chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Hypertonic bladder, Investigation
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient. A female patient received BNT162b2 (BNT162B2), on 17Dec2021 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: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: HYPERTONIC BLADDER (non-serious) with onset Dec2021, outcome "unknown", described as "Overactive bladder". The event "overactive bladder" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypertonic bladder. Additional information: It was reported that, patient received booster for COVID 17Dec and within a week she had an overactive bladder. she didn't realize what the problem was at the time. she thought she had vaginal infection. she made an appointment to see my gynecologist in Feb and he did tests for both urinary and vaginal disease. Everything was negative. In Apr I started on Ditropan XL. she believe it was due to the COVID booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4511566-00 (Agency).  A 61-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), on 01Jun2021 as dose 2, single (Batch/Lot number: unknown) and on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis. The patient's relevant medical history was not reported. Concomitant medication(s) included: Z-PAK. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED 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: Unknown results. The action taken for adalimumab was unknown.The reporter considered "covid-19" related to BNT162b2. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of COVID with Humira (Adalimumab) was a reasonable possibility.  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 available information, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events "Drug ineffective and "Suspected covid-19".
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Magnetic resonance imaging neck
Clinical narrative: On 16Nov2021 and in Jul2022 patient had COVID twice.; On 16Nov2021 and in Jul2022 patient had COVID twice.; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4512552-00 (Agency).  A 34-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; upadacitinib (RINVOQ), (Lot number: 1160069), oral for psoriatic arthropathy. 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 16Nov2021, outcome "recovered" and all described as "On 16Nov2021 and in Jul2022 patient had COVID twice.". The patient underwent the following laboratory tests and procedures: COVID-19: (16Nov2021) positive, notes: On 16Nov2021 and in Jul2022 patient had COVID twice; Magnetic resonance imaging neck: (16Nov2021) ??-MAR-2022, notes: Disc damage. The action taken for upadacitinib was unknown.  Clinical course: Solicited report from a consumer of a 34-year-old female with events of non-serious pain, two bulging discs in neck/cervical spine, COVID and magnetic resonance imaging showed disc damage with Rinvoq (Upadacitinib). There was no reported medical history. On unknown dates, the patient experienced pain, two bulging discs in neck/cervical spine and magnetic resonance imaging showed disc damage. On 16Nov2021, the patient experienced COVID. In Jul2022, the patient experienced COVID. On an unknown date, COVID resolved. Pfizer BioNTech COVID-19 VACCINE (Tozinameran) was also considered suspect. On 16Nov2021 and in Jul2022 patient had COVID twice. She was feeling pain. She had two bulging discs in her neck and cervical spine. In Jan2022 She had started physical therapy. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Rinvoq (Upadacitinib) provided as the reporter's causality for the event(s) of pain, two bulging discs in neck/cervical spine, COVID onset 16Nov2021, COVID onset in Jul2022 and magnetic resonance imaging showed disc damage was not provided. Drug pfizer bioNTech COVID-19 Vaccine (Tozinameran) (Tozinameran), unknown daily dose booster (1 in 1 Once). Causality as per reporter (Drug/Vaccine): Possible.  The reporter considered "on 16nov2021 and in jul2022 patient had covid twice." related to BNT162b2. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Rheumatoid arthritis
Clinical narrative: COVID; COVID/Hard time breathing; Rheumatoid arthritis Spikes in flares; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4511720-00.  A 67-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID"; COVID-19 (medically significant), outcome "unknown", described as "COVID/Hard time breathing"; RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis Spikes in flares". The patient underwent the following laboratory tests and procedures: COVID-19: Positive. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "covid", "covid/hard time breathing" and "rheumatoid arthritis spikes in flares" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "hard time breathing" related to BNT162b2.  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 available information, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of  "covid" , "rheumatoid arthritis spikes in flares" and "drug ineffective".
