chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jun2022 at 10:00 as dose number unknown, single (Lot number: FS4991) at the age of 74 years, in left arm and on 17Sep2022 at 15:00 as dose number unknown, single (Lot number: 652524), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was unknown whether the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine.
Age: 75.0
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 75-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2022 at 14:00 as dose 1, single (Lot number: FJ4989), in right arm and on 12Sep2022 at 14:00 as dose 2, single (Lot number: NCD #59267-0304-02) at the age of 75 years, in right leg for covid-19 immunisation. The patient's relevant medical history included: "Mild kidney disease" (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 2023, outcome "unknown" and all described as "COVID 19 Treatment".  Clinical course: COVID 19 was treated with Paxlovid. Paxlovid treatment start date: 03Mar2023 and stop date: 07Mar2023. It was reported that there was no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300118739 Same patient, different product/event;US-PFIZER INC-202300118838 Same patient, different dose/ event;
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) 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: "Major depression" (unspecified if ongoing); "Generalized anxiety" (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 19Oct2022 at 12:00, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were not 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine brand other: Moderna; Dose number: 04; Patient Drug Start Date: 01Apr2022; 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 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: EW0151), in left arm, on 28Apr2021 as dose 2, single (Lot number: EW0179), in left arm and on 31Oct2021 as dose 3 (booster), single (Lot number: FC3180) at the age of 55 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 026L21B), in right arm and on 07Oct2022 at 16:00 as dose 5 (booster), single (Lot number: 066F22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune hepatitis" (unspecified if ongoing). Concomitant medication(s) included: MYCOPHENOLATE MOFETIL, start date: 01Jan2012, stop date: 17Mar2023. Past drug history included: Tramadol, reaction(s): "known allergies: Tramadol", notes: known allergies: Tramadol. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Apr2022, outcome "unknown", described as "vaccine brand other: Moderna; Dose number: 04; Patient Drug Start Date: 01Apr2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Positive, notes: Then 5 days after that am testing positive for COVID again; (17Mar2023) Negative, notes: Tested negative 6 days after Paxlovid treatment began. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid was used from 07Mar2023 to 11Mar2023 for treatment of COVID-19. Tested negative 6 days after Paxlovid treatment began. Then 5 days after that am testing positive for COVID again.
Age: 31.0
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 contactable reporter(s) (Consumer or other non HCP).  A 32-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booter), single (Batch/Lot number: unknown) at the age of 31 years 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: "Ulcerative colitis" (unspecified if ongoing); "bipolar II" (unspecified if ongoing). No Known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment Paxlovid from 08Mar2023 to 12Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cervical vertebral fracture, Drug ineffective, Fall, Pulmonary fibrosis
Clinical narrative: COVID-19; COVID-19; He had too much scarring to his lungs; Fell and broke his neck; Fell and broke his neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 76-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Had Cardio/renal issues" (unspecified if ongoing); "Had Cardio/renal issues" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death), COVID-19 (death), outcome "fatal" and all described as "COVID-19"; PULMONARY FIBROSIS (death, medically significant), outcome "fatal", described as "He had too much scarring to his lungs"; FALL (medically significant), CERVICAL VERTEBRAL FRACTURE (medically significant), outcome "unknown" and all described as "Fell and broke his neck". The patient date of death was 28Jul2022. Reported cause of death: "COVID-19", "He had too much scarring to his lungs". It was not reported if an autopsy was performed. Clinical course: He had complications from COVID. He was totally vaccinated but had Cardio/renal issues so he was high risk. He had too much scarring to his lungs. He died. He did get over the first bought with COVID, but fell and broke his neck and got COVID again and died 28Jul2022. He had all but the last two boosters.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: He had too much scarring to his lungs; COVID-19; COVID-19
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: vaccine brand other=Janssen; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 as dose 3 (booster), single (Lot number: GL0446) at the age of 75 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Dec2021 as dose 2 (booster), single (Lot number: FJ8762), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 03Apr2021 as dose 1, single (Lot number: 042A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Htn" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "asthma" (unspecified if ongoing); "known allergies Rosemary" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovering", described as "vaccine brand other=Janssen"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 28Feb2023 to 06Mar2023.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccines cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.
Age: 73.0
Sex: M
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 74-year-old male patient received BNT162b2 (BNT162B2), on 06Aug2022 as dose 4 (booster), single (Lot number: fp7137) at the age of 73 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: I tested Covid positive after 3 continuous Covid test negative; Negative, notes: I tested Covid positive after 3 continuous Covid test negative; Negative, notes: Tested Covid positive after 3 continuous Covid test negative; Negative, notes: Tested Covid positive after 3 continuous Covid test negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 09Mar2023 to 13Mar2023.
