chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a 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 09Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 80 years, in right 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), 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 was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid was used for the treatment of COVID-19 from 16Oct2022 to 20Oct2022.  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: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19 pneumonia, Drug ineffective, Oxygen saturation
Clinical narrative: had COVID-19 pneumonia while in the hospital; had COVID-19 pneumonia while in the hospital; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003869.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 14Mar2022 as dose 1, single (Batch/Lot number: unknown) and on 04Apr2022 as dose 2, single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 PNEUMONIA (hospitalization, medically significant) all with onset 2022, outcome "unknown" and all described as "had COVID-19 pneumonia while in the hospital". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (2022) Blood pressure increased to 200s, notes: Blood pressure increased to 200s; Oxygen saturation: (2022) Low blood oxygen, notes: Low blood oxygen.  Clinical course: On 14Oct2022, it was reported that a patient started treatment on 14Mar2022 with Pfizer BioNTech COVID-19 Vaccine at dose 1 and reported that everything was fine with the patient. The patient had the second dose on 04Apr2022. It was reported, the patient then had heart palpitations and blood pressure increased to 200s. It made the patient sick. Body was buzzing inside and then had the shakes, was shaky and ill. It was also reported that Pfizer had a bad batch of the COVID-19 vaccine which was never recalled. Patient also had COVID-19 pneumonia while in the hospital and low blood oxygen.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: FH8028), in right arm and on 09Nov2021 as dose 2, single (Lot number: EN6205) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Experienced a significant rebound after taking Paxlovid. Started taking Paxlovid one day after symptoms first appeared. The last dose was Sunday morning. On Monday tested negative, and again tested negative on Wednesday. On Thursday very bad cold-like symptoms appeared. Went back into isolation, then tested positive on Saturday. Rebound symptoms were similar to and slightly worse than the original symptoms. The patient did not receive any other medications/product within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. The patient did not received any other medication in 2 weeks
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Cerebrovascular accident, Cough, Dyspnoea, Fatigue
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 210/110, notes: blood pressure went to 210/110; Catheterisation cardiac: showed she had a 20 to 30 percent blockage, notes: showed she had a 20 to 30 percent blockage in two arteries; SARS-CoV-2 test: Positive, notes: Had COVID-19 after the third shot of Pfizer COVID-19 vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypertension, Investigation, Myocardial infarction, Weight increased
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 210/110, notes: blood pressure went to 210/110; Catheterisation cardiac: showed she had a 20 to 30 percent blockage, notes: showed she had a 20 to 30 percent blockage in two arteries; SARS-CoV-2 test: Positive, notes: Had COVID-19 after the third shot of Pfizer COVID-19 vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, COVID-19, Catheterisation cardiac, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 210/110, notes: blood pressure went to 210/110; Catheterisation cardiac: showed she had a 20 to 30 percent blockage, notes: showed she had a 20 to 30 percent blockage in two arteries; SARS-CoV-2 test: Positive, notes: Had COVID-19 after the third shot of Pfizer COVID-19 vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: one out of seven people he checked on that had a death.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: DEATH (death, medically significant), outcome "fatal", described as "one out of seven people he checked on that had a death.". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course was reported that the 67-year-old caller refers that after the two initial doses of Pfizer BioNTech COVID-19 vaccine she has experienced extreme fatigue, brain fog, dizziness but not vertigo and difficulty processing information orally. Caller provides her Dr address to. Caller states: "That's part of it. I´m just not functional. There´s been some improvement but not enough for me to function normally. it´s a known side effect there´s an online community, about a year ago there were about 10 thousand people worldwide, it´s affected not only Pfizer but Moderna, Johnson & Johnson and Astra Zeneca. I don´t feel well. I feel dizzy all the time. I need to be able to function. I need to be able to see. I need to be able to feel like a can drive safely. The two lots that were given to me have some of the highest adverse responses submitted to VAERS to the CDC. If you have further information in regard to the lot numbers EN6198 EN6201. The brain fog is absolutely a side effect of the vaccine, because I´ve talked to other people whose had it. I had the vaccine and 5 hours later it happens. Because of my allergy I hadn't seen anyone in the preceding 10 days so it couldn't be that I got COVID. I tested negative. I haven't had COVID. this was caused by the vaccine. I have an allergy to alcohol fumes. With all people using sanitizer I could not go to hospitals or even go shopping for over a year. I was basically self-quarantining. There was a disparity between batches because once my nephew found what was going on with those two batches, he checked for everyone's else in the family most of them had negligible adverse reactions like people complaining about aches and stuff but there were there was one out of seven people he checked on that had a death. My batches (EN6198 EN6201) have 3 or 4 hundred deaths between them. "  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: one out of seven people he checked on that had a death.