chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Caught covid/Covid test Nasal Swab positive; Caught covid/Covid test Nasal Swab positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 13-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in Dec2021 as dose 1, single (Batch/Lot number: unknown), in Jan2022 as dose 2, single (Batch/Lot number: unknown) and in May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 12 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Allergic reaction only to covid vaccine - previously reported" (unspecified if ongoing), notes: Other medical history: None. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" and all described as "Caught covid/Covid test Nasal Swab positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300309499 same reporter/patient, different dose number/event;US-PFIZER INC-202300309500 same reporter/patient, different dose number/event;US-PFIZER INC-202300309498 same reporter/patient, different dose number/event;
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: 1st and 2nd hurt really bad at injection site/her arm was so sore/whole arm hurt; 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 76-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "1st and 2nd hurt really bad at injection site/her arm was so sore/whole arm hurt".  Additional information: Caller was going to have surgery on her lungs and wants to know if she should have the Pfizer covid vaccine 2023-24 formula before or after she has surgery. She stated she had 4 covid vaccines in the past, all Pfizer and with the first two vaccines, they pinched up her skin to give the vaccine and it hurt really bad. She thought that's why her arm was so sore and thought she would pass it on if it would help. Reaction: 1st and 2nd hurt really bad at injection site. The 1st and 2nd hurt really bad at injection site, but she noticed it was when nurse pinched up skin to give injection. The 3rd and 4th she asked them not to do that and it didn't hurt.   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) : US-PFIZER INC-202300309738 same patient, vaccine, event with different dose;US-PFIZER INC-202300309740 same reporter, vaccine, different patient and event;
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Eye disorder
Clinical narrative: had a problem on his heart and on his eye; had a problem on his heart and on his eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An male patient 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: CARDIAC DISORDER (non-serious), EYE DISORDER (non-serious), outcome "unknown" and all described as "had a problem on his heart and on his eye". Additional information: Serious was No. Caller told previous agent that he got the Pfizer COVID shot three years prior to the time of report and had some side side effects and now they want to apply COVID-19 vaccine to his children and he doesn't want to do that. Caller got COVID-19 vaccine two years prior to the time of report and had a problem on his heart and on his eye. (tried to clarify if it was the Pfizer COVID vaccine but caller continued on). After he felt his life being changed by using that shot, he doesn't want to put his kids at risk and somebody is asking him to do it. Its no good, what it seems to him right now.  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: Anaphylactic reaction
Clinical narrative: had an anaphylactic reaction; 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 70-year-old female patient 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: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "had an anaphylactic reaction". Clinical course: Patient allergic to the Pfizer covid 19 vaccine, had an anaphylactic reaction. She got it when it first came out, they had to wait a little while, because there was a problem getting an appointment to get it. It was cold out, so might have been winter or fall. Reporter would like to get Pfizer's RSV Vaccine, and wants to know if there are any common ingredients with the Pfizer Covid19 vaccine that would prohibit her from getting it.  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: Hypersensitivity, Nasal congestion, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: stuffy nose; has colds; allergies; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 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: NASAL CONGESTION (non-serious), outcome "unknown", described as "stuffy nose"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "has colds"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergies". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller would like to know if she can get the new covid 19 shot, because the caller had a stuffy nose and has colds. Confirmed question with caller. She mentioned she took a COVID-19 test in the morning and tested negative, but he wanted to be sure because of her stuffy nose. Caller added she really wants the vaccine because she's had all the previous vaccines and she doesn't want to have COVID again. The caller said that she has an appointment for the new COVID-19 vaccine in about 45 minutes. The caller just has a preliminary question. The caller mentioned that she has mild congestion and a stuffy nose. The caller stated that she gave herself a COVID test at home and was negative this morning. The caller said that it could be allergies. The caller also said that she got the Pfizer vaccines and had no side effects. The caller would like to know if she can get the new Pfizer COVID-19 vaccine. Seriousness was reported as no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chills, Fatigue, Headache, Illness
