISATION REACTION (non-serious), outcome "unknown", described as "bad reaction to covid-19 vaccine". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (01Oct2021) High. The action taken for adalimumab was dosage not changed.  Clinical course: It was unknown if patient was enrolled in covid-19-vaccine trial.  The reporter's assessment of the causal relationship of "cataract in eye", "diabetes", "liver issues", "high blood pressure", "calcification in lungs" and "bad reaction to covid-19 vaccine" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, the causal relationship of "cataract in eye", "diabetes", "liver issues", "high blood pressure", "calcification in lungs" and "bad reaction to covid-19 vaccine" with the suspect product(s) BNT162b2 cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Gastritis, Inflammatory bowel disease, Lymphadenopathy
Clinical narrative: swollen lymph node in my right breast; Other inflammation episodes in my stomach and intestines have occurred; Other inflammation episodes in my stomach and intestines have occurred; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 2, single (Lot number: ER8734) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "hypothyroidism thyroid disease" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: TRULICITY; JARDIANCE. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Left), administration date: 11Mar2021, when the patient was 43-year-old, for COVID-19 immunization. The following information was reported: INFLAMMATORY BOWEL DISEASE (medically significant), GASTRITIS (non-serious) all with onset 01Jul2021, outcome "recovered" and all described as "Other inflammation episodes in my stomach and intestines have occurred"; LYMPHADENOPATHY (non-serious) with onset Aug2021, outcome "recovered", described as "swollen lymph node in my right breast". The events "other inflammation episodes in my stomach and intestines have occurred" and "swollen lymph node in my right breast" required physician office visit. Therapeutic measures were not taken as a result of inflammatory bowel disease, gastritis, lymphadenopathy.  Clinical course: In February of 2022 I began to experience extreme abdominal pain. I went for ultrasound and found out it was my Fallopian tubes were filled with fluid. My doctor thought it was old infection resurfaced but I am not sure if this. Also I had a swollen lymph node in my right breast in Aug2021. I was called back for extra cancer screening. Other inflammation episodes in my stomach and intestines have occurred. No other vaccine in four weeks.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 08:00 as dose 4 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: FN8208), on 06Apr2021 as dose 2, single (Lot number: ER8737) and on 20Oct2021 as dose 3 (booster), single (Lot number: FF2593) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "PCN" (unspecified if ongoing); "Known allergies: Cephalosporin" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN; LOSARTAN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Oct2022) Negative, notes: Tested negative on 23Oct2022; (25Oct2022) Positive, notes: Tested positive 25Oct2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid as treatment of COVID-19.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Postural Orthostatic Tachycardia Syndrome (POTS)" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing). Concomitant medication(s) included: XYREM; TIROSINT; TYLENOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measure of Paxlovid was taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknow, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications.Other medication in 2weeks. 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: Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, from 15Oct2022 to 19Oct2022 for treatment of COVID-19.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 18:00 as dose 4 (booster), single (Lot number: GH9703) at the age of 56 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Mar2021 at 15:00 as dose 1, single (Lot number: EW0150), in right arm, on 21Apr2021 at 11:00 as dose 2, single (Lot number: ER8729), in right arm and on 27Nov2021 at 14:00 as dose 3 (booster), single (Lot number: FJ8762), in right arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; ASPIRIN [ACETYLSALICYLIC ACID]. Other medication in 2 weeks product included Covidalal and MultiVitamins. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Oct2022) Negative; (24Oct2022) Positive. The patient received Paxlovid as COVID 19 Treatment from 16Oct2022 to 20Oct2022.
