chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: She also got Covid 19 in Oct2021; She also got Covid 19 in Oct2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 67-year-old female patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: IN6199) and on 12Apr2021 as dose 2, single (Lot number: ER8730) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2021, outcome "unknown" and all described as "She also got Covid 19 in Oct2021". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: She had gotten the Pfizer COVID 19 vaccines and the booster. They received their doses on the same day and they have the same lot numbers. The 3rd dose (booster) was received on 12Nov2021, lot: 3203080. She also got COVID 19 in Oct2021 at the same time he did. She also took Paxlovid, and it worked; it helped a lot.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201337408 same patient/drug, different event;
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cartilage injury, Fall, Lower limb fracture, Rhinitis, Tibia fracture
Clinical narrative: She also got Covid 19 in Oct2021; She also got Covid 19 in Oct2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 67-year-old female patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: IN6199) and on 12Apr2021 as dose 2, single (Lot number: ER8730) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2021, outcome "unknown" and all described as "She also got Covid 19 in Oct2021". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: She had gotten the Pfizer COVID 19 vaccines and the booster. They received their doses on the same day and they have the same lot numbers. The 3rd dose (booster) was received on 12Nov2021, lot: 3203080. She also got COVID 19 in Oct2021 at the same time he did. She also took Paxlovid, and it worked; it helped a lot.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201337408 same patient/drug, different event;
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight bearing difficulty
Clinical narrative: She also got Covid 19 in Oct2021; She also got Covid 19 in Oct2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 67-year-old female patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: IN6199) and on 12Apr2021 as dose 2, single (Lot number: ER8730) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2021, outcome "unknown" and all described as "She also got Covid 19 in Oct2021". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: She had gotten the Pfizer COVID 19 vaccines and the booster. They received their doses on the same day and they have the same lot numbers. The 3rd dose (booster) was received on 12Nov2021, lot: 3203080. She also got COVID 19 in Oct2021 at the same time he did. She also took Paxlovid, and it worked; it helped a lot.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201337408 same patient/drug, different event;
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood culture, COVID-19, SARS-CoV-2 test, Vaccination failure, X-ray
Clinical narrative: diagnosed with Covid 19; diagnosed with Covid 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: IN6199), on 12Apr2021 as dose 2, single (Lot number: ER8730) and on 12Nov2021 as dose 3 (booster), single (Lot number: 3203080) at the age of 69 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "diagnosed with Covid 19". The patient underwent the following laboratory tests and procedures: Blood culture: (26Nov2022) doesn't have the flu; SARS-CoV-2 test: (Oct2022) Caller was diagnosed with Covid 19; (Nov2022) He was diagnosed again in Nov2022 with Covid 19, notes: and RSV; X-ray: (26Nov2022) doesn't have the flu. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: patient was diagnosed with Covid 19 last month in early Oct2022 and took a full course of Paxlovid, which worked well for him. He was diagnosed again in Nov2022 with Covid 19 and RSV, and was prescribed Paxlovid again which he just started 27Nov2022. The patient did not receive any other vaccines within 4 weeks prior to the first administration date of the suspect vaccine.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 74 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Batch/Lot number: unknown), on 20Feb2021 as dose 2, single (Lot number: EL9266), in right arm, on 12Oct2021 as dose 3 (booster), single (Lot number: FE3590), in right arm and on 02May2022 as dose 4 (booster), single (Lot number: FK9894), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing); "DJD" (unspecified if ongoing); "psoriasis" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL, start date: Apr2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (22Nov2022) Negative; (26Nov2022) Positive, notes: with a home antigen test; (28Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient finished the 5 day course of Paxlovid on 21Nov. Tested negative on 22Nov. On the evening of 25Nov started mild cold symptoms, increasing to moderate cold symptoms on 26Nov. Tested Positive with a home antigen test on 26Nov. No fever, no shortness of breath, just tiredness and moderate runny nose, congestion and mild cough. Moderate cold symptoms persist and test positive 28Nov. No known allergies.   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, SARS-CoV-2 test
