chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; 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 23Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Kidney disease" (unspecified if ongoing); "heart disease" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing); "allergies" (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 21Dec2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Dec2023) Positive; (28Dec2023) Negative; (31Dec2023) Positive. Treatment Paxlovid was taken as a result of event covid-19 from 21Dec2023 to 27Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 72-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Nov2023 at 10:00 as dose 1, single (Lot number: HJ5892) at the age of 72 years, 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: BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Vaccine administration time: 10:00 AM, Vaccine lot number: GJ6665, Vaccine dose number: 4, Vaccine location: Left arm), administration date: 05Nov2022, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Vaccine administration time: 10:00 AM, Vaccine lot number: 301558A, Vaccine dose number: 3, Vaccine location: Left arm), administration date: 13Oct2022, when the patient was 71-year-old, 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 "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 17:00 as dose 1, single (Lot number: 3030371) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "ensophiliac esophagus" (unspecified if ongoing); "asthma" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Phenergan, reaction(s): "known allergies: phenergan". Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: 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. Patient used Paxlovid from 20Dec2023 to 24Dec2023 as treatment.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  An 81-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Dec2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Afib" (unspecified if ongoing). Patient had no hypersensitivity. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EL9261, Anatomical location: Arm Left), administration date: 22Jan2021, when the patient was 78-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EN9581, Anatomical location: Arm Left), administration date: 12Feb2021, when the patient was 78-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: EW0165, Anatomical location: Arm Left), administration date: 08Oct2021, when the patient was 79-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: FK9729, Anatomical location: Arm Left), administration date: 05May2022, when the patient was 80-year-old, for Covid-19 Immunization; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Batch/Lot No: GH9694, Anatomical location: Arm Left), administration date: 01Oct2022, when the patient was 80-year-old, for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (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. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 16Dec2023 to 21Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 72.0
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 from product quality group.  A 72-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Sep2023 as dose 1, single (Lot number: HH7595) at the age of 72 years, 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: moderna (DOSE 1, SINGLE, Batch/ lot number: 025J20-2A, Vaccine location: Left arm), administration date: 19Jan2021, when the patient was 69-year-old, for COVID-19 immunization; moderna (DOSE 2, SINGLE, Batch/ lot number: 026021A, Vaccine location: Left arm), administration date: 23Oct2021, when the patient was 70-year-old, for COVID-19 immunization; moderna (DOSE 3 (BOOSTER), SINGLE, Batch/ lot number: 002MZ1A, Vaccine location: Left arm), administration date: 05Apr2022, when the patient was 70-year-old, for COVID-19 immunization; moderna (DOSE 4 (BOOSTER), SINGLE, Batch/lot number: AS7148B, Vaccine location: Left arm), administration date: 09Sep2022, when the patient was 71-year-old, for COVID-19 immunization; moderna (DOSE 5 (BOOSTER), SINGLE, Batch/ lot number: 011H22A, Vaccine location: Left arm), administration date: 21Apr2023, when the patient was 71-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 17Dec2023 to 21Dec2023.
Age: 42.0
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 42-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2023) Negative; (29Dec2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information : The patient received the vaccine. No other medication in 2 weeks. The patient received paxlovid 150 (X2)-100 mgpk (Eua) Tablets, Dose Pack since 18Dec2023 to 23Dec2023 for the treatment of COVID-19. During the treatment the side effect were nausea, diarrhea, not feeling well in general. The patient reported that after taking Paxlovid for 5 days I felt better. I tested negative for covid 3 days after finishing the medicine although I still had the congestions and cough then I had a bad congestions on day 6. I tested positive for COVID again.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 62-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 at 12:00 as dose 1, single (Lot number: HG2649) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "mild hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE NUMBER UNKNOWN, SINGLE, Batch/lot: GF19693, Anatomical location: Right arm), administration date: 22Oct2022, when the patient was 61-year-old, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" (28Dec2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Dec2023) Positive; (28Dec2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 20Dec2023 to 24Dec2023. Clinical course: Patient had no known allergies.  No follow-up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from an Other HCP from product quality group.  A 38-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Lot number: 391458A) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Post-traumatic stress disorder (PTSD)" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine". Vaccination history included: Bnt162b2 (Dose 1, single , Batch/ Lot number: EK5730, Anatomical location: Right arm), for Covid-19 Immunization; Bnt162b2 (Dose 2, single , Batch/ Lot number: EL3248,), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" (26Dec2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid treatment from 20Dec2023 to 24Dec2023. Clinical course: She recovered and tested negative on the 26th.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Age: 39.0
