chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: killed all those 5 people; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. 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 "killed all those 5 people". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: This has killed the most people out of any other drugs since any drug has came out. I've had friends who had strokes, heart attacks, lost their babies. There will be lots of people like me calling. It takes me 2 buttons and funny sounds to be able to get to you. Do you want everybody to do that to your phone system? I can share it with 100 million people. There's only one punishment for what you're doing. You put that man's daughter in a coma. This is an experiment on people. You cant go around killing people. This stuff is made to make people sterile. We don't need sterility right now. We have an inverted triangle. Because we're losing that many people. It's about people not being born, not people dying. We have 700,000 people who have just been grilled and dawned through. I don't want anybody to get hurt. How do you sleep at night knowing that you supported this. You guys loosely call this a vaccine when you don't have a Comirnaty. I don't see labels for Comirnaty and any of that. I see EUA vaccines, and over the holiday, it went bivalent. It's still twice the dosage of the original. You're saying that it's 2 variants, but it's not. In 49 out of 50 states, you have to pass 2 different things legally to go from a jab to go to a vaccine. Therefore, your vaccine will never get there. In order for it to be a vaccine, it needs to be made from the virus. It wasn't. 2nd, it's supposed to get rid of the virus. It doesn't. It's just straight mRNA. It killed all those 5 people. We weren't told the truth. We weren't given a choice. Companies are saying you have to get the shot. Is that even legal? CDC finally admitted PCR is not a test. PCR is an amplification for DNA. It's used in law enforcement. If you test for something with, you will find it 97 times out of 100 that it's there or not. It will give you a false positive every time almost. That's why your company picked this test for COVID. You sure you're testing for COVID Not SARS-COV 2 Have you tried to test for something else 97 out of 100 will show up small pox. How many people have you killed Millions. How many more people are going to die? Billions. People are dying because of the shot. Not because of COVID."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: killed all those 5 people
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: killed all those 5 people; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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), outcome "fatal", described as "killed all those 5 people". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course:Reporter had friends who had strokes, heart attacks, lost their babies. They put that man's daughter in a coma. It killed all those 5 people. They weren't told the truth. They weren't given a choice. Companies said they had to get the shot. AE transmitted. Caller hung up before being able to ask for demographics.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: killed all those 5 people
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Syncope
Clinical narrative: Caller replied he knows it is causing strokes; Collapsed and is on a respirator; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A male patient received BNT162b2 (BNT162B2 NOS), 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: CEREBROVASCULAR ACCIDENT (medically significant, life threatening), outcome "unknown", described as "Caller replied he knows it is causing strokes"; SYNCOPE (medically significant, life threatening), outcome "unknown", described as "Collapsed and is on a respirator". Therapeutic measures were taken as a result of cerebrovascular accident, syncope. Clinical course: Caller (Son) reported an adverse event with the Comirnaty. He talked about the vaccine having a direct link to strokes. He said he knew the vaccine caused strokes. He asked why it was causing strokes? Caller said that his father randomly collapsed in the morning and now was on a respirator. Caller stated that his father received Comirnaty vaccine (unclear timeline). Caller stated he was angry, asking how long does his father have left? He stated that his grandpa also received Comirnaty vaccine, he also stated that Comirnaty does not care too much about customer satisfaction. Patient was currently on a respirator at the moment. Caller was just calling to ask and wanted to speak to someone who made the vaccine or who worked on helping create the vaccine. The CDC was investigating Pfizer currently about how the COVID-19 vaccine has a direct correlation to strokes. He mentioned the documentary that speak about how thousands of people are dropping and it was a direct correlation to Pfizer's vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: collapsed; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2 (BNT162B2 NOS), 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: SYNCOPE (medically significant), outcome "unknown", described as "collapsed". Clinical course: Warm transfer from (Name withheld). Transfer agent had a caller on the other line calling about the Pfizer COVID-19 vaccine. Caller's father, the patient, just collapsed and patient received the Pfizer COVID-19 vaccine and caller had wanted to speak to someone higher up about this. Upon transfer caller stated caller was pissed off citizen, and caller continued to use inappropriate language, therefore call handler disconnected the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; 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 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 12:00 as dose number unknown (booster), single (Lot number: GJ6739) at the age of 50 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 31Jan2023 to 05Feb2023.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abscess, Back pain, Vaccination site mass, Vaccination site pain
