chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Anonymous caller states that after her husband received covid boosters "he had many symptoms and was very sick; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Anonymous caller states that after her husband received covid boosters "he had many symptoms and was very sick) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Anonymous caller states that after her husband received covid boosters "he had many symptoms and was very sick). At the time of the report, ILLNESS (Anonymous caller states that after her husband received covid boosters "he had many symptoms and was very sick) outcome was unknown.            No concomitant medication was reported.  Caller stated that after her husband received COVID boosters, he had many symptoms and was very sick.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Bowel movement irregularity
Clinical narrative: He can't get the bowel movement out of him as easily as he could before. It really takes a lot of effort.; This spontaneous case was reported by a patient and describes the occurrence of BOWEL MOVEMENT IRREGULARITY (He can't get the bowel movement out of him as easily as he could before. It really takes a lot of effort.) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A, 031A21A, 013F21A and 056A22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BOWEL MOVEMENT IRREGULARITY (He can't get the bowel movement out of him as easily as he could before. It really takes a lot of effort.). At the time of the report, BOWEL MOVEMENT IRREGULARITY (He can't get the bowel movement out of him as easily as he could before. It really takes a lot of effort.) had not resolved.            No concomitant medication was reported. It was reported that patient received bivalent dose on 28-Oct-2022. It was reported that patient was inoculated, he found out his push muscle to remove bowel movements has not worked as well as it had for the last 81 years of his life. He was wondering if there was something that could be done about it. He explained that when he goes to the toilet to have a bowel movement, he has to wiggle and squirm. He can't get the bowel movement out of him as easily as he could before. It really takes a lot of effort. When he had a bowel movement, it doesn't seem to be complete. He still had some in him. He noticed this shortly after his first shot on 13-Feb-2021. No treatment information was provided.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Bursitis, Inflammation, Swelling
Clinical narrative: bursitis of the left elbow; This spontaneous case was reported by a consumer and describes the occurrence of BURSITIS (bursitis of the left elbow) in a 24-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for Cold.     Concurrent medical conditions included Type I diabetes mellitus.    On 16-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 18-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced BURSITIS (bursitis of the left elbow). The patient was treated with IBUPROFEN (ADVIL 12) for Swelling and Inflammation, at an unspecified dose and frequency. At the time of the report, BURSITIS (bursitis of the left elbow) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       Concomitant medications were not reported. The Left shoulder was the site of vaccine administration. The patient had Bursitis symptoms as swelling, and inflammation. It was unknown if the patient experienced any additional symptoms/events. The cold presses on the inflicted site.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: The patient caught Covid-19 on July 1, 2023; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (The patient caught Covid-19 on July 1, 2023) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1, Batch- 013M20A) on 20-Feb-2021, Moderna COVID-19 Vaccine (Dose 2, Batch-008B21A) on 26-Mar-2021, Moderna COVID-19 Vaccine (Dose-3, lot number 066F21A) on 19-Nov-2021, Moderna COVID-19 Vaccine (Dose- 4 and lot number 084J21A) on 14-Apr-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 31-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (The patient caught Covid-19 on July 1, 2023). At the time of the report, COVID-19 (The patient caught Covid-19 on July 1, 2023) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. It was reported that patient did not reported any side effects. Patient did not remembered which arm she received the all her Moderna Covid-19 vaccines. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: death; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (death) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. Death occurred on 2022 The patient died in 2022. The cause of death was not reported. It is unknown if an autopsy was performed.            It was unknow if the patient receives any other vaccine in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  It was reported that patient got moderna vaccine and she died last year.  Treatment information was not provided. Company comment  This spontaneous case reported by a patient family member or friend concerns a female patient of an unknown age with no medical history reported, who experienced the unexpected, serious (medically significant and fatal), event of Death, that occurred on an unknown date in the context of a dose of SPIKEVAX NOS (SPIKEVAX NOS). The vaccination date and event onset date were not provided, thus, exact latency between vaccination and onset of the event could not be assessed. The patient died in the same year that the vaccine was given. The cause of death was not reported. It is unknown if an autopsy was performed. It was unknow if the patient receives any other vaccine in the 4 weeks prior to COVID-19 vaccine. No further clinical information was provided for review. The benefit-risk relationship of SPIKEVAX NOS (SPIKEVAX NOS) vaccine is not affected by this report.   Reporter did not allow further contact; Reported Cause(s) of Death: unknown if autopsy was done
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Malaise, Musculoskeletal stiffness
Clinical narrative: sick; headache/brain felt like it was squeezing; stiff; chills; didn't feel good; 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 female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 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 Completed, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 2022, outcome "unknown"; MALAISE (non-serious) with onset 2022, outcome "unknown", described as "didn't feel good"; HEADACHE (non-serious) with onset 2022, outcome "unknown", described as "headache/brain felt like it was squeezing"; ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "sick"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2022, outcome "unknown", described as "stiff". Additional information: The last time she took a vaccine last year, she got a Pfizer bivalent and got so sick. She had a headache for over a month, my brain felt like it was squeezing, I was stiff for 2 days, had chills and just didn't feel good. She believes the bivalent was not safe for patients, so Pfizer has changed it back to a monovalent product. She understands she can't say that but that is what she believes. She states she will never get another Bivalent vaccine because it made her so sick.  