chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Myalgia, X-ray
Clinical narrative: muscle soreness; bursitis; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Oct2023 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: MYALGIA (non-serious), outcome "unknown", described as "muscle soreness"; BURSITIS (non-serious), outcome "unknown". The events "muscle soreness" and "bursitis" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia, bursitis.  Additional information: She had muscle soreness and bursitis and wondering if the vaccine caused this, she mentioned she got the vaccine last Oct and there was no evidence that this was because of the vaccine, but patient wanted to know if there have been other reports of this being a side effect. The very next day she woke up with her arm sore and it continued to be sore. She kind of let it go thinking it would get better. It didn't. The next thing she knew the other arm was sore. Finally she went to the doctor in Dec2023, two months later. Maybe she shouldn't have let it go that long but she was thinking she was getting older and maybe arthritis set in. She was given a steroid and therapy. While she was on steroid, there was no soreness at all. When the steroid was over the soreness came right back. The doctor felt like caller had bursitis. Now she had the soreness in her buttock and the tops of her legs, so now she was back on a steroid. She had soreness in the arms and shoulders and now in her buttock.   The information on the batch/lot number for [bnt162b2 omi xbb.1.5] will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Memory impairment, Pain
Clinical narrative: Almost passing out every day; Memory is getting bad; Pains all over her body; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), in 2022 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: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "Almost passing out every day"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "Memory is getting bad"; PAIN (non-serious), outcome "unknown", described as "Pains all over her body".   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid result- Positive; Covid result- Positive; Covid result- Positive; This is a spontaneous report received from a Consumer or other non HCP.  An 86-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Jun2023 at 11:30 as dose 1, single (Lot number: GJ3268) at the age of 85 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "cardio myopathy" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ofloxatin, reaction(s): "Known allergies: Ofloxatin". The following information was reported: COVID-19 (medically significant) with onset 12Jun2023, outcome "not recovered", DRUG INEFFECTIVE (medically significant), DISEASE RECURRENCE (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "Covid result- Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jun2023) Positive; (18Sep2023) Positive  Clinical course:Serious shortness of breath was also her only symptom when she had Covid in Sep2023.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Vaccination site pain
Clinical narrative: having sore and painful arms where she received the vaccine/ I got a sore arm; affected range of motion; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 62-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18May2023 as dose 5 (booster), single (Lot number: 2F3007A) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3 (booster), manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 4 (booster), manufacturer unknown), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18May2023, outcome "recovering", described as "having sore and painful arms where she received the vaccine/ I got a sore arm"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 2023, outcome "recovering", described as "affected range of motion". Therapeutic measures were not taken as a result of vaccination site pain, joint range of motion decreased.  Additional information: patient was travelling and had a Pfizer booster shot and she was concerned because the side effects she had has not gone away yet. So, she got a sore arm on the day of vaccination and then it just became very painful when she moved it in certain positions and other affected range of motion and she was in very bad pain and it is now 9 months later and it has not gone away. She was having sore and painful arms where she received the vaccine and it has been 9 months but the pain has not been resolved. It's affected range of motion and it's extraordinarily painful for about the first 6 months, very very painful and now. It is improved a bit but it has not gone away, but it still affects range of motion a lot and it's still very painful in certain positions. It's not bad as it first occurred.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brain injury, Cytokine increased, Immune system disorder, SARS-CoV-2 test
Clinical narrative: Immune system over reacted and continued to make mass production of cytokine cells and attacked her brain.; Immune system over reacted and continued to make mass production of cytokine cells and attacked her brain.; Immune system over reacted and continued to make mass production of cytokine cells and attacked her brain.; This is a spontaneous report received from a Consumer or other non HCP.  A 21-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 21 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No Known allergies. The following information was reported: IMMUNE SYSTEM DISORDER (hospitalization, disability, life threatening), CYTOKINE INCREASED (hospitalization, disability, life threatening), BRAIN INJURY (hospitalization, disability, life threatening) all with onset 14Jun2021, outcome "not recovered" and all described as "Immune system over reacted and continued to make mass production of cytokine cells and attacked her brain.". The patient was hospitalized for immune system disorder, cytokine increased, brain injury (hospitalization duration: 305 day(s)). The events "immune system over reacted and continued to make mass production of cytokine cells and attacked her brain." required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of immune system disorder, cytokine increased, brain injury. AE treatment: Medical induced coma for seizures.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Encephalopathy, Immune system disorder
