chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC20, RV5, UNK
Symptoms: Bilirubin conjugated normal, Blood bilirubin normal, Blood bilirubin unconjugated normal, Blood lactic acid normal, Decreased appetite
Clinical narrative: Dehydration; Lethargy; Poor feeding; Inadvertently receive a pneumococcal 20 (Prevnar 20), in addition to the Vaxelis and RotaTeq; it did result in an emergency room visit; received this vaccine the wrong time; This spontaneous report was received from the physician and referred to a 3-day year old (currently 2 weeks 4 days) female.   The patient's medical history, concurrent condition, concomitant therapies were not reported. The current (reported as today) weight was 7 pounds 8 ounces and the length was 20 inches.  The baby was feeding well. On 11-JUL-2024, the patient went to the clinic outside facility and was inadvertently vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally (strength, lot #, and expiry date were not provided); diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection (strength, lot #, expiry date, and route of administration were not provided), and pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) (strength, formulation, lot #, expiry date, and route of administration were not provided), all for prophylaxis. It was reported that it was a staffing error, there was another baby that needed it, a two-month-old like apparently in a door or an exam room next to that baby and the staff went into the wrong patient and gave it to the wrong patient. The patient received these vaccines at the wrong time (Wrong patient received product).  On the same day, about a half day later baby developed lethargy and poor feeding, dehydration. On 12-JUL-2024, the patient went to the emergency room visit for dehydration and lethargy. On 13-JUL-2024 (during an emergency room visit), she got labs done. She had a complete blood count done and she had a comprehensive metabolic panel (CMP), comprehensive metabolic panel done. A lactic acid, a direct bilirubin, a total bilirubin and an indirect bilirubin. All the results were considered normal for her age. The patient received bolus of Intravenous (IV) fluid. On an unknown day in July 2024, the patient recovered from all the events.   The causality between suspect vaccines and events was reported as related (vaccination was the only precipitating events). It was reported that the patient was transferred care to the reporter. It was reported that the patient was transferred care to the reporter. It was reported that probably because the baby was feeding fantastically prior and so like two months or four months that feeding could change a little bit when the baby getting, they get fussy. It did seem like to be corelated.
Sex: F
Vaccine: PNC20, RV5, UNK
Symptoms: Dehydration, Full blood count normal, Lethargy, Metabolic function test normal, Wrong patient received product
Clinical narrative: Dehydration; Lethargy; Poor feeding; Inadvertently receive a pneumococcal 20 (Prevnar 20), in addition to the Vaxelis and RotaTeq; it did result in an emergency room visit; received this vaccine the wrong time; This spontaneous report was received from the physician and referred to a 3-day year old (currently 2 weeks 4 days) female.   The patient's medical history, concurrent condition, concomitant therapies were not reported. The current (reported as today) weight was 7 pounds 8 ounces and the length was 20 inches.  The baby was feeding well. On 11-JUL-2024, the patient went to the clinic outside facility and was inadvertently vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally (strength, lot #, and expiry date were not provided); diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection (strength, lot #, expiry date, and route of administration were not provided), and pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) (strength, formulation, lot #, expiry date, and route of administration were not provided), all for prophylaxis. It was reported that it was a staffing error, there was another baby that needed it, a two-month-old like apparently in a door or an exam room next to that baby and the staff went into the wrong patient and gave it to the wrong patient. The patient received these vaccines at the wrong time (Wrong patient received product).  On the same day, about a half day later baby developed lethargy and poor feeding, dehydration. On 12-JUL-2024, the patient went to the emergency room visit for dehydration and lethargy. On 13-JUL-2024 (during an emergency room visit), she got labs done. She had a complete blood count done and she had a comprehensive metabolic panel (CMP), comprehensive metabolic panel done. A lactic acid, a direct bilirubin, a total bilirubin and an indirect bilirubin. All the results were considered normal for her age. The patient received bolus of Intravenous (IV) fluid. On an unknown day in July 2024, the patient recovered from all the events.   