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: 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 65-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2023 at 09:45 as dose 4 (booster), single (Batch/Lot number: unknown), 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), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid on 20Sep2023. 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: 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 contactable reporter(s) (Nurse). 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 15Sep2022 as dose 5 (booster), single (Lot number: GJ5342) 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: "Asthma" (unspecified if ongoing). No Known allergies. Concomitant medication(s) included: FAMOTIDINE; SYNTHROID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 13Sep2023 to 18Sep2023.; Sender's Comments: Vaccine efficacy varies from person to person. The association between the event lack of effect (COVID-19) with BNT162B2, BNT162B2 OMI BA.4-5 can not be fully excluded.
Sex: U
Vaccine: COVID19
Symptoms: Blood disorder, Blood test, Cardiac disorder
Clinical narrative: My blood levels and heart were affected after I received the vaccine. I received one unit of blood in Feb2023; My blood levels and heart were affected after I received the vaccine. I received one unit of blood in Feb2023; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID:. The reporter is the patient.  A patient (no qualifiers provided) 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 Immunisation. The following information was reported: BLOOD DISORDER (medically significant), CARDIAC DISORDER (non-serious), outcome "unknown" and all described as "My blood levels and heart were affected after I received the vaccine. I received one unit of blood in Feb2023". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results. Therapeutic measures were taken as a result of blood disorder. Clinical course: Patient enquired: Was there any literature on Bivalent Covid -19 mRNA booster. Patients blood levels and heart were affected after received the vaccine. Than received one unit of blood in Feb2023.  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: Based on the information available, a possible contributory role of the suspect drug cannot be excluded for the reported event Blood disorder.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: M
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 60-year-old male patient received bnt162b2 (BNT162B2), on 07Jul2021 as dose 1, single (Lot number: FA6780), in left arm and on 23Aug2021 as dose 2, single (Lot number: FC3181) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE, start date: 12Jul2020; LUPIN, start date: 12Jul2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 13Sep2023 to 14Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300306860 same patient, different drug and event;US-PFIZER INC-202300306916 same patient, different dose and event;
Age: 35.0
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.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 10Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "obesity" (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 Sep2023, outcome "recovered" (Sep2023) and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 13Sep2023 to 18Sep2023.  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-202300306836 same patient and reporter, different drug and event;
Age: 39.0
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 40-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 27Dec2020 as dose 1, single (Batch/Lot number: unknown), on 02Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 04Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthropathy" (unspecified if ongoing); "Known allergies: garlic" (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 "not recovered" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 06Sep2023 to 11Sep2023. 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: F
Vaccine: COVID19
Symptoms: Fatigue, Joint stiffness
Clinical narrative: fatigue; stiff joints; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (004756). The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 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 immunisation. The following information was reported: FATIGUE (non-serious), outcome "unknown"; JOINT STIFFNESS (non-serious), outcome "unknown", described as "stiff joints". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Apr2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07May2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 11Apr2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 01Oct2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Nov2022 at 12:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  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: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 44-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 43 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 1 day for covid-19 immunisation. The patient's relevant medical history included: "Gastritis" (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 "recovering" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19 included Paxlovid from 12Sep2023 to 16Sep2023.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation, Heart rate, Heart rate increased
Clinical narrative: AFib heart palpitation really bad; Beats per minute: 116/way too high I almost passed away; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Aug2023 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 02, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 03, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 04, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset Aug2023, outcome "unknown", described as "AFib heart palpitation really bad"; HEART RATE INCREASED (medically significant) with onset Aug2023, outcome "unknown", described as "Beats per minute: 116/way too high I almost passed away". The patient underwent the following laboratory tests and procedures: Heart rate: (2023) 116, notes: beats per minute.  Additional information: The patient had Omicron vaccine, the last part of August, within 3 days, the patient ended up with AFib, heart palpitation really bad. The patient suffered from AFib; had all the other 4 COVID vaccines and did not have the problem. All of this happened when the patient got the Omicron and those are really bad. The patient's beats for a minute was 116 beats for a minute, that is way too high I almost passed away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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: "known allergies: Penicillin" (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 "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 12Sep2023 to 17Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine bnt162b2, bnt162b2 omi ba.4-5 in this patient cannot be completely excluded.