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 22 years 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); "known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; ABILIFY and Adderall XR. Past drug history included: Zyrtec, reaction(s): "Drug Allergy"; Azithromycin, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received anti viral medication Paxlovid from 18Oct2022 to 23Oct2022 to treat COVID-19.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in right 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 was not reported. There were no concomitant medications. Past drug history included: Known allergies: aspirin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details: Product: COVID 19 Treatment Brand: Paxlovid from 18Oct2022 to 22Oct2022. No other medication in 2 weeks  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 2, single (Lot number: EW0161) at the age of 62 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arrhythmia" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL oral taken for arrhythmia (ongoing); MELOXICAM oral taken for arthritis. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, LOT NUMBER: EN6207, Anatomical Location: Arm left, Route of Administration: Intramuscular), administration date: 05Mar2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "sore arm", "Fatigue". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown".  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 31Aug2021 as dose 3 (booster), single (Lot number: FA6780) at the age of 62 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Arrhythmia" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL oral taken for arrhythmia (ongoing); MELOXICAM oral taken for arthritis. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, LOT NUMBER: EN6207, Anatomical Location: Arm left, Route of Administration: Intramuscular), administration date: 05Mar2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "sore arm", "Fatigue"; BNT162b2 (DOSE 2, SINGLE, LOT NUMBER: EW0161, Anatomical Location: Arm left, Route of Administration: Intramuscular), administration date: 15Apr2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "sore arm", "Fatigue".  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown".  Additional information: Vaccination Facility Type at Pharmacy or drug store. The patient had no adverse events associated with any of her vaccine. Just sore arm plus fatigue for one day. No specific relevant test for thromboembolic events with thrombocytopenia.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Body temperature, Fatigue, Pain in extremity, SARS-CoV-2 test
Clinical narrative: sore arm; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Arrhythmia" (ongoing); "Arthritis" (ongoing). Concomitant medication(s) included: METOPROLOL oral taken for arrhythmia (ongoing); MELOXICAM oral taken for arthritis. Vaccination history included: BNT162b2 (Dose 1, Time: Morning , Site and route of injection:, Anatomical site of injection: arm (Left), Route of administration: Intramuscular, Batch/lot number: EN6207), administration date: 05Mar2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "Sore arm", "Fatigue"; BNT162b2 (Dose 2, Time: morning, Site and route of injection:, Anatomical site of injection: arm (Left), Route of administration: Intramuscular, Batch/lot number: EW0161), administration date: 15Apr2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "Sore arm", "Fatigue"; BNT162b2 (Dose 3, Date: 31Aug2021, Time: morning, Site and route of injection:, Anatomical site of injection: arm (Left), Route of administration: Intramuscular, Batch/lot number: FA6780), administration date: 31Aug2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "Sore Arm", "Fatigue"; BNT162b2 (Dose 4, Time: morning, Site and route of injection:, Anatomical site of injection: arm (Left), Route of administration: Intramuscular, Batch/lot number: FJ5683), administration date: 28Jan2022, when the patient was 63-year-old, for Covid-19 immunization, reaction(s): "Sore Arm", "Fatigue". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no adverse events associated with any of vaccine, just sore arm plus fatigue for one day. The patient did not have prior vaccination. No specific relevant test for thromboembolic events with thrombocytopenia  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: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 10May2022 at 18:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 59 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Mar2021 at 11:00 as dose 1, single (Lot number: 039A21A), in left arm, on 22Apr2021 at 15:30 as dose 2, single (Lot number: 007C21A), in left arm, on 03Dec2021 at 17:00 as dose 3 (booster), single (Lot number: 027H21B), in left arm and on 04Oct2022 at 17:45 as dose 5 (booster), single (Lot number: AS71G4D), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN [LORATADINE], start date: 01Jan2001, stop date: 18Oct2022; CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PHOSPHATE;CHROMIC CHLORIDE;COLECALCIFEROL;CUPRIC OXIDE;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE SULFATE;NICKEL;NICOTINAMIDE;PANTOTHENIC ACID;POTASSIUM CHLORIDE;POTA, start date: 04Dec2017, stop date: 28Oct2022. Past drug history included: Succinylcholine, reaction(s): "Known allergies: Yes - succinylcholine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had received other medication in 2weeks included Multivitamin. Patient was treated with Paxlovid form 19Oct2022 to 23Oct2022 as a treatment for covid-19.  Rebound of COVID-19 symptoms, verified by positive rapid test, five days after finishing 5-day Paxlovid course of treatment.
