chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
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. A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (PFIZER BIONTECH COVID-19 VACCINE), on 15Dec2022 at 16:30 as dose 3 (booster), single (lot number unknown) at the age of 38 years, in left arm for covid-19 immunisation; BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), as dose 1, single (lot number unknown), in left leg and on 17Dec2021 at 16:45 as dose 2, single (lot number unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "premenstrual dysphoric disorder (PMDD)" (unspecified if ongoing); "auditory processing disorder" (unspecified if ongoing); "OCD" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing). Concomitant medications included: BUSPIRONE, start date: 02Mar2020, manufacturer: Aurobindo; GUANFACINE, start date: 31Oct2022, manufacturer: Sun/Ohm. Past drug history included: Fluconazole, reaction: "allergies"; Metronidazole, reaction: "allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid taken from 10Sep2023 to 11Sep2023. Clinical course: Dose 1 was reported with vaccination date/time of 21Apr2020 at 14:00.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 will be requested and submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive on 23Jan2024 with relatively mild symptoms of sore throat, cough, congestion and fatigue/Strong positive and resumption of symptoms on 31Jan; Tested positive on 23Jan2024 with relatively mild symptoms of sore throat, cough, congestion and fatigue/Strong positive and resumption of symptoms on 31Jan; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mild high cholesterol" (unspecified if ongoing); "hypothyroidism" (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 23Jan2024, outcome "unknown" and all described as "Tested positive on 23Jan2024 with relatively mild symptoms of sore throat, cough, congestion and fatigue/Strong positive and resumption of symptoms on 31Jan". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jan2024) positive; (30Jan2024) faint positive; (12Feb2024) still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovd from 23Jan2024 to 29Jan2024.  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: 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.  A 69-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 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Egg yolks" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Onions" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Synthetic opioids, reaction(s): "allergies". Vaccination history included: BNT162b2 (Dose 6 (Booster), Single, vaccine lot number=GJ6743, vaccine location=Left arm), administration date: 27May2023, when the patient was 68-year-old, for Covid-19 immunization; BNT162b2 (Dose 5 (Booster), Single, vaccine lot unknown=True, vaccine location=Left arm), administration date: 17Sep2022, when the patient was 67-year-old, for COVID-19 immunization; moderna (Dose 4 (Booster), Single, vaccine lot number=056M21A, vaccine location=Left arm), administration date: 20Apr2022, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2 (Dose 3 (Booster), Single, vaccine lot number=301358A, vaccine location=Left arm), administration date: 01Oct2021, when the patient was 66-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Single, vaccine lot number=EL9266, vaccine location=Left arm), administration date: 01Mar2021, when the patient was 66-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, Single, vaccine lot number=EL9269, vaccine location=Left arm), administration date: 07Feb2021, when the patient was 66-year-old, 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". Therapeutic measures were taken as a result of drug ineffective, 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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8732), in right arm, on 15Apr2021 as dose 2, single (Lot number: EW0162), in left arm and on 04Nov2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 34 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Sep2022 as dose 4 (booster), single (Lot number: AS7163B), in left arm and on 19Sep2023 as dose 5 (booster), single), in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN [LORATADINE], start date: 01Jan2020, stop date: 01Feb2024. The patient also took other concomitant therapy.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Sep2022, outcome "unknown"; 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 which included Paxlovid taken from 02Feb2024 to 06Feb2024.
