chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, single (Lot number: HD9876) at the age of 78 years 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 number: EL1284), administration date: 20Jan2021, when the patient was 75-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE , Batch/lot number: 9262), administration date: 10Feb2021, when the patient was 75-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE , Batch/lot number: FD8448), administration date: 14Apr2022, when the patient was 76-year-old, for COVID-19 immunisation; moderna COVID-19 vaccine (DOSE 4 (BOOSTER), SINGLE), administration date: 12Sep2022, when the patient was 77-year-old, for COVID-19 immunisation. Patient had no known allergies. The following information was reported: COVID-19 (medically significant) with onset Jan2024, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Jan2024, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 17Jan2024 to 22Jan2024.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Hypoxia, Intensive care, Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: RSV causing hypoxia, ICU stay; RSV causing hypoxia, ICU stay; This is a spontaneous report received from a Physician.  A 69-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 08Oct2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years for immunisation. The patient's relevant medical history included: "mild asthma" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM; DILTIAZEM; GABAPENTIN. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant, life threatening), RESPIRATORY SYNCYTIAL VIRUS INFECTION (hospitalization, medically significant, life threatening) all with onset 11Dec2023, outcome "recovering" and all described as "RSV causing hypoxia, ICU stay". The patient was hospitalized for vaccination failure, respiratory syncytial virus infection (start date: 11Dec2023, discharge date: 30Dec2023, hospitalization duration: 20 day(s)). It was unknown if therapeutic measures were taken as a result of vaccination failure, respiratory syncytial virus infection. Clinical course: The patient received Abrysvo, she was hospitalized subsequently from 11Dec2023-30Dec2023 with RSV causing hypoxia, ICU stay.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event life-threatening vaccination failure (respiratory syncytial virus infection) with the suspect product RSV VACCINE PROT.SUBUNIT PREF 2V cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Decreased appetite, Feeling cold, Headache, Lip blister
Clinical narrative: lip sore; sore in mouth; morning woke up with blisters on lips and in mouth; morning woke up with blisters on lips and in mouth; couldn't eat or drink; Fever; chills; cold; freezing; real bad headache; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 70-year-old female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 22Jan2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years for immunisation. The patient's relevant medical history included: "high blood pressure" (ongoing), notes: for years, been taking medication a long time; "Fibromyalgia", start date: 2000 (ongoing). There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 23Jan2024, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 23Jan2024, outcome "unknown"; NASOPHARYNGITIS (non-serious) with onset 23Jan2024, outcome "unknown", described as "cold"; FEELING COLD (non-serious) with onset 23Jan2024, outcome "unknown", described as "freezing"; HEADACHE (non-serious) with onset 23Jan2024, outcome "unknown", described as "real bad headache"; EATING DISORDER (non-serious) with onset 24Jan2024, outcome "unknown", described as "couldn't eat or drink"; LIP BLISTER (non-serious), ORAL MUCOSAL BLISTERING (non-serious) all with onset 24Jan2024, outcome "not recovered" and all described as "morning woke up with blisters on lips and in mouth"; LIP PAIN (non-serious), outcome "unknown", described as "lip sore"; STOMATITIS (non-serious), outcome "unknown", described as "sore in mouth". The event "fever" required physician office visit. Therapeutic measures were taken as a result of pyrexia, lip blister, oral mucosal blistering. Additional information: Caller stated caller took injection, clarified an RSV injection, Monday, was okay 24 hours, then Tuesday evening started with chills, cold, freezing, took temperature, had real bad headache. Start date: After fever broke on 3rd day last week, couldn't eat or drink, fever was so high. Caller lives by herself so hard to tend to self, not barely able to take Advil for fever and check it. Blisters probably started the day after that night or day when caller started with the fever which was Tuesday night. Caller went to doctor on 22Jan2024, then 23Jan2024 had fever, next morning woke up with blisters on lips and in mouth, which was 24Jan2024. Stop date, outcome: Doesn't feel blisters in mouth, just feels like had them, but the one on corner of lip caller can't get to heal, it is a tiny slit and caller is using hydrocortisone. Never had in mouth, has bitten self and gotten sore in mouth, stated these in mouth did go away, had 3 at a time, never had so many, never had a lip sore like that, never gets sores.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Lip pain, Nasopharyngitis, Oral mucosal blistering, Pyrexia, Stomatitis
