chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Exposure during pregnancy
Clinical narrative: Pregnant: Yes/ Due Date: 24Aug2022; 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 40-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 11Jan2021 as dose 2, single (Lot number: EL3248), in left arm and on 25Oct2021 as dose 3 (booster), single (Lot number: 32030BD), in left arm for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient is expected to deliver a baby(s) on 24Aug2022. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment"; EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Pregnant: Yes/ Due Date: 24Aug2022". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with Paxlovid from 01Jun2022 to 06Jun2022. Other medication in 2 weeks product was Prenatal vitamins (brand- Nature made).
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 13Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 24 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 included: "Mild exercise induced asthma" (unspecified if ongoing), notes: Mild exercise induced asthma. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-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), as dose 3 (booster), single (Batch/Lot number: unknown) and on 16May2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS, start date: 01Mar2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) contracted COVID; (Jun2022) Negative; (Jun2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient was given Paxlovid from 03Jun2022 to 07Jun2022 for the treatment of Covid-19. The patient recovered after five days and was negative by antigen test. Three days later, the patient felt ill again and tested positive by antigen test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 05Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 08Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing), notes: Diabetes type 2; "hypertension" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Dose 1, 2: Pfizer/ Dose 3: Moderna" (unspecified if ongoing), notes: Dose 1, 2: Pfizer/ Dose 3: Moderna. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". 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: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, 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) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "allergies" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL SINUS [PARACETAMOL;PSEUDOEPHEDRINE HYDROCHLORIDE], start date: 06Jun2022, stop date: 09Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical information: Anti viral details product for COVID 19 Treatment Paxlovid, treatment start date: 03Jun2022, treatment stop date: 04Jun2022, indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 59-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown) and in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years for Covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: high blood pressure. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jun2022) Negative, notes: Took home COVID test on Tuesday, NEG; (10Jun2022) Positive, notes: Tested POS for COVID on home test. Therapeutic measures were taken as a result of Covid-19. 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: 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 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 06Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative; (Jun2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective included Paxlovid.  Clinical course: Tested negative after 5 days of treatment, tested positive for covid after 10 days. Runny nose came back after 9 days.  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: Drug ineffective, Suspected COVID-19
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 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 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 and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of suspected covid-19, drug ineffective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, 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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: EW0150), on 23Apr2021 as dose 2, single (Lot number: ER8735) and on 10Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing), notes: Mild asthma. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin; Azithromycin, reaction(s): "Known allergies: Azithromycin", notes: Known allergies: Azithromycin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Rebound of symptoms on 06Jun2022, positive test again on 07Jun2022. (note received chemotherapy on 03Jun2022) Initial sx rhinorrhea, congestion, 1 day low grade fever Rebound sx headache, congestion, throat clearing, no fever. Mild asthma. Diffuse B cell lymphoma diagnosed Jan2022, on R-CHOP therapy every 3 weeks. Final chemo 03Jun2022.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diffuse large B-cell lymphoma
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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: EW0150), on 23Apr2021 as dose 2, single (Lot number: ER8735) and on 10Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing), notes: Mild asthma. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin; Azithromycin, reaction(s): "Known allergies: Azithromycin", notes: Known allergies: Azithromycin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Rebound of symptoms on 06Jun2022, positive test again on 07Jun2022. (note received chemotherapy on 03Jun2022) Initial sx rhinorrhea, congestion, 1 day low grade fever Rebound sx headache, congestion, throat clearing, no fever. Mild asthma. Diffuse B cell lymphoma diagnosed Jan2022, on R-CHOP therapy every 3 weeks. Final chemo 03Jun2022.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 64-year-old female patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported.The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: 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 65-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reported as adverse event treated with Paxlovid and received Positive COVID test after two negative tests. Rebound COVID adverse event.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 13Oct2021 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing), notes: known allergies No. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective. Anti viral details, product=COVID 19 Treatment, brand=Paxlovid, treatment start date=01Jun2022, treatment stop date=05Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Sep2021 at 16:15 as dose 3 (booster), single (Lot number: FE3592) at the age of 33 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: WELCHOL, start date: 01Jul2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 11Jun2022 to 11Jun2022 (NDC 0069-1085-30). Known allergies reported as NA.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Pulmonary congestion, Pyrexia, Vaccination failure
