chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Illness
Clinical narrative: very sick; This is a spontaneous report received from a Nurse from medical information team.  A 68-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "very sick".  Additional information: Caller was calling to know if Pfizer has a vaccine for the flu, as she wanted to take the flu shot (does not have a product name). Caller states she was disabled for the moment, so they told her they will go to her home to give her the shot, but she does not trust them. The caller states they told her the manufacture was something like "FEQ Secura". The caller stated she usually gets Pfizer products, she trusted Pfizer products as she has taken them for years. The caller stated she got the Pfizer Covid injection the last time with the flu shot, states she got them both at the same time, 1 each in each arm and it made her very sick. At the end of the call, caller stated she was also a Nurse.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Shellfish" (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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Dec2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 10Dec2023 to 14Dec2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Kidney disease" (unspecified if ongoing); "Sulpha allergy" (unspecified if ongoing); "Penicillin Allergy" (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 Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Dec2023) Positive, notes: always tested positive from 10Dec onward but the line got very light. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 10Dec2023 to 15Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Nov2023, stop date: 20Dec2023. 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 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 6 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Nov2023) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 21Nov2023 to 26Nov2023.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: experienced intermittent generalized malaise; chills; injection site pain with 6/10 pressure, erythema, and swelling; injection site pain with 6/10 pressure, erythema, and swelling; injection site pain with 6/10 pressure, erythema, and swelling; This is a spontaneous report received from a Pharmacist.  An adult female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Dec2023 as dose 1, single (Lot number: HG7557) intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. 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. The following information was reported: CHILLS (non-serious) with onset 16Dec2023 at 05:00, outcome "recovered" (Dec2023); MALAISE (non-serious) with onset 16Dec2023 at 05:00, outcome "recovered" (Dec2023), described as "experienced intermittent generalized malaise"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 16Dec2023 at 05:00, outcome "recovered" (Dec2023) and all described as "injection site pain with 6/10 pressure, erythema, and swelling". Therapeutic measures were taken as a result of malaise, chills, vaccination site pain, vaccination site erythema, vaccination site swelling. Additional information: The patient received covid monovalent injection 15Dec2023 on left upper arm. The next day (16Dec2023) from 5 am to 2 pm, she experienced intermittent generalized malaise and chills. At 7am, she noted injection site pain with 6/10 pressure, erythema, and swelling (2 in by 1.5 in clearly marked). She took levocetirizine 5 mg. The following day (17Dec2023), injection site pain with pressure (2/10) with less swelling and redness. On 18Dec2023, redness and swelling at injection site improved after levocetirizine 5 mg and mometasone 0.1% cream. Events fully resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 34-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 13Dec2023 to 17Dec2023. Clinical course: The patient had no known allergies.  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 an Other HCP from a sales representative.  An adult 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. Vaccination history included: Covid-19 vaccine (Dose: 1, Unknown Manufacturer), for Covid-19 Immunization. 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.  Clinical information: The patient received oral Paxlovid from 01Dec2023 to 02Dec2023 for COVID-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by varied factors; however, a contributory role of the suspect product to the reported Drug ineffective / COVID-19 cannot be ruled out.
Sex: U
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.  An elderly patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Nov2023 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: pfizer / biontech (Dose 6 (booster), single, Vaccine Administration Time: 12:00 PM, Vaccine location: Left arm, Vaccine lot unknown: true, Vaccine lot unknown reason: Not available/ provided to reporter at the time of report completion), administration date: 24Apr2023, for COVID-19 immunization; 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 (booster); Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (booster); Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 5 (booster); Manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had no known allergies. Paxlovid treatment was taken for COVID-19 from 11Dec2023 to 16Dec2023. Paxlovid rebound started on 21Dec2023, currently patient was recovering, and no treatment was taken for AE.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunization. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "type 2 diabetes" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: TELMISARTAN, start date: Feb2006; ROSUVASTATIN, start date: Feb2008; EZETIMIBE, start date: Mar2012; FISH OIL, start date: Oct2023; COENZYME Q10 [UBIDECARENONE], start date: Apr2014; VITAMIN C [ASCORBIC ACID], start date: Jul2022; METFORMIN, start date: Sep2022; B12 [CYANOCOBALAMIN], start date: Dec2022. Vaccination history included: Bnt162b2 (Dose 4 (Booster), single on Feb2022.), administration date: Feb2022, when the patient was 66 years old, for Covid-19 Immunization; Bnt162b2 (Dose 3 (Booster), single on Sep2021.), administration date: Sep2021, when the patient was 66 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2, single on May2021), administration date: May2021, when the patient was 66 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1, single on Dec2020), administration date: Dec2020, when the patient was 65 years old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Dec2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Dec2023) Positive, notes: tested positive for Covid on 08Dec2023; (14Dec2023) Negative, notes: Tested negative for Covid on 14Dec and 16/23; (16Dec2023) Negative, notes: Tested negative for Covid on 14Dec and 16/23. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Patient had no known allergies. Patient received Anti-viral treatment for Covid 19 with Paxlovid from 08Dec2023 to 13Dec2023. Rebound covid symptoms on 20Dec2023, originally became ill on and tested positive for Covid on 08Dec2023. Started Paxlovid on the same day, completed on 13Dec2023. Tested negative for Covid on 14Dec and 16/23. Then infection returned on 20Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 37.0
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.  A 37-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE; 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" (Dec2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Negative, notes: Tested negative for two days following completion of paxlovid; (Dec2023) Positive, notes: Paxlovid rebound. (8 days after first onset of symptoms) before testing positive and symptoms returning. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Paxlovid from 11Dec2023 to 16Dec2023 for the treatment of COVID-19. The patient tested negative for two days following completion of Paxlovid (8 days after first onset of symptoms).     No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 53.0
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.  A 53-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacture: Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacture: Unknown), for Covid-19 immunization; Covid-19 vaccine (Primary immunization series completed; Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (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 test: (12Dec2023) Negative; (13Dec2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Patient had no known allergies. Patient received Anti-viral treatment for Covid 19 with Paxlovid from 05Dec2023 to 10Dec2023. After Completing Treatment, 3 Days Later Congestion And Cough Resumed And Tested Positive Again After Testing Negative The Day Before.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 66.0
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 66-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Known allergies: Penicillin" (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 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Anti viral details: Product: COVID 19 Treatment, Brand: Pfizer, Treatment start date: 07Dec2023, Treatment stop date: 12Dec2023, Indication: 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: 62.0
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 62-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). Concomitant medication(s) included: RYALTRIS, start date: 22May2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received Paxlovid from 12Dec2023 to 18Dec2023 for the 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 33-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation. The patient had no relevant medical history. 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 (Booster);  MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (Booster);  MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Dec2023) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Patient received Anti-viral treatment for Covid 19 with Paxlovid from 11Dec2023 to 15Dec2023. Tested negative on Sunday 17Dec after completing Paxlovid on Friday 15Dec2023. No Known allergies.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on available information a contributory role of BNT162b2 omi xbb.1.5 to the reported event, vaccination failure, covid-19 cannot be totally excluded as efficacy of a drug varies from individual to individual.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 as dose 1, single (Lot number: HG2282) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "IBS-C" (unspecified if ongoing), notes: IBS-C (Irritable bowel syndrome with constipation); "thumb arthritis" (unspecified if ongoing); "gastroparesis" (unspecified if ongoing), notes: borderline gastroparesis; "obesity" (unspecified if ongoing), notes: borderline; "sleep apnea" (unspecified if ongoing), notes: mild; "depression/anxiety" (unspecified if ongoing); "depression/anxiety" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "TMJ (temporomandibular joint)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna (Dose 6 (Booster), single, Batch/Lot No: AS7185B, Location of injection: Arm Left), administration date: 09Jun2023, when the patient was 53-year-old, for Covid-19 immunization; moderna (Dose 5 (Booster), single, Batch/Lot No: 062F22A, Location of injection: Arm Left), administration date: 21Nov2022, when the patient was 53-year-old, for Covid-19 Immunization; pfizer / biontech (Dose 4 (Booster), single, Batch/Lot No: FM0698, Location of injection: Arm Left), administration date: 11Apr2022, when the patient was 52-year-old, for Covid-19 Immunization; pfizer / biontech (Dose 3 (Booster), single, Batch/Lot No: 33130BA, Location of injection: Arm Left), administration date: 09Dec2021, when the patient was 52-year-old, for Covid-19 Immunization; moderna (Dose 2, single, Batch/Lot No: 038B21A, Location of injection: Arm Left), administration date: 23Apr2021, when the patient was 51-year-old, for Covid-19 Immunization; moderna (Dose 1, single, Batch/Lot No: 016B21A, Location of injection: Arm Left), administration date: 26Mar2021, when the patient was 51-year-old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Patient received Anti-viral treatment for Covid 19 with Paxlovid (Lot: GJ7130) from 08Dec2023 to 13Dec2023, patient received other medication in 2 weeks.
