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; covid-19; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Batch/Lot number: unknown), on 01Mar2021 as dose 2, single (Batch/Lot number: unknown), on 09Oct2021 at 09:30 as dose 3 (booster), single (Lot number: FH8020), in right arm and on 05Apr2022 at 13:15 as dose 4 (booster), single (Lot number: FM0698) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "Meniere syndrome" (unspecified if ongoing); "Vestibular disequilibrium" (unspecified if ongoing), notes: vestibular disequilibrium; "Atrial Tachycardia" (unspecified if ongoing); "Cardiac dysrhythmia" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN oral, start date: 09Mar2011, stop date: 18May2022; VENLAFAXINE oral, start date: 11Feb2010; VITAMIN D NOS. Past drug history included: Prednisolone, reaction(s): "Known allergies: prednisolone", notes: Known allergies: prednisolone. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: home antigen test positive results; (unspecified date) Unknown results, notes: Indication: treatment of covid-19; (30May2022) Positive, notes: 30May2022 symptoms returned and patient again tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received other medication in 2 weeks. Patient phoned in with home antigen test positive results and symptomatic of covid 19 infections was triaged to the paxlovid medication protocol. Patient received from 18May2022 to 28May2022 with Paxlovid. 65y/o cardiovascular dz. Patient was improved and 30May2022 symptoms returned and patient again tested positive with home antigen testing. She felt it necessary to report.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Vaccination Failure (LOE) and COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 2 (booster), single (Lot number: FH8028), in left arm for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 22Jun2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CKD stage", start date: 2020 (unspecified if ongoing), notes: other medical history: 2020 - Chronic kidney disease stage; "non hodgkins lymphoma", start date: Mar2021 (unspecified if ongoing), notes: other medical history: Mar2021-non hodgkins lymphoma. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: If vaccine received reported as Yes. No other medication in 2 weeks reported. Anti viral details: product: COVID 19 Treatment, brand: Paxlovid, treatment start date:19Jun2022, treatment stop date: 21Jun2022, indication: Treatment of COVID-19. Adverse event reported as FYI the last page would not allow me to add my initial vaccination data which was J&J on 22Jun2021 My adverse event was extreme rectal burning with diarrhea and some bleeding which is why he did not finish the full 5 days. known allergies reported as no.  No follow-up attempts were possible. No further information was expected.
Age: 36.0
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 a non-contactable reporter(s) (Physician). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "Known allergies: Almonds" (unspecified if ongoing); "known allergies: Walnuts" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ, start date: 18Mar2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details: Product- COVID 19 Treatment,  Brand: Paxlovid, Treatment start date- 12Jun2022, Treatment stop date- 17Jun2022, Indication- Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug Ineffective and COVID-19 cannot be ruled out.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 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), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had received anti-viral medication; Paxlovid as COVID 19 Treatment. Treatment started on 06Jun2022 and stop date was 10Jun2022. Patient had other medication in 2weeks was unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 80.0
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) (Physician).  An 80-year-old male patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 17Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing), notes: other medical history: hypertension controlled with meds; "atrial fibrillation" (unspecified if ongoing), notes: other medical history: atrial fibrillation controlled after 2 ablations. Concomitant medication(s) included: LISINOPRIL; ATORVASTATIN, start date: May1985; HYDROCHLOROTHIAZIDE; TAMSULOSIN; ASPIRIN [ACETYLSALICYLIC ACID]; GAVISCON [ALGELDRATE;ALGINIC ACID;MAGNESIUM TRISILICATE;SODIUM BICARBONATE]; CHOLECALCIFEROL; VITAMIN D3; CRANBERRY; GLUCOSAMINE SULFATE; REFRESH TEARS. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jun2022) Positive; (16Jun2022) Negative; (20Jun2022) Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical course: Yes the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. Yes the patient previously receive a COVID-19 Vaccine. There is no known allergies. Positive test on 09Jun2022 with mild URI symptoms. Paxlovid 09Jun-13Jun, resolution of symptoms after 3 days. Negative test 16Jun. Recurrent symptoms, worse, 20Jun. Positive test 20Jun. Other medical history: hypertension controlled with meds; atrial fibrillation controlled after 2 ablations.