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 36-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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: "Type 1 diabetes" (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: (unspecified date) Positive, notes: Even stronger positive than my original; (14Sep2023) Negative, notes: I tested negative last Thursday; (21Sep2023) Positive, notes: Today is Thursday again / I just tested positive on two different brands of at home test. 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: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27May2023 as dose 6 (booster), single (Lot number: Gj3268) at the age of 71 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's relevant medical history included: "Known allergies: Antibiotics" (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 "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (Sep2023) Positive, notes: Rebound - tested positive for Covid on day 13. Therapeutic measures were taken as a result of covid-19 included Paxlovid from 11Sep2023 to 16Sep2023.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 on 20Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 48 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: "Ankylosing spondylitis" (unspecified if ongoing); "history of stroke" (unspecified if ongoing); "Known allergies: Latex" (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 "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 12Sep2023 to 16Sep2023.  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: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.
Age: 71.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received bnt162b2 (BNT162B2), on 27May2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 71 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: "allergy: statin drugs" (unspecified if ongoing); "Previous MDS", start date: Mar2021 (unspecified if ongoing), notes: Previous MDS w 5q deletion-received; "cell tansplant", start date: Mar2021 (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Drug allergy: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures included Paxlovid from 12Sep2023 to 17Sep2023 were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 1: Moderna/ Dose 2: Moderna/ Dose 3: Pfizer/ Dose 4: Pfizer/ Dose 5: Pfizer.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). 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 13Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 67 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 26Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FH8020), in left arm and on 04Apr2022 at 15:00 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Jan2021 at 14:00 as dose 1, single (Lot number: 042L20A), in left arm and on 24Feb2021 at 11:30 as dose 2, single (Lot number: 030M26A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Celiac disease" (unspecified if ongoing); "dematitis herpetiformis" (unspecified if ongoing); "Sjogrens Syndrome" (unspecified if ongoing); "GERD" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Known allergires: gluten" (unspecified if ongoing); "Known allergires: wheat" (unspecified if ongoing); "Known allergires: oats" (unspecified if ongoing); "Known allergires: flax, caragheenan" (unspecified if ongoing); "Known allergies: soy" (unspecified if ongoing); "Known allergies: dander" (unspecified if ongoing); "Known allergies: pollen" (unspecified if ongoing); "Known allergies: dust" (unspecified if ongoing); "Known allergies: feather" (unspecified if ongoing); "Known allergies: NSAIDs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "known allergies"; Demerol, reaction(s): "known allergies". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Oct2021 at 10:00, outcome "unknown", described as "Dose 1: Moderna/ Dose 2: Moderna/ Dose 3: Pfizer/ Dose 4: Pfizer/ Dose 5: Pfizer."; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 19Sep2023 to 20Sep2023.
