chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 09Aug2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "Immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Covid Rebound after two days of testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Known allergies: No. Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment Start Date: 12Jan2023, Treatment Stop Date: 16Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 27 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Latex" (unspecified if ongoing); "food dye" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment".
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Inappropriate schedule of product administration, Pain
Clinical narrative: Chills; body aches; fatigue; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Jan2023 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE; ROSUVASTATIN. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (Pfizer, lot number: Unknown, dose number: 3, vaccine location: Left arm.), administration date: 24Jan2023, for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 24Jan2023 at 10:00, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; CHILLS (non-serious) with onset 24Jan2023 at 18:00, outcome "recovered" (25Jan2023 at 06:00); PAIN (non-serious) with onset 24Jan2023 at 18:00, outcome "recovered" (25Jan2023 at 06:00), described as "body aches"; FATIGUE (non-serious) with onset 24Jan2023 at 18:00, outcome "recovered" (25Jan2023 at 06:00). Therapeutic measures were not taken as a result of chills, pain, fatigue.  Additional information: Chills, body aches, fatigue starting approx. 8 hours after dose, and continuing for about 12 hours. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other vaccine in four weeks. Other medications in two weeks including Omeprazole, Rosuvastatin. Facility type vaccine was reported that Doctor's office/urgent care.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Dry skin, Sjogren's syndrome
Clinical narrative: Reaction to MRNA vaccine and now declared allergic to it; tremors; lymphocytic dermatitis with purpura; 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), 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: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Reaction to MRNA vaccine and now declared allergic to it"; TREMOR (non-serious), outcome "unknown", described as "tremors"; SUPERFICIAL INFLAMMATORY DERMATOSIS (non-serious), outcome "unknown", described as "lymphocytic dermatitis with purpura".  Additional information: Caller asking what can be done for lymphocytic dermatitis with purpura and if others experienced this adverse event after vaccination. Caller asking if Pfizer has any information on the potential adverse effects the Covid-19 vaccine may have on patients with scleroderma. Caller reported experiencing tremors and lymphocytic dermatitis with purpura after receiving the Covid-19 vaccine more than one year ago.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Allergy to vaccine, Superficial inflammatory dermatosis, Tremor
Clinical narrative: Reaction to MRNA vaccine and now declared allergic to it; tremors; lymphocytic dermatitis with purpura; 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), 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: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Reaction to MRNA vaccine and now declared allergic to it"; TREMOR (non-serious), outcome "unknown", described as "tremors"; SUPERFICIAL INFLAMMATORY DERMATOSIS (non-serious), outcome "unknown", described as "lymphocytic dermatitis with purpura".  Additional information: Caller asking what can be done for lymphocytic dermatitis with purpura and if others experienced this adverse event after vaccination. Caller asking if Pfizer has any information on the potential adverse effects the Covid-19 vaccine may have on patients with scleroderma. Caller reported experiencing tremors and lymphocytic dermatitis with purpura after receiving the Covid-19 vaccine more than one year ago.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Biopsy, Condition aggravated, Sjogren's syndrome, Superficial inflammatory dermatosis
Clinical narrative: Reaction to MRNA vaccine and now declared allergic to it; tremors; lymphocytic dermatitis with purpura; 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), 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: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Reaction to MRNA vaccine and now declared allergic to it"; TREMOR (non-serious), outcome "unknown", described as "tremors"; SUPERFICIAL INFLAMMATORY DERMATOSIS (non-serious), outcome "unknown", described as "lymphocytic dermatitis with purpura".  Additional information: Caller asking what can be done for lymphocytic dermatitis with purpura and if others experienced this adverse event after vaccination. Caller asking if Pfizer has any information on the potential adverse effects the Covid-19 vaccine may have on patients with scleroderma. Caller reported experiencing tremors and lymphocytic dermatitis with purpura after receiving the Covid-19 vaccine more than one year ago.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Biopsy, Condition aggravated, Discomfort, Drug hypersensitivity, Parotitis
Clinical narrative: Reaction to MRNA vaccine and now declared allergic to it; tremors; lymphocytic dermatitis with purpura; 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), 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: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Reaction to MRNA vaccine and now declared allergic to it"; TREMOR (non-serious), outcome "unknown", described as "tremors"; SUPERFICIAL INFLAMMATORY DERMATOSIS (non-serious), outcome "unknown", described as "lymphocytic dermatitis with purpura".  Additional information: Caller asking what can be done for lymphocytic dermatitis with purpura and if others experienced this adverse event after vaccination. Caller asking if Pfizer has any information on the potential adverse effects the Covid-19 vaccine may have on patients with scleroderma. Caller reported experiencing tremors and lymphocytic dermatitis with purpura after receiving the Covid-19 vaccine more than one year ago.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Purpura, Rash, Sjogren's syndrome, Superficial inflammatory dermatosis, Tremor