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 from product quality group.  A 39-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Oct2023 as dose 1, single (Lot number: HF9299) at the age of 39 years, 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: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EW0150, Location of injection: Arm Left), administration date: 04Apr2021, when the patient was 36-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EP7533, Location of injection: Arm Left), administration date: 26Apr2021, when the patient was 36-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: FH8020, Location of injection: Arm Left), administration date: 06Nov2021, when the patient was 37-year-old, for Covid-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: GJ2524, Location of injection: Arm Left), administration date: 17Sep2022, when the patient was 38-year-old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Dec2023, outcome "recovered" (27Dec2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Dec2023) Positive; (27Dec2023) Negative; (30Dec2023) Negative. Therapeutic measures (Paxlovid treatment start date: 20Dec2023, treatment stop date: 25Dec2023) were taken as a result of vaccination failure, covid-19. Clinical course: Patient tested positive for COVID-19 on 20Dec2023. She was symptom free and tested negative 27Dec2023 and 30Dec2023.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 35-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Nov2023 as dose 1, single (Lot number: HG9498) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Depression" (unspecified if ongoing); "allergies:Cats" (unspecified if ongoing); "Allergies:steri-strips" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ, start date: 01Jan2020, stop date: 16Dec2023; ESCITALOPRAM; FEROSUL; NUVARING vaginal; CYMBALTA. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Vaccine lot number: GJ6665, Vaccine location: Left arm), administration date: 14Oct2022, when the patient was 34-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Vaccine lot number: FM0698, Vaccine location: Left arm), administration date: 05Apr2022, when the patient was 33-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Vaccine lot number: FH8020, Vaccine location: Left arm), administration date: 02Nov2021, when the patient was 33-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Vaccine lot number: ER8734, Vaccine location: Left arm), administration date: 06Apr2021, when the patient was 32-year-old, for Covid-19 immunization; BNT162b2 (DOSE 1, SINGLE, Vaccine lot number: ER2613, Vaccine location: Left arm), administration date: 16Mar2021, when the patient was 32-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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: positive at-home test result. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received Paxlovid from 19Dec2023 to 23Dec2023 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: 79.0
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 from product quality group.  A 79-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing); "pre diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single, Batch/lot number: 301458a, Anatomical location: Left arm), administration date: 04Oct2021, when the patient was 77-year-old, for COVID-19 immunisation; BNT162b2 (Dose 2, Single, Batch/lot number: FP7139, Anatomical location: Left arm), administration date: 22Jul2022, when the patient was 77-year-old, for COVID-19 immunisation, reaction(s): "Dose 04Oct2021/Dose 22Jul2022". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes paxlovid from 27Dec2023 to Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400001208 Same patient, same product, different events;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Nurse from product quality group.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2023 at 17:30 as dose 5 (booster), single (Lot number: GJ6742) at the age of 70 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Jan2021 at 15:00 as dose 1, single (Lot number: EL0142), in right arm, on 28Jan2021 at 12:00 as dose 2, single (Lot number: EL9261), in right arm, on 08Oct2021 at 18:30 as dose 3 (booster), single (Lot number: FF2590), in right arm and on 28May2022 at 18:00 as dose 4 (booster), single (Lot number: FP4554), in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MVI 3, start date: 15Jul1990; CITRACAL-D, start date: 17Jul2003; VITAMIN D3, start date: 15Jul2006; TRAZODONE, start date: 15Jul2015, stop date: 12Dec2023; BIOTIN, start date: 15Oct2022; METOPROLOL, start date: 31Aug2023, stop date: 31Aug2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Dec2023, outcome "recovered" (22Dec2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Dec2023) Positive; (22Dec2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 13Dec2023 to 17Dec2023. Clinical course: COVID + with symptoms of fever, aching, nasal congestion, malaise on 12Dec2023. Fever resolved 15Dec. Felt well on 18Dec2023-22Dec2023 and was covid negative.; Sender's Comments: Based on the given information and known safety profile , the possible contributory role of the suspect for the event drug ineffective and covid-19 cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202400003300 Same patient/product, different dose/events;
Sex: F
Vaccine: RSV