The causality between suspect vaccines and events was reported as related (vaccination was the only precipitating events). It was reported that the patient was transferred care to the reporter. It was reported that the patient was transferred care to the reporter. It was reported that probably because the baby was feeding fantastically prior and so like two months or four months that feeding could change a little bit when the baby getting, they get fussy. It did seem like to be corelated.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: he started with Moderna and kept up with the boosters, however last August, she went to the dentist and caught covid.; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (he started with Moderna and kept up with the boosters, however last August, she went to the dentist and caught covid.) in a 63-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included COPD (COPD had from last 18 years), Arthritis (she had that since she  was in her late 30s but it  was worsened), Spinal stenosis (began when she was in  her late 30s or early 40s.) and Joint disorder (joint disease).    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (he started with Moderna and kept up with the boosters, however last August, she went to the dentist and caught covid.). At the time of the report, COVID-19 (he started with Moderna and kept up with the boosters, however last August, she went to the dentist and caught covid.) outcome was unknown.            No Concomitant medications provided by the reporter. No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope
Clinical narrative: fainted; unconscious; 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)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: SYNCOPE (medically significant) with onset 2023, outcome "unknown", described as "fainted"; LOSS OF CONSCIOUSNESS (medically significant) with onset 2023, outcome "recovered" (2023), described as "unconscious". Clinical Course: When covid become a danger to the general public reporter believed the best way to stop this deadly virus and reverse the pandemic was to have vaccinations. Reporter worked regularly with young children. Reporter's daughter fell into a high-risk category, due to ulcerative colitis, and reporter came in regular contact with it's mother and other health compromised/disabled individuals. Reporter's mother was in her late 80's. Reporter did not want to be responsible for carrying or causing any one that reporter love and care about to get COVID. Reporter's daughter took a Covid booster by Pfizer last fall (2023). She left her clinic after waiting of her the injection. She drove to work. Upon arrival, she fainted. She was out cold! EMS was called. She stayed unconscious for over 15 mins. Again this was a Pfizer vaccine. It was 2023 booster. Now, she too is forbidden from ever taking a covid shot of any kind.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201156993 same reporter/vaccine, different patient/events;
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Culture, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: Covid/Got Paxlovid that day, he wants to say 05Jun2022; Covid/Got Paxlovid that day, he wants to say 05Jun2022; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 25Apr2022 as dose 4 booster , single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 26Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "run over by a car", start date: 2008 (unspecified if ongoing); "had COVID" (unspecified if ongoing), notes: One time he had Covid. The patient's concomitant medications were not reported. Past drug history included: Meloxicam, start date: 2008, for traumatic arthritis, reaction(s): "stage 3 kidney disease". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovered" (Jun2022) and all described as "Covid/Got Paxlovid that day, he wants to say 05Jun2022". The patient underwent the following laboratory tests and procedures: Blood test: Result Unknown; Culture: Negative; SARS-CoV-2 antibody test: Negative; X-ray dental: wasn't a cold sore and not shingles, notes: said it wasn't a cold sore and not shingles. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: They had gone to REDACTED and his wife had it but didn't know it and she tested positive there and then negative so they flew home. As soon as they got home, he didn't feel good (COVID). Got Paxlovid that day, he wants to say 05Jun2022 or something like that and it was the same deal where it cleared it up in 2 days and boom he was fine. Then a week to a week and a half later it hits like ton of bricks. Did not do Paxlovid again because he didn't know he could.   Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400227364 same reporter/patient/suspect vaccine; different dose/event;US-PFIZER INC-202400227365 same reporter/patient/suspect vaccine; different dose/event;US-PFIZER INC-202400227366 same reporter/patient/suspect vaccine; different dose/event;
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray dental