Clinical narrative: Immune system over reacted and continued to make mass production of cytokine cells and attacked her brain.; Immune system over reacted and continued to make mass production of cytokine cells and attacked her brain.; Immune system over reacted and continued to make mass production of cytokine cells and attacked her brain.; This is a spontaneous report received from a Consumer or other non HCP.  A 21-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 21 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No Known allergies. The following information was reported: IMMUNE SYSTEM DISORDER (hospitalization, disability, life threatening), CYTOKINE INCREASED (hospitalization, disability, life threatening), BRAIN INJURY (hospitalization, disability, life threatening) all with onset 14Jun2021, outcome "not recovered" and all described as "Immune system over reacted and continued to make mass production of cytokine cells and attacked her brain.". The patient was hospitalized for immune system disorder, cytokine increased, brain injury (hospitalization duration: 305 day(s)). The events "immune system over reacted and continued to make mass production of cytokine cells and attacked her brain." required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of immune system disorder, cytokine increased, brain injury. AE treatment: Medical induced coma for seizures.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Emotional distress, Illness, Pain
Clinical narrative: Immune system over reacted and continued to make mass production of cytokine cells and attacked her brain.; Immune system over reacted and continued to make mass production of cytokine cells and attacked her brain.; Immune system over reacted and continued to make mass production of cytokine cells and attacked her brain.; This is a spontaneous report received from a Consumer or other non HCP.  A 21-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 21 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No Known allergies. The following information was reported: IMMUNE SYSTEM DISORDER (hospitalization, disability, life threatening), CYTOKINE INCREASED (hospitalization, disability, life threatening), BRAIN INJURY (hospitalization, disability, life threatening) all with onset 14Jun2021, outcome "not recovered" and all described as "Immune system over reacted and continued to make mass production of cytokine cells and attacked her brain.". The patient was hospitalized for immune system disorder, cytokine increased, brain injury (hospitalization duration: 305 day(s)). The events "immune system over reacted and continued to make mass production of cytokine cells and attacked her brain." required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of immune system disorder, cytokine increased, brain injury. AE treatment: Medical induced coma for seizures.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Nasal Swab Positive 20SEP2023; Nasal Swab Positive 20SEP2023; This is a spontaneous report and received from Consumer or other non HCPs from product quality group.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 06Mar2021 at 15:00 as dose 1, single (Lot number: EN6206), in left arm and on 27Mar2021 as dose 2, single (Lot number: ER8732) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gallbladder removal", start date: 11Feb2021, stop date: 11Feb2021. The patient's concomitant medications were not reported. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Sep2023, outcome "unknown" and all described as "Nasal Swab Positive 20SEP2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Sep2023) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021337249 same patient/drug, different dose/event;US-PFIZER INC-202400047643 same patient/drug, different dose/event;
Sex: F
Vaccine: RSV
Symptoms: Immunisation reaction, Respiratory distress
Clinical narrative: Respiratory distress; This is a spontaneous report received from a Physician.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RESPIRATORY DISTRESS (medically significant), outcome "unknown".  Clinical course details: The patient's doctor reported that the patient experienced an adverse reaction when she had an appointment with the doctor. It was some type of respiratory distress but the provider did not go into detail about the event at all. It was reported that it was the Abrysvo with the maternal indication.  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: As there is limited information in the case provided, the causal association between the event respiratory distress and the suspect drug RSV VACCINE PROT.SUBUNIT PREF 2V cannot be excluded. The case will be reassessed once new information is available. 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.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: pneumonia; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An elderly female patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergic to egg" (unspecified if ongoing), notes: carries Epipen. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: PNEUMONIA (medically significant), outcome "unknown". Clinical course: Caller also mentioned that she had 2 Pfizer COVID vaccines but still got COVID. Caller stated that she hadn't eaten egg in the past years which as she assumed may cause the allergy to be less severe. Caller was over 65. The doctor said that the patient was healthy but they were seeing a lot of pneumonia last week and this week. Caller didn't get Flu shot even though there was a Flu shot that was made without egg because a pharmacist told her it was not that good. Caller said she would get the Pneumonia vaccine, but has to knowand make sure it didn't have egg in it. Clarified caller was asking if egg is in Pfizer's Pneumonia Vaccine.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400047712 same patient/drug, different dose/events;
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 41-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), Manufacturer Unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 12Feb2024 to 16Feb2024).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400049929 same patient, different product and event;