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 43 year old healthy female, approx 5'2" 125 lbs with no underlying medical conditions other than allergies tested positive for Covid today; 43 year old healthy female, approx 5'2" 125 lbs with no underlying medical conditions other than allergies tested positive for Covid today; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 23Aug2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "43 year old healthy female, approx 5'2" 125 lbs with no underlying medical conditions other than allergies tested positive for Covid today". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Aug2022) Positive, notes: tested positive for Covid today.  Clinical course: Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Autoimmune disorder, Costochondritis, Depression, Fibromyalgia, Rheumatoid arthritis
Clinical narrative: autoimmune disorder sero-positive rheumatoid arthritis; autoimmune disorder sero-positive rheumatoid arthritis; fibromyalgia; costochondritus; depression; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 2, single (Lot number: EN5318) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Covid-19 immunization Manufacturer unknown), for Covid-19 Immunization. The following information was reported: AUTOIMMUNE DISORDER (medically significant), RHEUMATOID ARTHRITIS (medically significant), outcome "unknown" and all described as "autoimmune disorder sero-positive rheumatoid arthritis"; FIBROMYALGIA (non-serious), outcome "unknown"; COSTOCHONDRITIS (non-serious), outcome "unknown", described as "costochondritus"; DEPRESSION (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Rheumatoid arthritis: Positive.  Clinical course: The patient had an adverse reaction to second Covid vaccine Pfizer EN5318, February 4, 2021. As a result, the patient had an autoimmune disorder sero-positive rheumatoid arthritis, fibromyalgia, costochondritus, depression, etc. A VAERS report was filed.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: 663249), in arm, on 11Feb2021 as dose 2, single (Lot number: EL9262), in arm, on 27Sep2021 as dose 3 (booster), single (Lot number: FC3184), in arm and on 12Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 82 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Macrobid for UTI infection, reaction(s): "Chills", notes: symptoms went away when stopped; Antibiotics, reaction(s): "Fainted", notes: When on the antibiotic, fainted both times. Vaccination history included: Shingles (Dose: 1 at arm, need another one but century), for Immunization; Polio (when a child), for Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Negative; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-000002913. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "experienced cardiac event". Additional information: On 08Aug2022 it was reported that a patient started treatment on an unspecified date with PFIZER BIONTECH COVID-19 VACCINE. It was reported the patient experienced cardiac event.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Musculoskeletal disorder, Nodule, Peripheral swelling, Vaccination site movement impairment
Clinical narrative: my arm swelled up; had a huge knot in it; I couldnt lift or use my arm for about a week and a half; I couldnt lift or use my arm for about a week and a half; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "my arm swelled up"; NODULE (non-serious), outcome "unknown", described as "had a huge knot in it"; VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious), MUSCULOSKELETAL DISORDER (non-serious), outcome "unknown" and all described as "I couldnt lift or use my arm for about a week and a half".  Additional information: Patient had that vaccine and had a bad experience with it her arm swelled up and had a huge knot in it and she couldnt lift or use her arm for about a week and a half. No more vaccines for her. open ended question: Thinking of the video you just saw, please enter anything you felt, thought, or were reminded of while viewing it. Everything is acceptable. There are no right or wrong answers, no silly or dumb feelings. Don't worry about spelling, punctuation, or grammar.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline", notes: Known allergies: Tetracycline.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: it was reported that, Patient taking Paxlovid for COVID-19 treatment, treatment start date: 16Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Prostate cancer, SARS-CoV-2 test
Clinical narrative: Prostate cancer diagnosis 07Sep2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 2, single (Lot number: EN6204) at the age of 65 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose1, single, Anatomical site of injection: Left Deltoid, Route of administration: Intramuscular, Batch/Lot number: EL9266), administration date: 13Feb2021, when the patient was 65-year-old, for COVID-19 immunization, reaction(s): "Following Paxlovid I tested negative". The following information was reported: PROSTATE CANCER (medically significant) with onset 07Sep2021, outcome "recovered" (05Jan2022), described as "Prostate cancer diagnosis 07Sep2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jul2022) Negative; (01Aug2022) Negative; (02Aug2022) Negative; (04Aug2022) Positive, notes: COVID Rebound Positive Test; (07Aug2022) Negative; (08Aug2022) Negative; (11Aug2022) Negative; (12Aug2022) Negative; (15Aug2022) Negative; (21Jul2022) Positive, notes: Positive COVID, Home Test; (22Jul2022) Positive, notes: Positive COVID, Clinic Test. Therapeutic measures were taken as a result of prostate cancer. Patient had Radical prostatectomy. Clinical course: No Prior Vaccinations (within 4 weeks). Patient received BNT162b2 on 30Aug2021 as dose3, single (Lot number: 301308A) and on 14Apr2022 as dose4, single (Lot number FP4554) via intramuscular, in left deltoid for covid-19 immunisation. Paxlovid administration date was 22Jul2022.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Paraesthesia, Pyrexia, Syncope