Clinical narrative: Covid/Got Paxlovid that day, he wants to say 05Jun2022; Covid/Got Paxlovid that day, he wants to say 05Jun2022; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 25Apr2022 as dose 4 booster , single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 26Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "run over by a car", start date: 2008 (unspecified if ongoing); "had COVID" (unspecified if ongoing), notes: One time he had Covid. The patient's concomitant medications were not reported. Past drug history included: Meloxicam, start date: 2008, for traumatic arthritis, reaction(s): "stage 3 kidney disease". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovered" (Jun2022) and all described as "Covid/Got Paxlovid that day, he wants to say 05Jun2022". The patient underwent the following laboratory tests and procedures: Blood test: Result Unknown; Culture: Negative; SARS-CoV-2 antibody test: Negative; X-ray dental: wasn't a cold sore and not shingles, notes: said it wasn't a cold sore and not shingles. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: They had gone to REDACTED and his wife had it but didn't know it and she tested positive there and then negative so they flew home. As soon as they got home, he didn't feel good (COVID). Got Paxlovid that day, he wants to say 05Jun2022 or something like that and it was the same deal where it cleared it up in 2 days and boom he was fine. Then a week to a week and a half later it hits like ton of bricks. Did not do Paxlovid again because he didn't know he could.   Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400227364 same reporter/patient/suspect vaccine; different dose/event;US-PFIZER INC-202400227365 same reporter/patient/suspect vaccine; different dose/event;US-PFIZER INC-202400227366 same reporter/patient/suspect vaccine; different dose/event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive on the 16th; Tested positive on the 16th; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old male patient received BNT162b2 (BNT162B2 NOS), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown), on 26Mar2021 as dose 2, single (Batch/Lot number: unknown), on 12Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), on 25Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), on 12Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) and in 2023 as dose 6 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "has stage 3 kidney disease", start date: 2024 (ongoing), notes: Was diagnosed, this has been ongoing since beginning of 2024; "Ran over by a car", start date: 2008 (unspecified if ongoing), notes: Taking due to being run over by a car in 2008. Took for like 10 years for traumatic arthritis. The patient's concomitant medications were not reported. Past drug history included: Meloxicam, start date: 2008, for traumatic arthritis, notes: Taking due to being run over by a car in 2008. Took for like 10 years for traumatic arthritis. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Jul2024, outcome "unknown" and all described as "Tested positive on the 16th". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative, notes: no, just Covid test, lots of negative tests and then only test is home test now; (16Jul2024) positive, notes: tested positive on the 16th and before that he ended up with weird. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Batch/lot number is not provided, and it cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, COVID-19, Culture, SARS-CoV-2 test, Vaccination failure
Clinical narrative: One time he had Covid/This happened he thinks between Pfizer Covid vaccine 2 and 3 but isn't sure; One time he had Covid/This happened he thinks between Pfizer Covid vaccine 2 and 3 but isn't sure; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 26Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "stage 3 kidney disease", start date: 2024 (ongoing), notes: stage 3 kidney disease , he developed kidney disease. Was diagnosed, this has been ongoing since beginning of 2024, so for the last 2-3 months. The patient's concomitant medications were not reported. Past drug history included: Meloxicam, start date: 2008, for traumatic arthritis, notes: taking Meloxicam long term from being run over by a car in 2008, Does not have manufacturer, NDC, lot and expiry to provide. He took for like 10 years because of traumatic arthritis. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "One time he had Covid/This happened he thinks between Pfizer Covid vaccine 2 and 3 but isn't sure". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) there are some issues, notes: blood tests and was watching it and said ok there are some issues so he saw urologist and was taken off Meloxicam; Culture: (unspecified date) Negative, notes: culture that was negative dermatologist cultured and it was negative for everything and they got the health department involved; SARS-CoV-2 test: (unspecified date) Negative, notes: lots of negative tests; (16Jul2024) Positive, notes: tested positive on the 16th and before that he ended up with weird; X-ray: (unspecified date) it wasn't a cold sore, notes: said it wasn't a cold sore and not shingles.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400227363 same reporter/patient/suspect vaccine; different dose/event;