Clinical narrative: Back pain; She has got the bump also after the needle; Bump also after the needle. It was burning; Abscess; 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 female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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 NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation, reaction(s): "The last time I got the Pfizer or I got an abscess and I had to go to the hospital", "Back pain happened with the previous shots as well ". The following information was reported: BACK PAIN (non-serious), outcome "unknown"; VACCINATION SITE MASS (non-serious), outcome "unknown", described as "She has got the bump also after the needle"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Bump also after the needle. It was burning"; ABSCESS (non-serious), outcome "unknown". The events "back pain", "she has got the bump also after the needle", "bump also after the needle. it was burning" and "abscess" required physician office visit.   Aditional information: Patient started having back pain, she went to the hospital. It happened with the previous shots as well and now she has got the bump also after the needle. It was burning, she complained to the administrator, but she did not put any bandage and now she was suffering. Caller later added during interaction She thought it was an abscess because the last time she got the Comirnaty, or she got an abscess and she had to go to the hospital. And they said it was not ready yet, they told to keep putting compresses on it and it will ooze out. Then finally it did and then it closed and there was like a little something in there. And she went to the dermatologist he said she have to cut it up to get the rest of it out and she did not want to do that. So, this time the same thing happened, and it just hurts. It was not coming to a head like the other one did. She just noticed it and thought that she will be going to put hot compresses. It hurts on pressing. If she was sitting on her bed with her back against the pillow it hurts.  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.; Sender's Comments: Linked Report(s): PFIZER INC-202300062452 same patient/drug, different dose/events;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abscess, Back pain
Clinical narrative: Back pain; She has got the bump also after the needle; Bump also after the needle. It was burning; Abscess; 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 female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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 NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation, reaction(s): "The last time I got the Pfizer or I got an abscess and I had to go to the hospital", "Back pain happened with the previous shots as well ". The following information was reported: BACK PAIN (non-serious), outcome "unknown"; VACCINATION SITE MASS (non-serious), outcome "unknown", described as "She has got the bump also after the needle"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Bump also after the needle. It was burning"; ABSCESS (non-serious), outcome "unknown". The events "back pain", "she has got the bump also after the needle", "bump also after the needle. it was burning" and "abscess" required physician office visit.   Aditional information: Patient started having back pain, she went to the hospital. It happened with the previous shots as well and now she has got the bump also after the needle. It was burning, she complained to the administrator, but she did not put any bandage and now she was suffering. Caller later added during interaction She thought it was an abscess because the last time she got the Comirnaty, or she got an abscess and she had to go to the hospital. And they said it was not ready yet, they told to keep putting compresses on it and it will ooze out. Then finally it did and then it closed and there was like a little something in there. And she went to the dermatologist he said she have to cut it up to get the rest of it out and she did not want to do that. So, this time the same thing happened, and it just hurts. It was not coming to a head like the other one did. She just noticed it and thought that she will be going to put hot compresses. It hurts on pressing. If she was sitting on her bed with her back against the pillow it hurts.  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.; Sender's Comments: Linked Report(s): PFIZER INC-202300062452 same patient/drug, different dose/events;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abscess, Back pain, Vaccination site mass, Vaccination site pain
Clinical narrative: the last time I got the Pfizer or I got an abscess; back pain; 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 female patient received BNT162b2 (BNT162B2 NOS), 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: ABSCESS (non-serious), outcome "unknown", described as "the last time I got the Pfizer or I got an abscess"; BACK PAIN (non-serious), outcome "unknown". The events "the last time i got the pfizer or i got an abscess" and "back pain" required physician office visit. Therapeutic measures were taken as a result of abscess.  Additional information: It was reported that patient started having back pain. Caller later added during interaction, she think it's an abscess because the last time she got the Pfizer or she got an abscess.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s): PFIZER INC-202300062357 same patient, different dose and event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abscess, Back pain
Clinical narrative: the last time I got the Pfizer or I got an abscess; back pain; 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 female patient received BNT162b2 (BNT162B2 NOS), 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: ABSCESS (non-serious), outcome "unknown", described as "the last time I got the Pfizer or I got an abscess"; BACK PAIN (non-serious), outcome "unknown". The events "the last time i got the pfizer or i got an abscess" and "back pain" required physician office visit. Therapeutic measures were taken as a result of abscess.  Additional information: It was reported that patient started having back pain. Caller later added during interaction, she think it's an abscess because the last time she got the Pfizer or she got an abscess.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s): PFIZER INC-202300062357 same patient, different dose and event;