Clinical narrative: quite uncomfortable; headache; chills; tiredness; She slept most of the evening in the daytime; I was quite sick; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 87-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 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: COVID-19 (non-serious) with onset 25Sep2023, outcome "unknown", described as "COVID"; MALAISE (non-serious), outcome "unknown", described as "quite uncomfortable"; HEADACHE (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; SOMNOLENCE (non-serious), outcome "unknown", described as "She slept most of the evening in the daytime"; ILLNESS (non-serious), outcome "unknown", described as " I was quite sick". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  Additional information: Caller asking if her COVID that she now is testing positive for covered by the Comirnaty vaccine that she received? Is comirnaty vaccine for covid. she received it last friday and the next day she day terrible headache tiredness and slept most of the evening. 87 year old female stated, 'I received the Pfizer COVID vaccine Comirnaty for 12 years of age and older on Friday and the next day, I was quite sick. I was quite uncomfortable with a headache and chills, and tiredness for about a day and a half. Today (25Sep2023), I was diagnosed with COVID.  So I'm on Paxlovid now. I'm wondering if the vaccine caused that reaction or if I already had COVID at that point.'  The caller had the Pfizer COVID shot last Friday, and she experienced a lot of difficulty that evening, and the next day she had a terrific headache and tiredness. She slept most of the evening in the daytime. She would like to know if there are usually reactions to that. She is asking the Comirnaty vaccine for Covid-19. She mentioned that she experienced a lot of difficulty that evening, and the next day she had a terrific headache and tiredness. She slept most of the evening in the daytime.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300311116 same patient, different Vaccine dose/event ;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, SARS-CoV-2 test, Somnolence
Clinical narrative: quite uncomfortable; headache; chills; tiredness; She slept most of the evening in the daytime; I was quite sick; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 87-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 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: COVID-19 (non-serious) with onset 25Sep2023, outcome "unknown", described as "COVID"; MALAISE (non-serious), outcome "unknown", described as "quite uncomfortable"; HEADACHE (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; SOMNOLENCE (non-serious), outcome "unknown", described as "She slept most of the evening in the daytime"; ILLNESS (non-serious), outcome "unknown", described as " I was quite sick". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  Additional information: Caller asking if her COVID that she now is testing positive for covered by the Comirnaty vaccine that she received? Is comirnaty vaccine for covid. she received it last friday and the next day she day terrible headache tiredness and slept most of the evening. 87 year old female stated, 'I received the Pfizer COVID vaccine Comirnaty for 12 years of age and older on Friday and the next day, I was quite sick. I was quite uncomfortable with a headache and chills, and tiredness for about a day and a half. Today (25Sep2023), I was diagnosed with COVID.  So I'm on Paxlovid now. I'm wondering if the vaccine caused that reaction or if I already had COVID at that point.'  The caller had the Pfizer COVID shot last Friday, and she experienced a lot of difficulty that evening, and the next day she had a terrific headache and tiredness. She slept most of the evening in the daytime. She would like to know if there are usually reactions to that. She is asking the Comirnaty vaccine for Covid-19. She mentioned that she experienced a lot of difficulty that evening, and the next day she had a terrific headache and tiredness. She slept most of the evening in the daytime.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300311116 same patient, different Vaccine dose/event ;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: quite uncomfortable; headache; chills; tiredness; She slept most of the evening in the daytime; I was quite sick; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 87-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 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: COVID-19 (non-serious) with onset 25Sep2023, outcome "unknown", described as "COVID"; MALAISE (non-serious), outcome "unknown", described as "quite uncomfortable"; HEADACHE (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; SOMNOLENCE (non-serious), outcome "unknown", described as "She slept most of the evening in the daytime"; ILLNESS (non-serious), outcome "unknown", described as " I was quite sick". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  Additional information: Caller asking if her COVID that she now is testing positive for covered by the Comirnaty vaccine that she received? Is comirnaty vaccine for covid. she received it last friday and the next day she day terrible headache tiredness and slept most of the evening. 87 year old female stated, 'I received the Pfizer COVID vaccine Comirnaty for 12 years of age and older on Friday and the next day, I was quite sick. I was quite uncomfortable with a headache and chills, and tiredness for about a day and a half. Today (25Sep2023), I was diagnosed with COVID.  So I'm on Paxlovid now. I'm wondering if the vaccine caused that reaction or if I already had COVID at that point.'  The caller had the Pfizer COVID shot last Friday, and she experienced a lot of difficulty that evening, and the next day she had a terrific headache and tiredness. She slept most of the evening in the daytime. She would like to know if there are usually reactions to that. She is asking the Comirnaty vaccine for Covid-19. She mentioned that she experienced a lot of difficulty that evening, and the next day she had a terrific headache and tiredness. She slept most of the evening in the daytime.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300311116 same patient, different Vaccine dose/event ;
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chills, Fatigue, Headache, Illness
