chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Eczema, Joint range of motion decreased, SARS-CoV-2 test, Vision blurred
Clinical narrative: blurred vision in my left eye due to extreme dryness; blurred vision in my left eye due to extreme dryness; have difficulty raising and lowering my arms at times; arms and legs below the knees developed small sores that then became rough textured rash that sort of looked like eczema; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jul2022 at 14:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hyprthyroidism" (unspecified if ongoing); "cancer" (unspecified if ongoing); "CHF" (unspecified if ongoing), notes: CHF. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EL3246, Vaccine location: Left arm), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE; Lot number: EL3246, Vaccine location: Left arm), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FE3590, Vaccine location: Left arm), for COVID-19 immunization. The following information was reported: ECZEMA (non-serious) with onset 04Aug2022 at 12:00, outcome "not recovered", described as "arms and legs below the knees developed small sores that then became rough textured rash that sort of looked like eczema"; VISION BLURRED (non-serious), DRY EYE (non-serious) all with onset 2023, outcome "unknown" and all described as "blurred vision in my left eye due to extreme dryness"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 2023, outcome "unknown", described as "have difficulty raising and lowering my arms at times". The events "arms and legs below the knees developed small sores that then became rough textured rash that sort of looked like eczema" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of eczema.  Additional information: For about two weeks the patient's arms and legs below the knees developed small sores that then became rough textured rash that sort of looked like eczema but not quite. Her dermatologist ordered creams to apply, but after three tubes of use there were no changes. Has not abated as of this date. She also now have blurred vision in her left eye due to extreme dryness. She had difficulty raising and lowering her arms at times. She was a retired nurse and this skin condition does not look like any eczema she had ever seen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination were prescribed medications.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: breakthrough case of COVID; breakthrough case of COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "breakthrough case of COVID". Additional information: The patient had breakthrough case of COVID after being vaccinated the Pfizer vaccine, wanted to know if there is an antidote for the vaccine because he stated that it is really hurting him. The reporter considered the event as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300092557 same reporter/drug, different patient/event;
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4471699-00.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 01Jan2021 as dose 1, single, on 02Feb2021 as dose 2, single and on 04Oct2021 as dose 3 (booster), single at the age of 66 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ENBREL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Drug ineffective, Suspected COVID-19
Clinical narrative: Three breakthrough cases of COVID; Three breakthrough cases of COVID; Heart is in bad shape; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the parent.  A 40-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Three breakthrough cases of COVID"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "Heart is in bad shape". Clinical course: The caller is reporting that he and several members of his family had breakthrough cases of COVID after being vaccinated. The caller reports specifically that his daughter's "heart is in bad shape" and has had three breakthrough cases of COVID. The caller said her doctor recommends a total blood cleanse with blood from a person who hasn't had the COVID vaccine. The caller said they got the Pfizer vaccine. The caller is asking if there is an antidote in the works for the Pfizer COVID-19 vaccine? The caller asked to "tell your people that there are a lot of people are hurting" that the "misinformation came from Pfizer and CDC", Pfizer has "got to find an antidote'', and that Pfizer has a "got a storm come their way you got to find something for us the vaccine is a disaster for them". Caller wanted to know if there is an antidote for the vaccine because he stated that it is really hurting him and his daughter and that they are in a really bad shape.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300092240 same reporter/patient, different drug/event;US-PFIZER INC-202300092558 same reporter/drug, different patient/event;
Age: 39.0
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 40-year-old male patient received BNT162b2 (BNT162B2), on 03Jun2021 as dose 2, single (Lot number: EW0168) at the age of 39 years for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cephalexin, reaction(s): "Known allergies: Cephalexin"; Minocycline, reaction(s): "Known allergies: Minocycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, 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. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a 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 16Sep2022 as dose 5 (booster), single (Lot number: Gh9702) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient 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 Feb2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive; (02Mar2023) Positive, notes: positive COVID test after recovery/ negative test; (2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 21Feb2023 to 26Feb2023).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "positive for abnormal antibody- anticentromere b" (unspecified if ongoing), notes: positive for abnormal antibody- anticentromere b; "osteopenia" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "penecillin allergy" (unspecified if ongoing), notes: known allergies: penecilli. The patient's concomitant medications were not reported. Past drug history included: Erythromycin for Allergy; Cleocin for Allergy; Propofol for Allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (unspecified date) Positive, notes: several days later I began to have symptoms and tested positive; (unspecified date) Positive, notes: I also had COVID 1 month prior to this, took paxlovid and also had rebound. That time I had no sx, just a positive test; (01Mar2023) Negative, notes: After completing Paxlovid, 5 days of isolation and 5 days of making I tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took nirmatrelvir, ritonavir (PAXLOVID) from 19Feb2023 to 24Feb2023 as Treatment of COVID-19.