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: One time he had Covid/This happened he thinks between Pfizer Covid vaccine 2 and 3 but isn't sure; One time he had Covid/This happened he thinks between Pfizer Covid vaccine 2 and 3 but isn't sure; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 26Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "stage 3 kidney disease", start date: 2024 (ongoing), notes: stage 3 kidney disease , he developed kidney disease. Was diagnosed, this has been ongoing since beginning of 2024, so for the last 2-3 months. The patient's concomitant medications were not reported. Past drug history included: Meloxicam, start date: 2008, for traumatic arthritis, notes: taking Meloxicam long term from being run over by a car in 2008, Does not have manufacturer, NDC, lot and expiry to provide. He took for like 10 years because of traumatic arthritis. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "One time he had Covid/This happened he thinks between Pfizer Covid vaccine 2 and 3 but isn't sure". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) there are some issues, notes: blood tests and was watching it and said ok there are some issues so he saw urologist and was taken off Meloxicam; Culture: (unspecified date) Negative, notes: culture that was negative dermatologist cultured and it was negative for everything and they got the health department involved; SARS-CoV-2 test: (unspecified date) Negative, notes: lots of negative tests; (16Jul2024) Positive, notes: tested positive on the 16th and before that he ended up with weird; X-ray: (unspecified date) it wasn't a cold sore, notes: said it wasn't a cold sore and not shingles.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400227363 same reporter/patient/suspect vaccine; different dose/event;
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Culture, Rash
Clinical narrative: One time he had Covid/This happened he thinks between Pfizer Covid vaccine 2 and 3 but isn't sure; One time he had Covid/This happened he thinks between Pfizer Covid vaccine 2 and 3 but isn't sure; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 26Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "stage 3 kidney disease", start date: 2024 (ongoing), notes: stage 3 kidney disease , he developed kidney disease. Was diagnosed, this has been ongoing since beginning of 2024, so for the last 2-3 months. The patient's concomitant medications were not reported. Past drug history included: Meloxicam, start date: 2008, for traumatic arthritis, notes: taking Meloxicam long term from being run over by a car in 2008, Does not have manufacturer, NDC, lot and expiry to provide. He took for like 10 years because of traumatic arthritis. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "One time he had Covid/This happened he thinks between Pfizer Covid vaccine 2 and 3 but isn't sure". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) there are some issues, notes: blood tests and was watching it and said ok there are some issues so he saw urologist and was taken off Meloxicam; Culture: (unspecified date) Negative, notes: culture that was negative dermatologist cultured and it was negative for everything and they got the health department involved; SARS-CoV-2 test: (unspecified date) Negative, notes: lots of negative tests; (16Jul2024) Positive, notes: tested positive on the 16th and before that he ended up with weird; X-ray: (unspecified date) it wasn't a cold sore, notes: said it wasn't a cold sore and not shingles.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400227363 same reporter/patient/suspect vaccine; different dose/event;
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Neuropathy peripheral, Tinnitus
Clinical narrative: autoimmune; neuropathy feet; tinnitus; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on (30Jul2024), this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 13Jan2022 as dose 3 (booster), single (Lot number: 33130BA) at the age of 61 years intramuscular, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (dose 1, single, via intramuscular lot: EW0162, expiry: 31Jul2021 in the left deltoid, Healthcare Professional or Clinic site: Hometown (withheld)), administration date: 09Apr2021, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (dose 2, single, via intramuscular lot: EW0179, expiry: 31Aug2021 in the left deltoid, Healthcare Professional or Clinic site: Hometown Pharmacy), administration date: 30Apr2021, when the patient was 60-year-old, for COVID-19 immunization. The following information was reported: AUTOIMMUNE DISORDER (medically significant) with onset 09Feb2022, outcome "not recovered", described as "autoimmune"; NEUROPATHY PERIPHERAL (medically significant) with onset 09Feb2022, outcome "not recovered", described as "neuropathy feet"; TINNITUS (non-serious) with onset 09Feb2022, outcome "not recovered". Therapeutic measures were taken as a result of autoimmune disorder, neuropathy peripheral, tinnitus with ozone therapy and supplements. Additional information: The patient experienced tinnitus, autoimmune and neuropathy feet on 09Feb2022. The patient was very healthy until vaccine