Age: 33.0
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 33-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing); "Celiac disease" (unspecified if ongoing); "Allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication included: HUMALOG. 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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid for treatment of COVID-19 from 03Feb2024 to 07Feb2024.    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; Covid; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 51-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 as dose 1, single (Lot number: HG2649) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "known allergies: Lisinopril".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 47.0
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 48-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid from 01Feb2024 to 05Feb2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 56.0
Sex: M
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 56-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19; patient was given PAXLOVID on 03Feb2024 as treatment.  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, Vaccination failure
Clinical narrative: COVID -19; COVID -19; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "some infection-induced asthma" (unspecified if ongoing); "sinus issues" (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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Jan2024, outcome "unknown" and all described as "COVID -19". Therapeutic measures included starting paxlovid (one day after symptoms started) from 27Jan2024 to 31Jan2024 were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 74.0
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 74-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1 (toppac), single (Lot number: HG4680) at the age of 74 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Gout" (unspecified if ongoing); "Controlled BP" (unspecified if ongoing). Concomitant medications included: BISOPROLOL;HYDROCHLOROTHIAZIDE; ALLOPURINOL; AREDS 2 PLUS MULTI VITAMIN. Vaccination history included: COVID-19 vaccine (primary immunization series completed; manufacturer unknown), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Jan2024, outcome "not recovered" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jan2024) Positive; (Feb2024) Positive; (Feb2024) Positive. Therapeutic measures were taken as a result of vaccination failure, COVID-19. Additional information: The patient tested positive on 31Jan2024. She took Paxlovid (lot number: GJ7330) from 01Feb2024 to 05Feb2024. The patient took the full dose, and she tested after 10 days and 13 days and was still positive.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a consumer from Medical Information Team. A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5 (PFIZER BIONTECH COVID-19 VACCINE)), in Nov2022 as dose 5 (booster), single (lot number unknown) for covid-19 immunisation; BNT162b2 (BNT162B2 NOS (PFIZER BIONTECH COVID-19 VACCINE)), in Aug2022 as dose 4 (booster), single (lot number unknown) for covid-19 immunisation; BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), in Mar2021 as dose 1, single (lot number unknown), in Mar2021 as dose 2, single (lot number unknown) and in Dec2021 as dose 3 (booster), single (lot number unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) positive, notes: beginning of Oct2023. Clinical course: The patient was asking about the Pfizer COVID-19 vaccine. She mentioned she got all the shots for COVID. Her vaccination history is as follows: Mar2021 two doses, Dec2021 one dose, Aug2022 one dose, Nov2022. She tested positive for COVID the beginning of Oct2023. She was told by her HCP to not get vaccinated for COVID-19 vaccine too soon. She wants to confirm if she can get another vaccination now if it is time for her to get another one.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 will be requested and submitted if and when received.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech /Moderna; COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Mar2023 at 10:00 as dose 4, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Oct2023 at 15:00 as dose number unknown, single), in right arm; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3, single). The patient's relevant medical history included: "Tuna allergy" (unspecified if ongoing), notes: allergies: Tuna. 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"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Pfizer / BioNTech /Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 29Jan2024 to 02Feb2024.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained
Age: 52.0
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 53-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolaemia" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR, stop date: 03Feb2024. 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), outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included taking PAXLOVID from 03Feb2024 until 08Feb2024. The Covid symptoms improved while taking Paxlovid. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: He's had 6 doses of the Pfizer BioNtech COVID-19 vaccine; the last one around Sep of last year. And this is his third time with COVID; He's had 6 doses of the Pfizer BioNtech COVID-19 vaccine; the last one around Sep of last year. And this is his third time with COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 61-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 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: Pfizer biontech covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Pfizer biontech covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Pfizer biontech covid-19 vaccine (DOSE 3 BOOSTER, SINGLE), for COVID-19 immunization; Pfizer biontech covid-19 vaccine (DOSE 4 BOOSTER, SINGLE), for COVID-19 immunization; Pfizer biontech covid-19 vaccine (DOSE 5 BOOSTER, SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "He's had 6 doses of the Pfizer BioNtech COVID-19 vaccine; the last one around Sep of last year. And this is his third time with COVID". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient had 6 doses of the Pfizer BioNTech COVID-19 vaccine; the last one around Sep of last year (2023). And this is his third time with COVID. The patient was treated with Paxlovid.   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: it did not work for her, and she got sick too; it did not work for her, and she got sick too; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 73-year-old 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: Covid-19 vaccine (Primary immunization series completed, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose number unknown (Booster), 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 "it did not work for her, and she got sick too". Clinical course: The reporter's sister got all the covid vaccines and it did not work for her, and she got sick too. The reporter believed it was Pfizer Covid-19 vaccine but was not sure. She is 73 years old.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from an Other HCP.  A 32-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 32 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), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received COVID-19 treatment with Paxlovid from 03Feb2024 to 07Feb2024.   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: RSV