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 69-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. Vaccination history included: Covid-19 vaccine (DOSE 4 BOOSTER, SINGLE, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 BOOSTER, SINGLE, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (Primary Immunisation completed, DOSE 2, SINGLE, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (Primary Immunisation completed, DOSE 1, SINGLE, Manufacturer Unknown), for Covid-19 Immunization. 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.  Clinical course: Anti-viral details: Paxlovid for the treatment of COVID 19 from 11Dec2023 to 15Dec2023.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: 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; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 Immunization. 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.  Clinical course: Anti viral details: The patient received Paxlovid as COVID 19 treatment.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive with home antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details: The patient received Paxlovid as COVID 19 treatment from 11Dec2023 to 15Dec2023. The patient does not have any known allergies. Other medical history: None.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 57.0
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 57-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Nov2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, 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 "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Anti viral details included Paxlovid (Lot number: GY1961) for COVID 19 Treatment started on 13Dec2023 and stopped on 17Dec2023. Patient experienced Covid rebound after completing the Paxlovid treatment.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested covid positive on 21Dec2023; Tested covid positive on 21Dec2023; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MENINGOCOCCAL VACCINE CONJ taken for immunisation, on 19Oct2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER); Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1; Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant) with onset 21Dec2023 at 12:00, outcome "recovering", COVID-19 (medically significant) with onset 21Dec2023 at 12:00, outcome "recovering" and all described as "Tested covid positive on 21Dec2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Dec2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received.  Clinical course No covid prior vaccination and covid tested post vaccination was YesVaccine location Left arm and Facility type vaccine: Workplace clinic. Other vaccine 4weeks product=Sanofi meningococcal conjugate vaccine, and vaccine date=19Oct2023. Covid test type post vaccination Nasal Swab, and name post vaccination= Flowflex, (withheld) on 21Dec2023, covid test result=Positive
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE. Vaccination history included: pfizer / biontech (DOSE 5 (BOOSTER), SINGLE, vaccine location=Right arm), administration date: 29Sep2022, when the patient was 66-year-old, for COVID-19 Immuniztion; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE', Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Dec2023) Negative, notes: Tested negative on 19Dec2023; (22Dec2023) positive, notes: positive covid test noted on 22Dec2023. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course : The patient received paxlovid since 11Dec2023 to 16Dec2023 for the treatment of COVID-19. The patient received sertraline, atorvastatin and fish oil since 10Dec2023 in 2 weeks. Known allergies: No  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 51-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient received Paxlovid (lot number GJ7130) from 13Dec2023 to 17Dec2023 for the treatment of COVID-19. No known allergies.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 32-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Nov2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Kidney disease (I took a variation of paxlovid due to this)" (unspecified if ongoing), notes: other medical history: Kidney disease (I took a variation of paxlovid due to, this); "Yes, opioids" (unspecified if ongoing), notes: known allergies: Yes, opioids and many food allergies - certain fruits, vegetables, nuts, and certain shellfish; "many food allergies-certain fruits" (unspecified if ongoing), notes: known allergies: Yes, opioids and many food allergies - certain fruits, vegetables, nuts, and certain shellfish; "many food allergies-certain vegetables" (unspecified if ongoing), notes: known allergies: Yes, opioids and many food allergies - certain fruits, vegetables, nuts, and certain shellfish; "many food allergies-certain nuts" (unspecified if ongoing), notes: known allergies: Yes, opioids and many food allergies - certain fruits, vegetables, nuts, and certain shellfish; "many food allergies-certain shellfish" (unspecified if ongoing), notes: known allergies: Yes, opioids and many food allergies - certain fruits, vegetables, nuts, and certain shellfish. Concomitant medication(s) included: VYVANSE; XOLAIR; FAMOTIDINE; LISINOPRIL; ALLERTEC [CETIRIZINE]; ALLERFEX; DAYQUIL; NYQUIL. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Dec2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Dec2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information : The patient received Paxlovid treatment since 13Dec2023 to 17Dec2023 for COVID 19 Treatment. Vaccine received. Received other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose 1, single), for Covid-19 immunization; Bnt162b2 (Dose 2, single), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 06Dec2023 to 10Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Physician.  A 45-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "breast cancer" (unspecified if ongoing), notes: hx (history) of breast cancer; "Known allergies: NSAIDS" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Single, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Single, Unknown manufacturer, ), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (Booster), Single, Unknown manufacturer, ), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received Paxlovid treatment for COVID-19 from 12Dec2023 to 16Dec2023.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac monitoring abnormal, Dizziness, Dyspnoea, Electrocardiogram, Hypothyroidism
Clinical narrative: After the 2nd shot I developed a heart rate of 120 bpm while resting, feeling of a thumping heart beat, dizziness, and shortness of breath. Later diagnosed with tachycardia. Even though I am a firm believer I told these new symptoms to my doctor and he unfortunately dismissed my symptoms as my adderall prescription. This has made me hesitant to get the boosters as I felt my initial symptoms were dismissed and still continue.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Left atrial enlargement, Palpitations, Pulmonary function test normal, Supraventricular extrasystoles, Tachycardia
Clinical narrative: After the 2nd shot I developed a heart rate of 120 bpm while resting, feeling of a thumping heart beat, dizziness, and shortness of breath. Later diagnosed with tachycardia. Even though I am a firm believer I told these new symptoms to my doctor and he unfortunately dismissed my symptoms as my adderall prescription. This has made me hesitant to get the boosters as I felt my initial symptoms were dismissed and still continue.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thyroid function test abnormal, Ventricular extrasystoles
Clinical narrative: After the 2nd shot I developed a heart rate of 120 bpm while resting, feeling of a thumping heart beat, dizziness, and shortness of breath. Later diagnosed with tachycardia. Even though I am a firm believer I told these new symptoms to my doctor and he unfortunately dismissed my symptoms as my adderall prescription. This has made me hesitant to get the boosters as I felt my initial symptoms were dismissed and still continue.