Clinical narrative: lip sore; sore in mouth; morning woke up with blisters on lips and in mouth; morning woke up with blisters on lips and in mouth; couldn't eat or drink; Fever; chills; cold; freezing; real bad headache; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 70-year-old female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 22Jan2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years for immunisation. The patient's relevant medical history included: "high blood pressure" (ongoing), notes: for years, been taking medication a long time; "Fibromyalgia", start date: 2000 (ongoing). There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 23Jan2024, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 23Jan2024, outcome "unknown"; NASOPHARYNGITIS (non-serious) with onset 23Jan2024, outcome "unknown", described as "cold"; FEELING COLD (non-serious) with onset 23Jan2024, outcome "unknown", described as "freezing"; HEADACHE (non-serious) with onset 23Jan2024, outcome "unknown", described as "real bad headache"; EATING DISORDER (non-serious) with onset 24Jan2024, outcome "unknown", described as "couldn't eat or drink"; LIP BLISTER (non-serious), ORAL MUCOSAL BLISTERING (non-serious) all with onset 24Jan2024, outcome "not recovered" and all described as "morning woke up with blisters on lips and in mouth"; LIP PAIN (non-serious), outcome "unknown", described as "lip sore"; STOMATITIS (non-serious), outcome "unknown", described as "sore in mouth". The event "fever" required physician office visit. Therapeutic measures were taken as a result of pyrexia, lip blister, oral mucosal blistering. Additional information: Caller stated caller took injection, clarified an RSV injection, Monday, was okay 24 hours, then Tuesday evening started with chills, cold, freezing, took temperature, had real bad headache. Start date: After fever broke on 3rd day last week, couldn't eat or drink, fever was so high. Caller lives by herself so hard to tend to self, not barely able to take Advil for fever and check it. Blisters probably started the day after that night or day when caller started with the fever which was Tuesday night. Caller went to doctor on 22Jan2024, then 23Jan2024 had fever, next morning woke up with blisters on lips and in mouth, which was 24Jan2024. Stop date, outcome: Doesn't feel blisters in mouth, just feels like had them, but the one on corner of lip caller can't get to heal, it is a tiny slit and caller is using hydrocortisone. Never had in mouth, has bitten self and gotten sore in mouth, stated these in mouth did go away, had 3 at a time, never had so many, never had a lip sore like that, never gets sores.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "Allergies: Fish" (unspecified if ongoing); "Allergies: tree nuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received PAXLOVID from 17Jan2024 to 22Jan2024 for the events. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 12:15 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "RA." (unspecified if ongoing); "Osteo arthritis" (unspecified if ongoing); "Sulfites" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Antiviral details: COVID 19 Treatment, brand=Pfizer, treatment start date=25Dec2023, treatment stop date=29Dec2023, indication=Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; COVID 19 Treatment; COVID 19 Treatment; The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.  This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 Insulin Dependent Diabetic for 50 years" (unspecified if ongoing); "Known allergies: Pollen allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Metoclopramide, reaction(s): "Known allergies: Metoclopramide". Vaccination history included: pfizer / biontech (DOSE 5 (BOOSTER), SINGLE, lot number: HCH9693, in the left arm), administration date: 27Sep2022, when the patient was 56-year-old, for COVID-19 Immunization; moderna (DOSE 4 (BOOSTER), SINGLE, lot number: 004M21A, in the left arm), administration date: 01May2022, when the patient was 56-year-old, for COVID-19 Immunization; pfizer / biontech (DOSE 3 (BOOSTER), SINGLE, lot number: 301258A, in the left arm), administration date: 10Oct2021, when the patient was 55-year-old, for COVID-19 Immunization; pfizer / biontech (DOSE 2, SINGLE, lot number: EW0150, in the left arm), administration date: 30Mar2021, when the patient was 55-year-old, for COVID-19 Immunization; pfizer / biontech (DOSE 1, SINGLE, lot number: EN6204, in the left arm), administration date: 09Mar2021, when the patient was 55-year-old, for Covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of interchange of vaccine products, drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 as dose 1, single (Lot number: HF9298) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Neuropathy" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; FLUOXETINE; FLAXSEED OIL; FISH OIL; BILBERRY FRUIT; EVENING PRIMROSE OIL [OENOTHERA BIENNIS OIL]. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE 6 (BOOSTER), SINGLE, Batch/Lot No: GJ3268, Location of injection: Arm Left), administration date: 07Jun2023, when the patient was 69-year-old, for COVID-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Batch/Lot No: GJ6738, Location of injection: Arm Right), administration date: 21Nov2022, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: FP7135, Location of injection: Arm Left), administration date: 03Aug2022, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: FF2587, Location of injection: Arm Left), administration date: 25Sep2021, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EP7534, Location of injection: Arm Left), administration date: 18Mar2021, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EN6202, Location of injection: Arm Left), administration date: 25Feb2021, when the patient was 66-year-old, for COVID-19 immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Jan2024, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400028208 same patient/vaccine, different dose/AE;