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The company cannot completely exclude the possible causality between the reported COVID-19, which is considered as failure of vaccine BNT162B2, and the administration of BNT162B2, as the efficacy of a vaccine varies individually and may be affected by different factors including drug potency.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 21Apr2022 at 16:00 as dose number unknown, single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR, start date: Dec2020, stop date: 11Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Indication: Treatment of COVID-19; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid symptoms Came back; covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) 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: "Crohn's disease" (unspecified if ongoing). Concomitant medication(s) included: DEPO-TESTOSTERONE, start date: 22Apr2021. Past drug history included: Humira, reaction(s): "Allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Covid symptoms Came back"; 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. Clinical course: Covid rebound several days after stopping Paxlovid. Covid symptoms Came back after they had previously resolved. Other medication within 2 weeks of vaccination was Depo-testosterone.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: PAA156051) and on 29Mar2021 as dose 2, single (Lot number: EN6208) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 02Nov2021 as dose 3 (booster), single (Lot number: 939905) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Erythromycin for Allergy; Cephalosporin for Allergy. The following information was reported: VACCINATION FAILURE (medically significant) with onset 06Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 06Jun2022, outcome "recovering" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) positive, notes: I tested positive for Covid on June 6,2022 and started taking Covid on the same day; (09Jun2022) negative., notes: My symptoms cleared by June 8, 2022, and took an antigen test on June 9, 2022 which came back negative; (19Jun2022) positive, notes: Nine days later (June 18) I started sneezing and became congested and took another antigen test on June 19 which came back positive; (23Jun2022) positive, notes: am still recovering from Covid and continue to test positive on June 23, 2022. My symptoms are mild and consistent with a head cold. Therapeutic measures were taken as a result of vaccination failure.  Clinical course: I tested positive for Covid on 06Jun2022 and started taking Covid on the same day. My symptoms cleared by 08Jun2022 and took an antigen test on 09Jun2022 which came back negative. Nine days later (18Jun) I started sneezing and became congested and took another antigen test on 19Jun which came back positive. I am still recovering from Covid and continue to test positive on 23Jun2022. My symptoms are mild and consistent with a head cold.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4269884-00.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1155481), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1; Route of Administration: Intramuscular), administration date: 12Mar2021, when the patient was 62-year-old, for Covid-19 Vaccination, reaction(s): " Drug ineffective", "COVID-19", "Glaucoma", "Sarcoidosis". The following information was reported: FATIGUE (non-serious) with onset 09Apr2021, outcome "recovered". The action taken for adalimumab was unknown. Additional information: It was unknown if patient was enrolled in a COVID-19 vaccine trial. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of fatigue was not provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Amendment: This follow-up report is being submitted to amend previously reported information: Updated the report type from Non-interventional study to spontaneous, added stimulated in classification.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Pain in extremity, Urticaria
Clinical narrative: did have something on her skin on her face under her eye near her cheek bone, she had what looked like a hive/ blister but it was red and it looked like it was raised; did have something on her skin on her face under her eye near her cheek bone, she had what looked like a hive/ blister but it was red and it looked like it was raised; did have something on her skin on her face under her eye near her cheek bone, she had what looked like a hive/ blister but it was red and it looked like it was raised; arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu vaccine (Reaction: had swelling in her arm and an itchy patch on her left arm ), for immunization. The following information was reported: URTICARIA (non-serious), BLISTER (non-serious), ERYTHEMA (non-serious), outcome "unknown" and all described as "did have something on her skin on her face under her eye near her cheek bone, she had what looked like a hive/ blister but it was red and it looked like it was raised"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness".  Additional information: States patient was panicked. States that was 2 days after the vaccine and she saw her dermatologist and they said it looked like a dog scratch and she feels it was from the vaccine. States that took 2 weeks to go away.  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: Blood pressure measurement, Pain in extremity, SARS-CoV-2 test, Urticaria