Clinical narrative: still tested positive for COVID; still tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "still tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive, notes: still tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Completed a 5-day course of Paxlovid; at the end of day 5, he was still positive for COVID virus. A patient is calling about the medication Paxlovid. He mentioned that he got COVID after getting the primary series and booster series of the COVID-19 vaccine. He added that he completed the full dose of Paxlovid for 5 days and still tested positive on his antigen test. He wanted to know additional information on the effectiveness of Paxlovid and how soon can he take another antigen test.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid; covid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2, on 30Jan2021 as dose 1, single (Lot number: EL9265), on 12Mar2021 as dose 2, single (Lot number: EN6207), on 16Sep2021 as dose 3 (booster), single (Lot number: 30145BA) and on 11Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "she has a lot of back problems" (unspecified if ongoing), notes: taking some unspecified back medications prior to her back surgery; "back surgery" (unspecified if ongoing), notes: few years ago. Concomitant medication(s) included: LOSARTAN taken for blood pressure measurement; AMLODIPINE [AMLODIPINE BESILATE] taken for blood pressure measurement. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "covid". Caller states then she got Covid for a third time, it was a mild case, but she was so upset about getting it. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: test that was negative; (Jun2022) Positive, notes: Caller states that in June she took two home tests that were positive; (Jun2022) Positive, notes: Caller states that in June she took two home tests that were positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2021 at 12:00 as dose 3 (booster), single (Lot number: P220395-0089L) at the age of 52 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Iv iodine, reaction(s): "Known allergies: IV Iodine".The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid (lot: 1918529A) from 15Nov2022 to 19Nov2022; and AngioCath.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 at 21:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown), 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: "asplenic/spleen was removed" (unspecified if ongoing), notes: at 4; due to trauma; "Trauma" (unspecified if ongoing); "Environmental allergies" (unspecified if ongoing); "eczema" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "overweight" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION HCL ER; CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PHOSPHATE;CHROMIC CHLORIDE;COLECALCIFEROL;CUPRIC OXIDE;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE SULFATE;NICKEL;NICOTINAMIDE;PANTOTHENIC ACID;POTASSIUM CHLORIDE;POTA; CETIRIZINE HCL; METFORMIN; MONTELUKAST; NALTREXONE HCL; OMEPRAZOLE; VITAMIN C [ASCORBIC ACID]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Nov2022) Negative; (26Nov2022) Negative; (28Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 14:15 as dose 5 (booster), single (Lot number: GH9694) at the age of 72 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: "history of bronchitis" (unspecified if ongoing). There were no concomitant medications. Known allergies: none.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, the patient received paxlovid from Nov2022 to 22Nov2022.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: I got left hand shake after receiving the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old male patient received BNT162b2 (BNT162B2), on 08Nov2022 as dose 1, single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TREMOR (non-serious) with onset 29Nov2022, outcome "recovered with sequelae" (Nov2022), described as "I got left hand shake after receiving the first dose". The event "i got left hand shake after receiving the first dose" required physician office visit. Therapeutic measures were not taken as a result of tremor.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling
Clinical narrative: Swelling of breast that was visibly noticed and felt; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 51-year-old female patient (not pregnant) received COVID-19 Vaccine - Manufacturer Unknown, in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2 Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 3 Unknown manufacturer), for Covid-19 Immunization. The following information was reported: BREAST SWELLING (non-serious) with onset Nov2022, outcome "recovering", described as "Swelling of breast that was visibly noticed and felt". The events "swelling of breast that was visibly noticed and felt" required physician office visit. Therapeutic measures were not taken as a result of breast swelling.  Additional information: Administration time for suspect was 02:30pm on unknown date in Nov2022, adverse event start time was 07:00am on unknown date in Nov2022. No other medication in 2 weeks. It was unknown did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine, it was unknown prior to vaccination, was the patient diagnosed with COVID-19 and it was also unknown that since the vaccination, had the patient been tested for COVID-19. Device Date: 29Nov2022  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Dyspnoea, SARS-CoV-2 test
Clinical narrative: He had his first Pfizer shot and recently got Covid; He had his first Pfizer shot and recently got Covid; breathing getting bad and pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID. The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 30Jun2022 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sarcoidosis", start date: 1989 (ongoing), notes: Sarcoidosis has created other conditions. No further details provided.; "Autoimmune disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DYSPNOEA (medically significant) with onset Nov2022, outcome "unknown", described as "breathing getting bad and pain"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Nov2022, outcome "unknown" and all described as "He had his first Pfizer shot and recently got Covid". The events "he had his first pfizer shot and recently got covid" required physician office visit. The events "breathing getting bad and pain" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Nov2022) Positive, notes: confirmed he had Covid. Those test were done on the 23Nov2022. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID Treatment). The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache, Hypertensive crisis, Optic nerve disorder, Visual impairment