Symptoms: Lung carcinoma cell type unspecified stage IV
Clinical narrative: stage 4 lung cancer; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. According to the reporter (patient's niece), the patient was diagnosed with stage 4 lung cancer. The outcome for the event stage 4 lung cancer was unknown.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: My best friend died from the Covid-19 vaccine issued by Pfizer; 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 (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: DEATH (death, medically significant), outcome "fatal", described as "My best friend died from the Covid-19 vaccine issued by Pfizer". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical information: The patient's Other medication, past medication, family history, and social history was reported as unknown. Reporters best friend died from the Covid-19 vaccine issued by Pfizer.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: My best friend died from the Covid-19 vaccine issued by Pfizer
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I usually got sick when I got their vaccines; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 42-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I usually got sick when I got their vaccines".  Additional Information: Patient consider event as caused by suspect product.  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: I did not see an overall effectiveness when it came to preventing me from getting COVID; I did not see an overall effectiveness when it came to preventing me from getting COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 20-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I did not see an overall effectiveness when it came to preventing me from getting COVID". Clinical course: The patient stated, "I said that it is a brand I somewhat trust because I did get the Pfizer Covid vaccine back in 2021 and it has not caused any major health complications, so I trust that it is safe. But I did not see an overall effectiveness when it came to preventing me from getting Covid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Off label use
Clinical narrative: Physician is asking if he could administer Quadracel to a patient of 3 years of age and use the IPV component for that vaccine for the Polio vaccination for the patient instead, with no reported adverse event.; Initial information received on 05-Feb-2024 regarding an unsolicited valid non-serious case received from a Physician.  This case involves a 3 years old unknown gender patient for whom the physician is asking if he could administer Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/IPV (MRC5) Vaccine [Quadracel] and use the ipv component for that vaccine for the polio vaccination for the patient instead, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, 3 years old patient received a  dose of suspect Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/IPV (MRC5) Vaccine [Quadracel] (lot number, expiration date, strength, formulation and dose not reported) (route and administration site: unknown) (off label use).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: YF
Symptoms: Incorrect route of product administration
Clinical narrative: inadvertently administer the Yf-Vax IM instead of SC, with no reported adverse event; Initial information was received on 09-Feb-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and gender patient who was inadvertently administer the yellow fever vaccine- [YF-VAX] intramuscular instead of subcutaneous with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect yellow fever vaccine- (Solution for injection) (lot UJ830AC, expiry date: 01-Jul-2024, strength: unknown) via intramuscular route in unknown administration site for Immunization and inadvertently administer the yf-vax im instead of sc, with no reported adverse event (incorrect route of product administration) (latency: same day)  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Deathly ill; This spontaneous case was received on 05-Feb-2024, reported by other non-healthcare professional (consumer) via Med Communications (reference number: SEQW24-00502), and concerned a patient of an unreported age and gender.   The patient's medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with influenza virus vaccine (brand not specified; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving influenza virus vaccine, the patient got deathly ill and had to be isolated for a week. The patient's children were bringing food to the door, as reported.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  This case is linked with case 202400718 (the same patient and reporter).  Company Comment: Due to a lack of information about the event and unclear temporal relationship, causality for the event of 'illness' is assessed as unassessable.; Sender's Comments: Due to a lack of information about the event and unclear temporal relationship, causality for the event of 'illness' is assessed as unassessable.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Deathly ill; This spontaneous case was received on 05-Feb-2024, reported by other non-healthcare professional (consumer) via Med Communications (reference number: SEQW24-00502), and concerned a patient of an unreported age and gender.   The patient's concomitant medication were not reported. The patient's historical vaccine included an unspecified influenza vaccine (batch not specified) on an unspecified date, for an unreported indication after which the patient was deathly ill, as reported.   On an unspecified date, the patient was vaccinated with influenza virus vaccine (brand not specified; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving influenza virus vaccine, the patient got deathly ill and had to be isolated for a week. The patient's children were bringing food to the door, as reported.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  This case is linked with case 202400713 (Same patient and reporter).  Company Comment: Due to a lack of information about the event and unclear temporal relationship, causality for the event of 'illness' is assessed as unassessable.; Sender's Comments: Due to a lack of information about the event and unclear temporal relationship, causality for the event of 'illness' is assessed as unassessable.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: During the visit on 11/03/2023, patient was received COVID Spike-VAX for 12 years and up instead of 6 11-year-old vaccine. A follow up visit was made on 02/12/2024 with patient's mother regarding the vaccination. Per mother, patient is doing well without adverse reactions. He recently had URI symptoms, but no other reactions noted from the vaccination. No acute respiratory distress noted at home.
Age: 54.0
Sex: F
Vaccine: COVID19, FLU4, RSV
Symptoms: Unevaluable event
Clinical narrative: unknown- pt didn't answer
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: No adverse reactions .