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: had an anaphylactic reaction; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NOV24-00059 (Novavax).  A 78-year-old patient received BNT162b2 (BNT162B2), in 2020 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Very immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "had an anaphylactic reaction". The event "had an anaphylactic reaction" required physician office visit. Clinical course: Patient stated that, they remain in a very vulnerable category because patient was 78-years old and very immunocompromised and  had a reaction with the Pfizer vaccine. Patient stated that, their situation was true to many people. Patient was vaccinated before just once in 2020 and had an anaphylactic reaction to Pfizer vaccine number one. So their doctors refused further vaccines.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Myocardial infarction
Clinical narrative: heart attack; cardiac issues; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "cardiac issues". Clinical course: Patient was having cardiac issues and heart attack from their COVID shots.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: FLU4
Symptoms: Diplopia, Eyeglasses therapy, Vision blurred
Clinical narrative: double vision; Severe blurred vision; Initial information received on 22-Jul-2024 regarding an unsolicited valid serious courtesy case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who had double vision and severe blurred vision after receiving vaccine influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Atrial fibrillation in 2016 and Type 2 diabetes mellitus.   On 09-Oct-2023, the patient received a 0.7 ml dose of suspect influenza quadrival A-B high dose HV vaccine (strength, form: unknown) (lot: UT8094CA, expiry date: 30-jun-2024) via unknown route in the left deltoid as Prophylactic vaccination (immunization).  On 10-Oct-2023 the patient had double vision (diplopia) and severe blurred vision (vision blurred) 1 day following the administration of influenza quadrival A-B high dose HV vaccine.   It was unknown if any lab data/test results were available.  Action taken: not applicable.  The patient was treated with prism glasses for the events.  Outcome: Recovering / Resolving for both the events.  Seriousness Criteria: These events were leading to disability. The patient was hospitalized for both the events.; Sender's Comments: Sanofi company comment dated 30-Jul-2024: This case involves an unknown age and unknown gender patient who had double vision and severe blurred vision after receiving vaccine influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent]. Furthermore, information regarding condition at the time of vaccination, role of medical history,  lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed. Additionally the role of ongoing medical condition of the patient cannot be ignored either.
Age: 4.0
Sex: U
Vaccine: TYP
Symptoms: Exposure via skin contact, Incorrect dose administered, Patient uncooperative, Underdose
Clinical narrative: nurse administered typhim-vi to a patient and the child jerked their arm part of the vaccine came out and dribbled down the child's arm with no reported adverse event; nurse administered typhim-vi to a patient and the child jerked their arm part of the vaccine came out and dribbled down the child's arm with no reported adverse event; Initial information received on 16-Jul-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old and unknown gender patient to whom nurse administered typhoid VI polysaccharide vaccine [Typhim VI] and the child jerked their arm part of the vaccine came out and dribbled down the child's arm with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient to whom nurse administered 0.5 ml dose (once) of suspect typhoid VI polysaccharide vaccine, Solution for injection (lot X2A231M; Expiration Date :23-Feb-2026) via unknown route in the arm nos (not otherwise specified) for immunization and the child jerked their arm part of the vaccine came out and dribbled down the child's arm with no reported adverse event (incorrect dose administered) (accidental exposure to product) (latency: on same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: MEN