Clinical narrative: Hypertensive crisis; headaches; bruising; visual changes; slowing of optic nerve; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 21-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2022 as dose 1, single (Lot number: FK9894) at the age of 21 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing). No known allergies. The patient took concomitant medications. Other medications in two weeks included birth control. No other vaccine in four weeks. The following information was reported: HYPERTENSIVE CRISIS (hospitalization, life threatening) with onset Apr2022, outcome "recovered with sequelae"; CONTUSION (non-serious) with onset Apr2022, outcome "recovered with sequelae", described as "bruising"; HEADACHE (non-serious) with onset Apr2022, outcome "recovered with sequelae", described as "headaches"; OPTIC NERVE DISORDER (non-serious) with onset Apr2022, outcome "recovered with sequelae", described as "slowing of optic nerve"; VISUAL IMPAIRMENT (non-serious) with onset Apr2022, outcome "recovered with sequelae", described as "visual changes". The patient was hospitalized for hypertensive crisis (hospitalization duration: 8 day(s)). The events "hypertensive crisis", "headaches", "bruising", "visual changes" and "slowing of optic nerve" required emergency room visit. Therapeutic measures were taken as a result of hypertensive crisis, headache, contusion, visual impairment, optic nerve disorder which included Potassium drip, anti-hypertensive meds. Clinical courses is as follows:  The patient received BNT162b2 (BNT162B2), on 11May2022 as dose 2, single (Lot number: FK9894) intramuscular for covid-19 immunisation. The patient  experienced hypertensive crisis, requiring emergency hospitalization with 5 days in Intensive Care Unit. headaches, bruising, visual changes, slowing of optic nerve. Covid wasn't tested post vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Vertigo
Clinical narrative: dizziness; vertigo; try not to move my head because if I move it I feel worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Nov2022 at 14:45 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: Other medical history: No, Known allergies: No. The patient took concomitant medications. Vaccination history included: jansenn (DOSE 1, SINGLE; Batch/Lot No: Unknown. Unable to locate or read the details; Location of injection: Arm Left; Vaccine Administration Time: 04:00 PM), administration date: 27Mar2021, when the patient was 51-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2 (INITIAL PFIZER DOSE), SINGLE; Batch/Lot No: Unknown. Unable to locate or read the details; Location of injection: Arm Left; Vaccine Administration Time: 06:00 PM), administration date: 12Nov2021, when the patient was 52-year-old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 26Nov2022 at 08:00, outcome "not recovered"; CONDITION AGGRAVATED (non-serious) with onset 26Nov2022 at 08:00, outcome "not recovered", described as "try not to move my head because if I move it I feel worse"; VERTIGO (non-serious) with onset 26Nov2022 at 08:00, outcome "not recovered". Therapeutic measures were not taken as a result of dizziness, vertigo, condition aggravated.  Additional information: Patient had dizziness, vertigo. It had improved but it did not go away. Patient don't know what to do. Patient tried not to move her head because if she move it feel worse. Patient did not had COVID prior to vaccination. Patient had not tested for covid post vaccination. Patient had no known allergies.  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: M
Vaccine: COVID19
Symptoms: Diabetic ketoacidosis, Type 1 diabetes mellitus
Clinical narrative: DKA; My son was diagnosed as type 1 diabetes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 3-year-old male patient received BNT162b2 (BNT162B2), in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose; vaccination site: thigh), administration date: 2022, for COVID-19 Immunization; Bnt162b2 (2nd dose), administration date: 2022, for COVID-19 Immunization. The following information was reported: DIABETIC KETOACIDOSIS (hospitalization, disability, life threatening) with onset 14Nov2022, outcome "recovered with sequelae", described as "DKA"; TYPE 1 DIABETES MELLITUS (hospitalization, disability, life threatening) with onset 14Nov2022, outcome "recovered with sequelae", described as "My son was diagnosed as type 1 diabetes". The patient was hospitalized for diabetic ketoacidosis, type 1 diabetes mellitus (hospitalization duration: 4 day(s)). The events "dka" and "my son was diagnosed as type 1 diabetes" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of diabetic ketoacidosis, type 1 diabetes mellitus. The clinical course was reported as follows: My 03-year-old son was hospitalized due to DKA and diagnosed as type 1 diabetes on 14Nov2022. He had 3 doses COVID vaccines. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201340824 same reporter/patient, different event/dose;
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain in extremity