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: ER8737), in right arm, on 26Apr2021 as dose 2, single (Lot number: EW0172), in right arm and on 01Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 53 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Anxiety/depression" (unspecified if ongoing); "Anxiety/depression" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; TRAZODONE; CIMETIDINE; CETIRIZINE; FINASTERIDE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID infection"; PULMONARY CONGESTION (medically significant) with onset 27May2022, outcome "unknown", described as "congestion in lungs"; PYREXIA (non-serious) with onset 27May2022, outcome "unknown", described as "fever"; HEADACHE (non-serious) with onset 27May2022, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, Covid-19. Patient did receive the vaccine. Patient received treatment for COVID-19 as Paxlovid from 28May2022 to 01Jun2022. Adverse event Rebound COVID infection after taking Paxlovid and having symptoms disappear; initial COVID infection manifested as chest cold (congestion in lungs, fever, headache) on 27May, and rebound infection is manifesting as head cold (sneezing, sinus congestion) starting 08Jun. No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 01Apr2021 as dose 2, single (Lot number: ER8737), in left arm, on 31Aug2021 as dose 3 (booster), single (Lot number: FE3184), in right arm and on 09Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Ulcerative Colitis" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ, start date: 01Dec2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid Rebound. Two days after completing Paxlovid I developed a runny nose, congestion & cough with fatigue.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 as dose number unknown, single (Lot number: 30145ba) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). There were no 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: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Palaxovid from 23May2022 to 28May2022 for COVID 19 Treatment.   Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 at 19:15 as dose 1, single (Lot number: EL9262), in left arm and on 02Mar2021 at 16:15 as dose 2, single (Lot number: EN6198) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "crohns" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "macular degeneration" (unspecified if ongoing); "dry eye" (unspecified if ongoing). Concomitant medication(s) included: PRESERVISION, start date: Jan2009; SIMVASTIN, start date: Jan2007. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Antiviral details Product-COVID 19 Treatment, Treatment start date-29May2022, Treatment stop date-10Jun2022, Indication-Treatment of COVID-19. Other medication details, Other medication in 2 weeks product-Prednisone, Other medication in 2 weeks start date-21Apr2022, Other medication in 2 weeks stop date-03Jun2022, Other medication in 2 weeks product-B-100 Complex, Other medication in 2 weeks brand-Nature Made, Other medication in 2 weeks product-Triamterene/HCTZ, Other medication in 2 weeks product-Caltrate 600 +D, Other medication in 2 weeks product-fenofibrate 48mg. Adverse event runny nose, plugged ear off and on, hoarse voice, minor throat scratch. Adverse events start date 10Jun2022, Adverse event start time 07:45 AM. If patient recovered Not recovered, If treatment ae no.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 11Jan2021 as dose 2, single (Lot number: EK4176), in left arm and on 24Sep2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 49.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Nov2021 as dose 3 (booster), single (Lot number: 301135BA) at the age of 49 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 included: "Psoriatic arthritis" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allergies: bananas, avocado" (unspecified if ongoing); "Known allergies: avocado" (unspecified if ongoing); "Known allergies: birch" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Prednisone, reaction(s): "Known allergies: prednisone"; Cortisone, reaction(s): "Known allergies: cortisone"; Flucatisone, reaction(s): "Known allergies: flucatisone". No other medication in 2 weeks. 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: COVID-19, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55-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) at the age of 55 years for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Apr2022, outcome "not recovered" and all described as "test positive on 15Apr2022, I had 2 Pfizer COVID vaccination and 1 booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Apr2022) Positive; (24Apr2022) Negative; (26Apr2022) Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical information: Patient received on 16Apr2022 Paxlovid for COVID Positive. tested positive on 15Apr2022, tested Negative on 24Apr2022, tested Positive on 26Apr2022. Fine now. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal neoplasm, Abdominal pain, Chemotherapy, Death, Lymphoma
Clinical narrative: The patient received her first booster following an initial double dose without complaint nine months before.  She developed extreme abdominal pain in the days immediately following the booster injection.  This was diagnosed the next month as occult source malignant lymphoma with accompanying lower abdominal tumors, some or all of which presumably were already present before the booster injection.  Chemotherapy was begun but failed to arrest the spread and growth of tumors and resultant kidney failure.  Leukocyte count remained unproblematic.  The patient passed away 3 months after the booster injection.  Other than proximity in time, the relationship, if any, of her adverse event with the booster or the earlier injections is unclear.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Renal failure, White blood cell count