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  A female patient in her 80's received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown".  Additional information: The patient was a female, about 87 or 88 years old. The patient had fatigue from RSV vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19 pneumonia, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: Drug ineffective; Suspected Covid-19; COVID Pneumonia; Sick; Bronchitis; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old female patient received BNT162b2 (BNT162B2), on 30Jun2021 at 13:00 as dose 1, single (Lot number: EW0151) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes", start date: 2016 (ongoing); "Obesity", start date: Mar2021 (ongoing), notes: I went to start the process for bariatric surgery. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus, start date: 2018 (ongoing). The following information was reported: BRONCHITIS (non-serious) with onset Jul2021, outcome "recovered" (Jul2021); COVID-19 PNEUMONIA (medically significant) with onset Jul2021, outcome "recovered" (Jul2021), described as "COVID Pneumonia"; DRUG INEFFECTIVE (medically significant) with onset Jul2021, outcome "recovered" (Jul2021); ILLNESS (non-serious) with onset Jul2021, outcome "recovered" (Jul2021), described as "Sick"; SUSPECTED COVID-19 (medically significant) with onset Jul2021, outcome "recovered" (Jul2021). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2021) Negative; X-ray: (Jul2021) COVID Pneumonia. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19, covid-19 pneumonia, illness, bronchitis. Clinical course: In Aug2021, patient was advised she would need to have the COVID vaccine in order to keep her job at the time as an authorization coordinator for a local home health agency. She chose Pfizer over Moderna and Johnson and Johnson because she believed she trusted more than the other two options. Patient received the first vaccine and two days before she was scheduled to get the second, she got sick with what she thought was just bronchitis. Patient was told by withheld office that it appeared to be COVID pneumonia based on the x ray, but the COVID test was negative. She took 10 days of antibiotics and other medications and started to feel better and then decided to consult with the pharmacist at the withheld pharmacy about what she had just gotten over before taking the second. Patient took second vaccine in Jul2021. Antibiotics, inhaler, nebulizer prescribed. 2nd COVID Vaccine taken after medicine was done and pharmacist was consulted. Diagnosis Jul2021 possible COVID Pneumonia with negative COVID test. She had never had a heart-issue in her life and before shots, the only health issue she ever had was diabetes and obesity.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300331932 Same patient/same product, different dose/event;
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, X-ray
Clinical narrative: Drug ineffective; Suspected Covid-19; COVID Pneumonia; Sick; Bronchitis; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old female patient received BNT162b2 (BNT162B2), on 30Jun2021 at 13:00 as dose 1, single (Lot number: EW0151) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes", start date: 2016 (ongoing); "Obesity", start date: Mar2021 (ongoing), notes: I went to start the process for bariatric surgery. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus, start date: 2018 (ongoing). The following information was reported: BRONCHITIS (non-serious) with onset Jul2021, outcome "recovered" (Jul2021); COVID-19 PNEUMONIA (medically significant) with onset Jul2021, outcome "recovered" (Jul2021), described as "COVID Pneumonia"; DRUG INEFFECTIVE (medically significant) with onset Jul2021, outcome "recovered" (Jul2021); ILLNESS (non-serious) with onset Jul2021, outcome "recovered" (Jul2021), described as "Sick"; SUSPECTED COVID-19 (medically significant) with onset Jul2021, outcome "recovered" (Jul2021). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2021) Negative; X-ray: (Jul2021) COVID Pneumonia. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19, covid-19 pneumonia, illness, bronchitis. Clinical course: In Aug2021, patient was advised she would need to have the COVID vaccine in order to keep her job at the time as an authorization coordinator for a local home health agency. She chose Pfizer over Moderna and Johnson and Johnson because she believed she trusted more than the other two options. Patient received the first vaccine and two days before she was scheduled to get the second, she got sick with what she thought was just bronchitis. Patient was told by withheld office that it appeared to be COVID pneumonia based on the x ray, but the COVID test was negative. She took 10 days of antibiotics and other medications and started to feel better and then decided to consult with the pharmacist at the withheld pharmacy about what she had just gotten over before taking the second. Patient took second vaccine in Jul2021. Antibiotics, inhaler, nebulizer prescribed. 2nd COVID Vaccine taken after medicine was done and pharmacist was consulted. Diagnosis Jul2021 possible COVID Pneumonia with negative COVID test. She had never had a heart-issue in her life and before shots, the only health issue she ever had was diabetes and obesity.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300331932 Same patient/same product, different dose/event;
Sex: F
Vaccine: RSV
Symptoms: Peripheral swelling
Clinical narrative: her arm is swollen; thought that vaccine was administered incorrectly; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female 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. Vaccination history included: Pfizer covid vaccines (dose 1, single), for covid-19 immunisation, reaction(s): "it does hurt a bit".The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "her arm is swollen"; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious), outcome "unknown", described as "thought that vaccine was administered incorrectly". Additional information: Caller mentioned that she is upset because she got her vaccine and thought that vaccine was administered incorrectly. She always get all Pfizer COVID vaccines it does hurt a bit but this time, when the vaccine was administered. her arm is swollen the next day and it seems that the pharmacist injected the vaccine. Created Manual AE form because patient experienced an adverse event after the vaccine was administered which is swollen arm compare to the previous vaccines she always receives which she did not experience anything. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  will be requested and submitted if and when received.
