chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: after receiving a dose of Trumenba on May 2023, a patient received Bexsero on December 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a 17-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Meningococcal vaccine B rfHbpA/fHbpB (Trumenba) for prophylaxis.   In DEC-2023, the patient received Bexsero. In MAY-2023, the patient received Trumenba. In DEC-2023, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: after receiving a dose of Trumenba on May 2023, a patient received Bexsero on December 2023). The outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 08-JAN-2024 A pharmacist informed that after receiving a dose of Trumenba, a patient received Bexsero, which led to interchange of vaccine products. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement); Mild fever (100.4 to 101.2 degree F); Moderate fatigue with some interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement)), PYREXIA (Mild fever (100.4 to 101.2 degree F)) and FATIGUE (Moderate fatigue with some interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement)), PYREXIA (Mild fever (100.4 to 101.2 degree F)) and FATIGUE (Moderate fatigue with some interference with activity). At the time of the report, VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement)), PYREXIA (Mild fever (100.4 to 101.2 degree F)) and FATIGUE (Moderate fatigue with some interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: 100.4 to 101.2 degree F.         Concomitant medication was not provided. The patient experienced events anytime during the 2 days after COVID-19 vaccination, which occurred on 23-Dec-2023 and 24-Dec-2023. Treatment information was not reported.  Health Authority Subject ID was reported as 78366-33139 and Database Subject ID was reported as 5472011.   This case was linked to US-MODERNATX, INC.-MOD-2024-755971 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-755971:Same reporter
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma
Clinical narrative: asthmatic bronchitis; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient (unknown if pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: ASTHMA (non-serious), outcome "unknown", described as "asthmatic bronchitis".  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400001551 Same patient, partial same vaccine, different event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: asthmatic bronchitis; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient (unknown if pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: ASTHMA (non-serious), outcome "unknown", described as "asthmatic bronchitis".  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400001551 Same patient, partial same vaccine, different event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma
Clinical narrative: had all the covid vaccines available and she is totally up to date but she still had covid; had all the covid vaccines available and she is totally up to date but she still had covid; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had all the covid vaccines available and she is totally up to date but she still had covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: The caller said she had tested positive for covid and her doctor called a prescription to the neighborhood (withheld) for paxlovid and she was told that it would cost (Currency sign) 1700 but her insurance did not cover it and her diagnosis was asthmatic bronchitis and she has not had (Currency sign) 1700 and she could not pay that. She said that she had all the covid vaccines available and she was totally up to date but she still had covid.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400004136 Same patient, same vaccine, different event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had all the covid vaccines available and she is totally up to date but she still had covid; had all the covid vaccines available and she is totally up to date but she still had covid; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had all the covid vaccines available and she is totally up to date but she still had covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: The caller said she had tested positive for covid and her doctor called a prescription to the neighborhood (withheld) for paxlovid and she was told that it would cost (Currency sign) 1700 but her insurance did not cover it and her diagnosis was asthmatic bronchitis and she has not had (Currency sign) 1700 and she could not pay that. She said that she had all the covid vaccines available and she was totally up to date but she still had covid.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400004136 Same patient, same vaccine, different event;
Age: 49.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19 after receipt of COVID-19 vaccine; Tested positive for COVID-19 after receipt of COVID-19 vaccine; This is a spontaneous report received from an Other HCP.  A 50-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Nov2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 21Nov2023 as dose number unknown, single), in right arm for immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Lot: GJ6742, anatomical location: arm left), administration date: 10Nov2022, when the patient was 48-year-old, for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER: UNKNOWN), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER: UNKNOWN), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER: UNKNOWN), for COVID-19 IMMUNIZATION. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jan2024 at 07:00, outcome "recovering" and all described as "Tested positive for COVID-19 after receipt of COVID-19 vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jan2024) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical information: Adverse event: Tested positive for COVID-19 after receipt of COVID-19 vaccine. If Covid prior vaccination: No. If Covid tested post vaccination: Yes.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on the known safety profile of the drug and temporal association, a causal relationship between suspect drug BNT162b2 omi xbb.1.5, and the events vaccination failure and covid 19 cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Still has pain in shoulder it was injected in; This is a spontaneous report received from a Consumer or other non HCP.  