Age: 64.0
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 non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Sep2022 as dose number unknown, single (Lot number: GH9694) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was used for treatment of COVID-19 from 20Oct2022 to 25Oct2022. The patient had reoccurrence of all symptoms (headache, congestion, body aches, fatigue) 3 days after stopping Paxlovid and isolating for 9 days.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (bivalent), single (Lot number: GH9694) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 06Apr2021 as dose 2, single (Lot number: ER8733), in left arm, on 06Oct2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 06May2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "Known allergies : Pollen" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Oct2022) Positive, notes: COVID 19 Treatment; (28Oct2022) Positive, notes: Rebound of Covid symptoms on 28 including positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Rebound of covid symptoms on 28Oct2022 including positive test outcome was not recovered.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; vaccine brand other=Moderna; 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 male patient received BNT162b2 (BNT162B2), on 11Mar2021 at 09:00 as dose 1, single (Lot number: El3247), in left arm, on 08Apr2021 at 09:00 as dose 2, single (Lot number: Ew0151), in left arm and on 06Nov2021 at 12:00 as dose 3 (booster), single (Lot number: 320308d) at the age of 64 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Apr2022 at 12:00 as dose 4 (booster), single (Lot number: 056m21a), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Apr2022, outcome "unknown", described as "vaccine brand other=Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (18Oct2022) Negative, notes: a negative test on 18Oct2022; (28Oct2022) Positive, notes: Tested positive with symptoms 10 days after last dose of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid from 13Oct2022 to 18Oct2022 for treatment of COVID-19. Paxlovid rebound. Patient was tested positive with symptoms 10 days after last dose of Paxlovid and a negative test on 18Oct2022. Event did not resulted in emergency room visit or physician office visit. No treatment received for Paxlovid rebound. No known allergies.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: I also had a bad case of COVID Aug2021; I also had a bad case of COVID Aug2021; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EK5730), in left arm and on 13Jan2021 as dose 2, single (Lot number: EK9231) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure treated for 10 years" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "sleep apnea with CPAP" (unspecified if ongoing); "sleep apnea with CPAP" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I also had a bad case of COVID Aug2021". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course : The patient Recvied treatment with Eliquis on 24Oct2022; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Pain
Clinical narrative: she feels really achy and uncomfortable; she feels really achy and uncomfortable; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 5-year-old female patient received BNT162b2 (BNT162B2), on 07Nov2021 as dose 1 (orange cap), 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: PAIN (non-serious), DISCOMFORT (non-serious), outcome "unknown" and all described as "she feels really achy and uncomfortable".  Additional information: Pediatrician is calling about two patients: 5-year-old female and 10-year-old male, who were accidently administered the adult gray cap bivalent formulation of the Pfizer BioNTech Covid 19 vaccine at their local pharmacy instead of getting the pediatric 5-11 bivalent orange cap booster. They received their primary series of the monovalent orange formulation on 07Nov2021 and 04Dec2021. He was not worried so much about repercussions of the vaccines, he is more concerned as to whether or not this will affect the series going forward. Physician states that five-year-old is getting her butt kicked, that she feels really achy and uncomfortable as reported by her mother. No fever, no headache, no respiratory distress, no chest pain.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: PNC13
Symptoms: Drug ineffective, Malaise, Pneumonia pneumococcal
Clinical narrative: got a different pneumococcal pneumonia strain; got a different pneumococcal pneumonia strain; This is a spontaneous report received from non-contactable reporter (Nurse) from a sales representative.  A male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), PNEUMONIA PNEUMOCOCCAL (hospitalization, medically significant), outcome "recovering" and all described as "got a different pneumococcal pneumonia strain".  Clinical course: the patient got Prevnar 13 and got very sick, he ended at the hospital. Reporter thought that baby got a different pneumococcal pneumonia strain. Patient was doing better now. Event took place after use of product.  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 information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.  Further information like confirmative serotype results and vaccination schedule are needed for full medical assessment.