Age: 69.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 3 (booster), single (Lot number: gh9693) at the age of 69 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 52 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Mar2023) Positive, notes: Was barely positive on 16Mar; (17Mar2023) Positive, notes: Strong positive test on 18Mar. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and in Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 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: "Thyroid cancer survivor" (unspecified if ongoing); "Prostate cancer survivor" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM, start date: Jun2008. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Mar2023) Negative; (19Mar2023) Positive. The events were reported as non-serious. The patient received PAXLOVID as treatment for COVID-19 from 06Mar2023 to 11Mar2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic Migraine" (unspecified if ongoing); "Lichen sclerosis" (unspecified if ongoing); "Psoriasis" (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 Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative, notes: 2 negative tests; (Mar2023) Negative, notes: 2 negative tests; (19Mar2023) strongly Positive, notes: strongly positive rapid antigen test result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19, FLUC3
Symptoms: Pemphigoid
Clinical narrative: bulluous pemphigoid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 11Nov2022 as unk, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FH8028, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 18Nov2021, when the patient was 46-year-old, for Covid-19 immunization, reaction(s): "bulluous pemphigoid", "itchy blisters on my skin", "itchy blisters on my skin"; Covid-19 vaccine (Dose Number: 2, manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose Number: 1, manufacturer unknown), for Covid-19 immunization. The following information was reported: PEMPHIGOID (medically significant) with onset 21Nov2022, outcome "not recovered", described as "bulluous pemphigoid". The event "bulluous pemphigoid" required physician office visit. Therapeutic measures were taken as a result of pemphigoid. Clinical course: The patient was given oral and topical steroid and it improved. This time it is lasting longer. The blisters begin as itchy and if she scratched them they would pop and turn into a scab to heal. She has never had any of these symptoms before receiving the covid vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300120267 same patient/vaccine, different dose/events;US-PFIZER INC-202300120268 same patient/vaccine/event, different dose;
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Pre-diabetes" (unspecified if ongoing); "High cholesterol" (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 Mar2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative, notes: for 3 days after last dose of Paxlovid; (Mar2023) Positive, notes: on day 5. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid from 09Mar2023 to 14Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Product use issue, Productive cough, Sinusitis
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Pre-diabetes" (unspecified if ongoing); "High cholesterol" (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 Mar2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative, notes: for 3 days after last dose of Paxlovid; (Mar2023) Positive, notes: on day 5. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid from 09Mar2023 to 14Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Blood urine, Dysuria, Feeling hot
Clinical narrative: it feels very warm and I feel warmer; I feel my urine was like pinkish now it is getting worse and now I get come out with blood, Urine with blood; little bit pain now it pain more and it come out with blood; Pain with blood and this is very painful and it make me sticky; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Mar2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: BLOOD URINE (non-serious) with onset 17Mar2023, outcome "unknown", described as "I feel my urine was like pinkish now it is getting worse and now I get come out with blood, Urine with blood"; DYSURIA (non-serious) with onset 17Mar2023, outcome "unknown", described as "little bit pain now it pain more and it come out with blood; Pain with blood and this is very painful and it make me sticky"; FEELING HOT (non-serious), outcome "unknown", described as "it feels very warm and I feel warmer".  Additional information: Consumer had the Booster shot (Clarified as Pfizer COVID 19 Booster shot) yesterday (as reported) morning and then last night felt the urine was like pinkish now it is getting worse and now come out with blood, Urine with blood. After took the Booster shot yesterday morning and it start last night there start to be little bit pain now it pains more and it come out with blood. Doesn't have like that before and it feels very warm/feel warmer.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine_brand_other=Moderna; This is a spontaneous report received from contactable reporter (consumer). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: EL9269), in left arm, on 12Mar2021 as dose 2, single (Lot number: E16200), in left arm and on 05Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 68 years, in left arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10May2022 as dose 4 (booster), single (Lot number: 056MZ1A), in left arm and on 13Sep2022 as dose 5 (booster), single (Lot number: AS714SB), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). Concomitant medication included: L-THYROXINE [LEVOTHYROXINE], start date: Jan2021. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10May2022, outcome "unknown", described as "Vaccine_brand_other=Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, COVID-19. Clinical course: The patient was treated with Paxlovid for COVID- 19 treatment from 08Mar2023 to 13Mar2023. She has no known allergies.
