chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Nodule, Vaccination site pain
Clinical narrative: small nodule on left collar bone; Left arm pain; general fatique; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Nov2023 at 14:00 as dose 1, single (Lot number: Unknown) at the age of 47 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 09Nov2023 (Batch/Lot number: unknown), in left arm. The patient had no relevant medical history. Concomitant medication(s) included: ADVIL [IBUPROFEN]. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Nov2023 at 18:00, outcome "not recovered", described as "Left arm pain"; FATIGUE (non-serious) with onset 09Nov2023 at 18:00, outcome "not recovered", described as "general fatique"; NODULE (non-serious) with onset 09Nov2023 at 18:00, outcome "not recovered", described as "small nodule on left collar bone". Therapeutic measures were not taken as a result of nodule, vaccination site pain, fatigue.  Additional information: Patient has no allergy history. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination or since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Pruritus, Rash
Clinical narrative: rash; itchy; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID:   A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown"; PRURITUS (non-serious), outcome "unknown", described as "itchy". Additional information: The patient got both flu vaccine and Pfizer covid-19 vaccine and got rash and itchy reaction. Caller wanted to check the ingredients that caused the reaction and if there was any way to get the list of the ingredients of the vaccine.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: my blood pressure shot.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 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: BLOOD PRESSURE INCREASED (non-serious) with onset 2023, outcome "unknown", described as "my blood pressure shot.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypertension
Clinical narrative: extreme dizziness; high blood pressure; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers 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: DIZZINESS (non-serious), outcome "unknown", described as "extreme dizziness"; HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: "I had extreme dizziness and high blood pressure after the vaccine. Yes, yes, person adverse reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Hypotension, Pruritus
Clinical narrative: severe itching; dizziness; fast heart rate; low blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 at 15:30 as dose 1, single (Lot number: HG4628) at the age of 70 years, in right arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing), notes: generally healthy. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 03Oct2023 at 02:00, outcome "recovered"; HEART RATE INCREASED (non-serious) with onset 03Oct2023 at 02:00, outcome "recovered", described as "fast heart rate"; HYPOTENSION (non-serious) with onset 03Oct2023 at 02:00, outcome "recovered", described as "low blood pressure"; PRURITUS (non-serious) with onset 03Oct2023 at 02:00, outcome "recovered", described as "severe itching". Therapeutic measures were not taken as a result of pruritus, dizziness, heart rate increased, hypotension.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: Blood pressure elevated higher than it is ever been (144/101); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 83 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroidism" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hyperthyroidism; TRIAMTERENE taken for hypertension. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 10Nov2023, outcome "unknown", described as "Blood pressure elevated higher than it is ever been (144/101)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was 83-years-and-6-months old. The vaccination site was reported as the patient's left. The patient reported that she had the Pfizer COVID-19 Vaccine (clarified as Comirnaty 2023-2024) two days ago. On the morning of 10Nov2023, her blood pressure was elevated higher than it is ever been to 144/101. The patient had no other lab work or treatment done for the event (as reported). The patient had no other vaccines administered on same date or previous immunizations within 4 weeks with the Pfizer vaccine.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 76.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 15:00 as dose 1, single (Lot number: HG4627) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Had a-fib." (unspecified if ongoing); "ablation" (unspecified if ongoing); "dust" (unspecified if ongoing); "grasses" (unspecified if ongoing); "Allergies to common media" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Carbocaine for dental, reaction(s): "known allergies: Carbocaine"; Carrageenan, reaction(s): "known allergies: carrageenan". Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (DOSE 6 (BOOSTER), SINGLE, Batch/Lot No: G6742, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 19May2023, when the patient was 75-year-old, for COVID-19 immunization; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Batch/Lot No: GH9694, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 20Sep2022, when the patient was 75-year-old, for COVID-19 immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: FK9893, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 25Apr2022, when the patient was 74-year-old, for COVID-19 immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: FF8839, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 25Sep2021, when the patient was 74-year-old, for COVID-19 immunization; bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EN6201, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 03Mar2021, when the patient was 73-year-old, for COVID-19 immunization; bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EL8982, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 10Feb2021, when the patient was 73-year-old, 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive for Covid; positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Feb2021, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: 2021, for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 2021, for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 2022, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Nov2023, outcome "recovered" and all described as "positive for Covid". The event "positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) positive; (Nov2023) Negative; (Nov2023) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: In Feb2021 the patient got their first shot and got 2 boosters in 2021, for a total of 3 doses in 2021. They got another dose in 2022. They just received a another booster on 24Oct2023. All Pfizer Covid-19 vaccines. The patient had no underlying conditions. After they got the 5th booster on 30Oct2023 they went to concert went out without a mask on 30Oct2023. By Thursday 02Nov2023 the patient had an earache. The patient came up positive for covid. Friday (03Nov2023) the patient called their physician and he put in for Paxlovid. The patient took the Paxlovid medication and she was testing negative. They did another test the next day and she was negative.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Lanolin " (unspecified if ongoing); "afib" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "high blood pressure " (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 30Oct2023, outcome "unknown". Therapeutic measures were taken as a result of covid-19. Additional information: paxlovid treatment 30Oct2023-03Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2 (BNT162B2), as dose 1, single (Lot number: EK4176) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness in the arm".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300367340 same patient, different vaccine dose number/different event;
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2), as dose 2, single (Lot number: EL9261) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: on antihypertension meds; "Atrial fibrillation paroxysmal" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Atenolol for hypertension, notes: take 50 mg in the morning and 25 mg in the evening. Vaccination history included: Bnt162b2 (EK4176, dose 1), for COVID-19 immunization, reaction(s): "soreness in the arm". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness in the arm".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300367340 same patient, different vaccine dose number/different event;
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2), as dose 3 (booster), single (Lot number: 30155BA) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: on antihypertension meds (Atenolol, take 50 mg in the morning and 25 mg in the evening). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, lot number: EK4176), for Covid-19 immunisation, reaction(s): "soreness in the arm"; Bnt162b2 (Dose 2, single, lot number: EL9261), for Covid-19 immunisation, reaction(s): "soreness in the arm". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness in the arm".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300367340 same patient, different vaccine dose number/different event;
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FJ4895) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, lot number:EK4176), for COVID-19 immunisation, reaction(s): "Soreness in the arm"; Bnt162b2 (dose 2, lot number:EL9261), for COVID-19 immunisation, reaction(s): "Soreness in the arm"; Bnt162b2 (dose 3), for COVID-19 immunisation, reaction(s): "Soreness in the arm". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness in the arm".  Additional information: lot number was reported as "FJ4895 or 85".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300367340 same patient, different vaccine dose number/different event;
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Lot number: GJ6738) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, lot number: EK4176), for COVID-19 immunisation, reaction(s): "soreness in the arm"; Bnt162b2 (DOSE 2, SINGLE, lot number: EL9261), for COVID-19 immunisation, reaction(s): "soreness in the arm"; Bnt162b2 (DOSE 3, SINGLE, lot number: 3055BA or 30155BA, the writing is not very clear.), for COVID-19 immunisation, reaction(s): "soreness in the arm"; Bnt162b2 (DOSE 4, SINGLE, lot number: FJ4895 or 85), for COVID-19 immunisation, reaction(s): "soreness in the arm". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness in the arm". Additional information: When probed to clarify consumer did not experienced side effect after previous Pfizer COVID-19 Vaccines, consumer stated, "The previous, no, just soreness in the arm. I guess the usual common side effects but nothing unusual.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300367340 same patient, different vaccine dose number/different event;
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Running a fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Nov2023 as dose 1, 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: PYREXIA (non-serious) with onset 11Nov2023, outcome "unknown", described as "Running a fever". Additional information: It was stated that the patient had the Pfizer COVID-19 Vaccine yesterday (10Nov2023) and was running a fever today (11Nov2023). The patient wanted to know if that is a common side effect.