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Product administered to patient of inappropriate age, Product preparation error, Underdose, Wrong product administered
Clinical narrative: patient was incorrectly given bivalent vaccine ad dose 1; patient received 0.3ml undiluted 5-11 Pfizer COVID vaccine; patient received 0.3ml undiluted 5-11 Pfizer COVID vaccine; patient received 0.3ml undiluted 5-11 Pfizer COVID vaccine; is pregnant: Yes; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 24-year-old female patient (pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Feb2023 at 13:45 as dose 1 (orange cap), 0.3 ml single (Lot number: GK1657) at the age of 24 years intramuscular, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Anemia" (unspecified if ongoing). The patient was 23 weeks pregnant at the event onset. The patient took concomitant medications. Vaccination history included: flucelvax (DOSE NUMBER UNKNOWN, SINGLE; Lot number: 942413), administration date: 11Jan2023, when the patient was 23-year-old. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 09Feb2023 at 13:45, outcome "unknown", described as "is pregnant: Yes"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), PRODUCT PREPARATION ERROR (non-serious), UNDERDOSE (non-serious) all with onset 09Feb2023 at 13:45, outcome "unknown" and all described as "patient received 0.3ml undiluted 5-11 Pfizer COVID vaccine"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 09Feb2023 at 13:45, outcome "unknown", described as "patient was incorrectly given bivalent vaccine ad dose 1". Therapeutic measures were not taken as a result of maternal exposure during pregnancy.  Additional information: Other medication in two weeks were prenatal vitamins.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, 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) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 5 (booster), single (Lot number: GH9703), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Feb2021 as dose 1, single (Lot number: EM9809), in left arm, on 01Mar2021 as dose 2, single (Lot number: EN1203), in left arm and on 29Sep2021 as dose 3 (booster), single (Lot number: FF8839), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer" (unspecified if ongoing); "known allergies: Sulpha drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "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; (09Feb2023) Positive, notes: Tested positive for Covid 4 days after the 5 day Pavlovid treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 (PAXLOVID Treatment).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 71 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Jan2021 as dose 1, single (Lot number: 011L20A), in left arm, on 09Feb2021 as dose 2, single (Lot number: 013M20A), in left arm, on 31Oct2021 as dose 3 (booster), single (Lot number: 939903), in left arm and on 06Sep2022 as dose 5 (booster), single (Lot number: AS7143C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Slightly high blood pressure" (unspecified if ongoing), notes: Slightly high blood pressure; "high cholesterol" (unspecified if ongoing); "seborrheic dermatitis" (unspecified if ongoing). The patient had no drug allergy. Concomitant medication(s) included: OLMESARTAN, start date: 07Aug2021; EZETIMIBE, start date: 06Aug2021; AMLODIPINE BESYLATE, start date: 13Aug2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 30Jan2023, 6 days after testing positive.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; vaccine brand: Pfizer / BioNTech; vaccine dose number: 5/vaccine brand other: Moderna;vaccine dose number: 4; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Dec2020 as dose 1, single (Lot number: 025J20-2A), on 21Jan2022 as dose 2, single (Lot number: 057G20A), on 19Nov2022 as dose 3 (booster), single (Lot number: 081F21A) and on 27Jun2022 as dose 4 (booster), single (Lot number: 054A22A) for covid-19 immunisation. The patient's relevant medical history included: "Sjogren's" (unspecified if ongoing); "NASH w/F3 liver fibrosis" (unspecified if ongoing); "Autoimmune gastritis" (unspecified if ongoing); "CKD Stage2" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "known allergie", notes: known allergies. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Oct2022, outcome "unknown", described as "vaccine brand: Pfizer / BioNTech; vaccine dose number: 5/vaccine brand other: Moderna;vaccine dose number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jan2023) positive; (03Feb2023) negative; (05Feb2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID Treatment).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; 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 36-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; 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 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". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 01Feb2023 to 05Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had covid; had covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Unknown). The reporter is the patient.  An 88-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (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 "unknown" and all described as "had covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:  The patient was asking how long does the Paxlovid would stay in system after taken it because she was taking statin. She wanted to make sure, stated she was not even sure that she was comfortable taking a Paxlovid, she do not know even if I needed to take it, because she was 88 years old and she was not even sure if she had covid, somebody told her that when you test with those quick covid tests they were not always accurate, and she should had not been beating herself up and she was fine. She wanted to make sure when can she took her statin and she was looking forward when she can took her vaccine again and she was fully vaccinated and that she even had covid. She was fully vaccinated and when she can get another booster. (Stated that she had last covid vaccine booster in Sep.