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 contactable reporter(s) (Physician). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: FL3249), on 08Feb2021 as dose 2, single (Lot number: EL9261), on 03Oct2021 as dose 3 (booster), single (Lot number: FF2588) and on 28Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "allergic rhinitis" (unspecified if ongoing); "GERD" (unspecified if ongoing), notes: (with h/o gastric ulcer); "remote h/o asthma" (unspecified if ongoing), notes: remote h/o asthma; "remote h/o alopecia areata" (unspecified if ongoing), notes: remote h/o alopecia areata; "h/o depression" (unspecified if ongoing), notes: (weaned off Lexapro 10/6/2022, after being on it for 25 years); "Penicillin allergy" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE, start date: Jan1990, stop date: 25Oct2022; MONTELUKAST, start date: Jan2000, stop date: 25Oct2022; PANTOPRAZOLE, start date: Apr2019, stop date: 25Oct2022; FISH OIL, start date: Jan2010, stop date: 25Oct2022; PROBIOTICS, start date: Jan2015, stop date: 25Oct2022; LEXAPRO taken for depression, start date: 1997, stop date: 06Oct2022. Past drug history included: Wellbutrin, reaction(s): "Wellbutrin allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Oct2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Oct2022) Positive, notes: Positive rapid COVID in clinic; (21Oct2022) Negative, notes: Neg home tests 10/21 and 23; (23Oct2022) Negative, notes: Neg home tests 10/21 and 23. Therapeutic measures were taken as a result of vaccination failure, covid-19, which included Paxlovid from 15Oct2022 to 20Oct2022. Clinical course: Patient experienced positive rapid COVID in clinic 15Oct2022; started Paxlovid that day. Neg home tests 21Oct and 23. Symptoms improved, but lingering headache, brain fog, fatigue, and sleep disruption.; Sender's Comments: Based on the information currently available, a causal association between the reported event and BNT162b2 cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: came down with COVID; came down with COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 80-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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) all with onset 01Sep2022, outcome "recovered" (Sep2022) and all described as "came down with COVID". The patient had Covid from 01Sep up until the end of Sep. He was ill for one month; by the end of Sep, he was both over it. He wanted to know if they should wait longer before they get their second booster which was scheduled on 27Oct2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Sep2022) Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201256200 same reporter/products/AEs, different patient;
Age: 79.0
Sex: M
Vaccine: UNK
Symptoms: Discomfort, Loss of personal independence in daily activities, Mobility decreased, Pain in extremity, Vaccination site nodule
Clinical narrative: Pain in arm; can only lift up arm so high and then has a problem; Still has a little knot there; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), in Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 79 years for pneumonia. The patient's relevant medical history included: "pneumonia" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Pneumovax injections, for Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Oct2022, outcome "not recovered", described as "Pain in arm"; VACCINATION SITE MASS (non-serious) with onset Oct2022, outcome "not recovered", described as "Still has a little knot there"; MOVEMENT DISORDER (non-serious) with onset Oct2022, outcome "not recovered", described as "can only lift up arm so high and then has a problem". Additional information: Pneumovax injection is a Pfizer product. The patient got a pneumovax injection about a month ago at (Specialty pharmacy). Has never had reaction to an injection before. The patient has pain in arm, at times unbearable, can only lift up arm so high and then has a problem. About a month ago, pain started the same day as caller received the injection, pain got worse next day, got worse, but has gotten a little better maybe not even a week ago, and then the last 2 days started getting more uncomfortable again. Still has a little knot there. Can't even get jacket off by caller's self. Pain started somewhere around 06Oct2022 or 07Oct2022, could have been 08Oct2022 or 09Oct2022, not sure. The people at pharmacy said maybe something 20, maybe Pneumovax 20 but did not say that was the pneumovax injection the patient received. Gave the patient the 1 injection and said to come back in a year for another one. The patient has had prior pneumovax injections for at least 20 or 30 years, has never had a reaction. The patient stated that is unknown which pneumovax injections received before, was at least 7 or 8 years ago. Patient complained that just put alcohol on arm and jabbed and that was it, very unprofessional. Has had pneumonia over 25 times. The patient having pneumonia was prior to he receiving the pneumovax injections, he has not had pneumonia in probably at least 30 or 35 years. Concomitant products: On tons of medications, has been on those medications for 40 years, so caller stated none of those medications would be relevant to include in report.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: came down with COVID; came down with COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. An 80-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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) all with onset 01Sep2022, outcome "recovered" (Sep2022) and all described as "came down with COVID". Patient's husband reported that his wife (patient) came down with COVID on 01Sep2022 and was for two weeks; by the end of Sep, she was over it. They had an appointment for the new Bivalent booster on 27Oct2022. Patient's husband wanted to know if they should wait longer before they get their second booster. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Sep2022) Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201256055 same reporter/products/AEs, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Got Covid; Got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "recovered" and all described as "Got Covid". Patient and her husband are seniors. They both received the first dose of the Covid Vaccine Feb2021 and three weeks later got the second dose of the Covid Vaccine. They received a third dose, it was the Regular Covid Shot in Sep2021. Then, in May2022, she got Covid. After getting well they both got another Pfizer Covid Shot in Jul2022. Now she has questions about the new Covid Booster, the Omicron one, the one that just came out in the . Patient mentioned they read something about if take the Booster one can get Covid. She just wanted her questions answered because need to try and see if can get the vaccine. She was aware of the new Omicron booster dose, and she knew that she was an eligible patient to receive it. However, she wanted to know if 5 doses of the vaccine would be considered an overdose. She was wondering if a person can get "too many" COVID shots.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 31Jan2022 as dose 2, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRAMADOL. 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: Patient received Paxlovid as Treatment of COVID-19. No Known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.