Sex: F
Vaccine: UNK
Symptoms: Antibody test negative, Immunoglobulin therapy, No adverse event, Product administered at inappropriate site
Clinical narrative: got five vaccines plus I got the immunoglobulins, but it was all given in the wrong area with no adverse event; Initial information received on 27-Dec-2023 regarding an unsolicited valid non-serious case received from a patient.  This case involves Adult female patient who got five vaccines, IPV (VERO) [Imovax] plus got the immunoglobulins, but it was all given in the wrong area with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect IPV (VERO), Suspension for injection (strength, lot number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization) and five vaccines plus i got the immunoglobulins, but it was all given in the wrong area with no adverse event (product administered at inappropriate site) (latency: same day).  It was reported, On November 10th I was attacked by an armadillo and I have contacted my state Health Department. They have recommended that I had the rabies vaccine. I reported to my local Emergency Room and I got five vaccines plus I got the immunoglobulins, but it was all given in the wrong area. None of them was done correctly with the exception of the last shot that I received. Everything else was placed on my hip and the last shot that I took was placed in my arm. I found out through our Health Department that I needed to get a titer test to see if I had any of the rabies antibodies. The test came with undetectable, I had less than 0.1 of the antibodies. The Health Department suggested that I go and get two rabies booster shots. I had originally taken the Ivamax. I reported to a different hospital, because I didn't want to go back to where they had done incorrectly. I got the RABAVERT booster shots and I had two.   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.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product storage error
Clinical narrative: got pentacle immunization on 13-sep-2023 when vaccine was exposed to low temperature, the lowest excursion was 31.3 f with no reported adverse event; Initial information received on 28-Dec-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old female patient (65 cm and 6.16 kg) who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] immunization on 13-sep-2023 when vaccine was exposed to low temperature, the lowest excursion was 31.3 F with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine live oral 1V (Rotarix) for Immunization; and HIB vaccine (HIB) for Prophylactic vaccination.  On 13-Sep-2023, the patient received a dose of 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot: UY849AA; expiry date: 19-Apr-2024) via intramuscular route in the left thigh for 4month Immunizations (Immunisation).  On 13-Sep-2023 the patient got pentacel immunization when vaccine was exposed to low temperature, the lowest excursion was 31.3 F with no reported adverse event (poor quality product administered) (latency: same day).   It was reported, "No AE reported by the parents. No AE (adverse event) observed by us in the office at the time of administration of vaccine and during follow-up visits. Pt (patient) tolerated they agreed to re-immunize patient, which we did on 09-Nov-2023.  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.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: COVID-19, Chills, Fatigue, Feeling abnormal, Malaise
Clinical narrative: feeling fatigue; chills; urinary tract infection; felt bad after her flu shot; sick; covid, tested positive yesterday; Initial information was received on 29-Dec-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2024SA003908(CLUSTER).  This case involves a 59 years old female patient (78 kg) who experienced feeling fatigue, chills, urinary tract infection, felt bad after her flu shot, sick and covid, tested positive yesterday after receiving influenza vaccine.  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 influenza vaccine produced by unknown manufacturer (unknown formulation) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunization). The information on the batch number was requested.  On 27-Dec-2023 the patient had feeling fatigue (fatigue), chills, urinary tract infection, felt bad after her flu shot (feeling abnormal), sick (illness) and covid, tested positive yesterday (covid-19) (unknown latency) following the administration of influenza vaccine.  Relevant laboratory test results included: SARS-CoV-2 test - On an unknown date:  [tested positive]  Action taken:not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: SARS-CoV-2 test positive, Urinary tract infection
Clinical narrative: feeling fatigue; chills; urinary tract infection; felt bad after her flu shot; sick; covid, tested positive yesterday; Initial information was received on 29-Dec-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2024SA003908(CLUSTER).  This case involves a 59 years old female patient (78 kg) who experienced feeling fatigue, chills, urinary tract infection, felt bad after her flu shot, sick and covid, tested positive yesterday after receiving influenza vaccine.  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 influenza vaccine produced by unknown manufacturer (unknown formulation) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunization). The information on the batch number was requested.  On 27-Dec-2023 the patient had feeling fatigue (fatigue), chills, urinary tract infection, felt bad after her flu shot (feeling abnormal), sick (illness) and covid, tested positive yesterday (covid-19) (unknown latency) following the administration of influenza vaccine.  