Sex: F
Vaccine: RSV
Symptoms: Blood test, COVID-19, SARS-CoV-2 test positive
Clinical narrative: did have a vaccine one month prior to tested positive for COVID, she had the Flu vaccine (Unspecified Flu vaccine) and she had a RSV vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 26Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation; influenza vaccine (INFLUENZA VACCINE), in Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN taken for hypercholesterolaemia. Vaccination history included: bnt162b2 (Dose 1, single, lot number: EN6202), administration date: 29Jan2021, for COVID-19 immunisation; bnt162b2 (Dose 2, single, lot number: EN6208), administration date: 17Mar2021, for COVID-19 immunisation, reaction(s): "inappropriate schedule of vaccine administered"; bnt162b2 (Dose 3 (booster), single, lot number: FE3292), administration date: 11Oct2021, for COVID-19 immunisation; bnt162b2 (Dose 4 (booster), single, lot number: FJ4991), administration date: 09May2022, for COVID-19 immunisation; bnt162b2 (Dose 5 (booster), single, lot number: GJ6665), administration date: 12Oct2022, for COVID-19 immunisation; Moderna covid-19 vaccine (Dose 6 (booster), single, lot number: RA5325), for COVID-19 immunisation. The following information was reported: SARS-COV-2 TEST POSITIVE (non-serious) with onset 26Oct2023, outcome "unknown", described as "did have a vaccine one month prior to tested positive for COVID, she had the Flu vaccine (Unspecified Flu vaccine) and she had a RSV vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of sars-cov-2 test positive.  Additional information: She stated that she tested positive for COVID while she was in hospital. So, she was given, treatment with Paxlovid which she took, her last dose on Monday morning. She previously received other COVID-19 vaccines in the past. She said they were all Pfizer although she may have got one that was Moderna. She did have a vaccine one month prior to tested positive for COVID, she had the Flu vaccine (Unspecified Flu vaccine) and on 26Sep2023, she had RSV vaccine.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: I did not sleep for two days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Nov2023 as dose 1, single (Lot number: HF9300) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: FELODIPINE taken for hypertension; NP THYROID taken for hypothyroidism; BISOPROLOL taken for hypertension. The following information was reported: INSOMNIA (non-serious) with onset Nov2023, outcome "unknown", described as "I did not sleep for two days". Therapeutic measures were not taken as a result of insomnia.  Additional information: The patient had the Pfizer COVID-19 Vaccine on 02Nov2023, and basically she did not sleep for several days. She stated that she had not had any COVID vaccines before this.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue
Clinical narrative: extremely tired; This is a spontaneous report received from non-contactable reporter(s) (Pharmacist) from a sales representative.  An 80-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) at the age of 80 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "extremely tired". It was unknown if therapeutic measures were taken as a result of fatigue. Additional information: It was unknown if the patient received any other vaccines on the same date as the suspect vaccine. It was unknown if the patient received any other vaccines within four weeks prior to the suspect vaccine. It was unknown if the patient was taking any other medications within two weeks of the event starting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300372581 same reporter/vaccine/event, different patients;
Sex: U
Vaccine: RSV
Symptoms: Musculoskeletal disorder
Clinical narrative: arm is a mess; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 20Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 2023, outcome "not recovered", described as "arm is a mess".  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: F
Vaccine: RSV
Symptoms: Throat irritation
Clinical narrative: she already had a scratchy throat and it was discovered it was caused by RSV; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: THROAT IRRITATION (non-serious), outcome "unknown", described as "she already had a scratchy throat and it was discovered it was caused by RSV".  Clinical course: Patient wanted to know about the different COVID-19 boosters that are available. Patient said she had the RSV vaccine right now and she went to get the COVID-19 but she couldn't get it because she already had a scratchy throat and it was discovered it was caused by RSV. Patient would like to know how long she has to wait to try to get the vaccine afterwards.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she had a patient that got covid last Sunday.; she had a patient that got covid last Sunday.; This is a spontaneous report received from a contactable reporter(s) (Other HCP), Program ID:   A patient (no qualifiers 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Nov2023, outcome "unknown" and all described as "she had a patient that got covid last Sunday.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Nov2023) Positive, notes: Got covid last Sunday. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19 are  related to bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)  cannot be excluded.  This case will be reassessed should additional information become available.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Postural orthostatic tachycardia syndrome, Ventricular extrasystoles
Clinical narrative: developed heart issues ( PVCs and pots disease); developed heart issues ( PVCs and pots disease); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunedeficiency" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 Immunization, reaction(s): "Postural orthostatic tachycardia syndrome", "Premature ventricular contractions"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization, reaction(s): "Postural orthostatic tachycardia syndrome", "Premature ventricular contractions"; Bnt162b2 (DOSE 2), for Covid-19 Immunization, reaction(s): "Postural orthostatic tachycardia syndrome", "Premature ventricular contractions". The following information was reported: VENTRICULAR EXTRASYSTOLES (non-serious), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown" and all described as "developed heart issues ( PVCs and pots disease)". Additional information: The patient have a severe immune deficiency and have received four Pfizer covid vaccines and have developed heart issues ( PVCs and pots disease) since getting the vaccine and boosters. The patient was asking recommendation on protection.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Heart rate irregular, Palpitations, Postural orthostatic tachycardia syndrome, Ventricular extrasystoles