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing). Concomitant medication(s) included: NYQUIL. Past drug history included: Tetanus toxoid, reaction(s): "Known allergies: Tetanus Toxoid". Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid treatment from 17Jan2024 to 21Jan2024.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 46.0
Sex: M
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 47-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "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: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Aug2021 at 13:15 as dose 2, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer, treatment start date: 22Jan2024, treatment stop date: 26Jan2024, Indication: Treatment of COVID-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 at 01:00 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart palpitations" (unspecified if ongoing); "BPH" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL, start date: 15Apr2014, stop date: 29Jan2024; TAMSULOSIN, start date: 15Jun2023, stop date: 21Jan2024. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid received from 21Jan2024 to 26Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19 included Paxlovid from 20Jan2024 to 25Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 32-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 32 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 4 (Booster), Single, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 3 (Booster), Single, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Single, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 1, Single, Manufacturer: Unknown), for Covid-19 Immunization.The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19, Paxlovid treatment from 16Jan2024 to 20Jan2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included received Paxlovid from 20Jan2024 to 24Jan2024.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Haemoglobin, Haemoglobin decreased, Haemolytic anaemia
Clinical narrative: her hemoglobin was around 3; Hemolytic anemia; having trouble swallowing; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Apr2023 as dose 4 (booster), 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: 2021, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: 2021, for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 2022, for COVID-19 immunization. The following information was reported: DYSPHAGIA (hospitalization) with onset Jun2023, outcome "recovered" (Jun2023), described as "having trouble swallowing"; HAEMOLYTIC ANAEMIA (hospitalization, medically significant) with onset 02Dec2023, outcome "recovering", described as "Hemolytic anemia"; HAEMOGLOBIN DECREASED (hospitalization), outcome "recovered", described as "her hemoglobin was around 3". The patient was hospitalized for haemolytic anaemia (start date: Dec2023); for dysphagia (start date: Jun2023, discharge date: Jun2023). The patient underwent the following laboratory tests and procedures: Haemoglobin: (unspecified date) 7, notes: her hemoglobin is up to 7; (Jun2023) 10, notes: her hemoglobin was around 10; (Dec2023) Unknown Results, notes: it was about the same close to 3 a little below 3. Therapeutic measures were taken as a result of haemolytic anaemia, haemoglobin decreased. Clinical course: the patient has been hospitalized twice in the last 60 days diagnosed with hemolytic anemia. When was first diagnosed in Dec2023, hemoglobin was around 3 and when hospitalized for the second time (25Jan2024) it was about the same close to 3 a little below 3. Situation has improved (up to 7). Treatment: Steroids, antibiotics and other drugs. Hospitalized in Jun2023 for having trouble swallowing and Recovered completely (hemoglobin was around 10 at that time). Treatment: had a procedure.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 66.0
Sex: M
Vaccine: PNC20, RSV, VARZOS
Symptoms: Paraesthesia, Pruritus, Rash vesicular
Clinical narrative: Pt reported a tingling sensation on his back on 1/22/24 and developed "bumps/blisters" the next day. This lasted for a few days and resolved in its own. Pt is currently nearly fully recovered and is only experiencing slight itchiness in the area.
Age: 0.08
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine was administered too early for administration being 2mo rather than 1mo. MOC informed that there was no adverse reaction after administration of vaccines.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient described that her arm was red and swelling at the site of injection. The swelling was about the size of an egg. She stated it started to itch as well.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: reddness around injection site and tender to touch, and pain
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Facial pain, Neck pain, Rash, Swelling, Swelling face
Clinical narrative: Pain, rash and swelling in the right side of neck and face which started on 1/27/2024.  This morning (1/31/2024) symptoms had worsened since last night.