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 12-year-old male patient was given a dose earlier for Menquadfi (with no reported adverse event); Initial information received on 24-Jul-2024 regarding an unsolicited valid non-serious case received from a health professional.  This case involves a 12 years old male patient was given a dose earlier for Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi], with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant or "no other vaccines"= NONE.   On 24-Jul-2024, the 12 years old patient received 0.5 ml dose 2 earlier for the suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine, Solution for injection, with no reported adverse event (inappropriate schedule of product administration) (latency: same day) (lot: U7938AA, Expiry date: 28-Feb-2026) via intramuscular route in the left deltoid for Immunization.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: they were only able to inject 0.4 of the 0.5 ml dose with no adverse event; Initial information received on 25-Jul-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old female patient who was injectected 0.4 of the 0.5 ml dose of Ipv (Vero) [Ipol], 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 Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for Immunisation; and Varicella Zoster Vaccine (Varicella Vaccine) for Immunisation.  On 13-Jul-2024, the patient received (0.4 ml) dose of suspect IPV (VERO), Suspension for injection (strength: standard) of the 0.5 ml dose with no reported adverse event (incorrect dose administered) (latency: same day) (lot: W1A101M, Expiry date: not reported) via intramuscular route in the arm nos for immunization.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Lip swelling
Clinical narrative: Lip swelling; This spontaneous case, initially received on 22-Jul-2024, was reported by a non health professional and concerns an  male patient.  Administration of company suspect drugs: On 14-Oct-2023, the patient received Flucelvax Quadrivalent for Active immunization against influenza disease, Dose regimen: .5 ml, Route of administration: Unknown, Lot number: 944458.   No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Lip swelling (outcome: Recovered / Resolved).  The reporter did not provide the seriousness and causality of the events. We normally get a flu shot every year, and last year in October we went to the pharmacy and he got his, and a few hours after that his lip started swelling.  Non-drug treatment/Other action taken:  Flucelvax Quadrivalent action taken: not applicable  Reporter's assessment: The reporter did not provide the seriousness for event and causality was related to administration of Flucelvax Quadrivalent; Reporter's Comments: The reporter did not provide the seriousness for event and causality was related to administration of Flucelvax Quadrivalent.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: IPOL dose that was administered that was expired, with no reported adverse event; Initial information received on 24-Jul-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient received IPV (VERO) [IPOL] dose that was administered that was expired, 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 MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Prophylactic vaccination.  On 24-Jul-2024, the patient received an expired 0.5 ml 1X (total) dose of suspect IPV (VERO), Suspension for injection (lot V1B891M expiry 01-Jun-2024) (expired product administered, latency same day) (strength: unknown) via intramuscular route in unknown administration site for prophylactic vaccination. .  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mom called saying patient got shots on Tuesday on her right arm  and  since yesterday, pt has the area below from where she got shots, red hot hard and swollen and is more swollen today. Only had redness on Tuesday afternoon. Mom wanted to see if this is normal or a reaction. Emailed picture. Advice mom doctor this is a reaction and most likely to the Tdap. Advice to ice it, motrin and doctor will send an abx later on to prevent from it getting an infection.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncopy, vasovagal
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Pyrexia
Clinical narrative: PATIENT INDICATES FEVER, CHILLS AND COUGH SINCE RECEIVING VACCINE (SUNDAY), HAS BEEN TAKING NYQUIL AND DAYQUIL. TODAY (THURS) SHE REPORTS A SMIDGE IMPROVED SYMPTOMS
Age: 56.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Pain, Rash, SARS-CoV-2 test negative
Clinical narrative: Patient has had body aches and pains since receiving both vaccines together. She also reports a rash on arms and legs.
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV, PNC15
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt with swelling at injection site on L thigh, Hot to touch, painful to touch. Pt has been prescribed Cephalexin for possible skin infection.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Device use confusion, Incorrect dose administered, No adverse event
Clinical narrative: Pharmacist administered half a dose of the Engerix-B 20mcg/ml to create the 10mcg  dosage.  The prefilled syringe is not marked nor indicating 0.5ml dosing; therefore, this was an estimated dose following doctor's prescription order.  The patient did not have any adverse reaction to the vaccine.