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 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: "Anxiety" (unspecified if ongoing); "GERD" (unspecified if ongoing); "known allergies: Some forms of general anesthesia" (unspecified if ongoing), notes: known allergies: Some forms of general anesthesia. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 01Feb2023 to 06Feb2023  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech, Dose Number: 3 ; Moderna, Dose Number: 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EW0150), in left arm, on 30Apr2021 as dose 2, single (Lot number: EW0167), in left arm and on 16Nov2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 61 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Apr2022 as dose 4 (booster), single (Lot number: 066K21A), in left arm and on 06Sep2022 as dose 5 (booster), single (Lot number: AS7143C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Slightly overweight (BMI of 26-27)" (unspecified if ongoing), notes: Slightly overweight (BMI of 26-27); "History of TIA (1 event in 1992)", start date: 1992 (unspecified if ongoing), notes: History of TIA (1 event in 1992); "high blood sugar due to gestational diabetes" (unspecified if ongoing), notes: high blood sugar due to gestational diabetes; "high blood sugar due to gestational diabetes" (unspecified if ongoing), notes: high blood sugar due to gestational diabetes; "Hepatitis A", start date: 1989 (unspecified if ongoing); "Thyroid nodules" (unspecified if ongoing); "squamous and basal cell skin cancers (resolved)" (not ongoing), notes: squamous and basal cell skin cancers (resolved); "squamous and basal cell skin cancers (resolved)" (not ongoing), notes: squamous and basal cell skin cancers (resolved). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Apr2022, outcome "unknown", described as "Pfizer / BioNTech, Dose Number: 3 ; Moderna, Dose Number: 4"; VACCINATION FAILURE (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: Body mass index: 26-27. Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 31Jan2023.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2 NOS), on 14Oct2022 at 15:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 43 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 2023, latency 3 months 26 days 9 hrs after the suspect product(s) administration, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Testing negative two consecutive days; (unspecified date) Negative, notes: Testing negative two consecutive days; (Feb2023) Positive, notes: tested positive three. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was tested positive three days after completing course with PAXLOVID and developed cold symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Product Expiration Date issue/expired Pfizer vaccine on 30Nov2022 was given on 12Jan2023 at 0900am; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 09Feb2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 33-year-old patient received BNT162b2 (BNT162B2), on 12Jan2023 at 09:00 as dose 1, single (Lot number: FP7138, Expiration Date: 30Nov2022) at the age of 33 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "cervical cancer" (unspecified if ongoing), notes: Onset Date: age 28. There were no concomitant medications. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 12Jan2023 at 09:00, outcome "unknown", described as "Product Expiration Date issue/expired Pfizer vaccine on 30Nov2022 was given on 12Jan2023 at 0900am".  Additional Information: Product was Undiluted. Product was stored when excursion occurred in Fridge (2 -8 degree C). Maximum temperature reported / measured during excursion was Max 5.5 degree and minimum was Min 5 degree. Complete temperature data during storage at customer location was Attached. Pfizer delivered to this location. Upon follow-up (09Feb2023), Expired Pfizer vaccine on 30Nov2022 was given on 12Jan2023 at 09:00am. No adverse event contacted Pfizer for guidance was told vaccine was good no further instruction needed.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Colitis, Drug ineffective, Interchange of vaccine products, Pericardial effusion
Clinical narrative: pericardial effusion; pneumonia; UTI; colitis; fully vaccinated with a combination of Moderna and Pfizer vaccines; tested positive; tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 93-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Jan2023, outcome "unknown" and all described as "tested positive"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "fully vaccinated with a combination of Moderna and Pfizer vaccines"; PERICARDIAL EFFUSION (medically significant), outcome "unknown"; PNEUMONIA (medically significant), outcome "unknown"; URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "UTI"; COLITIS (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jan2023) Positive, notes: tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19, pericardial effusion, pneumonia, urinary tract infection, colitis. Clinical course: patient was tested positive for COVID on 30Jan. She's fully vaccinated with a combination of Moderna and Pfizer vaccines. Since testing positive, she's had other issues, colitis, a UTI, pneumonia and pericardial effusion. She is moving to palliative care this afternoon. Reporter was not sure if this is necessary to report, but reporter understood that reporter should bring this type of information to light.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia, SARS-CoV-2 test, Urinary tract infection