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Pharmacist administered RSV today 1/31/24, patient called and stated that she remember she got RSV shot already.  When asked before administer patient stated that she have not had RSV shot before,   Pharmacist can not log into system login not the pharmacy computer does not show in database, since pharmacist has to billed under batching.
Age: 85.0
Sex: M
Vaccine: RSV
Symptoms: Cough, Fatigue, Malaise
Clinical narrative: From 01/23/2024 until today 01/31/2024 he has felt very sick, fatigued, and coughing. All the symptoms started after receiving vaccine. He did not seek medical care when reported feeling sick to us.
Age: 26.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Asthenia, Asthma, Dizziness, Dyspnoea, Eructation
Clinical narrative: Patient with onset of weakness, fatigue, gastritis, burping, belching, skin rash, tachycardia, weight loss of almost 100 lbs., Chronic esophageal secretions, asthma, and mental health decline.  Lightheadedness, palpitations and sob.  Hypertension,
Age: 26.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Fatigue, Gastritis, Hypertension, Increased upper airway secretion, Laboratory test
Clinical narrative: Patient with onset of weakness, fatigue, gastritis, burping, belching, skin rash, tachycardia, weight loss of almost 100 lbs., Chronic esophageal secretions, asthma, and mental health decline.  Lightheadedness, palpitations and sob.  Hypertension,
Age: 26.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Mental impairment, Palpitations, Rash, Tachycardia, Weight decreased
Clinical narrative: Patient with onset of weakness, fatigue, gastritis, burping, belching, skin rash, tachycardia, weight loss of almost 100 lbs., Chronic esophageal secretions, asthma, and mental health decline.  Lightheadedness, palpitations and sob.  Hypertension,
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: I medical assistant gave patient a 6-11 yr old dose of moderna COVID vaccine
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site mass, Injection site warmth, Myalgia
Clinical narrative: Headache, nausea, vomiting muscle aches red lump on injection site redness hot to touch
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: Headache, nausea, vomiting muscle aches red lump on injection site redness hot to touch
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Headache
Clinical narrative: Patient states she has a really bad headache that began on Thursday 1/25/24. She states she has never had this happen before after receiving a vaccine. It is relieved somewhat by taking Tylenol, and has improved somewhat since it started. She describes it as a constant dull ache.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Vomiting projectile
Clinical narrative: starting at 8am on 1/24/24 patient has projectile vomited for the first time. She continued to throw up 2 more times that same day. over the course of 1 week after having the vaccine patient has thrown up at least once (to clarify this is not normal baby spit up this is full stomach emptying baby vomit)
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Electroencephalogram, Head titubation, Laboratory test, Musculoskeletal stiffness, Seizure like phenomena
Clinical narrative: Seizure like activity--arms stiff, straight out, head spasming forward in a rhythmic fashion.  Event lasted 10 seconds and occurred several times over 2 days
Age: 1.0
Sex: F
Vaccine: MMRV, UNK, UNK
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Fever up to 102.3 first noticed at 7am upon waking my daughter up. Fever persisted through the weekend,  with increased  irritability. Body rash noticed  4-5 days after vaccinations almost measles like in appearance.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Immunisation reaction, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Same day of vaccination she had a hard red area at the injection site. Then the redness began spreading and was tender. Pt went to ER 1-14-24 Dx with Vaccine reaction. Treatment cephalexin 500 mg BID diphenhydramine 25 mg / Prednisone 40 mg
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Rash erythematous
Clinical narrative: Migratory erythematous rash pain
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Carotid artery stenosis, Computerised tomogram abnormal, Computerised tomogram head abnormal, Death
Clinical narrative: Nausea, vomiting, diarrhea. After hospital presentation hypotension, shortness of breath, shock, and death.
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diarrhoea, Dyspnoea, Ejection fraction decreased, Enterocolitis, Hypotension
Clinical narrative: Nausea, vomiting, diarrhea. After hospital presentation hypotension, shortness of breath, shock, and death.
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, SARS-CoV-2 test positive, Shock, Troponin increased, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea. After hospital presentation hypotension, shortness of breath, shock, and death.