Age: 21.0
Sex: F
Vaccine: ANTH, TYP, TYP, UNK
Symptoms: Abdominal pain upper, Blindness, Hyperhidrosis, Malaise, Pallor
Clinical narrative: (Vaccinator's Statement): Pt received vaccines listed above, LPN went to get more vaccines (Heb B and MMR), and pt stated, "she could not see" and experienced syncope for approximately 5 seconds. Ice packs applied to neck and cold water given. Pt escorted by 2 Personales to the treatment center at the back. RN received pt, and she was place on a bed to lay down. Pt alert and oriented to name DOB, place and time. Skin color pale and sweety. Vitals as follows: BP 98/60 left arm lying down. HR: 83, SPO2: 99% on room air. Pt felt better after 15 minutes and requested she needed to use the bathroom. She was escorted by her buddy. 5 minutes later was called to come and attend to the pt in the bathroom. Upon arrival pt was sitting on the floor, looking paled, grabbing on her stomach, and stated she does not feel well. Pt latter threw up in the toilet (none bloody) and still complaining of severe stomach cramping. EMS called at 1535 after several interventions were non effective. EMS arrived at 1558 at escorted pt to the ER.
Age: 21.0
Sex: F
Vaccine: ANTH, TYP, TYP, UNK
Symptoms: Syncope, Vomiting
Clinical narrative: (Vaccinator's Statement): Pt received vaccines listed above, LPN went to get more vaccines (Heb B and MMR), and pt stated, "she could not see" and experienced syncope for approximately 5 seconds. Ice packs applied to neck and cold water given. Pt escorted by 2 Personales to the treatment center at the back. RN received pt, and she was place on a bed to lay down. Pt alert and oriented to name DOB, place and time. Skin color pale and sweety. Vitals as follows: BP 98/60 left arm lying down. HR: 83, SPO2: 99% on room air. Pt felt better after 15 minutes and requested she needed to use the bathroom. She was escorted by her buddy. 5 minutes later was called to come and attend to the pt in the bathroom. Upon arrival pt was sitting on the floor, looking paled, grabbing on her stomach, and stated she does not feel well. Pt latter threw up in the toilet (none bloody) and still complaining of severe stomach cramping. EMS called at 1535 after several interventions were non effective. EMS arrived at 1558 at escorted pt to the ER.
Age: 70.0
Sex: M
Vaccine: TDAP
Symptoms: Ascending flaccid paralysis, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture, Sensory loss
Clinical narrative: Progressed ascending paralysis and sensory loss for the course of 10 days what rapid progreesion.  Diagnosed with Guillain Barre sydnrome and treated with IVIG with improvement in symptoms.
Age: 31.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: Patient reported she was feeling extremely tired, sweaty, and dizzy all day.  No fever or any signs of infection. Patient will take OTC pain medication, and I advised if her symptoms getting worse, she needs to seek for medical help immediately.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Rash at injection site, then spread to chest & neck- persisted for several days
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Patient developed a welp at the injection site
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: 18 years old male patient came in to be vaccinated for his second dose of MCV-4. After administration of MCV-4 in left Deltoid at 3:18 pm during observation patient complained of feeling dizzy, was sweaty, felt hot and nauseous. Patient then began to vomit. Patient was alert and oriented times 4, did not lose consciousness. At 3:22 pm BP:103/75, HR 76, Temperature 97.8 f, O2:99%. At 3:25 pm BP:81/47, HR 73, O2:99%. At 3:26 pm Dr was contacted via phone and adverse reaction was reported to him. Patient refused ambulance transport. At 3:33 pm BP:103/62, HR 70, O2:97%.  Patient was asked to continue to sit in observation for another 15 minutes to be monitored. At 3:50 pm BP:104/65, HR 68, O2:98% - Patient stated he is feeling fine and ready to go home. Patient left in stable condition.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lethargy, Oropharyngeal pain, Pain, Rash
Clinical narrative: ON 7/31, PATIENT RECEIVED A RASH ON THE LEFT ARM WHICH IS OPPOSITE OF THE SITE OF INJECTION, PT EXPERIENCED LETHARGY, SORE THROAT AND BODY ACHES.  PT TOOK SOME IBUPROFEN AND PUT CORTISONE ON THE RASH.  RASH WENT AWAY BUT ON 8/1, RASH APPEARED AGAIN BUT ON THE RIGHT ARM.  PT IS STILL LETHARGIC.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Malaise