Clinical narrative: fainted; fever; dizzy; stomach hurting; little tinglies; hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000002931.  A female patient received BNT162b2 (BNT162B2), on 16Aug2021 as dose number unknown, single (Lot number: FC3180) 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 "fainted"; PYREXIA (non-serious), outcome "unknown", described as "fever"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach hurting"; PARAESTHESIA (non-serious), outcome "unknown", described as "little tinglies"; URTICARIA (non-serious), outcome "unknown", described as "hives". The events "fainted", "fever", "dizzy", "stomach hurting", "little tinglies" and "hives" required emergency room visit.  Clinical course: On 09Aug2022, it was reported that a patient started treatment on 16Aug2022 with Pfizer COVID-19 vaccine an unknown number of doses around 4:00PM CST for unknown indication. It was reported the patient had fever, dizzy, stomach hurting, fainted, little tingles, hives and went to ER. No further follow-up is anticipated.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: fainted; fever; dizzy; stomach hurting; little tinglies; hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000002931.  A female patient received BNT162b2 (BNT162B2), on 16Aug2021 as dose number unknown, single (Lot number: FC3180) 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 "fainted"; PYREXIA (non-serious), outcome "unknown", described as "fever"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach hurting"; PARAESTHESIA (non-serious), outcome "unknown", described as "little tinglies"; URTICARIA (non-serious), outcome "unknown", described as "hives". The events "fainted", "fever", "dizzy", "stomach hurting", "little tinglies" and "hives" required emergency room visit.  Clinical course: On 09Aug2022, it was reported that a patient started treatment on 16Aug2022 with Pfizer COVID-19 vaccine an unknown number of doses around 4:00PM CST for unknown indication. It was reported the patient had fever, dizzy, stomach hurting, fainted, little tingles, hives and went to ER. No further follow-up is anticipated.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4513732-00.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Batch/Lot number: unknown), on 25Jul2021 as dose 2, single (Batch/Lot number: unknown) and on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Lot number: 1141058), oral for rheumatoid arthritis. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "recovered", described as "Heart attack". The action taken for upadacitinib was unknown.  Clinical course: Patient stated he had a heart attack and cardiologist had him to stop taking Rinvoq and he had now been added Rinvoq per physician.  Causality for RINVOQ (UPADACITINIB): The reporter's causality for the event(s) of heart attack with RINVOQ (UPADACITINIB) was no reasonable possibility. Agency's opinion is that the event of heart attack is not assessable.   The reporter considered "heart attack" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As per the available information there can be possible causality of the event myocardial infarction and suspect Bnt162B2. It will be reassessed after more information available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Agency, Ethics committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bacterial test, Inflammation, Meningitis, Viral test
Clinical narrative: My 4 year old Grandson developed Meningitis within 1 week of receiving your COVID vaccine.; He had a lumbar tap that showed active inflammation but negative bacterial cultures and negative viral screening; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 4-year-old 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: MENINGITIS (medically significant), outcome "unknown", described as "My 4 year old Grandson developed Meningitis within 1 week of receiving your COVID vaccine."; INFLAMMATION (non-serious), outcome "unknown", described as "He had a lumbar tap that showed active inflammation but negative bacterial cultures and negative viral screening". The patient underwent the following laboratory tests and procedures: Bacterial test: Negative; Viral test: Negative.  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: Bacterial test, Lumbar puncture abnormal, Meningitis, Viral test
Clinical narrative: My 4 year old Grandson developed Meningitis within 1 week of receiving your COVID vaccine.; He had a lumbar tap that showed active inflammation but negative bacterial cultures and negative viral screening; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 4-year-old 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: MENINGITIS (medically significant), outcome "unknown", described as "My 4 year old Grandson developed Meningitis within 1 week of receiving your COVID vaccine."; INFLAMMATION (non-serious), outcome "unknown", described as "He had a lumbar tap that showed active inflammation but negative bacterial cultures and negative viral screening". The patient underwent the following laboratory tests and procedures: Bacterial test: Negative; Viral test: Negative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Brain injury, Cognitive disorder, Drug ineffective, Fatigue
