chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Batch/Lot number: EN62?1), in left arm, on 25Mar2021 as dose 2, single (Lot number: ER8730), in left arm and on 28Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 71 years, in right arm for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Jun2022 as dose 4 (booster), single (Lot number: 038A22A), in left arm for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "MVP" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: Counting 1st symptoms as day 0, new symptoms began day 11,; (Jul2022) Positive, notes: tested positive on day 12. Didn't test on day 11. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: mentions that she got all of her vaccines and boosters from Pfizer/ on Paxlovid; mentions that she got all of her vaccines and boosters from Pfizer/ on Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 92-year-old female patient received 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 included: "pain related to her broken arm" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; AVAPRO; BABY ASPIRIN; PRILOSEC [OMEPRAZOLE]; FISH OIL; LIPITOR; CALCIUM; VITAMIN D3; BIOTIN; MONTELUKAST; LOSARTAN; MAGNESIUM; TYLENOL taken for pain; TRAMADOL taken for pain.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "mentions that she got all of her vaccines and boosters from Pfizer/ on Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she got all of her vaccines and boosters from Pfizer and then still got Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, SARS-CoV-2 test, Upper limb fracture
Clinical narrative: mentions that she got all of her vaccines and boosters from Pfizer/ on Paxlovid; mentions that she got all of her vaccines and boosters from Pfizer/ on Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 92-year-old female patient received 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 included: "pain related to her broken arm" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; AVAPRO; BABY ASPIRIN; PRILOSEC [OMEPRAZOLE]; FISH OIL; LIPITOR; CALCIUM; VITAMIN D3; BIOTIN; MONTELUKAST; LOSARTAN; MAGNESIUM; TYLENOL taken for pain; TRAMADOL taken for pain.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "mentions that she got all of her vaccines and boosters from Pfizer/ on Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she got all of her vaccines and boosters from Pfizer and then still got Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: fallen and broken her arm; fallen and broken her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 92-year-old female patient received BNT162b2 (BNT162B2), 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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: UPPER LIMB FRACTURE (medically significant), FALL (non-serious), outcome "unknown" and all described as "fallen and broken her arm". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she got all of her vaccines and boosters from Pfizer and then still got Covid. Therapeutic measures were taken as a result of upper limb fracture. Clinical information: Patient verified that she received the Pfizer Covid Vaccines and Boosters and then got Covid. Stated she also broke her arm and was all alone in the house. Patient stated that her son was a doctor and he came in from (city name withheld) yesterday and ordered Paxlovid for her. Agent stated that the patient also has fallen and broken her arm. Patient mentioned that she was taking Tramadol and Tylenol for the pain related to her broken arm.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, SARS-CoV-2 test, Upper limb fracture
Clinical narrative: fallen and broken her arm; fallen and broken her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 92-year-old female patient received BNT162b2 (BNT162B2), 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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: UPPER LIMB FRACTURE (medically significant), FALL (non-serious), outcome "unknown" and all described as "fallen and broken her arm". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she got all of her vaccines and boosters from Pfizer and then still got Covid. Therapeutic measures were taken as a result of upper limb fracture. Clinical information: Patient verified that she received the Pfizer Covid Vaccines and Boosters and then got Covid. Stated she also broke her arm and was all alone in the house. Patient stated that her son was a doctor and he came in from (city name withheld) yesterday and ordered Paxlovid for her. Agent stated that the patient also has fallen and broken her arm. Patient mentioned that she was taking Tramadol and Tylenol for the pain related to her broken arm.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: TUSSIN CF, start date: Jul2022, stop date: Jul2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 18May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 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 was not reported. The patient was 29 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 16Sep2022. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], start date: 01Aug2020, stop date: 26Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (16Jul2022) Positive, notes: Treatment of COVID-19; (20Jul2022) Positive, notes: Rebound infection after testing negative on day 5; (26Jul2022) Positive, notes: Tested positive with recurrence of symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was received other medication in 2weeks of vaccine. Antiviral details included COVID 19 Treatment, Brand was Paxlovid started on 16Jul2022 to 20Jul2022. Other medication in 2weeks product was Prenatal vitamins, One a day started on 01Aug2020 to 26Jul2022. The patient was Covid positive on 16Jul2022. Started paxlovid that morning. Rebound infection after testing negative on day 5. Tested positive with recurrence of symptoms 26Jul2022. No known allergies were reported.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Maternal exposure during pregnancy, Off label use, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 18May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 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 was not reported. The patient was 29 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 16Sep2022. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], start date: 01Aug2020, stop date: 26Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (16Jul2022) Positive, notes: Treatment of COVID-19; (20Jul2022) Positive, notes: Rebound infection after testing negative on day 5; (26Jul2022) Positive, notes: Tested positive with recurrence of symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was received other medication in 2weeks of vaccine. Antiviral details included COVID 19 Treatment, Brand was Paxlovid started on 16Jul2022 to 20Jul2022. Other medication in 2weeks product was Prenatal vitamins, One a day started on 01Aug2020 to 26Jul2022. The patient was Covid positive on 16Jul2022. Started paxlovid that morning. Rebound infection after testing negative on day 5. Tested positive with recurrence of symptoms 26Jul2022. No known allergies were reported.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 44-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 18May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient was 29 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 16Sep2022. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURTER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURTER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3, SINGLE, MANUFACTURTER UNKNOWN), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 18May2022, outcome "unknown", described as "Age=44/Vaccine dose number=4"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 18May2022, outcome "unknown", described as "Gestational period: 29/Vaccine dose number = 4, administration date = 18May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (16Jul2022) Positive; (26Jul2022) Positive. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Maternal exposure during pregnancy, Off label use, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 44-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 18May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient was 29 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 16Sep2022. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURTER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURTER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3, SINGLE, MANUFACTURTER UNKNOWN), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 18May2022, outcome "unknown", described as "Age=44/Vaccine dose number=4"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 18May2022, outcome "unknown", described as "Gestational period: 29/Vaccine dose number = 4, administration date = 18May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (16Jul2022) Positive; (26Jul2022) Positive. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
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 74-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: EN6202) at the age of 74 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CKD" (unspecified if ongoing); "Trigeminal Neuralgia" (unspecified if ongoing), notes: TN; "Occipital Neuralgia" (unspecified if ongoing); "Factor 8 Blood disorder" (unspecified if ongoing). The patient took concomitant medications. 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: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Palpitations, Pericarditis, Weight increased
Clinical narrative: pericarditis; inflammation; weight gain (10 lbs); heart palpitations; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2 (COMIRNATY), 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 Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: PERICARDITIS (medically significant), outcome "recovering"; INFLAMMATION (non-serious), outcome "recovering"; WEIGHT INCREASED (non-serious), outcome "recovering", described as "weight gain (10 lbs)"; PALPITATIONS (non-serious), outcome "recovering", described as "heart palpitations". The events "pericarditis", "inflammation", "weight gain (10 lbs)" and "heart palpitations" required physician office visit. The patient underwent the following laboratory tests and procedures: Weight increased: 10lbs.  Clinical information: After 2nd dose of Comirnaty, patient experienced inflammation, pericarditis, weight gain (10 lbs), and heart palpitations.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Splenomegaly
Clinical narrative: multiple lymph nodes enlarged on US neck/hypermetabolic lymph nodes on CT; dyspnoea on exertion; Enlarged liver/spleen; Enlarged liver/spleen; Chest pains; Pulmonary edema; Pneumonia; IIH; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), on 30Aug2021 as dose 2, single (Lot number: FD8448) at the age of 38 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Raynaud's", start date: 2008 (ongoing), notes: Raynaud's; "M.C.T.D", start date: 2015 (ongoing), notes: M.C.T.D, Under control/ managed since 2018; "CVA", start date: 23Jul2021 (unspecified if ongoing); "Enlarged lymph nodes", start date: Jul2021 (unspecified if ongoing), notes: Enlarged lymph nodes. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1st, Site and route of injection: Right arm, Intramuscular, Batch/Lot number: FA7485), administration date: 23Jul2021, when the patient was 38-year-old, for COVID-19 Immunization, reaction(s): "CVA".  The following information was reported: IDIOPATHIC INTRACRANIAL HYPERTENSION (disability, medically significant) with onset Aug2021, outcome "not recovered", described as "IIH"; PNEUMONIA (medically significant) with onset Sep2021, outcome "unknown"; PULMONARY OEDEMA (disability, medically significant) with onset Sep2021, outcome "recovered", described as "Pulmonary edema"; CHEST PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "Chest pains"; SPLENOMEGALY (non-serious), HEPATOMEGALY (non-serious) all with onset Jan2022, outcome "unknown" and all described as "Enlarged liver/spleen"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "multiple lymph nodes enlarged on US neck/hypermetabolic lymph nodes on CT"; DYSPNOEA EXERTIONAL (non-serious), outcome "unknown", described as "dyspnoea on exertion". The event "iih" required physician office visit. The event "pulmonary edema" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Chest X-ray: (Sep2021) Abnormal, notes: Lung opacity/edema; (Nov2021) Normal, notes: No acute disease; (Mar2022) Normal; Computerised tomogram neck: (Jan2022) Normal, notes: Multiple enlarged lymph node (word not legible) more on back; Computerised tomogram thorax: (Jan2022) Normal, notes: Multiple enlarged lymph node (word not legible); Us neck: (Jan2022) Multiple enlarged lymph nodes; Lumbar puncture: (Aug2021) Abnormal, notes: High opening neck pressure; Magnetic resonance imaging head: (Jan2022) Abnormal, notes: Venous anomaly; Oxygen saturation: (Mar2022) Dyspnea on exertion; Positron emission tomogram: (May2022) Abnormal, notes: Hypermetabolic lymph nodes with high uptake -So much more labs, test on (word not legible). Therapeutic measures were taken as a result of idiopathic intracranial hypertension, pulmonary oedema.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Autoimmune disorder