Sex: M
Vaccine: COVID19-2
Symptoms: Myocardial infarction
Clinical narrative: he had a heart attack and died; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the parent.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 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. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant) with onset 08Oct2022, outcome "fatal", described as "he had a heart attack and died". The patient date of death was 08Oct2022. Reported cause of death: "Heart attack". Clinical course: Patient had his third booster shot on 03Oct2022, and on 08Oct2022 he had a heart attack and died. He did not have a heart problem according to his doctor. His pharmacist said the vaccines cause heart inflammation. We are sure the vaccine caused his death.  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.; Reported Cause(s) of Death: Heart attack
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Illness, Palpitations, Tremor
Clinical narrative: blood pressure increased to 200s; heart palpitations; sick / ill; Body was buzzing inside and then had the shakes, was shaky; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003869 (Novavax).  A 78-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 2, single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose:1, patient started treatment on 14Mar2022 with Pfizer BioNTech COVID-19 Vaccine at dose 1 and reported that everything was fine with the patient.), administration date: 14Mar2022, when the patient was 78-year-old, for COVID-19 Immunization, reaction(s): "no adverse effect".  The following information was reported: TREMOR (non-serious) with onset 2022, outcome "unknown", described as "Body was buzzing inside and then had the shakes, was shaky"; BLOOD PRESSURE INCREASED (medically significant) with onset 2022, outcome "unknown", described as "blood pressure increased to 200s"; PALPITATIONS (non-serious) with onset 2022, outcome "unknown", described as "heart palpitations"; ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "sick / ill". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (2022) blood pressure increased to 200s, notes: Blood pressure increased to 200s.  Clinical course: On 14Oct2022, it was reported that a patient started treatment on 14Mar2022 with Pfizer BioNTech COVID-19 Vaccine at dose 1 and reported that everything was fine with the patient. The patient had the second dose on 04Apr2022. It was reported, the patient then had heart palpitations and blood pressure increased to 200s. It made the patient sick. Body was buzzing inside and then had the shakes, was shaky and ill. It was also reported that Pfizer had a bad batch of the COVID-19 vaccine which was never recalled.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Burning sensation, Contusion, Pruritus, Skin exfoliation, Swelling
Clinical narrative: Bruising; swelling; burning; itching; peeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s):   A 46-year-old female patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation; poly-L-lactic acid (SCULPTRA), since 06Oct2022 (Batch/Lot number: unknown). The patient's relevant medical history included: "Immunoglobin G deficiency" (unspecified if ongoing), notes: Immunoglobin G deficiency. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Patient received COVID vaccine (Pfizer), 1st Vaccination: 21Apr2021), administration date: 21Apr2021, when the patient was 44-year-old, for COVID-19 immunization; BNT162b2 (Patient received COVID vaccine (Pfizer), Boosters: 12May2021; 03Dec2021; Apr2022), administration date: 12May2021, when the patient was 44-year-old, for COVID-19 immunization; BNT162b2 (Patient received COVID vaccine (Pfizer), Boosters: 12May2021; 03Dec2021; Apr2022), administration date: 03Dec2021, when the patient was 45-year-old, for COVID-19 immunization. The following information was reported: CONTUSION (non-serious) with onset Oct2022, outcome "recovered" (16Oct2022), described as "Bruising"; BURNING SENSATION (non-serious) with onset Oct2022, outcome "not recovered", described as "burning"; PRURITUS (non-serious) with onset Oct2022, outcome "not recovered", described as "itching"; SKIN EXFOLIATION (non-serious) with onset Oct2022, outcome "unknown", described as "peeling"; SWELLING (non-serious) with onset Oct2022, outcome "recovered" (16Oct2022). The action taken for poly-L-lactic acid was unknown. Therapeutic measures were taken as a result of contusion, swelling, burning sensation, pruritus, skin exfoliation.  