Relevant laboratory test results included: SARS-CoV-2 test - On an unknown date:  [tested positive]  Action taken:not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: The 1 OPEN IPOL was at  lowest temperature reached 31.3 F and the total excursion lasted 240 hours with no reported adverse event; vaccines have been administered post excursion with no adverse event; Initial information was received from country on 24-Oct-2023 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2023SA332232. This case involves a 4 years old male patient (101 cm and 16 kg) to whom 1 open IPV (VERO) [Ipol] was administered post excursion, at  lowest temperature reached 31.3 f and the total excursion lasted 240 hours with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Oct-2023, the patient received a 0.5ml (dose 1, Booster dose) of suspect IPV (VERO) Suspension for injection (lot VIB902M, expiry date, strength: unknown) via intramuscular route in the left thigh for Immunisation (poor quality product administered) (latency: same day).  On an unknown date, the 1 open ipol was at lowest temperature reached 31.3 f and the total excursion lasted 240 hours with no reported adverse event (product storage error).  Physician reported a temperature excursion due to an unknown cause.  Action taken: not applicable.  Outcome: Unknown.   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 Module of the 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.  Additional information was received on 28-Dec-2023 from physician: Case was updated to Valid, Patient age, Age group, Suspect start date, dosage, route of administration, site, Dosage sequence, Dose number, Batch number were added. Indication was updated. Text amended accordingly.
Age: 27.0
Sex: U
Vaccine: YF
Symptoms: No adverse event, Poor quality product administered, Product preparation error, Product preparation issue
Clinical narrative: accidentally administered the YF using the diluent of MMR vaccine which is sterile water instead of the Sodium Chloride for the Yellow Fever vaccine with no reported adverse event; accidentally administered the YF using the diluent of MMR vaccine which is sterile water instead of the Sodium Chloride for the Yellow Fever vaccine with no reported adverse event; Initial information received from country on 26-Dec-2023 regarding an unsolicited valid non-serious case received from a Pharmacist.  This case involves a 27 years old and unknown gender patient where reporter reported that accidentally administered the YELLOW FEVER VACCINE - [YF-VAX] using the diluent of mmr vaccine which is sterile water instead of the sodium chloride for the yellow fever vaccine 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 a dose of suspect yellow fever vaccine - Solution for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation (poor quality product administered) and (product preparation error) (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 Module of the 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.
Age: 27.0
Sex: F
Vaccine: YF
Symptoms: No adverse event, Product preparation error, Product preparation issue
Clinical narrative: used an alternate diluent when he reconstituted YF-VAX instead of the recommended 0.6 mL Sodium Chloride Injection USP with no adverse event; Initial information received on 27-Dec-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 27 years old female patient on whom used an alternate diluent when he (pharmacist) reconstituted yellow fever vaccine - [YF-VAX] instead of the recommended 0.6 ml sodium chloride injection usp with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included TYPHOID VACCINE (TYPHOID VACCINE) for Prophylactic vaccination.  On 26-Dec-2023, the patient received a 0.5 ml dose of suspect yellow fever vaccine - Solution for injection (lot UJ966AA, Expiry date: 31-Jan-2025 with unknown strength) via subcutaneous route in the right arm as immunization with the alternate diluent when reconstituted yf-vax instead of the recommended 0.6 ml sodium chloride injection usp with no adverse event (product preparation error) (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 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: TD, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: administration of a TENIVAC in place of another vaccine adacel with no reported adverse event; Initial information received from Regulatory Authority on 02-Jan-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient of unknown age and gender who was administered diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] in place of another vaccine diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] 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 was administered diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Suspension for injection) (lot number; strength; expiry date unknown) in place of another vaccine diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot number; strength; expiry date unknown) with no reported adverse event (wrong product administered) (latency: same day).   Information regarding batch number will be requested in this case.  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.
Age: 60.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: received an expired does of tenivac with no reported adverse event; Initial information received on 02-Jan-2024 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 61 years old male patient who had received an expired does of diphtheria-2/tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Jan-2023, the patient received expired dose of 0.5 ml dose of suspect diphtheria-2/tetanus-5 Adsorbed Toxoids No Preservative Adult (strength: standard, expiry date: 24-Jan-2023, frequency: once and lot U7092AA) via intramuscular route in the left deltoid as Immunization (expired product administered) (same day latency).   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.