Age: 74.0
Sex: F
Vaccine: 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 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 03Jun2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 04Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 04May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfur drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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-202300093113 same patient/product, different dose/event;
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 16:00 as dose 5 (booster), single (Lot number: Ff2590) at the age of 59 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17May2022 at 16:00 as dose 4 (booster), single (Lot number: FM7553), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Feb2021 at 13:15 as dose 1, single (Lot number: EN6200), in left arm, on 14Mar2021 at 12:00 as dose 2, single (Lot number: En6208), in left arm and on 07Oct2021 at 15:00 as dose 3 (booster), single (Lot number: Ff2590), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive; (2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Having a rebound infection with positive Covid test after she discontinued paxlovid and had a negative Covid test.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EW0153), in left arm, on 29Apr2021 as dose 2, single (Lot number: FF8841), in left arm, on 05Nov2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 21Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Negative; (Mar2023) Positive. Therapeutic measures were taken as a result of vaccination failure, 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.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis
Clinical narrative: developing arthritis or increasing the arthritis/developed arthritis in 4 different places; joint pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 16Jul2022 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; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: ARTHRITIS (non-serious), outcome "unknown", described as "developing arthritis or increasing the arthritis/developed arthritis in 4 different places"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain".  Additional information: the patient asked if the COVID vaccine had any relation to the developing arthritis or increasing the arthritis, since the patient got his 4th booster and 2 weeks later he developed arthritis in 4 different places. He wanted to know if the joint pain that were reported was a solid evidence associating the vaccine to arthritis, before he gets the omicron.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
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) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (COMIRNATY), on 21Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 11Feb2021 as dose 2, single (Lot number: EN5318), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 03Apr2022 as dose 4 (booster), single (Lot number: FM0698), 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures taken as a result of vaccination failure, covid-19 included administration of Paxlovid from 21Feb2023 to 26Feb2023.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event following immunisation
Clinical narrative: Vaccine injury from COVID vaccine.; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ADVERSE EVENT FOLLOWING IMMUNISATION (medically significant), outcome "unknown", described as "Vaccine injury from COVID vaccine.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history and no known allergies. The patient took concomitant medications statins, thyroid, vitamin D and baby aspirin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: initial positive test; (03Mar2023) positive, notes: Tested positive 03Mar. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 21Feb2023 to 26Feb2023. The patient developed typical cold symptoms 2 days after completing Paxlovid treatment, which kept getting worse through today. Cough, runny nose, malaise. Tested positive 03Mar2023, 12 days after initial positive test and COVID symptom onset and six days after last day of Paxlovid treatment.  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: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2022 as dose 3 (booster), single (Lot number: FL3197) at the age of 50 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: "Sulfa" (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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Feb2023) Negative, notes: tested negative on day 6; (2023) postive, notes: retested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid as treatment from 22Feb2023 to 27Feb2023.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Weight
Clinical narrative: covid; covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID. The reporter is the patient.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Jan2023 as dose 5 (booster), single (Lot number: GJ6742) at the age of 61 years, in arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EN6203), in arm, on 24Mar2021 as dose 2, single (Lot number: ER8733), in arm, on 06Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in arm and on 17Jun2022 as dose 4 (booster), single (Lot number: FJ4991), in arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes", start date: 2008 (ongoing), notes: Diagnosed in 2008 after hysterectomy; "hysterectomy" (unspecified if ongoing), notes: Diagnosed in 2008 after hysterectomy. Concomitant medication(s) included: INSULIN taken for type 2 diabetes mellitus (ongoing). She rarely takes medication, but does take Insulin 70/30 everyday. They put her on a keto diet recently. she has been on insulin a long time. The patient called because she wanted to report after getting the five Covid vaccines from Pfizer she got Covid this week. The first vaccine was in Feb2021 and then the last was on 14Jan2023. She never had Covid before. Her first Covid vaccine was in Feb2021, the second in Mar2021, the third was in Nov2021, the fourth was in Jun2022, and the last one was Jan of this year (2023). She took two different home test that said, she was positive. She went to a local walk in and thought about checking in to get the medication to shorten it. Her husband got sick first, but he only had four Covid shots. She thinks her husband brought Covid to her after a trip to. Her husband got "pissy," and wouldn't wait at the clinic, so they didn't get Paxlovid. She doesn't feel that sick. Feels like a bad cold. She coughs a lot. If she lays down, she coughs more. She is taking Alka-Seltzer Plus Cold during the day and Nyquil at night. She has also taken Sudafed once a day for the past two days. She is not falling down dead, but doesn't feel particular great. She clarified that her symptoms started Tuesday, 28Feb2023, but she tested positive for Covid on 02Mar2023. She weighs 170-175 pounds right now (2023). The patient had not recovered from COVID at the time of report.  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-202300094238 similar report from same reporter;