A 40-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Lot number: Not Provided) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "not recovered", described as "Still has pain in shoulder it was injected in". The action taken for BNT162b2 omi xbb.1.5 was unknown. Therapeutic measures were taken as a result of arthralgia.  Clinical course: Reporter got the shot last week and still has pain in shoulder it was injected in. Clarified shot to be the most recent Covid Vaccine made by Pfizer. He is at work and does not have a lot of time. He just wants to now if it is a common thing other people going through and is there a solution. Shoulder pain since the shot, it was last Friday. Today is Wednesday. Almost a week later and I am still having pain in my shoulder and it is flaring up. My priority is to find out solutions this is why I called earlier and they wanted to know about me and I said well that does not help me, it does help Pfizer not me. Any Vaccine administered on the same date was none. Other vaccinations four weeks prior to COVID Vaccine was none. Treatment included Ibuprofen. Dose: Consumer stated, I believe 200 milligrams.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he tested positive for covid; he tested positive for covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 82-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5, SINGLE), for Covid-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4, SINGLE), for Covid-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 3, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "he tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Positive, notes: on Sunday. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had 6 previous Pfizer covid vaccinations. He was shocked when he tested positive for covid on Sunday. He was prescribed Paxlovid which he started taking Monday and has competed 3 days. He wondered how is it possible to get covid after having 6 Pfizer covid vaccinations over the past couple of years?  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: FLUX, PNC20
Symptoms: Pain in extremity
Clinical narrative: experienced a "slight soreness in arm that went away rather quickly"; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 65-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 23Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 23Oct2023 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Oct2023, outcome "recovered", described as "experienced a "slight soreness in arm that went away rather quickly"". The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400001876 same patient/reporter; different dose vaccine/AE;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Incorrect dose administered, SARS-CoV-2 test, Vaccination failure
Clinical narrative: his wife had 8 Pfizer covid 19 shots/tested positive for covid today (home test); his wife had 8 Pfizer covid 19 shots/tested positive for covid today (home test); his wife had 8 Pfizer covid 19 shots/tested positive for covid today (home test); This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 69-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (DOSE 7 (BOOSTER), SINGLE), administration date: 22May2023, for Covid-19 immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "his wife had 8 Pfizer covid 19 shots/tested positive for covid today (home test)"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "his wife had 8 Pfizer covid 19 shots/tested positive for covid today (home test)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jan2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 25.0
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 Consumer or other non HCP.  A 25-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 25 years 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) all with onset Dec2023, 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 22Dec2023 to 27Dec2023. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 42.0
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 Consumer or other non HCP.  A 42-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Nov2023 as dose 1, single (Lot number: GJ2594) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "ulcerative colitis" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL, start date: 25Dec2023, stop date: 29Dec2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid started on 02Jan2024.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Pyrexia
Clinical narrative: I had a really bad metallic taste in my mouth; chills; fever; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Dec2023 at 18:30 as dose 1, single (Lot number: HG2649) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "low vitamin D" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: comirnaty (dose 1), administration date: 05Mar2021, when the patient was 51-year-old, for covid-19 immunisation; comirnaty (dose 2), administration date: 01Apr2021, when the patient was 51-year-old, for covid-19 immunisation; comirnaty (dose 3), administration date: 16Dec2021, when the patient was 52-year-old, for covid-19 immunisation; comirnaty (dose 4), administration date: 21Oct2022, when the patient was 53-year-old, for covid-19 immunisation. The following information was reported: DYSGEUSIA (non-serious) with onset 13Dec2023, outcome "unknown", described as "I had a really bad metallic taste in my mouth"; CHILLS (non-serious) with onset 13Dec2023, outcome "unknown"; PYREXIA (non-serious) with onset 13Dec2023, outcome "unknown", described as "fever". Therapeutic measures were taken as a result of dysgeusia. additional information: The patient tried to eat something that would get rid of the taste. So, the taste is horrible. The patient was trying to eat something that had a lot of flavor to it to get rid of the taste.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing), notes: Hypothyroid; "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, vaccination failure. Paxlovid was administered from 19Dec2023 to 23Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Mar2023 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single) 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 Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 26Dec2023 to 30Dec2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