Clinical narrative: The patient received her first booster following an initial double dose without complaint nine months before.  She developed extreme abdominal pain in the days immediately following the booster injection.  This was diagnosed the next month as occult source malignant lymphoma with accompanying lower abdominal tumors, some or all of which presumably were already present before the booster injection.  Chemotherapy was begun but failed to arrest the spread and growth of tumors and resultant kidney failure.  Leukocyte count remained unproblematic.  The patient passed away 3 months after the booster injection.  Other than proximity in time, the relationship, if any, of her adverse event with the booster or the earlier injections is unclear.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; vaccine administered after temperature excursion; Information has been received from an office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided.  On 13-MAY-2022, the patient received measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) 0.5 ML subcutaneously (SQ) (valid lot# U006485 with expiration date 26-FEB-2023; strength was not reported) for prophylaxis, the vaccine was administered after temperature excursion (8.5 Celsius (C) degree for 4 hours and 20 minutes; no previous temperature excursion)(Product storage error). No additional adverse event was reported (No adverse event).
Sex: F
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: 1st dose of Bexsero on 05May2022 and received a dose of Trumenba on 06June2022 as 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 5th May 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 6th June 2022, the patient received TRUMENBA. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-JUN-2022 Reporter's Comment: The patient received her 1st dose of Bexsero and instead of getting a 2nd dose of Bexsero, she was given a dose of Trumenba. The healthcare professional received information from the patient's mother. The mother said her daughter received the 1st dose of Bexsero a month and a day ago and healthcare professional gave estimated date of 5th May 2022. The reporter consented to follow up via email. Additional Supportive Information: The patient received her 1st dose of Bexsero and instead of getting a 2nd dose of Bexsero she was given a dose of Trumenba, which led to interchange of vaccine products.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Dizziness, Syncope, Vomiting
Clinical narrative: She sat on the floor and fainted; Stomach ache  less than 24 hours after receiving vaccine.; Being dizzy less than 24 hours after receiving vaccine; She came to a few seconds later she was vomiting; This case was reported by a consumer via call center representative and described the occurrence of fainting in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fainting (serious criteria GSK medically significant), stomach pain, dizziness and vomiting. On an unknown date, the outcome of the fainting, stomach pain, dizziness and vomiting were unknown.   It was unknown if the reporter considered the fainting, stomach pain, dizziness and vomiting to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-JUN-2022 Reporter's Comments: The patient reported case for herself. The patient received Shingrix dose 1 about 6 months ago from reporting (did not had the exact date) and reported having a stomachache and being dizzy less than 24 hours after receiving vaccine. The patient stated that evening she got up in the middle of the night and when she got to the bathroom, she sat on the floor and fainted, she stated that when she came to a few seconds later she was vomiting.    The patient was afraid to get dose 2 but would consult her health care professional.  The reporter did not consent to follow up.
Age: 30.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Oropharyngeal pain, Tonsillar inflammation
Clinical narrative: INFLAMED TONSILS; SORE THROAT; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLAR INFLAMMATION (INFLAMED TONSILS) and OROPHARYNGEAL PAIN (SORE THROAT) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Panuveitis.    Concomitant products included METHOTREXATE for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) Citrate free; Solution for injection in pre-filled pen. On an unknown date, the patient experienced TONSILLAR INFLAMMATION (INFLAMED TONSILS) and OROPHARYNGEAL PAIN (SORE THROAT). At the time of the report, TONSILLAR INFLAMMATION (INFLAMED TONSILS) outcome was unknown and OROPHARYNGEAL PAIN (SORE THROAT) had resolved.            No concomitant medications were reported.  It was unknown if the patient was enrolled in a COVID-19 vaccine trial.  The reporter causality for the events with HUMIRA was not reported.  No treatment information was reported.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Prostatic specific antigen
Clinical narrative: flu like symptoms/fever/ headache; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms/fever/ headache) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms/fever/ headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms/fever/ headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2022, Prostatic specific antigen: 4.43 Elevated to 4.43. On 14-May-2022, Prostatic specific antigen: 3.73 Result:3.73. On 10-Jun-2022, Prostatic specific antigen: 4.64 measured at 4.64.         Concomitant medications details were not reported by the reporter.  Reportedly, the symptoms occurred the same day as the injection, but much later in the day around 8-9 PM. It was stated that these symptoms that had experienced were typical to what he had reading on all the websites.   Additionally, the patient had been going to receive PSA tests for his prostate for the past 10 years and over the past 2-3 years he had been going to receive these tests more often and was scheduled to had this test at the beginning of MAY. The patient had discussed these findings with his urologist who recommended to received an MRI of his prostate and also had been following the research of another urologist online who had been seeing similar trends in patients after vaccination.   Patient had not taken any medications or treatments for any of his symptoms.   This case was linked to MOD-2022-588193, MOD-2022-588201, MOD-2022-588203 (Patient Link).