Clinical narrative: AA which is some sort of autoimmune response; Hair loss where approximately 50% of her hair has been removed; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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: Covid-19 vaccine (Dose number: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose number: 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose number: 3, 1st booster, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "AA which is some sort of autoimmune response"; ALOPECIA (non-serious), outcome "unknown", described as "Hair loss where approximately 50% of her hair has been removed". The clinical course was reported as the patient had her 4th booster shot and experienced side effects including hair loss where approximately 50% of her hair has been removed; and she has something called AA which is some sort of autoimmune response.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2020 as dose 1, single (Lot number: EK9231), in right arm, on 16Jan2021 as dose 2, single (Lot number: EL1283), in left arm and on 08Oct2021 as dose 3 (booster),single (Lot number: FE3590) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR; METFORMIN. Past drug history included: Topamax, reaction(s): "Known allergies: Topamax". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (25Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti viral details:  product=COVID 19 Treatment, brand=Paxlovid  Treatment start date=16Jul2022, Treatment stop date=20Jul2022, Lot number=GA2851, Indication=Treatment of COVID-19.  No follow-up attempts are Possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Age: 53.0
Sex: F
Vaccine: 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 a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: EN6198), on 21Mar2021 as dose 2, single (Lot number: ER2613), on 22Sep2021 as dose 3 (booster), single (Lot number: FF8839) and on 31Mar2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "pulmonary endometriosis" (unspecified if ongoing); "SVT" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN, start date: Oct2018; METOPROLOL, start date: Aug2020; POTASSIUM CHLORIDE, start date: May2020; LASIX [FUROSEMIDE], start date: May2020; KELNOR, start date: Jan2007; FAMOTIDINE, start date: Jan2019. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin"; Pneumovax, reaction(s): "Known allergies: Pneumovax". 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Product=COVID 19 Treatment, brand=Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Completed 5 day treatment with Paxlovid. Felt good and was returning to normal routine. Four (4) days after completing the 5 day course of treatment, symptoms began to return. General malaise, runny nose, scratchy throat, body aches, wet cough. All the same symptoms as initial indication plus a strange headache not present in the initial encounter.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 36.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 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 was not reported. Concomitant medication(s) in 2 weeks included: LEXAPRO; SPIRONOLACTONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Antiviral details for COVID-19 treatment included PAXLOVID (Brand), and treatment start date was on 15Jul2022 and treatment stop date was on 20Jul2022. Patient experienced rebound with worse symptoms starting 3 days after medication completion.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
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 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 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 was not pregnant at time of vaccination. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE, start date: 01Jan2021. Past drug history included: Compazine, reaction(s): "Known allergies: Compazine", notes: Known allergies: Compazine. 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received COVID 19 Treatment, Paxlovid, Brand=Pfizer, Treatment start date=19Jul2022, Treatment stop date=20Jul2022, Lot number=GC9431. Patient received Omepra-zole start date=01Jan2021 other medication in 2weeks. The patient Known allergies: Compazine and other medical history: asthma. Adverse event: Severe abdominal pain, vomiting for over 12 hours.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Nov2021 as dose 3 (booster), single (Lot number: 32030bd) at the age of 37 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: "Breast cancer survivor (Nov2020)", start date: Nov2020 (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known allergies: Tree nuts" (unspecified if ongoing); "Known allergies: soy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was treated with Paxlovid for COVID-19. Treatment start date was 16Jul2022. Treatment stop date was 20Jul2022. Patient received no other medications in two weeks. Paxlovid rebound after 11 days from starting the medicine. Adverse event start date was 26Jul2022.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL9263), on 17Feb2021 as dose 2, single (Lot number: EL9267), on 28Aug2021 as dose 3 (booster), single (Lot number: EW0187) and on 28May2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "thyroidectomy", start date: 2006, stop date: 2006, notes: Other medical history: thyroidectomy 2006; "osteoporosis" (unspecified if ongoing), notes: Other medical history: have osteoporosis; "labile blood pressure" (unspecified if ongoing), notes: Other medical history: labile blood pressure; "hip repair", start date: 2006, stop date: 2006, notes: Other medical history: 2016 hip repair; "appendectomy", start date: 2006, stop date: 2006, notes: Other medical history: 2006 appendectomy. Concomitant medication(s) included: SYNTHROID, start date: May2006; SERTRALINE, start date: Jan2017; AMLODIPINE, start date: Jul2022. Past drug history included: Septra, reaction(s): "Known allergies: septra", notes: Known allergies: septra; Demerol, reaction(s): "Known allergies: demerol", notes: Known allergies: demerol. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with with Paxlovid from 13Jul2022 to 18Jul2022.