Clinical narrative: Reaction to MRNA vaccine and now declared allergic to it; tremors; lymphocytic dermatitis with purpura; 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), 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: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Reaction to MRNA vaccine and now declared allergic to it"; TREMOR (non-serious), outcome "unknown", described as "tremors"; SUPERFICIAL INFLAMMATORY DERMATOSIS (non-serious), outcome "unknown", described as "lymphocytic dermatitis with purpura".  Additional information: Caller asking what can be done for lymphocytic dermatitis with purpura and if others experienced this adverse event after vaccination. Caller asking if Pfizer has any information on the potential adverse effects the Covid-19 vaccine may have on patients with scleroderma. Caller reported experiencing tremors and lymphocytic dermatitis with purpura after receiving the Covid-19 vaccine more than one year ago.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Cutaneous vasculitis, Discomfort, Drug hypersensitivity, Hypogammaglobulinaemia
Clinical narrative: Reaction to MRNA vaccine and now declared allergic to it; tremors; lymphocytic dermatitis with purpura; 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), 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: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Reaction to MRNA vaccine and now declared allergic to it"; TREMOR (non-serious), outcome "unknown", described as "tremors"; SUPERFICIAL INFLAMMATORY DERMATOSIS (non-serious), outcome "unknown", described as "lymphocytic dermatitis with purpura".  Additional information: Caller asking what can be done for lymphocytic dermatitis with purpura and if others experienced this adverse event after vaccination. Caller asking if Pfizer has any information on the potential adverse effects the Covid-19 vaccine may have on patients with scleroderma. Caller reported experiencing tremors and lymphocytic dermatitis with purpura after receiving the Covid-19 vaccine more than one year ago.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Parotitis, Purpura, Rash, Salivary gland resection, Sjogren's syndrome
Clinical narrative: Reaction to MRNA vaccine and now declared allergic to it; tremors; lymphocytic dermatitis with purpura; 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), 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: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Reaction to MRNA vaccine and now declared allergic to it"; TREMOR (non-serious), outcome "unknown", described as "tremors"; SUPERFICIAL INFLAMMATORY DERMATOSIS (non-serious), outcome "unknown", described as "lymphocytic dermatitis with purpura".  Additional information: Caller asking what can be done for lymphocytic dermatitis with purpura and if others experienced this adverse event after vaccination. Caller asking if Pfizer has any information on the potential adverse effects the Covid-19 vaccine may have on patients with scleroderma. Caller reported experiencing tremors and lymphocytic dermatitis with purpura after receiving the Covid-19 vaccine more than one year ago.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Superficial inflammatory dermatosis
Clinical narrative: Reaction to MRNA vaccine and now declared allergic to it; tremors; lymphocytic dermatitis with purpura; 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), 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: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Reaction to MRNA vaccine and now declared allergic to it"; TREMOR (non-serious), outcome "unknown", described as "tremors"; SUPERFICIAL INFLAMMATORY DERMATOSIS (non-serious), outcome "unknown", described as "lymphocytic dermatitis with purpura".  Additional information: Caller asking what can be done for lymphocytic dermatitis with purpura and if others experienced this adverse event after vaccination. Caller asking if Pfizer has any information on the potential adverse effects the Covid-19 vaccine may have on patients with scleroderma. Caller reported experiencing tremors and lymphocytic dermatitis with purpura after receiving the Covid-19 vaccine more than one year ago.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Sep2021 as dose 1, single (Lot number: EW0184), as dose 2, single (Lot number: FL3209 ) (Lot number also reported as FL3209 / HT326; vaccine administration date for dose 2 also reported as 06Apr2022, pending confirm), on 02Mar2022 as dose 3 (booster), single (Lot number: ENG6208) and on 13Apr2022 as dose 4 (booster), single (Lot number: ER8729) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's Disease" (unspecified if ongoing); "Stroke" (unspecified if ongoing); "Malaria" (unspecified if ongoing); "Colon removed" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 10Sep2022, stop date: 16Jan2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures paxlovid from 17Jan2023 to 21Jan2023 were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300040084 Same patient/product, different dose different event.;
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 11Mar2021 as dose 2, single (Lot number: EN6198), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 05Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "prostate cancer treated with surgery, hormones and radiation" (unspecified if ongoing), notes: treated with surgery, hormones and radiation; "Latex allergy" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN HCTZ, start date: Jul2017, stop date: Jan2023; PRAVASTATIN, start date: Jan2008, stop date: Jan2023. Past drug history included: Lisinopril, reaction(s): "drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Original symptoms runny nose, congestion, headache, scratchy throat, cough. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures (Paxlovid) were taken as a result of vaccination failure, covid-19.  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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 16Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis but I've not been on any medication's for it since Sep2022" (unspecified if ongoing), notes: Rheumatoid arthritis but I've not been on any medication's for it since Sep2022; "immunocompromised" (ongoing), notes: I'm immunocompromised. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, single; unknown manufacturer, Patient previously receive a COVID-19 Vaccine: Yes), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid treatment on 17Jan2023 and stop on 21Jan2023. Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. Other medications in two weeks was no. Patient took paxlovid to treat a COVID-19 infection because I'm immunocompromised   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.