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6205), on 05Apr2021 as dose 2, single (Lot number: ER8729), on 26Nov2021 as dose 3 (booster), single (Lot number: FJ1670) and on 02Apr2022 as dose 4 (booster), single (Lot number: FJ5682) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: Mar2020; OMEPRAZOLE, start date: Jan2015; FAMOTIDINE, start date: Jan2015. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on available information, a lack of efficacy (vaccination failure and COVID-19) with the suspect vaccines in this patient cannot be completely excluded.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for covid.; Tested positive for covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Aug2021 as dose 1, single (Lot number: FC3182) and on 16Sep2021 as dose 2, single (Lot number: FC3180) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Feb2023, outcome "recovered" and all described as "Tested positive for covid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Feb2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Caller is a consumer asking if there is ingredient in the vaccine that can cause hair loss.; 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 female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "Caller is a consumer asking if there is ingredient in the vaccine that can cause hair loss.".  Additional information: Caller was a consumer asking if there was an ingredient in the vaccine that can cause hair loss. Caller stated that she was calling about hair loss related to the Covid Vaccines. Stated that she does not know what was in it to cause hair loss. Asked if there was an ingredient in the vaccine that was known that could cause hair loss. Caller stated that she had the Pfizer Covid Vaccines, everyone having this problem from the Covid Vaccines. They don't want to lose their hair anymore.  Caller stated that it was a research study for her, not an official one, a self-reporting one. Stated that it all seems to go back to the vaccine. Caller declined to complete safety report, stated that she needed more information to see if she was on the right track. Caller mentioned that she was a healthcare professional and that she was a licensed counselor and a professor of mental health. Caller was not a doctor, pharmacist, or nurse. Declined to provide further contact information. Stated that the phone number she provided was the best contact. Disconnected from the call due to technical issues. The transfer was not completed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; 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 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: CHILLS (non-serious), outcome "unknown".  Additional information: Caller got the Pfizer booster shot and she's having chills. She would like to know the reason. Caller stated, "Off and on I'm still having them and they're terrible". Caller confirmed that she received the Pfizer BioNTech Bivalent vaccine but unable to confirm if she received the formulation for ages 12 and older. Caller mentioned that she had chills after receiving the Pfizer Booster. Caller wanted to know how long her chills may last. During the conversation, caller mentioned that she was 69. Caller accepted transfer but caller disconnected during the transfer. Call back was done to gather the information however it was unsuccessful. Further probing could not be done as consumer hung up the call abruptly. Thus, product details (NDC#, UPC# and expiry date) and purchase details were unknown. Hence, limited information was available over the call. Reporter type could not be probed over the call. Hence, captured as consumer and other non- health professional in tab.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2022 at 14:00 as dose 5 (booster), single (Lot number: FJ9943) at the age of 77 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "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 2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19: Treatment with Paxlovid.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: One dose of Pfizer COVID-19 Vaccine and other doses from Moderna; had all of his shots (maybe referring to covid vaccines) but he still contracted covid infection,confirmed that he received 1 dose of Pfizer covid vaccine (unverified formulation) and 1 from Moderna.; had all of his shots (maybe referring to covid vaccines) but he still contracted covid infection,confirmed that he received 1 dose of Pfizer covid vaccine (unverified formulation) and 1 from Moderna.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID: (172086). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "One dose of Pfizer COVID-19 Vaccine and other doses from Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had all of his shots (maybe referring to covid vaccines) but he still contracted covid infection,confirmed that he received 1 dose of Pfizer covid vaccine (unverified formulation) and 1 from Moderna.". 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: 29.0
Sex: F
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: Birth control" (unspecified if ongoing); "Known allergies: Melons (Allergy)" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Allergy"; Levaquin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient received treatment of Paxlovid started on 24Feb2023 and stopped on 28Feb2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes Type II" (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 Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19: Treatment with Paxlovid.