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 66-year-old male patient received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EL9269), in right arm, on 03Mar2021 as dose 2, single (Lot number: EN6202), in right arm, on 05Oct2021 as dose 3 (booster), single (Lot number: 30135BA), in left arm and on 09May2022 at 16:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 66 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LOSARTIN; SIMVASTATIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Positive, notes: I first tested positive 05Jul2022 and was prescribed Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.The patient was treated with Paxlovid from 07Jul2022 to 11Jul2022 for covid- 19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: 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.  An 81-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 02Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. 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: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: It was reported that, Anti-viral Paxlovid for COVID 19 Treatment started on 15Jul2022 and stopped on 20Jul2022. No known allergies were reported. Patient received vaccine and other medications in two weeks. The adverse event reported Paxlovid rebound on 25Jul2022. The event was recovering. Therapeutic measure was not taken for the event.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 24May2022 as dose 4 (booster), single (Lot number: Fk9895) at the age of 61 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: "Asthma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Known allergies : penicillin, reaction(s): "Allergy", notes: Known Allergies : Yes Penicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: The patient received antiviral treatment (PAXLOVID) from 16Jul2022 to 20Jul2022 as treatment of COVID-19. Cough and shortness of breath. Patient has asthma. After initial treatment completed, tested negative, but symptoms came back 3 days later and patient tested positive again. Rebound.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 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 was not reported. Concomitant medication(s) included: MAGNESIUM, start date: 01May2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Relapse/rebound of COVID-19 symptoms on day 9 of illness,Anti-viral details includes COVID 19 Treatment, Paxlovid, Treatment start date 14Jul2022, Treatment stop date 18Jul2022,Indication included Treatment of COVID-19.  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: COVID-19, Cough, Drug ineffective, Fatigue, Illness
Clinical narrative: caught COVID from her; caught COVID from her; Her aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired.; Her aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired.; Her aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired.; Her aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "caught COVID from her"; ILLNESS (non-serious), COUGH (non-serious), PYREXIA (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "Her aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: now positive and are sick. caught COVID from her.  Clinical course- This reporter belongs to reporters aunt. Reporter said that was really strange was his family and sons and daughter all went to withheld for a wedding and he stayed there to take care of the dogs. They got back the first day they all were fine and the next day literally out of a group of 7 people 5 were now positive and were sick. His wife came back in the house and they were together and obliviously caught COVID from her and his symptoms and her mother and aunt and stuff were vaccinated and sick as a dog and coughing, hacking, fever, tired and his wife was at her mothers house and sick too trying to help each other. son had it and not as bad. Caller declined report on mother, aunt and others and said it would take all day. Reporter said at the end of the day does he need to contact his doctor and he said he obliviously should not take the pills. There is a product complaint to report.  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: Pyrexia, SARS-CoV-2 test
Clinical narrative: caught COVID from her; caught COVID from her; Her aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired.; Her aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired.; Her aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired.; Her aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "caught COVID from her"; ILLNESS (non-serious), COUGH (non-serious), PYREXIA (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "Her aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: now positive and are sick. caught COVID from her.  Clinical course- This reporter belongs to reporters aunt. Reporter said that was really strange was his family and sons and daughter all went to withheld for a wedding and he stayed there to take care of the dogs. They got back the first day they all were fine and the next day literally out of a group of 7 people 5 were now positive and were sick. His wife came back in the house and they were together and obliviously caught COVID from her and his symptoms and her mother and aunt and stuff were vaccinated and sick as a dog and coughing, hacking, fever, tired and his wife was at her mothers house and sick too trying to help each other. son had it and not as bad. Caller declined report on mother, aunt and others and said it would take all day. Reporter said at the end of the day does he need to contact his doctor and he said he obliviously should not take the pills. There is a product complaint to report.  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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: now positive and are sick; now positive and are sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "now positive and are sick". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: now positive and are sick. caught COVID from her.  Clinical Course: He has a patient on the line and the patient was called regarding Paxlovid and he was prescribed Paxlovid. Report 4. He said what was really strange was his family and sons and daughter all went to withheld for a wedding and he stayed there to take care of the dogs. They got back the first day they all were fine and the next day literally out of a group of 7 people 5 are now positive and are sick. His wife came back in the house and they are together and obliviously caught COVID from her and his symptoms and her mother and aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired and his wife is now at her mothers house and sick too trying to help each other. son has it and not as bad. Caller declined report on mother, aunt and others and said it would take all day. He said at the end of the day does he need to contact his doctor and he said he obliviously should not take the pills and asked for call handlers opinion.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.