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Diarrhoea, Eructation, Flatulence, Muscle spasms, Nausea
Clinical narrative: Chronic Nausea symptoms started a month and a half after this vaccine. Symptoms include nausea, vomiting, diarrhea, gas, sulfur burps, cramps, and pain. Doctors do not know why this is happening and can t figure it out.
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain, Vomiting
Clinical narrative: Chronic Nausea symptoms started a month and a half after this vaccine. Symptoms include nausea, vomiting, diarrhea, gas, sulfur burps, cramps, and pain. Doctors do not know why this is happening and can t figure it out.
Age: 60.0
Sex: M
Vaccine: RSV
Symptoms: Chills, Depression, Injection site pain, Insomnia, Pollakiuria
Clinical narrative: Patient is complaining of side effects to vaccine started around 8pm today. Sx included nausea, chills and urinary frequency with difficulty sleeping and left arm soreness at site of injection. Denies hx of strong reaction to vaccines in the past. Has been using OTC tylenol (last dose 11pm) and keeping well hydrated with water and orange juice.  Denies fever, CP, SOB, DIB, weakness.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Haematoma, Immunoglobulin therapy, Immunoglobulins decreased, Laboratory test
Clinical narrative: "Healthy male.  43 years old.  No history of drug or alcohol use.  Normal weight for size and age.  Trains and runs at least 4 times  week.  Does not use nor did he use proteins, supplements or steroids.December 9, 2023 entered the guard with petechiae and hematomas on different parts of the body. Routine lab was done and a blood count is found with a platelet count of 10,000. A brain tomography, immediate hospitalization, and IV corticosteroids, was indicated. After two days of hospitalization and without the desired effect of the corticosteroids he was administered gamma globulin infusions on two consecutive days. The patient was discharged on the 5th day of hospitalization with platelets 100,000, at the moment continues outpatient treatment of oral corticosteroids and laboratory every week to evaluate evolution.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Petechiae, Platelet count decreased
Clinical narrative: "Healthy male.  43 years old.  No history of drug or alcohol use.  Normal weight for size and age.  Trains and runs at least 4 times  week.  Does not use nor did he use proteins, supplements or steroids.December 9, 2023 entered the guard with petechiae and hematomas on different parts of the body. Routine lab was done and a blood count is found with a platelet count of 10,000. A brain tomography, immediate hospitalization, and IV corticosteroids, was indicated. After two days of hospitalization and without the desired effect of the corticosteroids he was administered gamma globulin infusions on two consecutive days. The patient was discharged on the 5th day of hospitalization with platelets 100,000, at the moment continues outpatient treatment of oral corticosteroids and laboratory every week to evaluate evolution.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pharmacist reported, "A pregnant women was given Arexvy by mistake; below 60 years old patient received Arexvy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 33-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Pharmacist reported, "A pregnant women was given Arexvy by mistake) and inappropriate age at vaccine administration (Verbatim: below 60 years old patient received Arexvy). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 18-DEC-2023 The reporter was the Pharmacist. The pharmacist reported that a pregnant women was given Arexvy by mistake. However, the pharmacist was unable to provide full patient or vaccine details, he/she don't have that information unfortunately. The pharmacist also declined to store the information in the MI database and preferred to remain anonymous. The patient was unknown week pregnant at the time of the event onset. The reporter did not consented to follow up.