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 Consumer or other non HCP.  A 68-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "PBH/BPH" (unspecified if ongoing), notes: PBH/BPH; "High cholesterol" (unspecified if ongoing); "Overactive Bladder" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 6; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The patient received Paxlovid from 24Dec2023 to 28Dec2023 as treatment of COVID-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 67.0
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 Consumer or other non HCP from product quality group.  A 67-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 1, single (Lot number: HH7595) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "MS" (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 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 47-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (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 and included treatment with Paxlovid from 01Jan2024 to 04Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 46-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: 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. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 70.0
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 Consumer or other non HCP.  A 70-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 as patient received Paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 33.0
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 Consumer or other non HCP.  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single, as dose 2, single and as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history included: "Attention deficit hyperactivity disorder" (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 Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Throat tightness, Tinnitus
Clinical narrative: throat tighten a lil; ears are crackling; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "corn allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series complete, manufacturer unknown), for COVID-19 immunisation. The following information was reported: THROAT TIGHTNESS (non-serious), outcome "unknown", described as "throat tighten a lil"; TINNITUS (non-serious), outcome "unknown", described as "ears are crackling".  Additional information: The patient stated that he/she "recently had updated b covid shots." The patient asked if some "corn" filler were added because the patient is allergic to corn and this updated shot made patient's throat tighten a lil and ears are crackling, like the patient had ingested some form of corn. The patient specified that he/she had not experienced this with any other of the covid shots.      The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got Covid; got Covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 08Nov2023, outcome "unknown" and all described as "got Covid". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a consumer.  A 75-year-old female patient (not pregnant) received BNT162b2 OMI XBB.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Sep2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2, BNT162b2 OMI BA.4-5 (DOSE 5 (BOOSTER); 03:00 PM; left arm), administration date: 12Apr2023, when the patient was 74-year-old, for COVID-19 immunization; COVID-19 vaccine (DOSE 1, 2, 3, and 4; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered with sequelae" and all described as "COVID-19".  Therapeutic measures were taken as a result of the events which included nirmatrelvir/ritonavir (PAXLOVID) from 27Dec2023 to 31Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19, Weight
Clinical narrative: she said that she received the vaccine on Sep and got Covid on Dec; she said that she received the vaccine on Sep and got Covid on Dec; This is a spontaneous report received from a Consumer or other non HCP from medical information team and product quality group.  A 64-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single (Lot number: HG4680) at the age of 64 years for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), in Sep2023 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "kidney disease" (unspecified if ongoing), notes: stage three. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE , LOT#: ER8727.), administration date: 23Mar2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE , LOT#: EW0162), administration date: 13Apr2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, LOT#: FF2593), administration date: 16Oct2021, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, LOT#: FJ4991), administration date: 04Apr2022, when the patient was 62-year-old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 27Dec2023, outcome "unknown" and all described as "she said that she received the vaccine on Sep and got Covid on Dec". The patient underwent the following laboratory tests and procedures: Weight: 190. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.
Sex: F
Vaccine: PNC13
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in 2018 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), 4 days after the suspect product(s) administration, outcome "not recovered".  Additional information: 5.5 years before 05Jan2024, the patient received the Prevnar 13 vaccine. 4 days later she started having problems with dizziness and she is still experiencing dizziness.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Nov2023 as dose 1, single (Lot number: HG2282) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulphonamides" (unspecified if ongoing); "Known allergies:gluten" (unspecified if ongoing); "Known allergies:lactose" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing); "Graves Disease" (unspecified if ongoing); "Thyroid Eye Disease" (unspecified if ongoing); "Celiac Disease" (unspecified if ongoing); "Oral Lichen Planus" (unspecified if ongoing); "Breast Cancer" (unspecified if ongoing); "Mastectomy" (unspecified if ongoing); "Chemo", start date: 2001 (unspecified if ongoing); "Pulmonary Emboli", start date: 2001 (unspecified if ongoing); "Chronic Depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Known allergies: Macrolides" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "Known allergies: Augmentin". Vaccination history included: pfizer / biontech COVID-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Vaccine lot number=GJ6665,, Vaccine