Age: 80.0
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 (Consumer). The reporter is the patient. An 81-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 16:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 80 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EN5318), in right arm, on 19Feb2021 as dose 2, single (Lot number: EN6201), in right arm and on 22Oct2021 as dose 3 (booster), single (Lot number: FF2593), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Irritable bowel syndrome" (unspecified if ongoing). Concomitant medications included: COLACE, start date: 18Nov2022, stop date: 08Mar2023; MAGNESIUM CITRATE, start date: 15Dec2022, stop date: 08Mar2023; METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID], start date: 06Dec2021, stop date: 08Mar2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Mar2023) Positive, notes: Return of positive covid test and symptom worsening after 5 day course of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: The patient has no known allergies.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 treatment; COVID 19 treatment; Dose 4: Pfizer/BioNTech / Dose 3: Moderna / Dose 1 and 2: Manufacturer unknown; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 68 years, in right arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Dec2021 as dose 3 (booster), single (Lot number: 032h21a), 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: "Chronic lymphocytic leukemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Sep2022, outcome "unknown", described as "Dose 4: Pfizer/BioNTech / Dose 3: Moderna / Dose 1 and 2: Manufacturer unknown"; DRUG INEFFECTIVE (medically significant), 1 year 2 months 18 days after the suspect product(s) administration, outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Mar2023) Negative; (19Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 09Mar2023 to 14Mar2023.
Age: 77.0
Sex: M
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 contactable reporter(s) (Pharmacist). The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Lot number: GJ6342) at the age of 77 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL0142), in right arm, on 09Feb2021 as dose 2, single (Lot number: FL3302), in right arm, on 28Sep2021 as dose 3 (booster), single (Lot number: FF2587), in right arm and on 06Mar2022 as dose 4 (booster), single (Lot number: FK995), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type II DM" (unspecified if ongoing). No allergy. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included: Paxlovid from 03Mar2023 to 08Mar2023.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine and BNT162b2, BNT162b2 omi ba.4-5 vaccine can not be excluded for the reported events of COVID-19 and vaccination failure due to temporal relationship.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller states they only caught light Covid because they have the Pfizer's, his mom has 4 and he has 3.; Caller states they only caught light Covid because they have the Pfizer's, his mom has 4 and he has 3.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 81-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pneumonia" (ongoing), notes: Mother has pneumonia and had pneumonia in the past. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Mar2023, outcome "recovering" and all described as "Caller states they only caught light Covid because they have the Pfizer's, his mom has 4 and he has 3.". The events "caller states they only caught light covid because they have the pfizer's, his mom has 4 and he has 3." required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included the patient went to urgent care last Friday and tested positive. Reporter stated 3 hours into getting Paxlovid, the symptoms stopped, patient was feeling better and started to recover.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID 19; Treatment of COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03May2021 at 12:00 as dose 1, single (Lot number: er8735), in left arm, on 14May2021 at 15:30 as dose 2, single (Lot number: 208730), in left arm, on 24Nov2021 at 14:30 as dose 3 (booster), single (Lot number: 320208D), in left arm and on 31May2022 as dose 4 (booster), single (Lot number: em9803) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "spinal tendinosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Opioids morphine, reaction(s): "Allergy"; Hydrocodone, reaction(s): "Allergy"; Oxycodone, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received treatment with Paxlovid from 14Mar2023 for COVID-19; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300118741 same reporter, same patient, different product, different event;US-PFIZER INC-202300119914 same reporter, same patient, same product, different dose, different event;
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Oct2022 as dose 5 (booster), single (Lot number: CH9697) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 16Apr2021 as dose 2, single (Lot number: ER8732), in left arm, on 10Nov2021 as dose 3 (booster), single (Lot number: FH8030), in left arm and on 02Jul2022 as dose 4 (booster), single (Lot number: FM7553) for covid-19 immunisation. The patient's relevant medical history included: "Pollen allergies" (unspecified if ongoing), notes: Pollen allergies; "allergic to yellow jackets" (unspecified if ongoing), notes: previously allergic to yellow jackets but also took shots and became desensitized. The patient's concomitant medications were not reported. Past drug history included: Immunotherapy injections, notes: Patient took immunotherapy injections prior to pandemic. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative, notes: virtually negative; (Mar2023) Positive, notes: intensely positive; (Mar2023) Positive, notes: test positive 5 days after relapse. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: During 5- day course of Paxlovid, symptoms decreased, and tests became virtually negative. Approximately 3 days after last dose, nose started to run excessively, tests returned intensely positive results. Congestion and malaise returned. Seem to be getting better but continuing to test positive 5 days after relapse.