Age: 1.0
Sex: U
Vaccine: MMR, MMR
Symptoms: Unevaluable event
Clinical narrative: The patient did not experienced any adverse issue or side effects/ No additional AE reported; A HCP called to report that an expired dose of MMR II (W017556 01/07/2024) was inadvertently administered to a patient on 01/09/2024.; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided.    On 09-JAN-2024, the patient inadvertently received an expired vaccine of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) 0.5 mL once as prophylaxis (valid lot # W017556, with expiration date stablished on 07-JAN-2024) (route, anatomical location, not provided). The vaccine was reconstituted with 0.5 milliliter of an sterile diluent with valid lot# W011298 and expiration date stablished on 27-JAN-2024 but upon internal review was on 27-NOV-2024. The vaccine had not been exposed to any prior temperature excursions. The patient did not experience any adverse issues or side effect from the expired administered vaccine.
Age: 1.0
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient did not experienced any adverse issue or side effects/ No additional AE reported; A HCP called to report that an expired dose of MMR II (W017556 01/07/2024) was inadvertently administered to a patient on 01/09/2024.; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided.    On 09-JAN-2024, the patient inadvertently received an expired vaccine of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) 0.5 mL once as prophylaxis (valid lot # W017556, with expiration date stablished on 07-JAN-2024) (route, anatomical location, not provided). The vaccine was reconstituted with 0.5 milliliter of an sterile diluent with valid lot# W011298 and expiration date stablished on 27-JAN-2024 but upon internal review was on 27-NOV-2024. The vaccine had not been exposed to any prior temperature excursions. The patient did not experience any adverse issues or side effect from the expired administered vaccine.
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Cerebrovascular accident, Coma, Gait disturbance, Seizure
Clinical narrative: Coma; He first lost his ability to walk, then had 4 strokes; seizure; neurological complications; lost his ability to walk; This serious case was reported by a consumer and described the occurrence of coma in a 69-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   On an unknown date, the patient received RSV vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced coma (Verbatim: Coma) (serious criteria GSK medically significant), stroke (Verbatim: He first lost his ability to walk, then had 4 strokes) (serious criteria GSK medically significant), seizure (Verbatim: seizure) (serious criteria GSK medically significant), neurological disorder nos (Verbatim: neurological complications) and unable to walk (Verbatim: lost his ability to walk). The outcome of the coma, stroke, seizure, neurological disorder nos and unable to walk were not reported.   It was unknown if the reporter considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to RSV vaccine.     It was unknown if the company considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to RSV vaccine.   Additional Information: GSK receipt date: 25-JAN-2024 The reporter reported that their father being in a coma from  neurological complications after receiving the RSV and COVID vaccines the day after holiday. Reporter stated that their dater was lost his ability to walk, had 4 strokes and a seizure. The reporter stated that the patient was previously healthy. The reporter reported that all of the doctors were puzzled. The person wanted to know if GlaxoSmithKline had any data on this type of reaction to vaccines that could help the doctors figure this out, they appreciated any help that could be provided. It was unknown if the reporter considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to COVID-19 vaccine. The reporter requested to consented the follow up.
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Cerebrovascular accident, Coma, Gait inability, Nervous system disorder, Seizure
Clinical narrative: Coma; He first lost his ability to walk, then had 4 strokes; seizure; neurological complications; lost his ability to walk; This serious case was reported by a consumer and described the occurrence of coma in a 69-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   On an unknown date, the patient received RSV vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced coma (Verbatim: Coma) (serious criteria GSK medically significant), stroke (Verbatim: He first lost his ability to walk, then had 4 strokes) (serious criteria GSK medically significant), seizure (Verbatim: seizure) (serious criteria GSK medically significant), neurological disorder nos (Verbatim: neurological complications) and unable to walk (Verbatim: lost his ability to walk). The outcome of the coma, stroke, seizure, neurological disorder nos and unable to walk were not reported.   It was unknown if the reporter considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to RSV vaccine.     It was unknown if the company considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to RSV vaccine.   Additional Information: GSK receipt date: 25-JAN-2024 The reporter reported that their father being in a coma from  neurological complications after receiving the RSV and COVID vaccines the day after holiday. Reporter stated that their dater was lost his ability to walk, had 4 strokes and a seizure. The reporter stated that the patient was previously healthy. The reporter reported that all of the doctors were puzzled. The person wanted to know if GlaxoSmithKline had any data on this type of reaction to vaccines that could help the doctors figure this out, they appreciated any help that could be provided. It was unknown if the reporter considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to COVID-19 vaccine. The reporter requested to consented the follow up.