Clinical narrative: she got a hive on her face in a different spot on the same side of her face; arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diverticulitis" (unspecified if ongoing); "Pulmonary Langerhans autoimmune" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing); "blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement; TRAZODONE taken for sleep deficit; SIMVASTATIN taken for blood cholesterol; OMEPRAZOLE taken for gastrooesophageal reflux disease; B12 1000 SR taken for supplementation therapy; PEPCID AC taken for gastrooesophageal reflux disease. Vaccination history included: BNT162b2 (Dose number 1), administration date: 30Jan2021, when the patient was 68-year-old, for COVID-19 Immunization, reaction(s): "Covid-19". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm soreness"; URTICARIA (non-serious) with onset 2021, outcome "unknown", described as "she got a hive on her face in a different spot on the same side of her face". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: No additional vaccines were administered on same date of the Pfizer suspect. Patient believes that her flu shot was not with in four weeks of suspect administration.  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: Blood pressure measurement, Pain in extremity, SARS-CoV-2 test
Clinical narrative: arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diverticulitis", start date: 2009 (unspecified if ongoing), notes: Pulmonary Langerhans autoimmune of her lungs. States this is why she is high risk. Concomitant medication(s) included: B12 [CYANOCOBALAMIN]; LISINOPRIL taken for blood pressure measurement; OMEPRAZOLE taken for gastrooesophageal reflux disease; PEPCID AC taken for gastrooesophageal reflux disease; SIMVASTATIN taken for blood cholesterol; TRAZODONE taken for sleep disorder. Vaccination history included: BNT162b2 (Dose 1), administration date: 30Jan2021, for COVID-19 immunization, reaction(s): "did have something on her skin on her face under her eye near her cheek bone, she had what looked like a hive/ blister but it was red and it looked like it was raised", "did have something on her skin on her face under her eye near her cheek bone, she had what looked like a hive/ blister but it was red and it looked like it was raised", "did have something on her skin on her face under her eye near her cheek bone, she had what looked like a hive/ blister but it was red and it looked like it was raised", "arm soreness"; BNT162b2 (Dose 2), administration date: 20Feb2021, for COVID-19 immunization, reaction(s): "she got a hive on her face in a different spot on the same side of her face", "arm soreness". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Pain in extremity, SARS-CoV-2 test
Clinical narrative: arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diverticulitis", start date: 2009 (ongoing), notes: Pulmonary Langerhans autoimmune of lungs and was on high risk. Oxygen levels 97% and she functions; "acid reflux" (unspecified if ongoing); "blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "Pulmonary Langerhans" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement; TRAZODONE taken for sleep disorder; SIMVASTATIN taken for blood cholesterol; OMEPRAZOLE taken for gastrooesophageal reflux disease; PEPCID AC taken for gastrooesophageal reflux disease; B12 [CYANOCOBALAMIN] taken for supplementation therapy. Vaccination history included: BNT162b2 (Dose 1), administration date: 30Jan2021, for Covid-19 immunization, reaction(s): "did have something on her skin on her face under her eye near her cheek bone, she had what looked like a hive/ blister but it was red and it looked like it was raised", "Arm soreness"; BNT162b2 (Dose 1), administration date: 30Jan2021, for COVID-19 immunization, reaction(s): "did have something on her skin on her face under her eye near her cheek bone, she had what looked like a hive/ blister but it was red and it looked like it was raised"; BNT162b2 (Dose 1), administration date: 30Jan2021, for COVID-19 immunisation, reaction(s): "did have something on her skin on her face under her eye near her cheek bone, she had what looked like a hive/ blister but it was red and it looked like it was raised"; BNT162b2 (Dose 2), administration date: 20Feb2021, for Covid-19 immunization, reaction(s): "she got a hive on her face in a different spot on the same side of her face", "Arm soreness"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: Sep2021, for Covid-19 immunization, reaction(s): "Arm soreness". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diverticulitis", start date: 2009 (ongoing), notes: Pulmonary Langerhans autoimmune of lungs and was on high risk. Oxygen levels 97% and she functions; "acid reflux" (unspecified if ongoing); "blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "Pulmonary Langerhans" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement; TRAZODONE taken for sleep disorder; SIMVASTATIN taken for blood cholesterol; OMEPRAZOLE taken for gastrooesophageal reflux disease; PEPCID AC taken for gastrooesophageal reflux disease; B12 [CYANOCOBALAMIN] taken for supplementation therapy. Vaccination history included: BNT162b2 (Dose 1), administration date: 30Jan2021, for Covid-19 immunization, reaction(s): "did have something on her skin on her face under her eye near her cheek bone, she had what looked like a hive/ blister but it was red and it looked like it was raised", "Arm soreness"; BNT162b2 (Dose 1), administration date: 30Jan2021, for COVID-19 immunization, reaction(s): "did have something on her skin on her face under her eye near her cheek bone, she had what looked like a hive/ blister but it was red and it looked like it was raised"; BNT162b2 (Dose 1), administration date: 30Jan2021, for COVID-19 immunisation, reaction(s): "did have something on her skin on her face under her eye near her cheek bone, she had what looked like a hive/ blister but it was red and it looked like it was raised"; BNT162b2 (Dose 2), administration date: 20Feb2021, for Covid-19 immunization, reaction(s): "she got a hive on her face in a different spot on the same side of her face", "Arm soreness"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: Sep2021, for Covid-19 immunization, reaction(s): "Arm soreness". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2, solution for injection), on 15May2022 at 10:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 33 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: "Ankylosing Spondylitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested positive on an antigen test. Therapeutic measures were not taken as a result of drug ineffective, covid-19.
Age: 54.0
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) (Physician) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Dec2020 as dose 1, single (Lot number: Elo140), on 10Jan2021 as dose 2, single (Lot number: El1283) and on 24Sep2021 as dose 3 (booster), single (Lot number: 301358a) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 31Mar2022 at 12:00 as dose 4 (booster), single (Lot number: 025l21b), in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: OMEPRAZOLE, start date: Feb2020; WELLBUTRIN, start date: Nov2021; CYMBALTA, start date: Oct2019; ESTRADIOL, start date: Dec2017; MIRENA, start date: Dec2017; TESTOSTERONE, start date: Dec2018; MELATONIN, start date: Dec2017. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Rebound covid on 21Jun2022 at 20:00 with no treatment plus initial antigen test plus on 05Jun2022, 5 days of paxlovid and negative antigen tests. Recurrence of symptoms started 22Jun2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (unspecified date) Negative, notes: 5 days of paxlovid and negative antigen tests; (05Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid (start date- 04Jun2022, stop date- 09Jun2022).; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, vaccination failure  and the administration of the vaccine cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller stated that he had tested positive for Covid however he "hasn't gotten really sick, but was fairly sick yesterday."; Caller stated that he had tested positive for Covid however he "hasn't gotten really sick, but was fairly sick yesterday."; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jun2022, outcome "unknown", COVID-19 (medically significant) with onset Jun2022, outcome "recovering" and all described as "Caller stated that he had tested positive for Covid however he "hasn't gotten really sick, but was fairly sick yesterday."". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Reporter tested positive for COVID however he "hasn't gotten really sick, but was fairly sick yesterday." Caller stated that his doctor put him on Paxlovid and the Paxlovid has "given him terrible gastro stuff, and that's one of the side effects." "The more I read about it how people are rebounding after taking it (Paxlovid) and getting sick again, is it safe for me? Can I just stop it?" He does not have any underlying health conditions, is only on cholesterol medication, weighs 170 pounds, and is fit. He concerns of continuing to take the medication due to rebound effects. He provided that he received the 2 dose series and both boosters of the Pfizer COVID-19 vaccine and his "partner also got COVID, had one bad day, but now is getting better." He also had one bad day but is now getting better." He had only taken 1 pack, 3 