Age: 40.0
Sex: M
Vaccine: FLUA4
Symptoms: Back pain, Gait disturbance, Inflammation, Pain in extremity, Sacral pain
Clinical narrative: Experience extreme inflammatory conditions lasting now three months.  Pain in back, sacroiliac joint, leg, feet, leading to numbness and inability to walk.   Initial attempt to visit ER two days after shot.  I have never been to an emergency room prior.
Age: 40.0
Sex: M
Vaccine: FLUA4
Symptoms: Spinal X-ray
Clinical narrative: Experience extreme inflammatory conditions lasting now three months.  Pain in back, sacroiliac joint, leg, feet, leading to numbness and inability to walk.   Initial attempt to visit ER two days after shot.  I have never been to an emergency room prior.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient only received one COVID monovalent vaccine.  They were due for their second monovalent vaccine, but were given the bi-valent vaccine instead.  We found out when the patient returned to the pharmacy on 11/25/2022.  Patient did not have any adverse effects to the vaccine.  We reached out to Pfizer for directions.  They stated that at the moment, the patient is no eligible for any other COVID vaccines.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Chest pain
Clinical narrative: Chest pain/burning for 14 hours following injection. Ongoing for a year and half now but usually just last a few hours or less but with my current episode it has now been 2 full days with chest pain and arrhythmia.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Paxlovid as treatment for COVID-19; Paxlovid as treatment for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 at 12:00 as dose 1, single (Lot number: EL9265), in right arm, on 16Feb2021 at 12:00 as dose 2, single (Lot number: EN6200), in right arm, on 05Nov2021 at 12:00 as dose 3 (booster), single (Lot number: FH 8 or 3), in left arm, on 08Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FJ4989), in right arm and on 03Oct2022 at 12:00 as dose 5 (booster), single (Lot number: EL9265), in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypo thyroid" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Known allergies: sulpha antibiotics" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 02Jan2023, stop date: 16Jan2023; LOSARTAN POTASSIUM, start date: 02Jan2023, stop date: 16Jan2023; ROSUVASTATIN, start date: 02Jan2023, stop date: 15Jan2023; VITAMIN D NOS, start date: 02Jan2023, stop date: 16Jan2023; D-MANNOSE, start date: 02Jan2023, stop date: 16Jan2023; VITAMIN C ACID, start date: 02Jan2023, stop date: 16Jan2023; CALCIUM 600 + D, start date: 02Jan2023, stop date: 16Jan2023; B-12, start date: 02Jan2023, stop date: 16Jan2023; ESTRADIOL, start date: Jan2023, stop date: Jan2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid as treatment for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient was received Paxlovid as treatment. treatment start date Jan2023, and treatment stop date Jan2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300040180 Same patient/drug, different dose, different event;
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: clotting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "clotting".  Clinical information: The caller had called in regards to the Pfizer booster shot. The caller had called on behalf of caller's wife, the patient. The caller did have lot numbers for the product and wanted to know if there had been any adverse events on the lot numbers for issues because patient was clotting and patient had never clotted before. Wanted to know if these boosters could have caused the clotting. Called the other day for patients first 2 shots with the lot numbers. The caller had called now because the caller wanted to report on booster now and see if there were any issues.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC, start date: 06Jul2017, stop date: 26Jan2023; METFORMIN, start date: 04Jan2017, stop date: 26Jan2023; LISINOPRIL, start date: 15Aug2017, stop date: 26Jan2023; CHLORTHALIDONE, start date: 26Jan2017, stop date: 26Jan2023; CENTRUM, start date: 17Oct2017, stop date: 26Jan2023. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 14Jan2023 to 19Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Aug2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Pennicilin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19 positive; COVID-19 positive; Moderna, Date: 19Feb2021, Dose Number: 2 / Pfizer, Date: 02Mar2022, Dose Number: 3; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 31 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Mar2022 as dose 3 (booster), single (Lot number: FK9729), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Jan2021 as dose 1, single (Lot number: 013L20A), in left arm and on 19Feb2021 as dose 2, single (Lot number: 016M20A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Mar2022, outcome "recovered", described as "Moderna, Date: 19Feb2021, Dose Number: 2 / Pfizer, Date: 02Mar2022, Dose Number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Jan2023, outcome "recovered" and all described as "COVID-19 positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jan2023) Positive, notes: At home (Nasal Swab). Therapeutic measures were taken as a result of drug ineffective, covid-19 included Dayquil, Theraflu, Advil.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Had Covid in Sep2022; Had Covid in Sep2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6201), on 07Mar2021 as dose 2, single (Lot number: EN6208) and on 05Nov2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "She used to be a heavy smoker" (unspecified if ongoing); "she has a history of COPD" (unspecified if ongoing); "She has a semi-permanent implant" (unspecified if ongoing); "She has a little conditions and allergies" (unspecified if ongoing); "Within 4 weeks her cataract on right eye had gotten worse" (unspecified if ongoing), notes: Within 4 weeks her cataract on right eye had gotten worse. The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine (She took the flu shot on 14Dec or 14Nov.), for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Sep2022, outcome "unknown" and all described as "Had Covid in Sep2022". The patient underwent the following laboratory tests and procedures: Computerised tomogram: (unspecified date) Unknown results, notes: CT scan on her head; SARS-CoV-2 test: (Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was treated with Paxlovid.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "Heart attack". The patient date of death was unknown. Reported cause of death: "heart attack". It was not reported if an autopsy was performed.  Additional information: The reporter has lost family members from it they have died. They have tried, they reported to VAERS, already reported the deaths. They were on there and then they were scrubbed or taken off because they didn't find it was an actual Pfizer or vaccine death. One died of a heart attack, one died of stroke, and they said, no they died of a heart attack and a stroke not a Pfizer shot even though it was just 3 weeks after.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: heart attack
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder, Encephalitis, Lumbar puncture, Malaise, Scan
Clinical narrative: Seizures; Bad autoimmune reaction; Encephalitis; Sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  An 8-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2022 as dose 2 (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (son received the first Pfizer COVID-19 vaccine for 5-11 years), administration date: 27Dec2021, for COVID-19 immunization. The following information was reported: MALAISE (hospitalization) with onset 10Feb2022, outcome "unknown", described as "Sick"; SEIZURE (hospitalization), outcome "unknown", described as "Seizures"; AUTOIMMUNE DISORDER (hospitalization), outcome "unknown", described as "Bad autoimmune reaction"; ENCEPHALITIS (hospitalization), outcome "unknown". The patient underwent the following laboratory tests and procedures: Lumbar puncture: within normal limits, notes: had several scans and a spinal tap which all were within normal limits; Scan: within normal limits, notes: had several scans and a spinal tap which all were within normal limits.  Clinical course details: The caller reports that her son received the first Pfizer COVID-19 vaccine for 5-11 years on 27Dec2021, his second dose on 20Jan2022 and began getting sick on 10Feb2022. The caller said her son began having seizures, developed a bad autoimmune reaction, had to be admitted to the ICU, was vented, had several scans and a spinal tap which all were within normal limits. The caller asked if there were reports of children having encephalitis. The caller said her son was a healthy child previously, was up to date on care, never missed a well check appointment. The caller also said there was no toxic stuff in this house. The caller said the physicians could not rule out the vaccine. The caller said the vaccine was the only thing new.