Clinical narrative: I contracted covid anyway in Jan; I contracted covid anyway in Jan; Covid attacked my brain and joints.; Covid attacked my brain and joints.; cognitive issues; joint pain; fatigue; I have great trouble with daily activities; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I contracted covid anyway in Jan"; BRAIN INJURY (medically significant), JOINT INJURY (non-serious), outcome "unknown" and all described as "Covid attacked my brain and joints."; COGNITIVE DISORDER (non-serious), outcome "unknown", described as "cognitive issues"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; FATIGUE (non-serious), outcome "unknown"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "I have great trouble with daily activities". Clinical course: I was fully vaccinated for covid with your vaccine. I contracted covid anyway in Jan. Covid attacked my brain and joints. 8 months later and I am still suffering with debilitating cognitive issues, joint pain and fatigue. I can't work, I have great trouble with daily activities. I felt that I was safe using your vaccine, now I wonder if the vaccine is why I have these issues. I feel I was lied to.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Joint injury, Loss of personal independence in daily activities, Suspected COVID-19
Clinical narrative: I contracted covid anyway in Jan; I contracted covid anyway in Jan; Covid attacked my brain and joints.; Covid attacked my brain and joints.; cognitive issues; joint pain; fatigue; I have great trouble with daily activities; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I contracted covid anyway in Jan"; BRAIN INJURY (medically significant), JOINT INJURY (non-serious), outcome "unknown" and all described as "Covid attacked my brain and joints."; COGNITIVE DISORDER (non-serious), outcome "unknown", described as "cognitive issues"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; FATIGUE (non-serious), outcome "unknown"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "I have great trouble with daily activities". Clinical course: I was fully vaccinated for covid with your vaccine. I contracted covid anyway in Jan. Covid attacked my brain and joints. 8 months later and I am still suffering with debilitating cognitive issues, joint pain and fatigue. I can't work, I have great trouble with daily activities. I felt that I was safe using your vaccine, now I wonder if the vaccine is why I have these issues. I feel I was lied to.  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: Arthralgia, Arthritis
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP). A 76-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Xeljanz xr for arthritis. The following information was reported: ARTHRITIS (non-serious), outcome "unknown", described as "Patient reports arthritis symptoms flared up following covid vaccinations"; ARTHRALGIA (non-serious), outcome "unknown", described as "joints achy, shoulders the worst". Additional information: patient stated she was on Xeljanz XR a couple years ago; did not recall date started or how long taken. Patient stated therapy was changed; reason not stated. Patient reported arthritis symptoms flared up following covid vaccinations: joints achy, shoulders the worst. MD decided to re-start Xeljanz XR.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: He tested positive for COVID-19 on 17Jul2022; He tested positive for COVID-19 on 17Jul2022; he took johnson&johnson covid-19 vaccine on 12Jul2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), in Aug2021 as dose 2 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 12May2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Bi-polar disorder" (unspecified if ongoing); "Hypoglycemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Abilify, notes: 5mg- Abilify. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Aug2021, outcome "unknown", described as "he took johnson&johnson covid-19 vaccine on 12Jul2021"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 17Jul2022, outcome "unknown" and all described as "He tested positive for COVID-19 on 17Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jul2022) Positive. Clinical course: The patient felt fatigued and had a runny nose. The patient believed he received the COVID virus as the result of taking the vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: FLUX
Symptoms: Mesothelioma
Clinical narrative: mesothelioma; Initial information received on 18-Jul-2022 regarding an unsolicited valid Legal serious case received from a lawyer.  This case involves an 84 years old female patient who had mesothelioma while receiving vaccine influenza vaccine and while treated with dimeticone.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient started taking dimeticone (with an unknown batch number, expiry date, form, strength, dose, frequency, route and indication).  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number and expiry date not reported.  On an unknown date the patient had mesothelioma (unknown latency) following the first dose intake of dimeticone and influenza vaccine.  There were no lab data reported.  Action taken with dimeticone was unknown, not applicable for influenza vaccine.  It was not reported if the patient received a corrective treatment for the event (mesothelioma).  At time of reporting, the outcome was Unknown for the event mesothelioma.  Seriousness criteria: mesothelioma event was assessed as medically significant. The patient was hospitalized for this event.; Sender's Comments: Sanofi Company Comment on 21-Jul-2022: This case involves an 84 years old female patient who had mesothelioma while receiving vaccine influenza vaccine and while treated with dimeticone.Causal relationship of the suspect drugs cannot be excluded however limited information provided regarding this case precludes comprehensive assessment of this case. Case would be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.