pills in the evening, and 3 pills in the morning. He also had friends who have been vaccinated and gotten COVID afterwards. He asked if there "are any reports of people who got off of the first dose who have had terrible rebound effects?" It is hard for him to get in touch with his HCP as he doctors through the withheld hospital for healthcare. He reported that he was making the decision to stop taking Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; I was fully vaccinated (Pfizer) + boosted twice (Pfizer). Latest booster (Pfizer) 09Feb2022/Tested positive for Covid on 27May2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), 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 on 09Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 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), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "I was fully vaccinated (Pfizer) + boosted twice (Pfizer). Latest booster (Pfizer) 09Feb2022/Tested positive for Covid on 27May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27May2022) Positive, notes: I tested positive for COVID-19; (07Jun2022) Positive, notes: wake up with symptoms. Test showed & was positive again for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Home tested positive for Covid after being vaccinated x2 and boosted x2.; Home tested positive for Covid after being vaccinated x2 and boosted x2.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 28May2022 as dose 4 (booster), single (Lot number: FX9895) at the age of 74 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: "Blood pressure" (unspecified if ongoing); "GERD" (unspecified if ongoing); "AFib" (unspecified if ongoing); "BPH" (unspecified if ongoing); "Naproxen, Ibuprofen causes anaphylaxis" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Naproxen, reaction(s): "Known allergies: Naproxen causes anaphylaxis", notes: NSAIDS (Naproxen) causes anaphylaxis; Ibuprofen, reaction(s): "Known allergies: Ibuprofen causes anaphylaxis", notes: NSAIDS (Ibuprofen) causes anaphylaxis. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Home tested positive for Covid after being vaccinated x2 and boosted x2.". The patient underwent the following laboratory tests and procedures: Body temperature: (20Jun2022) 98.9, notes: low grade fever 98.9 (I am generally 97.5); SARS-CoV-2 test: (unspecified date) Positive, notes: Home tested positive for Covid; (unspecified date) Negative, notes: I tested negative; (unspecified date) Negative, notes: I continue to test negative w/home tests; (unspecified date) Unknown results, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: It was reported that, Adverse event: home tested positive for Covid after being vaccinated x2 and boosted x2. Virtually asymptomatic, slight scratch throat, clear nasal drainage (sinus allergy?). 4 days after testing positive I was prescribed Paxlovid which I completed. I tested negative x2 and never had fever. On 19062022 I began to exhibit symptoms, drippy nose and raspy throat. This time symptoms were much worse. I took expectorant to work on non-productive cough. Cough is persistent. On 20Jun2022 I ran a low-grade fever 98.9 (I am generally 97.5) Similar to serious allergy symptoms. Runny nose, chest congestion, cough and itchy eyes are persistent. I continue to test negative w/home tests.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 at 14:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 27Mar2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 13Apr2022 at 12:00 as dose 4 (booster, single) (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "recovering", COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". 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.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive rapid test; positive rapid test; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 years 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. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "positive rapid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jun2022) Positive, notes: positive rapid test 5 days after ending paxlovid treatment. Therapeutic measures were taken as a result of covid-19, drug ineffective. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Vomiting