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Musculoskeletal stiffness, Myalgia
Clinical narrative: Other then a sore arm, I had no reaction to the 1st shot. With the 2nd one, I had a terrible time starting about 6 hours after the injection, beginning with a severe headache and muscle pain and stiffness (took an aspirin). It proceeded after several hours to fever (100.4*) and chills, then nausea (no vomiting) and stomach pain. Upon getting up about 3 a.m., I fainted, but was fine after that last event. Because of the symptoms, I did take a self-administered COVID test, which was negative. I'm reporting these side effects because of the severity of the symptoms.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Other then a sore arm, I had no reaction to the 1st shot. With the 2nd one, I had a terrible time starting about 6 hours after the injection, beginning with a severe headache and muscle pain and stiffness (took an aspirin). It proceeded after several hours to fever (100.4*) and chills, then nausea (no vomiting) and stomach pain. Upon getting up about 3 a.m., I fainted, but was fine after that last event. Because of the symptoms, I did take a self-administered COVID test, which was negative. I'm reporting these side effects because of the severity of the symptoms.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Syringe issue
Clinical narrative: Error: Leaking from Injection Site-
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Headache-Severe
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Arthritis, Mobility decreased, Peripheral swelling, Skin reaction
Clinical narrative: Systemic: Joint Pain-Medium, Additional Details: finger swollen,red,hurting,cant move well
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Erythema, Peripheral swelling
Clinical narrative: Systemic: Joint Pain-Medium, Additional Details: finger swollen,red,hurting,cant move well
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Lethargy
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rheumatoid arthritis, Rheumatoid factor positive, Tendon disorder
Clinical narrative: Development of Rheumatoid Arthritis 6 weeks after 2nd shot, with no previous history of autoimmune disease or symptoms.  Patient was in excellent health, a competitive runner, with a healthy diet.  Degeneration of achilles tendon in both ankles, followed by multiple rheumatoid flareups in both feet and right hand and fingers.  RH factor positive.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Aspiration, COVID-19, Chest X-ray normal, Cough, Diarrhoea
Clinical narrative: Patient is fully vaccinate.  COVID positive on admission 5/13/2022.   66y.o. female w/ a PMHx of cerebral palsy, GERD, asthma, anxiety and depression who presents to the  ED d/t sudden difficulty in breathing and trouble swallowing. Patient's mother states that patient has been diagnosed with COVID-19 since May 4.  Her initial symptoms were cough, sore throat and body aches.  She then presented to her family physician who prescribed her Paxilovid, after few initial doses patient started develop diarrhea and then paxlovid was discontinued.  Mother reports overall improvement of COVID since taking Paxlovid.In the ED,  pt was patient presented for episode of shortness of breath secondary aspiration of food.  CXR: no acute process. not hypoxic, decadron not indication.  Monitor for signs of aspiration pneumonia.  Discharged home.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Oropharyngeal pain, Pain, SARS-CoV-2 test positive
Clinical narrative: Patient is fully vaccinate.  COVID positive on admission 5/13/2022.   66y.o. female w/ a PMHx of cerebral palsy, GERD, asthma, anxiety and depression who presents to the  ED d/t sudden difficulty in breathing and trouble swallowing. Patient's mother states that patient has been diagnosed with COVID-19 since May 4.  Her initial symptoms were cough, sore throat and body aches.  She then presented to her family physician who prescribed her Paxilovid, after few initial doses patient started develop diarrhea and then paxlovid was discontinued.  Mother reports overall improvement of COVID since taking Paxlovid.In the ED,  pt was patient presented for episode of shortness of breath secondary aspiration of food.  CXR: no acute process. not hypoxic, decadron not indication.  Monitor for signs of aspiration pneumonia.  Discharged home.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Confusional state, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Narrative: COVID fully vaccinated admitted with fevers and confusion found to be COVID positive (given remdesivir and dexamethasone)