Clinical narrative: developed heart issues ( PVCs and pots disease); developed heart issues ( PVCs and pots disease); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunedeficiency" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 Immunization, reaction(s): "Postural orthostatic tachycardia syndrome", "Premature ventricular contractions"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization, reaction(s): "Postural orthostatic tachycardia syndrome", "Premature ventricular contractions"; Bnt162b2 (DOSE 2), for Covid-19 Immunization, reaction(s): "Postural orthostatic tachycardia syndrome", "Premature ventricular contractions". The following information was reported: VENTRICULAR EXTRASYSTOLES (non-serious), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown" and all described as "developed heart issues ( PVCs and pots disease)". Additional information: The patient have a severe immune deficiency and have received four Pfizer covid vaccines and have developed heart issues ( PVCs and pots disease) since getting the vaccine and boosters. The patient was asking recommendation on protection.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: left arm soreness; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP), Program ID.  A 65-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for immunisation; covid-19 vaccine (COVID-19 VACCINE), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: XELJANZ XR. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Oct2023, outcome "unknown", described as "left arm soreness". Additional information: Patient reports left arm soreness over the past month but notes she had her vaccines (flu, COVID and RSV) all done in that arm in the last month. She sees her rheumatologist in one week and will discuss all this with her then.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Product container issue
Clinical narrative: received a vial that was broken when they opened it. Called to see if they can get a replacement. Has not been administered to any patients; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HF5019, Expiration Date: Feb2025) for immunisation, Device Lot Number: F658, Device Expiration Date: 01Jun2027. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "received a vial that was broken when they opened it. Called to see if they can get a replacement. Has not been administered to any patients".  Causality for "received a vial that was broken when they opened it. called to see if they can get a replacement. has not been administered to any patients" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). Product Quality Group provided investigational results on 09Nov2023 for rsv vaccine prot.subunit pref 2v: Examination results: vial lot HF5019, syringe lot GY5692, expiry date syringe and vial Feb2025. Pictures were taken. The label of the vial and syringe had no defects. The blister was opened and had no defects. The vial had a normal looking not reconstituted cake. The vial was full with an attached flip-off. The vial adapter was still in its packaging. The syringe was empty. The tip of the barrel was broken off, in tip cap. The luer lock was unopened. The rubber tip cap is loose. The rubber plunger was at starting position. The plunger rod was firmly attached. Complaint is confirmed. Sample was send for further investigation.  Additional information: Reportability Determination: Based on the new information received on a broken Abrysvo syringe during a sample evaluation associated with site investigation record PR#: on 30Oct2023 has changed the reportability from Not Device Related to 30-day Reportable Malfunction. The overall reportability on the case level has changed. This is Medical Device Related. This complaint for "Received a vial that was broken when they opened it. Site Investigation pictures evaluated on 30Oct2023 showed an Abrysvo syringe with the tip of the barrel broken off" for ABRYSVO SFDPO 5X0.5ML GVL+SYR is a reportable malfunction since if it were to recur it could likely cause or contribute to death or serious injury. Abrysvo Diluent Syringe: NDC: 00069025001, Lot: GY5692, Exp: Feb2025. Caller mentioned that they received Abrysvo directly from their distributor (not from Pfizer) but it was damaged. She wants a replacement for this.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Product container issue
Clinical narrative: the plastic broke off in the actual vial. They cannot use one dose of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) 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. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "the plastic broke off in the actual vial. They cannot use one dose of the vaccine".  Causality for "the plastic broke off in the actual vial. they cannot use one dose of the vaccine" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: He said that the customer had an issue with a dose of the Abrysvo vaccine, the vial adapter that comes with it, the plastic broke off in the actual vial. They cannot use one dose of the vaccine. Reportability Determination: This complaint for customer had an issue with a dose of the Abrysvo vaccine, the vial adapter that comes with it, the plastic broke off in the actual vial. They cannot use one dose of the vaccine is a reportable malfunction; if it were to recur, it could likely cause or contribute to death or serious injury.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: raise inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  A 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: INFLAMMATION (non-serious), outcome "unknown", described as "raise inflammation".  Additional information: The patient had no issue receiving vaccines that contained dead virus. mRNA vaccines were another and they raised inflammation and caused me serious side effects and the patient had no intention of repeating. The patient had long lasting issues from the vaccine so did not opt for boosters. Aside from that, the only people who got COVID more than once are those who got many boosters.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Emphysema