Age: 64.0
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 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization. No known allergies.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 14Feb2024 to 19Feb2024. 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
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 52-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Batch/Lot number: unknown), on 05May2021 as dose 2, single (Batch/Lot number: unknown) and on 22Nov2021 as dose 3 (booster), 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 2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 09Feb2024 to 12Feb2024 as treatment of COVID-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 70.0
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 09Oct2023 as dose 1, single (Lot number: H62292) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Sulfa" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 4 (BOOSTER), Single, Batch/Lot No: GJ6739, Location of injection: Arm Right), administration date: 12Nov2022, when the patient was 70-year-old, for Covid-19 immunization; moderna (Dose 3 (BOOSTER), Single, Batch/Lot No: 0065K214, Location of injection: Arm Left), administration date: 30Mar2022, when the patient was 69-year-old, for Covid-19 immunization; moderna (Dose 2, Single, Batch/Lot No: 013M20A), administration date: 22Feb2021, when the patient was 68-year-old, for Covid-19 immunization; moderna (Dose 1, Single, Batch/Lot No:039K20A), administration date: 24Jan2021, when the patient was 68-year-old, for Covid-19 immunization. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, vaccination failure which included Paxlovid.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "penicillin allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovered" (17Feb2024) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Feb2024) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19 starting on 12Feb2024 until 16Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Sep2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single), as dose 4 (booster), single) and as dose 5 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "DM2" (unspecified if ongoing); "HBP" (unspecified if ongoing); "PSA" (unspecified if ongoing). The patient's 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 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 - this included PAXLOVID from 11Feb2024 to 15Feb2024.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 at 14:00 as dose 1, single (Lot number: HG4629) at the age of 74 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. Vaccination history included: moderna (Dose Number: 5, Batch/Lot No: AS7148B, Location of injection: Arm Left), administration date: 21Sep2022, when the patient was 73-year-old, for Covid-19 immunization; moderna (Dose Number: 4, Batch/Lot No: 028K21A, Location of injection: Arm Left), administration date: 30Mar2022, when the patient was 72-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: FF2587, Location of injection: Arm Left), administration date: 29Sep2021, when the patient was 72-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: ENG6205, Location of injection: Arm Left), administration date: 05Mar2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3347, Location of injection: Arm Left), administration date: 12Feb2021, when the patient was 71-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", described as "COVID 19 "; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 including paxlovid from 04Feb2024 to 08Feb2024.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CYMBALTA; ZYTREC; SINGULAIR. 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 was treated with Paxlovid from 12Feb2024 to 18Feb2024. No known allergies.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from an Other HCP.  A 73-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 at 09:30 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing); "RA" (unspecified if ongoing); "Sjogren's" (unspecified if ongoing); "asthma" (unspecified if ongoing); "constrictive bronchiolitis" (unspecified if ongoing); "bronchiectasis" (unspecified if ongoing); "Mitral valve prolapse" (unspecified if ongoing); "aneurysm of ascending aorta" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ceclor, reaction(s): "Allergy"; Keflex, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid as treatment from 13Feb2024 to 18Feb2024.  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: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 at 15:00 as dose 1, single (Lot number: HG2282), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (DOSE 5 VACCINE BRAND: PFIZER/BIONTECH; LOT# GH9694, VACCINE LOCATION: Right Arm), administration date: 19Sep2022, for Covid-19 immunization; Covid-19 vaccine (DOSE 4, VACCINE BRAND: UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 3, VACCINE BRAND: UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, VACCINE BRAND: UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, VACCINE BRAND: UNKNOWN MANUFACTURER), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Plaxlovid from 08Feb2024 to 12Feb2024.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from an Other HCP.  A 56-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Seafood" (unspecified if ongoing); "known allergies: shellfish" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "asthma" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "known allergies: lisinopril". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 Included Paxlovid from 17Feb2024 to 21Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: He's had all your Pfizer vaccines and boosters, every one you've ever made but he still ended up with this; He's had all your Pfizer vaccines and boosters, every one you've ever made but he still ended up with this; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 66-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number unknown, single (had all your Pfizer vaccines and boosters)), for COVID-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (Dose number unknown, single (had all your Pfizer vaccines and boosters)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "He's had all your Pfizer vaccines and boosters, everyone you've ever made but he still ended up with this". Additional information: The wife of the patient called to see about possibly getting a prescription for Paxlovid to see if the insurance covered it before calling his husband's doctor. The husband was 66 and a half. He's had all the Pfizer vaccines and boosters; everyone ever made but he still ended up with this.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional information: The patient was upset, stating her mother was affected by the COVID-19 vaccination, and became sick.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: RSV