Age: 28.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received bnt162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6199), in left arm and on 02Apr2021 as dose 2, single (Lot number: ER8734) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 30Aug2023 to 04Sep2023.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: she has COVID about a year ago in mid Sep2022; she has COVID about a year ago in mid Sep2022; 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 78-year-old female patient received bnt162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Batch/Lot number: unknown), on 07Mar2021 as dose 2, single (Batch/Lot number: unknown), on 19Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 23May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "she has COVID about a year ago in mid Sep2022".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna, Dose: 1, 2 / Pfizer, Dose: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 65 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Mar2021 as dose 1, single (Lot number: 040AZ1A), in right arm and on 04Apr2021 as dose 2, single (Lot number: 008B21-24), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Thyroiditis" (unspecified if ongoing); "in remission from breast cancer (IDC - Triple Positive)" (unspecified if ongoing); "Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tylenol, reaction(s): "Allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Nov2021, outcome "not recovered", described as "Moderna, Dose: 1, 2 / Pfizer, Dose: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid from 31Aug2023 to 04Sep2023.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna, Dose: 1, 2 / Pfizer, Dose: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 65 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Mar2021 as dose 1, single (Lot number: 040AZ1A), in right arm and on 04Apr2021 as dose 2, single (Lot number: 008B21-24), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Thyroiditis" (unspecified if ongoing); "in remission from breast cancer (IDC - Triple Positive)" (unspecified if ongoing); "Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tylenol, reaction(s): "Allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Nov2021, outcome "not recovered", described as "Moderna, Dose: 1, 2 / Pfizer, Dose: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid from 31Aug2023 to 04Sep2023.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) 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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20-year-old male patient received bnt162b2 (BNT162B2 NOS), on 03Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 19 years for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "autism" (unspecified if ongoing); "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), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19, the patient received Paxlovid from 09Sep2023 to 13Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Interchange of vaccine products, Pain
Clinical narrative: sharp pain (recurrence); Extremely Tired; Revaccination with different covid-19 vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20210924164 (Janssen Research & Development, LLC), 20230911481 (Janssen Research & Development, LLC).  A 47-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. The patient's relevant medical history included: "Pre-vaccine broken injuries (Past injuries)" (not ongoing); "Wrist brace" (not ongoing); "pre-vaccine pain" (not ongoing); "wrist pain from old injury" (not ongoing); "seafood allergy" (ongoing); "cigarette smoker (Smoke once in a blue moon)" (ongoing); "Non-alcohol user" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: janssen covid-19 vaccine (dose 1, single (Batch/Lot number: 1808980), in left deltoid), administration date: 01Apr2021, when the patient was 47-year-old, for covid-19 immunisation, reaction(s): "unexpected therapeutic effect (exactly 72 hours after the vaccination, felt no more pain from past injuries and had best sleep ever", "stung by the bee (right wrist), had no known allergy", "diarrhea", "swelling on the hand felt like 3 bricks/ swelling going to her forearm", "pain on right wrist where she did break it and it happened to be the location of the bee string", "If put index finger in shape of an l on wrist on top of hand towards finger it feels like 4 bricks on top of hand (feeling of pressure everyday at 4 am)", "pain and Burning sensation in hand (Area of right wrist where bee sting)", "sleep issues"; moderna covid-19 vaccine (dose 2, single (Batch/Lot number: unknown)), administration date: 25Oct2021, when the patient was 47-year-old, for covid-19 immunisation, reaction(s): "mirror images of old injuries coming back on the opposite side of her body", "dog scratched her in the right arm and showed up on left arm", "had a dark red mark (no skin uplifted) on her left arm", "left toe was broken", "had pain in her right toe/ wrist pain from old injury on one of her hands and now she felt it in the other wrist", "lost taste buds", "it was weird". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 25Oct2021, 6 months 25 days after the suspect product(s) administration, outcome "unknown", described as "Revaccination with different covid-19 vaccine"; PAIN (non-serious), outcome "not recovered", described as "sharp pain (recurrence)"; FATIGUE (non-serious), outcome "unknown", described as "Extremely Tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lung disorder
Clinical narrative: lung problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LUNG DISORDER (non-serious), outcome "unknown", described as "lung problems".  Additional information: The caller would like to know where she can get the Pfizer COVID-19 vaccine because she stated that in her area, all of the pharmacies have moderna and they don't have the Pfizer vaccine. The caller also said that she is immunocompromised and has lung problems.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: autoimmune disorder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  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: AUTOIMMUNE DISORDER (medically significant), outcome "unknown".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.