Clinical narrative: Emphysema; COPD; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A female patient (unknown if pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EMPHYSEMA (non-serious), outcome "unknown"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD".  Additional information: The patient had all COVID vaccination and has emphysema and COPD.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Illness
Clinical narrative: I have been sicker than a dog; Shingles; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Shingles" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pneumonia shot flue; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 Immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I have been sicker than a dog"; HERPES ZOSTER (non-serious), outcome "unknown", described as "Shingles". Additional information: the patient considered the event as caused by the suspect product. The patient had a pneumonia shot flue and COVID booster shot all within the last three months and also had shingles and today and the last week, the patient was sick than a dog. The patient had no COVID but explained that the patient was still sick.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: never had flu till i took the shot; Initial information received on 05-Nov-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves an elderly patient (age in 70s) with unknown demographics who experienced never had flu till i took the shot after receiving vaccine 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 (strength, formulation, lot number and expiry: not reported) via unknown route in unknown administration site as prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date, the patient developed never had flu till i took the shot (influenza) (unknown latency) following the administration of Influenza vaccine.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (never had flu till i took the shot).  At time of reporting, the outcome was Unknown for the event never had flu till i took the shot.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discolouration, Injection site reaction, Skin reaction
Clinical narrative: she took the band aid off this morning and noticed a white circle an inch below where the injection was given and there is a tiny "pucker" mark in the middle of the white circle; Initial information received on 02-Nov-2023 (processed as non-case) and additional information on 03-Nov-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves 68 years old female patient who took the band aid off this morning and noticed a white circle an inch below where the injection was given and there is a tiny "pucker" mark in the middle of the white circle after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Nov-2023, the patient received a dose of suspect influenza quadrival A-B high dose HV vaccine (strength, formulation, dosage, lot number, expiry date- not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). Information on the batch number was requested.  On 02-NOV-2023, the patient took the band aid off this morning and noticed a white circle an inch below where the injection was given and there is a tiny "pucker" mark in the middle of the white circle (vaccination site reaction) (latency- 1 day) following the administration of influenza quadrival A-B high dose HV vaccine.  Reportedly, Caller says that she noticed that there was a different delivery system for the injection. Caller wants to know if the white mark is common with the new delivery system.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: staff members was administered an expired dose of the Flu vaccine with no reported adverse event; Initial information received on 06-Nov-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to case 2023SA350309(CLUSTER).  This case involves a 44 years old female patient who was administered an expired dose of the Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Oct-2023, the patient received an expired dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection (lot UT7680NA, Expiry date:  23-Jun-2023 with unknown strength) via intramuscular route in unknown administration site as prophylactic vaccination with no reported adverse event (expired product administered) (Latency: same day).  It was reported "A pharmacist reported that two of their staff members was administered an expired dose of the Flu vaccine and would like to know if it is still counted as a valid dose. She reported that the expired vaccine was not sent out to the pharmacist as it should have."   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: 22.0
Sex: F
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Typhim VI was given to a patient (with no reported adverse event); Initial information received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 22-years-old female patient (Not pregnant) who was administered expired dose of typhoid VI polysaccharide vaccine [Typhim VI] 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 Yellow Fever Vaccine, and Rabies Vaccine for Prophylactic vaccination.  On 06-Nov-2023, the patient received 0.5 mL expired dose of suspect typhoid VI polysaccharide vaccine (Frequency: once; Strength: Standard) (lot number: U2A471M; expiry date: 02-Nov-2023) via intramuscular route in the left deltoid as Immunization for Travel (Immunization) with no reported adverse event (expired product administered) following the administration of typhoid VI polysaccharide vaccine.  Treatment: No  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: 72.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Blood pressure increased, Chest pain, Heart rate increased
Clinical narrative: Increase blood pressure and heart rate chest pain
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Medical Assistant when she was inputting the vaccine information in the patient chart she realized that she gave the 16 yr old patient the Tdap instead of the Menb. She informed the provider and the practice manager, the provider called the mother to informed her of the incident.Patient is doing well with no reaction to the vaccine.