Clinical narrative: One day after receiving the her first dose of the vaccine, my daughter was not eating and vomited; One day after receiving the her first dose of the vaccine, my daughter was not eating and vomited. Thus far she has only had one round of vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 2-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jun2022 as dose 1, single (Lot number: FT9142) at the age of 2 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DECREASED APPETITE (non-serious) with onset 22Jun2022 at 18:00, outcome "recovering", described as "One day after receiving the her first dose of the vaccine, my daughter was not eating and vomited"; VOMITING (non-serious) with onset 22Jun2022 at 18:00, outcome "recovering", described as "One day after receiving the her first dose of the vaccine, my daughter was not eating and vomited. Thus far she has only had one round of vomiting". Therapeutic measures were not taken as a result of decreased appetite, vomiting.  Additional information: It was reported that other medical history and known allergies were noted as no. Facility type vaccine was noted as pharmacy or drug store. The patient did not experience covid-19 prior to vaccination and the patient was not tested for covid-19 post vaccination. The patient did not receive other vaccine in four weeks and did not receive other medications in two weeks. One day after receiving the her first dose of the vaccine, the patient was not eating and vomited. Thus far she has only had one round of vomiting. Up to this point no one else in the house had been sick so a stomach bug seemed less likely. Reporter's other daughter (age 4) received her first shot on the same day and has not had any symptoms.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Vaccination site cyst, Vaccination site joint movement impairment, Vaccination site pain
Clinical narrative: lesion or cyst that is on the side of her right arm; it hurts to lift her arm at the injection site; right arm hurts and it hurts to lift her arm at the injection site; effecting her exercise; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Anatomical location: in her right arm), when the patient was 43 years old, for covid-19 immunization; Hepatitis b (she had a Hepatitis B vaccine in her left arm), for Immunization. The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "not recovered", described as "effecting her exercise"; VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (non-serious) with onset 2021, outcome "not recovered", described as "it hurts to lift her arm at the injection site"; VACCINATION SITE CYST (medically significant) with onset 2021, outcome "not recovered", described as "lesion or cyst that is on the side of her right arm"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "right arm hurts and it hurts to lift her arm at the injection site". The events "lesion or cyst that is on the side of her right arm", "it hurts to lift her arm at the injection site", "right arm hurts and it hurts to lift her arm at the injection site" and "effecting her exercise" required physician office visit. Therapeutic measures were taken as a result of vaccination site cyst.  Clinical course: Vaccination facility type was hospital and not facility type. Vaccine Second Dose was taken in the morning. Caller reported that she received both Pfizer Covid 19 vaccines purposely administered in the same arm, her right arm. Caller stated that she had a Hepatitis B vaccine in her left arm. Caller states that she was going to have to go to a Cosmetic Surgeon to remove a lesion or cyst that was on the side of her right arm from the Covid Vaccine. Caller stated that her right arm hurt and it hurts to lift her arm at the injection site. Reported that she was having issues with her right  arm and she could feel it, it was a pretty good size. She had to get an ultrasound done to see if it was connected to her muscle and tissue and then went to the Cosmetic Surgeon. It was also effecting her exercise. The lesion/cyst and arm hurting started shortly after her second vaccination, which was either in Nov2021 or Dec2021.   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: Rash
Clinical narrative: rashes on the face and even in few places on body as well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: ER8736), in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0161), for COVID-19 immunisation. The following information was reported: RASH (non-serious), outcome "unknown", described as "rashes on the face and even in few places on body as well". The events "rashes on the face and even in few places on body as well" required physician office visit. Therapeutic measures were taken as a result of rash.  Additional information: Consumer stated, he just wanted to check in case after taking the Pfizer vaccination for COVID, Are there any non-side effect with respected to any skin allergy on face. Consumer didn't have Expiration Date. The patient had three dosages of Vaccination. The patient had no other medical condition and concomitant medication. No lab test was done. The consumer had consulted dermatologist, who actually prescribed hydrocortisone to apply wherever the rashes on the face and even in few places on body as well. The patient did not receive other vaccines within four weeks prior to COVID vaccine. Anatomical site of vaccination consumer stated on arm left and right arm. Reporter stated, after taking the vaccination only he was facing the problem of rashes and everything and rashes are not going away from last two years after he got vaccinated for the second dose.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200893991 same product and event, different dose;