Attached please find an adverse event report regarding a patient that received the COVID vaccine. Reference is made to the FDA Guidelines for Post-marketing Reporting of Adverse Drug Experiences dated March 1992, requires "Reports of ADEs in which the initial reporter identifies the suspect drug as one marketed by another applicant should be promptly forwarded to that applicant." In accordance with the guideline, we are forwarding the below information related to an adverse drug experience received.  Patient injected with Sculptra to temples, nasolabial folds, jowls, and cheeks on 06Oct2022. Bruising and swelling following the procedure as well as burning and itching, peeling. Treated with ice, massage, and OTC hydrocortisone. Bruising and swelling resolved by 16Oct2022. Burning and itching are ongoing. Patient has not contacted HCP yet but plans to. HCP information included above. Patient received COVID vaccine (Pfizer), 1st Vaccination: 21Apr2021, Boosters: 12May2021; 03Dec2021; Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6207) at the age of 62 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "arrhythmia" (ongoing); "arthritis" (not ongoing). Concomitant medication(s) included: METOPROLOL oral taken for arrhythmia (ongoing); MELOXICAM oral taken for arthritis. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown".  Additional information: The patient had no adverse events associated with any of vaccine. On an unknown date, the patient experienced sore arm plus fatigue for one day.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Breast cancer, Eye haemorrhage, Headache, Immune system disorder
Clinical narrative: Liver function is very high; horrendous headaches; every bone and muscle in body aches; The patient was in bed for 4 days; lymphoedema; which made them really unwell; their immune system is very low; had two little hemorrhages in their eye; The patient has had double breast cancer this year and radiotherapy; Dose 1, Dose 2 AstraZeneca dose 3 Pfizer then Dose 3 and Dose 4 Moderna; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MDGB22-01054 (Moderna).  A 76-year-old female patient received BNT162b2 (BNT162B2), on 03Nov2021 as dose 3 (booster), single (Lot number: FH3220); coviD-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA), on 04Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 17Apr2021 as dose 2, single (Lot number: PV46671) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Apr2022 as dose 4 (booster), single (Lot number: 000074A) and on 18Oct2022 as dose 5 (booter), single (Lot number: 000074A) for covid-19 immunisation. The patient's relevant medical history included: "Radiotherapy", start date: 2022 (unspecified if ongoing). Concomitant medication(s) included: COCODAMOL. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 03Nov2021, outcome "unknown", described as "Dose 1, Dose 2 AstraZeneca dose 3 Pfizer then Dose 3 and Dose 4 Moderna"; BREAST CANCER (medically significant) with onset 2022, outcome "unknown", described as "The patient has had double breast cancer this year and radiotherapy"; EYE HAEMORRHAGE (medically significant), outcome "unknown", described as "had two little hemorrhages in their eye"; LIVER FUNCTION TEST ABNORMAL (non-serious), outcome "unknown", described as "Liver function is very high"; HEADACHE (non-serious), outcome "unknown", described as "horrendous headaches"; PAIN (non-serious), outcome "unknown", described as "every bone and muscle in body aches"; BEDRIDDEN (non-serious), outcome "unknown", described as "The patient was in bed for 4 days"; LYMPHOEDEMA (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown", described as "which made them really unwell"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "their immune system is very low". The patient underwent the following laboratory tests and procedures: Liver function test: very high.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Liver function test, Liver function test abnormal, Lymphoedema, Malaise