Sex: F
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 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EM7809), in left arm, on 16Mar2021 as dose 2, single (Lot number: EN6206), in left arm, on 13Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm, on 26Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and as dose 5 (booster), single (Lot number: GJS342), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "dairy allergy" (ongoing); "gluten allergy" (ongoing); "sulfa allergy" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: Jan1983; ESTRADIOL, start date: May2016. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received treatment with Paxlovid from 04Mar2023 to 08Mar2023 for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300120120 same reporter, same patient, same product, different dose, different event;US-PFIZER INC-202300118971 same reporter, same patient, different product, different event;
Age: 50.0
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 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunization; BNT162b2 (BNT162B2), on 07Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstruation irregular, SARS-CoV-2 test
Clinical narrative: There is a pattern after 2 month from each shot where the periods get irregular and painful; there is a pattern after 2 month from each shot where the periods get irregular and painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient received BNT162b2 (BNT162B2), on 21Apr2021 as dose 2, single (Lot number: ER8729) at the age of 28 years, in arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical Sie of injection: Arm, Batch/Lot number: Pfizer EN6207), administration date: 31Mar2021, when the patient was 28-year-old, for COVID-19 Immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset Jun2021, outcome "not recovered", described as "There is a pattern after 2 month from each shot where the periods get irregular and painful"; DYSMENORRHOEA (non-serious) with onset Jun2021, outcome "not recovered", described as "there is a pattern after 2 month from each shot where the periods get irregular and painful". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation irregular, dysmenorrhoea.  Additional Information: Third dose was administered on 22Oct2021, Anatomical site of injection: Arm, Lot number: Pfizer FE3592, fourth dose was administered on 19Oct2022, Anatomical site of injection: Arm, Lot number: Pfizer GJ2524. Prior vaccinations within 4 weeks: None and not on birth control and have not been since 2018. No hormonal medications since 2018. No prescribed medications. Started taking Flovitamins Jan2023 to help with period symptoms since shot has had no effect. In summer 2021, noticed periods were not on time. Periods became random by 2022. Didn't take much note as not in relationships at the time. In summer 2022, started tracking her cycle. Had gone from 4 week cycle to 45 days cycle skipping weeks at a time. Periods were long, painful and severe. Periods have never returned to normal with no birth control or medications being used since 2018, the only thing that's changed besides a flu shot in her is the C-19 shot. There is a pattern after 2 months from each shot where the periods get irregular + painful. They have not gone back to normal and we fear this will affect the ability to get pregnant with non-regular cycles.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201364680 same patient/drug, different dose;
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Paxlovid rebound. Tested positive for Covid after Paxlovid treatment.; Paxlovid rebound. Tested positive for Covid after Paxlovid treatment.; 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 (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 6 (booster), single (Lot number: AH9463) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. 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 "Paxlovid rebound. Tested positive for Covid after Paxlovid treatment.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for Covid after Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Papule, Pruritus, Rash
Clinical narrative: Extreme rash and itch on arms and chest; Extreme rash and itch on arms and chest; Raised bumps that are symmetrical on body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 13Jul2022 as dose 4 (booster), single (Lot number: FP7135) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 27Sep2022 as unk unk, single; EZETIMIBE; ROSUVASTATIN; BABY ASPIRIN. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Pfizer "Purple Cap"; lot number: FH8028; vaccine location: Right arm), administration date: 19Nov2021, when the patient was 71-year-old, for Covid-19 Immunisation; BNT162b2 (DOSE 2, SINGLE; Pfizer "Purple Cap"; lot number: EN6203; vaccine location: Left arm), administration date: 16Mar2021, when the patient was 70-year-old, for Covid-19 Immunisation; BNT162b2 (DOSE 1, SINGLE; Pfizer "Purple Cap"; lot number: EN0201; vaccine location: Left arm), administration date: 23Feb2021, when the patient was 70-year-old, for Covid-19 Immunisation. The following information was reported: RASH (non-serious), PRURITUS (non-serious) all with onset 19Oct2022, outcome "not recovered" and all described as "Extreme rash and itch on arms and chest"; PAPULE (non-serious) with onset 19Oct2022, outcome "not recovered", described as "Raised bumps that are symmetrical on body". The events "extreme rash and itch on arms and chest" and "raised bumps that are symmetrical on body" required physician office visit. Therapeutic measures were taken as a result of rash, pruritus, papule.  Additional information: Patient received OTC Antihistamine, Prednasone 20 mg-ordered twice for events. Patient also received Pfizer Bivalent Sars-cov-2 Vaccine Booster 12+ Yrs (Lot number: GJ2524) on 25Oct2022 as dose 5 at right arm for covid-19 immunisation.