Symptoms: Device connection issue
Clinical narrative: one Abrysvo was defective. It has little connector to use to reconstitute from vial to syringe. It was crooked and broke off.; This is a spontaneous report received from a Pharmacist from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HP1193, Expiration Date: 30Apr2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE DEFECTIVE (non-serious), outcome "unknown", described as "one Abrysvo was defective. It has little connector to use to reconstitute from vial to syringe. It was crooked and broke off.".  Additional information: the reporter was informed that one Abrysvo device was defective. It was reported that there was little connector used to reconstitute from the vial to the syringe. The reporter stated it was crooked and broke off. The reporter stated they couldn't reconstitute so there was no patient involvement.  Causality for the event was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received double dose of vaccine within 12 days of each other in error with no reported adverse event; Initial information received on 15-Feb-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 31 years old female patient who received double dose of influenza quadrival A-B vaccine [Fluzone QIV] within 12 days of each other in error 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 diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix) for Prophylactic vaccination; hepatitis A vaccine INACT (Havrix) for Immunisation; and Elasomeran (Moderna Covid-19 Vaccine) for Immunisation.  On 03-Feb-2024, the patient received a standard dose of suspect influenza quadrival A-B vaccine Suspension for injection (lot number, expiry date, strength, dosage- not reported); then On 15-Feb-2024 she also received a dose of 0.5 mL total of the same vaccine (lot UT8129LA, expiry date- 30-JUN-2024) via unknown route in unknown administration site for Immunization. Information on the batch number was requested for the 1st dose administered.   On 15-FEB-2024 the patient received double dose of vaccine within 12 days of each other in error with no reported adverse event (extra dose administered) (latency- 12 days) following the first dose and (latency- same day) following the last dose administration of influenza quadrival A-B vaccine.  Reportedly, Nurse practitioner wanted to know what are the risk associated and harm to receiving double dose of TDAP Boostrix (Non-Sanofi) and FLUZONE QIV (PFS). Nurse Practitioner also stated that the patient needs to be vaccinated with 11 more vaccines for patient's card and she wanted to confirm after how many days are any other vaccines allowed to be given to the patient after the reported event?  They had the patient remained in the office for an hour after vaccination. There was no treatment given after administration and there was no side effects noted.   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.; Sender's Comments:  US-SA-2024SA059809:01948047
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: She got Gardasil vaccine on 2/21/2024 left upper arm and started having pain and swelling symptoms 48 hours after the vaccination on Friday, 2/23/2024.  No history of fever no other cough congestion.  Mom is doing local ice pack and Tylenol as needed.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Paraesthesia
Clinical narrative: Lower extremity tingling for several months each time I had a vaccine, continues to this day
Age: 87.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Feeling hot, Injection site pruritus, Swelling
Clinical narrative: Redness, swelling, bumps,warmth, itching roughly 4 inch diameter surrounding injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness, swelling, and itching.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hypoaesthesia, Injection site induration, Injection site swelling, Pain
Clinical narrative: About 15 mins after injection, my upper shoulder (all the way through to my back), armpit area, and a bit on my chest under the arm, went numb. The numbness and tingling was felt more when moved my arm. Then tingling and cool sensation I felt on my left ear, down left side of my neck and lower jaw. The pain came about 1:30 pm, and numbness became more localized; however if I move my arm I feel cool and tingling sensation down to my pinky and again in the ear and neck, lips and jaw. The injection site is swollen and hard; numbness is down but still there. No other effects. I am to see my provider tomorrow as the local county public health nurse advised I be monitored.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: About 15 mins after injection, my upper shoulder (all the way through to my back), armpit area, and a bit on my chest under the arm, went numb. The numbness and tingling was felt more when moved my arm. Then tingling and cool sensation I felt on my left ear, down left side of my neck and lower jaw. The pain came about 1:30 pm, and numbness became more localized; however if I move my arm I feel cool and tingling sensation down to my pinky and again in the ear and neck, lips and jaw. The injection site is swollen and hard; numbness is down but still there. No other effects. I am to see my provider tomorrow as the local county public health nurse advised I be monitored.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given and expiration date noted to be 2-25-24. Mother notified by provider. No adverse outcome noted.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED.