Clinical narrative: Interchange of vaccine products; Tested positive for covid; Tested positive for covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 87-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 02:00 as dose number unknown (booster), single (Lot number: HG4628, Expiration Date: 25Nov2023) at the age of 87 years, in left arm 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 included: "Blood pressure high" (ongoing); "thyroid problems" (ongoing); "heart problems" (ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM oral taken for hypertension (ongoing); LEVOTHYROXINE oral taken for thyroid disorder (ongoing); PRAVASTATIN oral taken for cardiac disorder (ongoing). Vaccination history included: bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE, Batch/Lot number: SM0698, Anatomical location: Arm left), administration date: 30Jun2022, for COVID-19 Immunisation; bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, Batch/Lot number: GH9693, Anatomical location: Arm left), administration date: 08Oct2022, for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Sep2023, outcome "unknown" and all described as "Tested positive for covid"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Sep2023) Positive. Therapeutic measures (Paxlovid treatment) were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300309636 same patient, different event;
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, SARS-CoV-2 test, Somnolence
Clinical narrative: Interchange of vaccine products; Tested positive for covid; Tested positive for covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 87-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 02:00 as dose number unknown (booster), single (Lot number: HG4628, Expiration Date: 25Nov2023) at the age of 87 years, in left arm 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 included: "Blood pressure high" (ongoing); "thyroid problems" (ongoing); "heart problems" (ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM oral taken for hypertension (ongoing); LEVOTHYROXINE oral taken for thyroid disorder (ongoing); PRAVASTATIN oral taken for cardiac disorder (ongoing). Vaccination history included: bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE, Batch/Lot number: SM0698, Anatomical location: Arm left), administration date: 30Jun2022, for COVID-19 Immunisation; bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, Batch/Lot number: GH9693, Anatomical location: Arm left), administration date: 08Oct2022, for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Sep2023, outcome "unknown" and all described as "Tested positive for covid"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Sep2023) Positive. Therapeutic measures (Paxlovid treatment) were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300309636 same patient, different event;
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; Tested positive for covid; Tested positive for covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 87-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 02:00 as dose number unknown (booster), single (Lot number: HG4628, Expiration Date: 25Nov2023) at the age of 87 years, in left arm 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 included: "Blood pressure high" (ongoing); "thyroid problems" (ongoing); "heart problems" (ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM oral taken for hypertension (ongoing); LEVOTHYROXINE oral taken for thyroid disorder (ongoing); PRAVASTATIN oral taken for cardiac disorder (ongoing). Vaccination history included: bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE, Batch/Lot number: SM0698, Anatomical location: Arm left), administration date: 30Jun2022, for COVID-19 Immunisation; bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, Batch/Lot number: GH9693, Anatomical location: Arm left), administration date: 08Oct2022, for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Sep2023, outcome "unknown" and all described as "Tested positive for covid"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Sep2023) Positive. Therapeutic measures (Paxlovid treatment) were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300309636 same patient, different event;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, SARS-CoV-2 test
Clinical narrative: have Covid; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 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: FATIGUE (non-serious) with onset 19Sep2023, outcome "unknown"; COVID-19 (non-serious) with onset 19Sep2023, outcome "unknown", described as "have Covid". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  Additional information: Reporter Type: Patient/Consumer. Serious: No. On 18Sep patient got the new vaccine. On 19Sep patient tested positive and have Covid including fatigue, etc. Paxlovid is helping. Once patient get better do patient need a another vaccination given the proximity of the shot and testing positive?   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: dizziness; headache; nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 82-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 82 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset Sep2023, outcome "unknown"; HEADACHE (non-serious) with onset Sep2023, outcome "unknown"; NAUSEA (non-serious) with onset Sep2023, outcome "unknown", described as "nauseous".  Additional information: The patient had the vaccine shot Thursday afternoon and she had symptoms of headache and dizziness. When the patient got dizzy, the patient got nauseas at the same time and the patient had been lying down for 4 days. The patient didn't have this before so she wanted to know if this was from the shot or should she go to the doctor. The patient couldn't even get up to go to the doctor. The patient asked how long do the side effects last and if there was any data on the maximum time the side effects last. The reporter also asked for treatment recommendations.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Off label use, Pain