Clinical narrative: Malise, Head ache, dizzyness, chills
Age: 36.0
Sex: F
Vaccine: HPV9
Symptoms: Lymphadenopathy, Neck mass, Tenderness
Clinical narrative: 3 days after the vaccination I discovered a rather large (around 1 inch in diameter) swollen lump on the lower left part of my neck, above my left collar bone. This is the same site I received the HPV vaccine in. The lump was soft and a bit tender to touch. I visited a doctor the day after my symptoms started (07/28/2024), who examined my lymph nodes visually and through touch. I was told that my symptoms point to an "activated lymph node", and the doctor also found other swollen nodes in my neck (same, left side) which I hadn't noticed. He instructed me to wait and it will most likely resolve by itself within 1-2 weeks. I never had this happen to me and I suspect that it is a reaction to the HPV vaccine I received. It has been 1 week since the vaccine and the swelling still persists. I'm afraid it will impact my travel plans, as I would have difficulty wearing a backpack, unable to put the weight of the straps over my swollen lump.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: mother and daughter came into the clinic requesting 7th grade TDAP. Upon confirmation of all information on the vaccine sheet and repeating what she needed the mother agreed that she needed the TDAP. I suggested that since she is 12 that she receive the meningitis vaccine as well. Mom agreed. After vaccines were administered, State registry was pulled up to print the certificate and it was noted that the child had already received these vaccines in 2022. I discussed this with mom before they left so that she was aware.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood glucose normal, Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness, Pallor
Clinical narrative: Immediately after the 3rd/last vaccine administered pt lost consciousness and had a witnessed seizure lasting approximately 20 seconds. Provider and RN called to the bedside and a rapid response was started. pt regained consciousness alert and oriented. skin was pale and diaphoretic.  BP 43/30 HR 43 blood glucose 76.  laid pt down and elevated feet. BP recheck 90/59 HR 88 O2 100% on room air. pt transported to ED via paramedic.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Seizure
Clinical narrative: Immediately after the 3rd/last vaccine administered pt lost consciousness and had a witnessed seizure lasting approximately 20 seconds. Provider and RN called to the bedside and a rapid response was started. pt regained consciousness alert and oriented. skin was pale and diaphoretic.  BP 43/30 HR 43 blood glucose 76.  laid pt down and elevated feet. BP recheck 90/59 HR 88 O2 100% on room air. pt transported to ED via paramedic.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Eye irritation, Eye swelling
Clinical narrative: Severe eye swelling and irritation
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Supraventricular tachycardia, Tachycardia
Clinical narrative: Pt states a few months after the vaccine he developed tachycardia. He did see cardiology and EP and was Dx with PSVT. This is currently treated with Diltiazem.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Full blood count normal, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: About a day after vaccine, large 2-3" red swollen patch to Rt thigh. Mom told to give motrin and benadryl and ice. Continued to get further enlarged, Today with large 5" ovoid patch to Rt thigh, with bruising/clearing to central aspect and redness to outside. Patient with pain around site and inguinal lymph nodes enlarged. Pt without itching. CBC to check for infection was normal and given benadryl and prednisolone dose today.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Lymphadenopathy
Clinical narrative: About a day after vaccine, large 2-3" red swollen patch to Rt thigh. Mom told to give motrin and benadryl and ice. Continued to get further enlarged, Today with large 5" ovoid patch to Rt thigh, with bruising/clearing to central aspect and redness to outside. Patient with pain around site and inguinal lymph nodes enlarged. Pt without itching. CBC to check for infection was normal and given benadryl and prednisolone dose today.