Sex: F
Vaccine: TTOX, UNK
Symptoms: Asthma, Hypersensitivity
Clinical narrative: she received tetanus shot and experienced allergic reaction; Initial information received on 12-Aug-2022 regarding an unsolicited valid serious case received from a consumer/non-hcp (healthcare professional).  This case involves an unknown age female patient who received tetanus shot and experienced allergic reaction after receiving vaccine TETANUS TOXOID and while treated with DUPILUMAB [DUPIXENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Dec-2021, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection 300 mg QOW (every other week) subcutaneous (lot - Unknown at this time) for moderate persistent asthma uncomplicated (Asthma). On an unknown date, the patient received a  dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious event "she received tetanus shot and experienced allergic reaction (drug hypersensitivity) (unknown latency) following  intake of TETANUS TOXOID and DUPILUMAB. It is unknown if the patient experienced any additional symptoms/events   Action taken with DUPILUMAB (DUPIXENT) was unknown. Action taken with TETANUS TOXOID (TETANUS TOXOID) was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  Seriousness criteria: The patient was hospitalized for this event.; Sender's Comments: Sanofi Company Comment dated 18-AUG-2022: This case involves an unknown age female patient who received tetanus shot and experienced allergic reaction and hospitalized after receiving vaccine Tetanus toxoid and while treated with Dupilumab [Dupixent]. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information the role of the individual suspect vaccine cannot be assessed.
Sex: M
Vaccine: RAB
Symptoms: Incorrect route of product administration, Medication error, No adverse event
Clinical narrative: got imovax a month through his gluteal region, with no reported adverse event; Initial information received on 17-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age male patient who got imovax a month through his gluteal region, with no reported adverse event while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date the patient got imovax a month through his gluteal region, with no reported adverse event (incorrect route of product administration) (latency: same day) following the administration of RABIES (HDC) VACCINE.. The product was to be used for immunization  He found out by reading the prescribing information that it was not supposed to given at that site  Action taken : not applicable.  Outcome: unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 33.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Delivery, Maternal exposure before pregnancy
Clinical narrative: Patient DOB:  10/27/1987   Date of Admission: 7/5/2022   Date of Discharge: 7/8/2022   Diagnosis: Vaginal Delivery   Hospital Course    OB History Gravida Para Term Preterm AB Living 6 5 5   1 5 SAB IAB Ectopic Multiple Live Births    1     0 1      # Outcome Date GA Lbr Len/2nd Weight Sex Delivery Anes PTL Lv 6 Term 07/06/22 39w3d   3.856 kg (8 lb 8 oz) F Vag-Spont None   LIV 5 Term 12/26/13     3.289 kg (7 lb 4 oz) M Vag-Spont       4 Term 07/12/12     2.778 kg (6 lb 2 oz) F Vag-Spont   N      Birth Comments: cleft palate 3 Term 03/30/10     3.402 kg (7 lb 8 oz) M Vag-Spont       2 Term 08/04/06     3.515 kg (7 lb 12 oz) M VBAC   N   1 SAB                         The patient  underwent a Vaginal delivery during this hospitalization.  She is now 2 days postpartum.  She has not had complications since the delivery.  She has not been febrile.  She did not have a surgical sterilization at the time of her delivery.     At the time of discharge, the patient was afebrile and has been tolerating a regular diet.  She has been ambulating and voiding without difficulty.  Denies symptoms of orthostasis.    Plan   She has been given discharge instructions which include the following: No straining, No lifting over 15 pounds, No sex, No tampons, No douche and No tub baths.  Follow up for a postpartum exam in 6 weeks.  Call for any signs of fever, foul discharge, increased bleeding, wound redness or draining, or signs of postpartum depression.   Discharge Medications   Motrin 800 mg one every 8 hours #30     Signed: 7/8/2022 8:00 AM
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Transient ischaemic attack, Urinary tract infection
Clinical narrative: Hospitalized 07/06/2021 with TIA and UTI
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: I got a second covid booster on April 19th, 2022, and on May 3 rd, I developed  a skin rash that was diagnosed as dermatographia urticaria. I still have it and I take Zyrtec to alleviate the itching. Could this have been caused by the vaccine booster? And what should I do about the booster coming out in the fall? I cannot connect this condition to any other event or allergies at the time. I thank you.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: We administered a Pfizer vaccine that expired the day previously, 8/26/22. I notified the patient and they did not report any adverse effects.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Myasthenia gravis
Clinical narrative: Myasthenia gravis.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vaccine positive rechallenge
Clinical narrative: Patient complain of dizziness 5 minutes after receiving 2nd dose of vaccine. Parents states that she only have seasonal allergies, no other know allergies. Patient had similar reaction to 1st dose. Vital signs monitored within normal limits. Offered juice, cracker and water. Dad at bedside. Patient was able to verbalized her needs. Alert and Oriented 4x.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Contusion, Fatigue, Hyperhidrosis, Joint injury