Clinical narrative: pain in my upper arm; felt sick; miserable headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 33-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, My arm was a little sore after the first shot), for Covid-19 immunization, reaction(s): "My arm was a little sore after the first shot". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in my upper arm"; MALAISE (non-serious), outcome "unknown", described as "felt sick"; HEADACHE (non-serious), outcome "unknown", described as "miserable headache".  Additional information: How scary Covid has been How relieved she was to get my first [Pfizer] Covid vaccine How great the nurse was at giving shots (she was terrified, she hate shots and needles) was great , she had given me the shot e fire she realized it .she did not even feel it. Then as she sat there for 15 mins she was so worried about the possible side effects. The short film she just watched mentioned the most common side effects and that fear/concern came back. Her arm was a little sore after the first shot. Her second [Pfizer] Covid vaccines experience was not as good as the first. She did experience pain in her upper arm , she felt sick had a miserable headache The two [Pfizer] boosters she had received have been unpleasant post injection side effects have been stronger the last one she was miserable. She just kept thinking this sucks but she have heard that Covid is really horrible so she was glad she dont have that.   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: Feeling abnormal, Mood altered
Clinical narrative: been unpleasant; the last one I was miserable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 33-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, My arm was a little sore after the first shot.), for Covid-19 immunization, reaction(s): "My arm was a little sore after the first shot"; Bnt162b2 (Dose: 2nd, My second [Pfizer] Covid vaccines experience was not as good as the first. I did experience pain in my upper arm , I felt sick had a miserable headache.), for Covid-19 immunization, reaction(s): "miserable headache", "felt sick", "pain in my upper arm"; Bnt162b2 (Dose: 3rd, The two [Pfizer] boosters I have received have been unpleasant (I wish I could find (name-withheld) again) post injection side effects have been stronger the last one I was miserable.), for Covid-19 immunization, reaction(s): "been unpleasant". The following information was reported: MOOD ALTERED (non-serious), outcome "unknown", described as "been unpleasant"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "the last one I was miserable".  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: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48-year-old female patient received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid, oral, Lot number: 663526, Treatment start date: 28Nov2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in my arm from the [Pfizer COVID-19] shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (176890). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "soreness in my arm from the [Pfizer COVID-19] shots". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in my arm from the [Pfizer COVID-19] shots".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200114074 Same patient/vaccine/event, different vaccine dose;
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Pruritus, Vaccination site swelling
Clinical narrative: itching; received her Pfizer booster in her left arm and the second booster on her right arm and both of those left her with bumps; she has joint pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022SA426189.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "lost 50 pounds" (unspecified if ongoing), notes: The patient's past medical history included lost 50 pounds intentionally and had skin ulcers; "skin ulcers" (unspecified if ongoing), notes: The patient's past medical history included lost 50 pounds intentionally and had skin ulcers. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "she has joint pain", "Itching", "received her Pfizer booster in her left arm and the second booster on her right arm and both of those left her with bumps". The following information was reported: PRURITUS (non-serious), outcome "not recovered", described as "itching"; VACCINATION SITE SWELLING (non-serious), outcome "not recovered", described as "received her Pfizer booster in her left arm and the second booster on her right arm and both of those left her with bumps"; ARTHRALGIA (non-serious), outcome "not recovered", described as "she has joint pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus.  Additional information: She received her Pfizer booster (second) on her right arm and both of those left her with bumps. Itching still has itching on her arms, she has joint pain Treatment included was she was adding over the counter cream (unspecified) for she stated that she still has itching on her arms and not reported for other events. Reporter causality: Not reported for all events. Company causality; Not reportable for all events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive rapid test for COVID; Positive rapid test for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EM9809), on 06Nov2021 as dose 2, single (Lot number: EN6203) and on 08Dec2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Nov2022, outcome "recovering" and all described as "Positive rapid test for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Nov2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Pyrexia, Rhinorrhoea
Clinical narrative: Positive rapid test for COVID; Positive rapid test for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EM9809), on 06Nov2021 as dose 2, single (Lot number: EN6203) and on 08Dec2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Nov2022, outcome "recovering" and all described as "Positive rapid test for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Nov2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error