Clinical narrative: pericardial effusion; pneumonia; UTI; colitis; fully vaccinated with a combination of Moderna and Pfizer vaccines; tested positive; tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 93-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Jan2023, outcome "unknown" and all described as "tested positive"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "fully vaccinated with a combination of Moderna and Pfizer vaccines"; PERICARDIAL EFFUSION (medically significant), outcome "unknown"; PNEUMONIA (medically significant), outcome "unknown"; URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "UTI"; COLITIS (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jan2023) Positive, notes: tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19, pericardial effusion, pneumonia, urinary tract infection, colitis. Clinical course: patient was tested positive for COVID on 30Jan. She's fully vaccinated with a combination of Moderna and Pfizer vaccines. Since testing positive, she's had other issues, colitis, a UTI, pneumonia and pericardial effusion. She is moving to palliative care this afternoon. Reporter was not sure if this is necessary to report, but reporter understood that reporter should bring this type of information to light.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: cardiac arrest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2 NOS), 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: CARDIAC ARREST (medically significant), outcome "unknown". Clinical course: She also mentioned that the Pfizer vaccine didn't work and she said that her son who was forced to take the Pfizer vaccine got cardiac arrest.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: he had an infection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2 (BNT162B2 NOS), 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: INFECTION (hospitalization), outcome "unknown", described as "he had an infection". Clinical course as followed: Caller mentioned that she took the Pfizer COVID-19 Vaccine and she forced her parents to take it, her father was a healthy man and all of the sudden from one night to another he's in the hospital. He had an infection and they're kind of looking towards his heart. He did not have problems at all before.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aversion, Drug ineffective, Suspected COVID-19
Clinical narrative: Booster doesn't work; Booster doesn't work; Disgust; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Booster doesn't work"; AVERSION (non-serious), outcome "unknown", described as "Disgust". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: much worse tinnitus and hearing loss; much worse tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 29Dec2021 as dose 3 (booster), single (Lot number: 33130BA) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "hearing aids", start date: Oct2022 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Time: 10:00 AM, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: ER8729), administration date: 14Apr2020, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "COVID test result Positive", "after covid in Dec2022"; BNT162b2 (Dose: 2, Time: 10:00 AM, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EW0182), administration date: 19May2020, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "Have lost half of my hearing ability", "Noticed ringing in my ears", "headache". The following information was reported: TINNITUS (disability) with onset Dec2022, outcome "not recovered", described as "much worse tinnitus"; DEAFNESS (disability, medically significant) with onset Dec2022, outcome "not recovered", described as "much worse tinnitus and hearing loss". The events "much worse tinnitus and hearing loss" and "much worse tinnitus" required physician office visit. Therapeutic measures were taken as a result of deafness, tinnitus. Clinical course: Aug2020: Tinnitus, gradual and continued hearing loss. Got hearing aids Oct2022. After COVID in Dec2022- much worse tinnitus and hearing loss under ENT Care- steroids, meds. Seriousness criteria was reported as being persistent/significant disability/incapacity.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201390482 same patient, different vaccine dose/event;US-PFIZER INC-202201390515 same patient, different vaccine dose/event;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: vaccinations don't work never again; vaccinations don't work never again; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "vaccinations don't work never again". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Amyotrophic lateral sclerosis
Clinical narrative: HCP believed that the vaccine caused ALS.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000000112.  A male patient received BNT162b2 (BNT162B2 NOS), 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: AMYOTROPHIC LATERAL SCLEROSIS (medically significant), outcome "unknown", described as "HCP believed that the vaccine caused ALS.". Therapeutic measures were taken as a result of amyotrophic lateral sclerosis. Additional information included: On 25Jan2023, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech Covid-19 Vaccine as unspecified dose for Covid-19 vaccination. It was reported that the individual's healthcare professional believed that the vaccine caused ALS (amyotrophic lateral sclerosis). The disease was still ongoing and the individual was getting treated. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid; Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FUROSEMIDE; HYDROXYCHLOROQUINE; IBUPROFEN; OMEPRAZOLE; GENTEAL [HYPROMELLOSE]; POTASSIUM; CYCLOBENZAPRINE; KADCYLA. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid".  Clinical course: Patient's concurrent condition included was not reported. We have no further information regarding the reported event(s) described above. Any additional material information received will be forwarded to you in accordance with company policies and procedures.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  SUSPECT PRODUCT is under agreement with company.