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizures; Bad autoimmune reaction; Encephalitis; Sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  An 8-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2022 as dose 2 (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (son received the first Pfizer COVID-19 vaccine for 5-11 years), administration date: 27Dec2021, for COVID-19 immunization. The following information was reported: MALAISE (hospitalization) with onset 10Feb2022, outcome "unknown", described as "Sick"; SEIZURE (hospitalization), outcome "unknown", described as "Seizures"; AUTOIMMUNE DISORDER (hospitalization), outcome "unknown", described as "Bad autoimmune reaction"; ENCEPHALITIS (hospitalization), outcome "unknown". The patient underwent the following laboratory tests and procedures: Lumbar puncture: within normal limits, notes: had several scans and a spinal tap which all were within normal limits; Scan: within normal limits, notes: had several scans and a spinal tap which all were within normal limits.  Clinical course details: The caller reports that her son received the first Pfizer COVID-19 vaccine for 5-11 years on 27Dec2021, his second dose on 20Jan2022 and began getting sick on 10Feb2022. The caller said her son began having seizures, developed a bad autoimmune reaction, had to be admitted to the ICU, was vented, had several scans and a spinal tap which all were within normal limits. The caller asked if there were reports of children having encephalitis. The caller said her son was a healthy child previously, was up to date on care, never missed a well check appointment. The caller also said there was no toxic stuff in this house. The caller said the physicians could not rule out the vaccine. The caller said the vaccine was the only thing new.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test
Clinical narrative: Stroke; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 06Nov2021 at 13:00 as dose 3 (booster), single (Lot number: FF2593) at the age of 30 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Plavix, reaction(s): "Known allergies: Plavix", notes: Known allergies: Plavix. Vaccination history included: BNT162b2 (lot number: EP7534, administration time: 10:00 AM, dose number: 1, vaccine location: Left arm), administration date: 20Mar2021, when the patient was 29-year-old, for COVID-19 Immunization; BNT162b2 (Lot number: ER8729, administration time: 10:00 AM, dose number: 2, vaccine location: Left arm), administration date: 10Apr2021, when the patient was 29-year-old, for COVID-19 Immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant, life threatening) with onset 12Dec2022 at 23:00, outcome "recovering", described as "Stroke". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 2 day(s)). The event "stroke" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Uknown results, notes: Covid test type post vaccination: Unknown. Therapeutic measures were taken as a result of cerebrovascular accident (Hospital stay and loop recorder implant). Additional information: Patient did not have COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Took your, Pfizer's Vaccine, COVID Vaccine and she died; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  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: DEATH (death), outcome "fatal", described as "Took your, Pfizer's Vaccine, COVID Vaccine and she died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Took your, Pfizer's Vaccine, COVID Vaccine and she died
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: one died of stroke; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (death, medically significant), outcome "fatal", described as "one died of stroke". The patient date of death was unknown. Reported cause of death: "one died of stroke". It was not reported if an autopsy was performed. Additional information: The reporter has lost family members from it they have died. They have tried, they reported to VAERS, already reported the deaths. They were on there and then they were scrubbed or taken off because they didn't find it was an actual Pfizer or vaccine death. One died of a heart attack, one died of stroke, and they said, no they died of a heart attack and a stroke not a Pfizer shot even though it was just 3 weeks after.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: one died of stroke
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: sister got COVID several times/they're getting sick from COVID; sister got COVID several times/they're getting sick from COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "sister got COVID several times/they're getting sick from COVID".  Clinical Course:Caller stated that pretty much people in his family has been taking the COVID vaccine; her sister got COVID several times, and her niece, nephew, etc. My family got sick. My neighbor took this. I got sick. And my sister told me they're getting sick from COVID  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: her sister got COVID several times, and her niece, nephew, etc; her sister got COVID several times, and her niece, nephew, etc; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "her sister got COVID several times, and her niece, nephew, etc".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; Moderna, Date: 10Oct2021, Dose Number: 3 / Pfizer, Date: 06May2022, Dose Number: 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 at 16:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06May2022 at 14:00 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Jan2021 at 14:00 as dose 1, single (Lot number: 028L20A), in left arm, on 26Feb2021 at 14:00 as dose 2, single (Lot number: 031L20A), in left arm and on 10Oct2021 at 14:00 as dose 3 (booster), single (Lot number: 020F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06May2022 at 14:00, outcome "unknown", described as "Moderna, Date: 10Oct2021, Dose Number: 3 / Pfizer, Date: 06May2022, Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive, notes: Rebound 4 day after completing 5 day course of Paxlovid COVID test positive again and symptoms returned. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.