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient received the covid vaccine and the flu shot at the same time. At some point later, the patient got covid. The patient would like us to report that getting both vaccines at the same time caused covid
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Local reaction in left thigh red and inflame
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain
Clinical narrative: Patient had described that they experienced nerve pain to the extent of not being able to raise their arm past their head without pain.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: pt came in requesting rsv vaccine. Patient received their shot previously from another store and did not mention it. RPH later saw that patient had received it months prior at a different location. patient was called and reported they are ok no issues
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site streaking, Peripheral swelling
Clinical narrative: patient received vaccination on 2/7/2024 and vaccination arm became swollen, and painful from shoulder to elbow, had red streaks,  patient sought treatment at clinic on 2/11/2024 and was given antibiotics to treat.  Patient's arm has improved since antibiotics were given and is pretty much cleared up and getting better.  Still has a little soreness but it is improving as of 2/14/2024.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait inability, Hypoaesthesia, Pain in extremity
Clinical narrative: PATIENT STATED 12-31-23 WHICH WAS 2 TO 3 DAYS LATER HE STARTED EXPERIENCING VERY BAD RIGHT LEF PAIN FROM THE HIP TO THE KNEE. HE HAS NUMBING AND AT TIMES CAN NOT WALK. HE HAS BEEN USING ALEVE AND HOT HEATING PAD. ON 2-14 -24 HE WENT TO SEE PA WHO GAVE HIM GABAPENTIN AND TYLENOL #3.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Laboratory test, Magnetic resonance imaging abnormal, Neuropathy peripheral, Paraesthesia
Clinical narrative: developed Neuropathy; experienced tingling in fingers and toes; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EW0150), in left arm and on 30Apr2021 at 14:45 as dose 2, single (Lot number: ER8729), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "experienced tingling in fingers and toes"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "developed Neuropathy". The events "developed neuropathy" and "experienced tingling in fingers and toes" required physician office visit. The patient underwent the following laboratory tests and procedures: tests: Unknown Results, notes: performed tests on me; Magnetic resonance imaging: Neuropathy. Clinical course: After getting the first two shots of the Pfizer Covid vaccine patient developed Neuropathy. Patient's Neurologist told patient that patient wasn't the only one. Patient got the 2 doses of the vaccine and approximately 30 days following she experienced tingling in her fingers and toes. Patient GP sent her to a neurologist who performed tests on her including a MRI and told her that it was from the vaccine and that he had other patients with the same thing.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.  Amendment: This follow-up report is being submitted to amend previous information: The case information was updated.  Follow-up (09Feb2024): This is a spontaneous follow-up report received from a same reporter (Consumer). Updated Information included: Reporter, Patient details (age and gender), Lab data, Suspect Vaccines details, and Event (Tingling on fingers and toes) added; Product coding and clinical course updated.
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Back pain, Musculoskeletal chest pain, Rash
Clinical narrative: Shingles; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 67-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Glaucoma" (ongoing), notes: glaucoma medicated eye drops; "Blood vessel dilation" (ongoing), notes: permanent blood vessel dilation of the eyes. The patient's concomitant medications were not reported. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "Shingles".  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.
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 67-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Glaucoma" (ongoing), notes: glaucoma medicated eye drops; "Blood vessel dilation" (ongoing), notes: permanent blood vessel dilation of the eyes. The patient's concomitant medications were not reported. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "Shingles".  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.
Age: 0.58
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Wrong product administered
Clinical narrative: No side effects from the inadvertent administration of the VARIVAX vaccine / No additional AE; The patient was supposed to receive the VAXELIS vaccine instead of the VARIVAX vaccine; A 7 month 8 days old female patient was inadverntly administered the VARIVAX vaccine; This spontaneous report has been received from a Licensed Practical Nurse, concerning a 7-month-old female patient.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 13-FEB-2024, the patient was inadvertently vaccinated with the 1st dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 ml, (lot number W024332 was verified to be valid, expiration date reported and confirmed as 01-AUG-2024), administered as prophylaxis by a Health Professional (route of administration and anatomical location were not provided) (Product administered to patient of inappropriate). She was supposed to receive the diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) vaccine instead of the varicella virus vaccine live (oka/merck) (VARIVAX) vaccine which was administered due to nursing error (Wrong product administered).  There were no side effects nor additional adverse event (AE) from the inadvertent administration of the varicella virus vaccine live (oka/merck) (VARIVAX) vaccine.