Age: 74.0
Sex: U
Vaccine: RSV, COVID19, COVID19, FLU4, PPV
Symptoms: Asthma, Atrial fibrillation, Dyspnoea, Heart rate increased, Laboratory test
Clinical narrative: (1) Developed A Fib after 1st Moderna vaccine Dx July 2023 (2) RSV - 9/17/23 Reported shortness of breath, hoardness from dry cough, wheezing, unable to exercise. This causes breathing to get worse, elevate heart rate, bouts of A fib, tired, interfers w/sleep   visit 10/16/23 called & report symptoms to Pfizer reference # 01129473
Age: 74.0
Sex: U
Vaccine: RSV, COVID19, COVID19, FLU4, PPV
Symptoms: Quality of life decreased, Respiratory disorder, Wheezing
Clinical narrative: (1) Developed A Fib after 1st Moderna vaccine Dx July 2023 (2) RSV - 9/17/23 Reported shortness of breath, hoardness from dry cough, wheezing, unable to exercise. This causes breathing to get worse, elevate heart rate, bouts of A fib, tired, interfers w/sleep   visit 10/16/23 called & report symptoms to Pfizer reference # 01129473
Age: 74.0
Sex: U
Vaccine: RSV, COVID19, COVID19, FLU4, PPV
Symptoms: Atrial fibrillation, Cough, Dysphonia, Dyspnoea, Exercise tolerance decreased
Clinical narrative: (1) Developed A Fib after 1st Moderna vaccine Dx July 2023 (2) RSV - 9/17/23 Reported shortness of breath, hoardness from dry cough, wheezing, unable to exercise. This causes breathing to get worse, elevate heart rate, bouts of A fib, tired, interfers w/sleep   visit 10/16/23 called & report symptoms to Pfizer reference # 01129473
Age: 74.0
Sex: U
Vaccine: RSV, COVID19, COVID19, FLU4, PPV
Symptoms: Fatigue, Heart rate increased, Sleep disorder, Wheezing
Clinical narrative: (1) Developed A Fib after 1st Moderna vaccine Dx July 2023 (2) RSV - 9/17/23 Reported shortness of breath, hoardness from dry cough, wheezing, unable to exercise. This causes breathing to get worse, elevate heart rate, bouts of A fib, tired, interfers w/sleep   visit 10/16/23 called & report symptoms to Pfizer reference # 01129473
Age: 26.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Maternal exposure before pregnancy, Pregnancy test negative, Pregnancy test positive
Clinical narrative: the patient presented a positive pregnancy test on 05-FEB-2024; No additional AE/PQC reported.; This spontaneous prospective pregnancy report was received from a physician and refers to a 26-year-old female patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 11-JAN-2024 after presenting a negative pregnancy test, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX), lot number X017487 with expiration date 25-JUN-2025 (dose, route, and anatomical location were not reported) for prophylaxis.  The physician reported that the patient presented a positive pregnancy test on 05-FEB-2024. The physician stated that they did not known which dose of the varicella virus vaccine live (oka/merck)(VARIVAX) vaccine the patient received. The last menstrual period (LMP) was not reported. The pregnancy outcome was outcome pending. No adverse event were reported.
Age: 26.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Maternal exposure before pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: the patient presented a positive pregnancy test on 05-FEB-2024; No additional AE/PQC reported.; This spontaneous prospective pregnancy report was received from a physician and refers to a 26-year-old female patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 11-JAN-2024 after presenting a negative pregnancy test, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX), lot number X017487 with expiration date 25-JUN-2025 (dose, route, and anatomical location were not reported) for prophylaxis.  The physician reported that the patient presented a positive pregnancy test on 05-FEB-2024. The physician stated that they did not known which dose of the varicella virus vaccine live (oka/merck)(VARIVAX) vaccine the patient received. The last menstrual period (LMP) was not reported. The pregnancy outcome was outcome pending. No adverse event were reported.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported; Nurse calling to report administration of VARIVAX that was administered to a patient after expiration.  Nurse states that VARIVAX was administered on 14-FEB-2024 and expired on 24-JAN-2024.  Confirmed no symptomatic adverse events were reported after; This spontaneous report was received from a nurse and refers to a 20-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 14-FEB-2024 the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # W002596 and expiration date 24-JAN-2024, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided) (experienced expired product administered and no adverse event).
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient did not experience any side effects after receiving the PNEUMOVAX 23; PNEUMOVAX 23 was inadvertently given 3-month-old female infant today 2/23/2024; This spontaneous report was received from a Physician and referred to a 3-month-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 23-FEB-2024, the patient was inadvertently given a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 1 dosage form, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). Patient did not experience any side effects after receiving the pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23). HCP sent the patient home.   Lot # is being requested and will be submitted if received.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received a dose of Infanrix instead of Boostrix on 31JAN2024.; 11 year old patient accidentally received a dose of Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa (Infanrix) (batch number GG39D, expiry date 07-JUN-2025) for prophylaxis.   On 31-JAN-2024, the patient received Infanrix. On 31-JAN-2024, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: received a dose of Infanrix instead of Boostrix on 31JAN2024.) and inappropriate age at vaccine administration (Verbatim: 11 year old patient accidentally received a dose of Infanrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-FEB-2024 Th nurse reported 11 year old patient accidentally received a dose of Infanrix instead of Boostrix which led to wrong vaccine administered and inappropriate age at vaccine administration.