Clinical narrative: Liver function is very high; horrendous headaches; every bone and muscle in body aches; The patient was in bed for 4 days; lymphoedema; which made them really unwell; their immune system is very low; had two little hemorrhages in their eye; The patient has had double breast cancer this year and radiotherapy; Dose 1, Dose 2 AstraZeneca dose 3 Pfizer then Dose 3 and Dose 4 Moderna; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MDGB22-01054 (Moderna).  A 76-year-old female patient received BNT162b2 (BNT162B2), on 03Nov2021 as dose 3 (booster), single (Lot number: FH3220); coviD-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA), on 04Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 17Apr2021 as dose 2, single (Lot number: PV46671) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Apr2022 as dose 4 (booster), single (Lot number: 000074A) and on 18Oct2022 as dose 5 (booter), single (Lot number: 000074A) for covid-19 immunisation. The patient's relevant medical history included: "Radiotherapy", start date: 2022 (unspecified if ongoing). Concomitant medication(s) included: COCODAMOL. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 03Nov2021, outcome "unknown", described as "Dose 1, Dose 2 AstraZeneca dose 3 Pfizer then Dose 3 and Dose 4 Moderna"; BREAST CANCER (medically significant) with onset 2022, outcome "unknown", described as "The patient has had double breast cancer this year and radiotherapy"; EYE HAEMORRHAGE (medically significant), outcome "unknown", described as "had two little hemorrhages in their eye"; LIVER FUNCTION TEST ABNORMAL (non-serious), outcome "unknown", described as "Liver function is very high"; HEADACHE (non-serious), outcome "unknown", described as "horrendous headaches"; PAIN (non-serious), outcome "unknown", described as "every bone and muscle in body aches"; BEDRIDDEN (non-serious), outcome "unknown", described as "The patient was in bed for 4 days"; LYMPHOEDEMA (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown", described as "which made them really unwell"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "their immune system is very low". The patient underwent the following laboratory tests and procedures: Liver function test: very high.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Liver function is very high; horrendous headaches; every bone and muscle in body aches; The patient was in bed for 4 days; lymphoedema; which made them really unwell; their immune system is very low; had two little hemorrhages in their eye; The patient has had double breast cancer this year and radiotherapy; Dose 1, Dose 2 AstraZeneca dose 3 Pfizer then Dose 3 and Dose 4 Moderna; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MDGB22-01054 (Moderna).  A 76-year-old female patient received BNT162b2 (BNT162B2), on 03Nov2021 as dose 3 (booster), single (Lot number: FH3220); coviD-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA), on 04Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 17Apr2021 as dose 2, single (Lot number: PV46671) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Apr2022 as dose 4 (booster), single (Lot number: 000074A) and on 18Oct2022 as dose 5 (booter), single (Lot number: 000074A) for covid-19 immunisation. The patient's relevant medical history included: "Radiotherapy", start date: 2022 (unspecified if ongoing). Concomitant medication(s) included: COCODAMOL. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 03Nov2021, outcome "unknown", described as "Dose 1, Dose 2 AstraZeneca dose 3 Pfizer then Dose 3 and Dose 4 Moderna"; BREAST CANCER (medically significant) with onset 2022, outcome "unknown", described as "The patient has had double breast cancer this year and radiotherapy"; EYE HAEMORRHAGE (medically significant), outcome "unknown", described as "had two little hemorrhages in their eye"; LIVER FUNCTION TEST ABNORMAL (non-serious), outcome "unknown", described as "Liver function is very high"; HEADACHE (non-serious), outcome "unknown", described as "horrendous headaches"; PAIN (non-serious), outcome "unknown", described as "every bone and muscle in body aches"; BEDRIDDEN (non-serious), outcome "unknown", described as "The patient was in bed for 4 days"; LYMPHOEDEMA (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown", described as "which made them really unwell"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "their immune system is very low". The patient underwent the following laboratory tests and procedures: Liver function test: very high.  No follow-up attempts are possible. No further information is expected.