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Narrative:  COVID fully vaccinated admitted with incidental positive COVID given remdesivir for 5 days
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Encephalopathy, Fall, SARS-CoV-2 test positive, Urinary tract infection
Clinical narrative: Narrative:  COVID fully vaccinated, admit for encephalopathy and falls found to be COVID positive with UTI
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Narrative:  COVID fully vaccinated, admitted on 5/24 found to be COVID positive on 5/30 incidentally
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Narrative: COVID fully vaccinated, COVID positive on admission and treated with remdesivir x 3 days
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Rectal haemorrhage, SARS-CoV-2 test positive
Clinical narrative: Narrative: COVID fully vaccinated, incidentally COVID positive on admit for BRBPR
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dehydration, Mental status changes, Pyrexia
Clinical narrative: Narrative:  Patient received Moderna booster yesterday. She developed chills, fever, weakness, and AMS overnight. She was transported to the ED via 911 and was dx with dehydration. She was treated with fluids and sent home. Patient felt back to her baseline within 3 days. Patient has 1st vaccine, also J&J on 3.31.21 and did not have any adverse effects.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Narrative:  77 yo male died on 6/2/2022 of unknown cause found at home by lawn care company at his residence. Pt had received a covid EUA vaccine (J&J) on 5/25/21. No info in chart regarding circumstances of pt's death. Past Medical History: Perforation of intestine (SCT 56905009) Colostomy bag changed (SCT 183209007) Renal failure (SCT 42399005) Recurrent urinary tract infection (SCT 197927001) Malnutrition (SCT 2492009) Gastroesophageal reflux disease (SCT 235595009) Cluster headache (SCT 193031009) Tobacco use (SCT 110483000) Anemia (SCT 271737000) Seen by palliative care medicine service (SCT 305824005) Postoperative peritonitis (SCT 427883005Pyelonephritis (SCT 45816000) Neck pain (SCT 81680005) Degeneration of cervical intervertebral disc (SCT 69195002) Mild cognitive disorder (SCT 386805003) Colonoscopy in 2003- normal. (ICD-9-CM 799.9) Osteopenia (ICD-9-CM 733.90) ACQUIRED (ICD-9-CM 727.03) Basal Cell Cancer (ICD-9-CM 173.9) Unspecified disorder of adrenal glands (ICD-9-CM 255.9) Headache (ICD-9-CM 784.0) Basal cell carcinoma - primary (ICD-9-CM 173.9) Benign essential hypertension (SCT 12010Hyperlipidemia (SCT 55822004) GERD (ICD-9-CM 530.81) Degeneration of lumbar intervertebral disc (SCT 26538006) Abdominal aortic aneurysm (SCT 233985008Anxiety reaction (SCT 48694002) Panic disorder without agoraphobia with Vitamin B12 deficiency (non anemic) (SCT 64117007) Chronic cluster headache (SCT 230473009)Kidney stone (SCT 95570007) Active problem list reviewed
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Injection site discolouration, Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Fever    Moderate amount of edema noted from under left axillary to the deltoid area (with two pools of edema). Injection site, raised and very red with purplish discoloration (not like a bruise). Shingles rash started < 48 hrs (under left breast  and down left ar    Narrative: Seen MD a couple of days after the injection (72 hours) after injection.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Fever    Moderate amount of edema noted from under left axillary to the deltoid area (with two pools of edema). Injection site, raised and very red with purplish discoloration (not like a bruise). Shingles rash started < 48 hrs (under left breast  and down left ar    Narrative: Seen MD a couple of days after the injection (72 hours) after injection.