Clinical narrative: chills; body aches; nausea; low grade fever that began approximately 8 hrs after vaccination and continued for at least 24 hours; Pfizer BioNTech 2023 2024 formulation; administartion date: 19Sep2023, Flu vaccine; administartion date: 19Sep2023; Pfizer BioNTech 2023 2024 formulation; administartion date: 19Sep2023, Flu vaccine; administartion date: 19Sep2023; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 12-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 12 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 19Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 19Sep2023 at 17:00, outcome "unknown" and all described as "Pfizer BioNTech 2023 2024 formulation; administartion date: 19Sep2023, Flu vaccine; administartion date: 19Sep2023"; PAIN (non-serious) with onset 20Sep2023 at 02:00, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 20Sep2023 at 02:00, outcome "recovering"; PYREXIA (non-serious) with onset 20Sep2023 at 02:00, outcome "recovering", described as "low grade fever that began approximately 8 hrs after vaccination and continued for at least 24 hours"; NAUSEA (non-serious) with onset 20Sep2023 at 02:00, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, pain, nausea, pyrexia.  Additional information: The patient experienced chills, body aches, nausea, low grade fever that began "approximately 8 hours" (as reported) after vaccination and continued for at least 24 hours. The patient did not receive other vaccine in four weeks. Treatment received for the events included acetaminophen (TYLENOL) and ibuprofen. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product use issue, Pyrexia
Clinical narrative: chills; body aches; nausea; low grade fever that began approximately 8 hrs after vaccination and continued for at least 24 hours; Pfizer BioNTech 2023 2024 formulation; administartion date: 19Sep2023, Flu vaccine; administartion date: 19Sep2023; Pfizer BioNTech 2023 2024 formulation; administartion date: 19Sep2023, Flu vaccine; administartion date: 19Sep2023; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 12-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 12 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 19Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 19Sep2023 at 17:00, outcome "unknown" and all described as "Pfizer BioNTech 2023 2024 formulation; administartion date: 19Sep2023, Flu vaccine; administartion date: 19Sep2023"; PAIN (non-serious) with onset 20Sep2023 at 02:00, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 20Sep2023 at 02:00, outcome "recovering"; PYREXIA (non-serious) with onset 20Sep2023 at 02:00, outcome "recovering", described as "low grade fever that began approximately 8 hrs after vaccination and continued for at least 24 hours"; NAUSEA (non-serious) with onset 20Sep2023 at 02:00, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, pain, nausea, pyrexia.  Additional information: The patient experienced chills, body aches, nausea, low grade fever that began "approximately 8 hours" (as reported) after vaccination and continued for at least 24 hours. The patient did not receive other vaccine in four weeks. Treatment received for the events included acetaminophen (TYLENOL) and ibuprofen. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: I started shaking, my hands were shaking so bad, my arms were shaking and my body started shaking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 at 17:00 as dose number unknown, single (Lot number: HG4629) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for hypertension; LOSARTAN taken for hypertension. The following information was reported: TREMOR (non-serious) with onset 25Sep2023 at 19:00, outcome "recovered" (25Sep2023), described as "I started shaking, my hands were shaking so bad, my arms were shaking and my body started shaking". Therapeutic measures were not taken as a result of tremor. Additional information: Consumer stated, she had her Pfizer/BioNTech COVID vaccine a day before reporting (24Sep2023) at 5 o clock and when she got the vaccine, the pharmacist told her that he had just gotten his and he had some severe shaking for a while after he got the vaccine and it does not show up as a side effect of the vaccine but he just wanted to warn me of that. At 7 o clock she started shaking, her hands were shaking so bad, she could not even hold anything, her arms were shaking and her body started shaking but not her legs so she got in bed and covered up and laid in bed and was shaking for probably 40 minutes may be 45 minutes and then it finally stopped. So, she was so grateful to the pharmacist for warning me about that otherwise she would have no idea what was happening to her and then she googled side effects and this particular side effect does not show up anywhere.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300309708 same reporter/drug/event, different patient.;
Sex: M
Vaccine: UNK
Symptoms: Tremor
Clinical narrative: Shaking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), 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: TREMOR (non-serious), outcome "unknown", described as "Shaking".  Additional Information: Reporter stated, "I had my Pfizer/BioNTech COVID vaccine yesterday at 17:00 o'clock at (Pharmacy name Withheld) in (City name Withheld), (State name Withheld) and when I got the vaccine, the pharmacist whose name was '(name Withheld)' told me that he had just gotten his and he had some severe shaking for a while after he got the vaccine and it does not show up as a side effect of the vaccine but he just wanted to warn me of that. Well, I am glad he did because tonight at 19:00 o'clock I started shaking, my hands were shaking so bad, I could not even hold anything, my arms were shaking and my body started shaking but not my legs so I got in bed and covered up and laid in bed and was shaking for probably 40 minutes may be 45 minutes and then it finally stopped. So, I was so grateful to the pharmacist for warning me about that otherwise I would have no idea what was happening to me and then I googled side effects and this particular side effect does not show up anywhere. So, I do not know if you have heard of this before or I just thought I should report it."  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300309706 same reporter/drug/event, different patient.;