location=Right arm), administration date: 10Oct2022, when the patient was 69-year-old, for COVID-19 immunization; pfizer / biontech COVID-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Vaccine lot number=FM0698,, Vaccine location=Right arm), administration date: 05Apr2022, when the patient was 68-year-old, for COVID-19 immunization; pfizer / biontech COVID-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Vaccine location=Right arm},), administration date: 30Nov2021, when the patient was 68-year-old, for COVID-19 immunization; astrazeneca COVID-19 vaccine (DOSE 2, SINGLE, Vaccine location=Right arm), administration date: 16Jun2021, when the patient was 67-year-old, for COVID-19 immunization; astrazeneca COVID-19 vaccine (DOSE 1, SINGLE, Vaccine location=Right arm), administration date: 23Mar2021, when the patient was 67-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures including Paxlovid from 12Dec2023 to 17Dec2023 were taken as a result of vaccination failure, covid-19.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; dose 1, dose 2, dose 3- BNT162B2; dose 4- BNT162B2, BNT162B2 OMI BA.4-5; dose 5 Spikevax; This is a spontaneous report received from a Physician.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Batch/Lot number: unknown), on 19Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), on 03Nov2023 as dose 5 (booster), single), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Depression" (unspecified if ongoing); "thyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Nov2023, outcome "unknown", described as "dose 1, dose 2, dose 3- BNT162B2; dose 4- BNT162B2, BNT162B2 OMI BA.4-5; dose 5 Spikevax"; 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. The patient received Paxlovid from 27Dec2023 to 01Jan2024.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2, BNT162B2 OMI BA.4-5 cannot be fully excluded.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a consumer.  A 67-year-old male patient received BNT162b2 OMI XBB.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Nov2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered with sequelae" and all described as "COVID-19". Therapeutic measures were taken as a result of the events which included nirmatrelvir/ritonavir (PAXLOVID) from 27Dec2023 to 01Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 62.0
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 Consumer or other non HCP from product quality group.  A 63-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 17:45 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Bronchial atresia" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: pfizer / biontech vaccine (DOSE 5(BOOSTER), SINGLE, Batch/Lot No: 625342, Location of injection: Arm Right, Vaccine Administration Time: 02:45 PM), administration date: 16Sep2022, when the patient was 61-year-old, for Covid-19 immunization; moderna (DOSE 4, Batch/Lot No: 002m21A, Location of injection: Arm Right, Vaccine Administration Time: 04:30 PM), administration date: 06Apr2022, when the patient was 61-year-old, for Covid-19 immunization; pfizer / biontech vaccine (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: 30145, Location of injection: Arm Right), administration date: 18Sep2021, when the patient was 60-year-old, for Covid-19 immunization; pfizer / biontech vaccine (DOSE 2, SINGLE, Batch/Lot No: EN 6206, Vaccine Administration Time: 06:00 PM), administration date: 18Mar2021, when the patient was 60-year-old, for Covid-19 immunization; pfizer / biontech vaccine (DOSE 1, SINGLE, Batch/Lot No: EN 5198, Location of injection: Arm Right, Vaccine Administration Time: 05:45 PM), administration date: 25Feb2021, when the patient was 60-year-old, for Covid 19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Dec2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Dec2023) Positive; (01Jan2024) Negative; (04Jan2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that the patient received other vaccination and medication in 2 weeks. Paxlovid was taken as treatment for COVID-19 from 26Dec2023 to 30Dec2023. The patient stated that I first tested positive for covid on 25Dec2023. I finished Paxlovid on 30Dec2023. I felt great and tested negative on 01Jan2024. On evening on 04Jan2024 my sore throat was back, sinus headache, stuffy nose and a bit achy- tested positive for Covid at 11:00PM.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Limb mass
Clinical narrative: Had a large, large almost like a orange sized knot on both of my arm; knot like I raised my arm and it just like protruded out; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (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 1, manufacturer unknown), for COVID-19 immunization. The following information was reported: LIMB MASS (non-serious), outcome "recovered", described as "Had a large, large almost like a orange sized knot on both of my arm; knot like I raised my arm and it just like protruded out". Additional information: Patient took a Pfizer shot (Covid-19 vaccine), well patient has taken two but with the second one patient had a large, large almost like a orange sized knot on both of arms and 2 days later it just disappeared. Batch/lot number is not provided, and it cannot be obtained.
Age: 20.0
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 Consumer or other non HCP.  A 22-year-old male patient received BNT162b2 (BNT162B2), in Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 20 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "peanuts allergy" (unspecified if ongoing); "tree nuts allergy" (unspecified if ongoing); "cats, dogs allergy" (unspecified if ongoing); "adhesives allergy" (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. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: got COVID around the same time, in 2022, after we were vaccinated; got COVID around the same time, in 2022, after we were vaccinated; This is a spontaneous report received from a Consumer or other non HCP  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and in 2022 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. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "got COVID around the same time, in 2022, after we were vaccinated".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400005827 same reporter, drug, different patient;US-PFIZER INC-PV202400002758 same reporter, drug, different patient;