Clinical narrative: drawn up into a syringe yesterday at 11am and left at room temperature, then administered today at 10:20am.; drawn up into a syringe yesterday at 11am and left at room temperature, then administered today at 10:20am.; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team, Program ID.  A 59-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 at 10:20 as dose number unknown (booster), 0.3 ml single (Lot number: GJ3277, Expiration Date: May2023) at the age of 59 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 30Nov2022 at 10:20, outcome "unknown" and all described as "drawn up into a syringe yesterday at 11am and left at room temperature, then administered today at 10:20am". Additional information: Pharmacist from [Facility name withheld] is calling about a 59-year-old female patient who received the bivalent gray cap formulation of the Pfizer BioNTech Covid 19 vaccine today but was inappropriately stored.  Product was drawn up into a syringe yesterday at 11am and left at room temperature, then administered today at 10:20am.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 pneumonia, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid and pneumonia in the ED; tested positive for covid and pneumonia in the ED; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), in Jun2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I Have COPD/emphysema" (unspecified if ongoing), notes: I Have COPD/emphysema; "I Have COPD/emphysema" (unspecified if ongoing), notes: I Have COPD/emphysema. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 PNEUMONIA (medically significant), outcome "not recovered" and all described as "tested positive for covid and pneumonia in the ED". The events "tested positive for covid and pneumonia in the ed" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: tested positive for covid; (30Nov2022) Positive, notes: The caller states he tested himself today and continues to test positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19 pneumonia. Clinical course: The patient has COPD/emphysema and had an acute COPD attack, went to the ED and tested positive for covid and pneumonia in the ED.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version; got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 OMI ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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 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 "got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version".  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.  Amendment: This follow-up report is being submitted to amend previously reported information: Removed patient information from patient tab as reporter is not a patient and updated dose description of third and fourth dose COVID-19 vaccine.  Follow-up (01Dec2022): This is a follow-up report to notify that  case 202201300085 and case 202201345851 are duplicates.  All subsequent follow-up information will be reported under Manufacturer report number 202201345851.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201300194 same reporter/vaccine/event, different patients;US-PFIZER INC-202201300196 same reporter/vaccine/event, different patients;US-PFIZER INC-202201300195 same reporter/vaccine/event, different patients;US-PFIZER INC-202201300197 same reporter/vaccine/event, different patients;US-PFIZER INC-202201307472 same reporter/vaccine, different events/patients;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Had COVID right after her last Pfizer shot; Had COVID right after her last Pfizer shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000004210.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; 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 immunization. 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 2022, outcome "unknown" and all described as "Had COVID right after her last Pfizer shot". Additional information: On 11Nov2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine at dose 4 for COVID-19 immunization. It was reported the patient had COVID right after her last Pfizer shot.  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
Symptoms: Autoimmune thyroiditis, Investigation
Clinical narrative: Hashimoto thyroid disease; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004202.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 immunization. The following information was reported: AUTOIMMUNE THYROIDITIS (non-serious), outcome "unknown", described as "Hashimoto thyroid disease". The patient underwent the following laboratory tests and procedures: Test: Hashimoto thyroid disease, notes: He did a test that confirmed Hashimoto thyroid disease.  Additional information: On 11Nov2022, it was reported that a patient started treatment on an unspecified date in 2021 with Pfizer BioNTech COVID-19 Vaccine at dose 1 and dose 2 for COVID-19 immunisation. The patient stated that after taking her second Pfizer shot she started having some really strange side effects, her arms were burning. She told her doctor and he did a test that confirmed Hashimoto thyroid disease.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: it did nothing for me; it did nothing for me; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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 "it did nothing for me".  Clinical course: Patient stated that patient did not believe in the booster and got the 2 does vaccine [Pfizer COVID-19 vaccine] and it did nothing for the patient.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.