Age: 62.0
Sex: F
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) from product quality group. The reporter is the patient.  A 62-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 62 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: "PreDiabetes" (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 Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19: the patient received Paxlovid from 23Feb2023 to 27Feb2023 for COVID-19 treatment.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GJ5342), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL3302), in left arm, on 17Feb2021 as dose 2, single (Lot number: EN6201), in left arm, on 20Aug2021 as dose 3 (booster), single (Lot number: FC3180), in left arm and on 20Mar2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "slightly elevated 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 Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Course of events: No known allergies. Patient received Paxlovid from 18Feb2023 to 23Feb2023 for COVID-19 Anti viral treatment.
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Electrocardiogram abnormal, Electrocardiogram ambulatory, Fatigue
Clinical narrative: Had mild allergy symptoms; Arm pain; Fatigue; Migraines; Hemiplegic migraine; ekg was weird; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (medically significant), outcome "recovered", described as "Had mild allergy symptoms"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain"; FATIGUE (non-serious), outcome "unknown"; MIGRAINE (non-serious), outcome "unknown", described as "Migraines"; HEMIPLEGIC MIGRAINE (non-serious), outcome "unknown"; ELECTROCARDIOGRAM ABNORMAL (non-serious), outcome "unknown", described as "ekg was weird". The events "had mild allergy symptoms", "arm pain", "fatigue", "migraines" and "hemiplegic migraine" required emergency room visit. The event "ekg was weird" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: Normal; Electrocardiogram: Weird; Electrocardiogram ambulatory: Unknown results, notes: 30-day Holter monitor. Therapeutic measures were taken as a result of hypersensitivity, migraine, hemiplegic migraine. Clinical course: Patient got first shot on 01Apr, had mild allergy symptoms that resolved with benedryl, arm pain and fatigue for about half the next day 2 migraines that week following then started cycling through nonstop hemiplegic migraines since a week after the shot. Patient went to the ER 6 days ago, the CT scan was normal but ekg was weird. The migraine cocktail helped for a couple days but patient was back to cycling through again. Patient's doctor gave samples of Ubrelvy and Nurtec to try. Patient was already on 20mg of nortriptyline for prevention and relpax as needed. Patient was scared to get the second dose this coming Thursday. Patient had to see a cardiologist because of the weird ekg and now have a 30-day Holter monitor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hemiplegic migraine, Hypersensitivity, Migraine, Pain in extremity
Clinical narrative: Had mild allergy symptoms; Arm pain; Fatigue; Migraines; Hemiplegic migraine; ekg was weird; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (medically significant), outcome "recovered", described as "Had mild allergy symptoms"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain"; FATIGUE (non-serious), outcome "unknown"; MIGRAINE (non-serious), outcome "unknown", described as "Migraines"; HEMIPLEGIC MIGRAINE (non-serious), outcome "unknown"; ELECTROCARDIOGRAM ABNORMAL (non-serious), outcome "unknown", described as "ekg was weird". The events "had mild allergy symptoms", "arm pain", "fatigue", "migraines" and "hemiplegic migraine" required emergency room visit. The event "ekg was weird" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: Normal; Electrocardiogram: Weird; Electrocardiogram ambulatory: Unknown results, notes: 30-day Holter monitor. Therapeutic measures were taken as a result of hypersensitivity, migraine, hemiplegic migraine. Clinical course: Patient got first shot on 01Apr, had mild allergy symptoms that resolved with benedryl, arm pain and fatigue for about half the next day 2 migraines that week following then started cycling through nonstop hemiplegic migraines since a week after the shot. Patient went to the ER 6 days ago, the CT scan was normal but ekg was weird. The migraine cocktail helped for a couple days but patient was back to cycling through again. Patient's doctor gave samples of Ubrelvy and Nurtec to try. Patient was already on 20mg of nortriptyline for prevention and relpax as needed. Patient was scared to get the second dose this coming Thursday. Patient had to see a cardiologist because of the weird ekg and now have a 30-day Holter monitor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Lot number: GH9702) for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6204), on 03Apr2021 as dose 2, single (Lot number: ER8735), on 03Sep2021 as dose 3 (booster), single (Lot number: FP2588) and on 18Jun2022 as dose 4 (booster), single (Lot number: FP4554) for covid-19 immunisation. The patient's relevant medical history included: "Chronic Bronchitis (as a child)" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "chronic high blood pressure (as result of COVID infection)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) negative, notes: Tested negative for 3 days; (unspecified date) negative, notes: Tested negative for 3 days; (unspecified date) negative, notes: Tested negative for 3 days; (01Mar2023) Positive, notes: tested positive again on 01Mar2023. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: The patient received treatment of Paxlovid started on 21Feb2023 and stopped on 25Feb2023. No known allergies.  No follow-up attempts are possible. No further information is expected.