Clinical narrative: Sleep at night was interrupted by the two usual bathroom trips. Woke up with a sore arm, and a general malaise, but went about the morning routine, preparing oatmeal for breakfast, and browsing news online. While on the toilet (for #2) in the lower level powder room (we live in a bilevel house), sweated suddenly and felt chills. And outside the powder room, the legs gave out. I just collapsed like a ragdoll, straight down. Hit my right elbow on the room divider cabinet and bruised that elbow. Got up without difficulty, and approached the stairs. Collapsed again! Made it somehow to the upstairs bedroom and felt fine after a 10-minute rest. Vaccine-induced syncope? My blood pressure and heart rate at the last physicals were normal but (always) on the low side. Did the vaccine lower it some more? As I write this I am a bit tired but fine otherwise. Thank you for addressing my concern.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Sleep disorder, Syncope
Clinical narrative: Sleep at night was interrupted by the two usual bathroom trips. Woke up with a sore arm, and a general malaise, but went about the morning routine, preparing oatmeal for breakfast, and browsing news online. While on the toilet (for #2) in the lower level powder room (we live in a bilevel house), sweated suddenly and felt chills. And outside the powder room, the legs gave out. I just collapsed like a ragdoll, straight down. Hit my right elbow on the room divider cabinet and bruised that elbow. Got up without difficulty, and approached the stairs. Collapsed again! Made it somehow to the upstairs bedroom and felt fine after a 10-minute rest. Vaccine-induced syncope? My blood pressure and heart rate at the last physicals were normal but (always) on the low side. Did the vaccine lower it some more? As I write this I am a bit tired but fine otherwise. Thank you for addressing my concern.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Pyrexia
Clinical narrative: Fever, dizzy, fatigue, SOB.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Brain oedema, Eyelid function disorder, Head discomfort, Headache, Musculoskeletal stiffness
Clinical narrative: Headache, feels like swelling and pressure in brain, and pressure in eyes. Can't keep eyes open. Body aches, especially back Stiffness Fever 99.9F  given ibuprofen to manage pain symptoms have not yet subsided
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Ocular discomfort, Pain, Pyrexia
Clinical narrative: Headache, feels like swelling and pressure in brain, and pressure in eyes. Can't keep eyes open. Body aches, especially back Stiffness Fever 99.9F  given ibuprofen to manage pain symptoms have not yet subsided
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on chest and back.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Injection site pain, Myalgia, Pyrexia
Clinical narrative: patient reported muscle aches, pain at injection site, chills, and fever
Age: 1.33
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Irritability, Oral mucosal eruption, Pyrexia, Rash erythematous
Clinical narrative: Patient started with fussiness and a fever at home, rash began roughly 36 hours after dose given. Started flat and red then quickly progressed to vesicular and fluid filled, covering legs, groin, arms, some to trunk/neck, mom noted some in mouth. Patient seen in office on Friday (roughly 72 hours after immunization). PO intake improving, no more fevers, rash still present with primarily vesicles present, some starting to scab.
Age: 1.33
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Scab
Clinical narrative: Patient started with fussiness and a fever at home, rash began roughly 36 hours after dose given. Started flat and red then quickly progressed to vesicular and fluid filled, covering legs, groin, arms, some to trunk/neck, mom noted some in mouth. Patient seen in office on Friday (roughly 72 hours after immunization). PO intake improving, no more fevers, rash still present with primarily vesicles present, some starting to scab.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Hypomania, Tachycardia
Clinical narrative: Hypomania Tachycardia
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: There were no adverse events from this vaccine. The patient told us she was due for her 3rd Hepatitis B vaccine and it was later found that her previous dose was 6/21/22, just a couple weeks before the vaccine we gave her on 7/5/22.  We reversed the insurance claim for the vaccine, filed an incident report that her series was not complete and the 3rd vaccine is invalid due to improper timing, and will give her the next dose at no charge.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of consciousness, Nausea, Syncope
Clinical narrative: Shortly after receiving the influenza vaccine the patient briefly fainted while sitting outside the vaccination area in a chair. After regaining consciousness, the patient briefly felt nauseous. The patient declined needing emergency services. The patient's mother was present at the time and took the patient home when she felt better. Patient was instructed to seek medical care if her condition worsened. Patient was contacted the day after the vaccination and was feeling much better.
Age: 37.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Hard red lump at injection site with itching