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Cerebrovascular accident, Coma, Fatigue, Gait inability, Magnetic resonance imaging
Clinical narrative: Coma; He first lost his ability to walk, then had 4 strokes; seizure; neurological complications; lost his ability to walk; This serious case was reported by a consumer and described the occurrence of coma in a 69-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   On an unknown date, the patient received RSV vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced coma (Verbatim: Coma) (serious criteria GSK medically significant), stroke (Verbatim: He first lost his ability to walk, then had 4 strokes) (serious criteria GSK medically significant), seizure (Verbatim: seizure) (serious criteria GSK medically significant), neurological disorder nos (Verbatim: neurological complications) and unable to walk (Verbatim: lost his ability to walk). The outcome of the coma, stroke, seizure, neurological disorder nos and unable to walk were not reported.   It was unknown if the reporter considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to RSV vaccine.     It was unknown if the company considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to RSV vaccine.   Additional Information: GSK receipt date: 25-JAN-2024 The reporter reported that their father being in a coma from  neurological complications after receiving the RSV and COVID vaccines the day after holiday. Reporter stated that their dater was lost his ability to walk, had 4 strokes and a seizure. The reporter stated that the patient was previously healthy. The reporter reported that all of the doctors were puzzled. The person wanted to know if GlaxoSmithKline had any data on this type of reaction to vaccines that could help the doctors figure this out, they appreciated any help that could be provided. It was unknown if the reporter considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to COVID-19 vaccine. The reporter requested to consented the follow up.
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Malaise, Pain, Paraesthesia, Scan brain, Seizure
Clinical narrative: Coma; He first lost his ability to walk, then had 4 strokes; seizure; neurological complications; lost his ability to walk; This serious case was reported by a consumer and described the occurrence of coma in a 69-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   On an unknown date, the patient received RSV vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced coma (Verbatim: Coma) (serious criteria GSK medically significant), stroke (Verbatim: He first lost his ability to walk, then had 4 strokes) (serious criteria GSK medically significant), seizure (Verbatim: seizure) (serious criteria GSK medically significant), neurological disorder nos (Verbatim: neurological complications) and unable to walk (Verbatim: lost his ability to walk). The outcome of the coma, stroke, seizure, neurological disorder nos and unable to walk were not reported.   It was unknown if the reporter considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to RSV vaccine.     It was unknown if the company considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to RSV vaccine.   Additional Information: GSK receipt date: 25-JAN-2024 The reporter reported that their father being in a coma from  neurological complications after receiving the RSV and COVID vaccines the day after holiday. Reporter stated that their dater was lost his ability to walk, had 4 strokes and a seizure. The reporter stated that the patient was previously healthy. The reporter reported that all of the doctors were puzzled. The person wanted to know if GlaxoSmithKline had any data on this type of reaction to vaccines that could help the doctors figure this out, they appreciated any help that could be provided. It was unknown if the reporter considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to COVID-19 vaccine. The reporter requested to consented the follow up.
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Biopsy brain abnormal, Death, Demyelination, Laboratory test, Neurological symptom
Clinical narrative: Coma; He first lost his ability to walk, then had 4 strokes; seizure; neurological complications; lost his ability to walk; This serious case was reported by a consumer and described the occurrence of coma in a 69-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   On an unknown date, the patient received RSV vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced coma (Verbatim: Coma) (serious criteria GSK medically significant), stroke (Verbatim: He first lost his ability to walk, then had 4 strokes) (serious criteria GSK medically significant), seizure (Verbatim: seizure) (serious criteria GSK medically significant), neurological disorder nos (Verbatim: neurological complications) and unable to walk (Verbatim: lost his ability to walk). The outcome of the coma, stroke, seizure, neurological disorder nos and unable to walk were not reported.   It was unknown if the reporter considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to RSV vaccine.     It was unknown if the company considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to RSV vaccine.   Additional Information: GSK receipt date: 25-JAN-2024 The reporter reported that their father being in a coma from  neurological complications after receiving the RSV and COVID vaccines the day after holiday. Reporter stated that their dater was lost his ability to walk, had 4 strokes and a seizure. The reporter stated that the patient was previously healthy. The reporter reported that all of the doctors were puzzled. The person wanted to know if GlaxoSmithKline had any data on this type of reaction to vaccines that could help the doctors figure this out, they appreciated any help that could be provided. It was unknown if the reporter considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to COVID-19 vaccine. The reporter requested to consented the follow up.