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Severe hip pain on right side; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidaemia" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ATORVASTATIN. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: ARTHRALGIA (non-serious) with onset 23Sep2023 at 18:00, outcome "recovering", described as "Severe hip pain on right side". Therapeutic measures were taken as a result of arthralgia with Tylenol, heating pad.  Additional information: Patient received vaccine from Pharmacy or Drug Store and no other vaccine was administered in four weeks. Patient was not tested for COVID prior vaccination and post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: 1st and 2nd hurt really bad at injection site/her arm was so sore/whole arm hurt/Her husband had the same experience; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 80-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "1st and 2nd hurt really bad at injection site/her arm was so sore/whole arm hurt/Her husband had the same experience".  Additional Information: The reporter was going to have surgery on her lungs and wants to know if she should have the Pfizer Covid vaccine 2023-24 formula before or after she has surgery. She stated she had 4 Covid vaccines in the past, all Pfizer and with the first two vaccines, they pinched up her skin to give the vaccine and it hurt really bad. For the second two, she asked them not to pinch up her skin and her arm wasn't sore. Her husband had the same experience.    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) : US-PFIZER INC-202300309532 same reporter, vaccine, different patient and event;
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pollakiuria, Vaccination site pain
Clinical narrative: frequent urination; Injection site pain; mild fatigue; mild chills; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 52-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 15:30 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 52 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for influenza immunisation, on 30Aug2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Sep2023 at 09:00, outcome "recovering", described as "Injection site pain"; POLLAKIURIA (non-serious) with onset 23Sep2023 at 09:00, outcome "recovering", described as "frequent urination"; HEADACHE (non-serious) with onset 23Sep2023 at 09:00, outcome "recovering"; CHILLS (non-serious) with onset 23Sep2023 at 09:00, outcome "recovering", described as "mild chills"; FATIGUE (non-serious) with onset 23Sep2023 at 09:00, outcome "recovering", described as "mild fatigue". Therapeutic measures were not taken as a result of pollakiuria, vaccination site pain, fatigue, chills, headache.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: He provided the lot number GJ5185 for his Paxlovid; He provided the lot number GJ5185 for his Paxlovid; 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 64-year-old male patient received bnt162b2 (BNT162B2), 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), COVID-19 (medically significant), outcome "unknown" and all described as "He provided the lot number GJ5185 for his Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GH9703) at the age of 71 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 07Feb2021 at 10:00 as dose 1, single (Lot number: EN5318), in left arm, on 28Feb2021 at 14:00 as dose 2, single (Lot number: EN6202), in left arm, on 07Sep2021 at 15:00 as dose 3 (booster), single (Lot number: FC3183), in left arm and on 09Apr2022 at 14:30 as dose 4 (booster), single (Lot number: Fj9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "kidney donor" (unspecified if ongoing), notes: therefore one kidney; "Moderate High BP" (unspecified if ongoing); "paroxysmal atrial fibrillation" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE, start date: 01Jun2018; ASPIRIN 81, start date: 01Jun2018; ATORVASTATIN, start date: 01Jun2018. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: moderate high. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient took Paxlovid as treatment from 14Sep2023 to 19Sep2023.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetanus, reaction(s): "Known Allergies: Tetanus". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 21Aug2023 to 26Aug2023. 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Lot number: GH5342) and on 20Apr2023 as dose 6 (booster), single (Lot number: GL2042) at the age of 63 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Lot number: EN6199), on 28Mar2021 as dose 2, single (Lot number: ER8730), on 11Sep2021 as dose 3 (booster), single (Lot number: EW0187) and on 16Feb2022 as dose 4 (booster), single (Lot number: FJ5683) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "emphysema" (unspecified if ongoing); "hypothroidism" (unspecified if ongoing); "osteopoenia" (unspecified if ongoing); "sensitivity to crab" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Iodine, reaction(s): "sensitivity to iodine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Sep2023) Negative; (23Sep2023) Negative; (25Sep2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Tested negative twice after Paxlovid on 21Sep2023 and 23Sep2023 then texted positive (very light line this time - whereas her first positives were almost immediate and very heavy lines) on 25Sep2023.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
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 contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Apr2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 72 years 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Additional information: The patient has no known allergies. The patient's COVID-19 treatment was Paxlovid from 15Sep2023 to 20Sep2023.  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: 54.0
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). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 12:00 as dose 4 (booster), single (Lot number: GH9693) at the age of 54 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 had no relevant medical history. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced treatment of covid-19. Also, tested positive for covid 4 days after finishing paxovid medication. Previously tested negative with now symptoms on day 8 of original covid illness. Rebound symptoms include sore throat, runny nose, headache. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid. Outcome of the events was not recovered.