Age: 0.58
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No side effects from the inadvertent administration of the VARIVAX vaccine / No additional AE; The patient was supposed to receive the VAXELIS vaccine instead of the VARIVAX vaccine; A 7 month 8 days old female patient was inadverntly administered the VARIVAX vaccine; This spontaneous report has been received from a Licensed Practical Nurse, concerning a 7-month-old female patient.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 13-FEB-2024, the patient was inadvertently vaccinated with the 1st dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 ml, (lot number W024332 was verified to be valid, expiration date reported and confirmed as 01-AUG-2024), administered as prophylaxis by a Health Professional (route of administration and anatomical location were not provided) (Product administered to patient of inappropriate). She was supposed to receive the diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) vaccine instead of the varicella virus vaccine live (oka/merck) (VARIVAX) vaccine which was administered due to nursing error (Wrong product administered).  There were no side effects nor additional adverse event (AE) from the inadvertent administration of the varicella virus vaccine live (oka/merck) (VARIVAX) vaccine.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dysstasia, Gait inability, Pain in extremity, Vomiting
Clinical narrative: unable to stand or eat; unable to stand or eat; It felt similar to an extreme hangover; Diarrhea; I woke up, it was dark, and I immediately vomited into my trash can; headache; fever; My joints hurt; This spontaneous case was reported by a patient and describes the occurrence of DYSSTASIA (unable to stand or eat), FEEDING DISORDER (unable to stand or eat), HANGOVER (It felt similar to an extreme hangover), DIARRHOEA (Diarrhea) and VOMITING (I woke up, it was dark, and I immediately vomited into my trash can) in a 37-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032680) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Feb-2024 at 12:30 PM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. In February 2024, the patient experienced DYSSTASIA (unable to stand or eat), FEEDING DISORDER (unable to stand or eat), HANGOVER (It felt similar to an extreme hangover), DIARRHOEA (Diarrhea), VOMITING (I woke up, it was dark, and I immediately vomited into my trash can), HEADACHE (headache), PYREXIA (fever) and ARTHRALGIA (My joints hurt). At the time of the report, DYSSTASIA (unable to stand or eat), FEEDING DISORDER (unable to stand or eat), DIARRHOEA (Diarrhea) and ARTHRALGIA (My joints hurt) outcome was unknown and HANGOVER (It felt similar to an extreme hangover), VOMITING (I woke up, it was dark, and I immediately vomited into my trash can), HEADACHE (headache) and PYREXIA (fever) was resolving.            Concomitant and treatment medications were not reported.  Patient had the vaccine administered at 12:30 pm, then went to sleep at 2:30pm. When patient woke up, it was dark, and he immediately vomited into his trash can. Patient had a splitting headache, his joints hurt, patient had a fever and diarrhea. Over the next several hours (patient don't know how many), patient vomited 8 times, visited the bathroom 6 times and was unable to stand or eat. Patient literally had to crawl across the floor to get to the bathroom. It felt similar to an extreme hangover.  It was unknown if the patient experienced any additional symptoms/events and medication Details and reason for taking the medicine.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Diarrhoea, Dysstasia, Feeding disorder, Hangover
Clinical narrative: unable to stand or eat; unable to stand or eat; It felt similar to an extreme hangover; Diarrhea; I woke up, it was dark, and I immediately vomited into my trash can; headache; fever; My joints hurt; This spontaneous case was reported by a patient and describes the occurrence of DYSSTASIA (unable to stand or eat), FEEDING DISORDER (unable to stand or eat), HANGOVER (It felt similar to an extreme hangover), DIARRHOEA (Diarrhea) and VOMITING (I woke up, it was dark, and I immediately vomited into my trash can) in a 37-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032680) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Feb-2024 at 12:30 PM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. In February 2024, the patient experienced DYSSTASIA (unable to stand or eat), FEEDING DISORDER (unable to stand or eat), HANGOVER (It felt similar to an extreme hangover), DIARRHOEA (Diarrhea), VOMITING (I woke up, it was dark, and I immediately vomited into my trash can), HEADACHE (headache), PYREXIA (fever) and ARTHRALGIA (My joints hurt). At the time of the report, DYSSTASIA (unable to stand or eat), FEEDING DISORDER (unable to stand or eat), DIARRHOEA (Diarrhea) and ARTHRALGIA (My joints hurt) outcome was unknown and HANGOVER (It felt similar to an extreme hangover), VOMITING (I woke up, it was dark, and I immediately vomited into my trash can), HEADACHE (headache) and PYREXIA (fever) was resolving.            Concomitant and treatment medications were not reported.  Patient had the vaccine administered at 12:30 pm, then went to sleep at 2:30pm. When patient woke up, it was dark, and he immediately vomited into his trash can. Patient had a splitting headache, his joints hurt, patient had a fever and diarrhea. Over the next several hours (patient don't know how many), patient vomited 8 times, visited the bathroom 6 times and was unable to stand or eat. Patient literally had to crawl across the floor to get to the bathroom. It felt similar to an extreme hangover.  It was unknown if the patient experienced any additional symptoms/events and medication Details and reason for taking the medicine.