chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from an Other HCP.  A 32-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation. The patient had no relevant medical history. The patient has no known allergies. 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on available information a contributory role of BNT162b2 omi xbb.1.5 to the reported event, drug ineffective, covid-19 cannot be totally excluded as efficacy of a drug varies from individual to individual. The case will be reassessed once further information is available
Age: 0.5
Sex: M
Vaccine: PNC13
Symptoms: Bronchiolitis, Wheezing
Clinical narrative: bronchiolitis/wheezing; This is a spontaneous report received from a Physician from medical information team. A 6-month-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in Dec2023 as dose 1, 0.5ml single (Lot number: GN2778, Expiration Date: 30Sep2025) at the age of 6 months intramuscular, in left thigh as routine vaccination. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BRONCHIOLITIS (medically significant) with onset Dec2023, 24 hrs after the suspect product(s) administration, outcome "not recovered", described as "bronchiolitis/wheezing". The event "bronchiolitis/wheezing" required physician office visit. Therapeutic measures were taken as a result of bronchiolitis. The patient had no other conditions, no investigations, and no other products. Clinical course: The physician (MD) stated that he called about Prevnar 13, a Pfizer product. NDC number of Prevnar 13: 00005-1971-01. He has a 6 month old patient that got the first dose about a month ago. Within 24 hours, the patient had wheezing and was diagnosed with bronchiolitis. He reported bronchiolitis (AE), experienced by a pediatric patient 24 hours after administration of Prevnar 13. The patient still wheezes (26Jan2024) and was going today for follow-up. The patient continued to have symptoms. Treatment noted as albuterol treatments. The MD's a pediatrician of 23-24 years and has never heard anyone complain about it. He read in the package insert that 1% of kids develop bronchiolitis after the shot. He wanted to know how was that possible, if it was a truly a known side effect, did it mean to stop the series or if the kid will have bronchiolitis with subsequent doses of Prevnar 13 or it happened once and was a fluke. He mentioned that the parents were bringing up the package insert and was hesitant about giving future doses. Package insert listing has caused the reporter to dismiss it. The MD was interested in the following: a) information regarding whether said AE (adverse event) was reported in clinical trials; b) information regarding whether the bronchiolitis will be experienced by the patient after each administration of Prevnar 13 (per the dose schedule); c) information regarding whether vaccination series should be continued in pediatric patient with bronchiolitis as AE.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event based on the known safety profile and temporal association.   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: RSV
Symptoms: Exposure during pregnancy, Premature rupture of membranes
Clinical narrative: premature rupture of membrane and want to hold/delay the birth until 34 weeks gestational age; This is a spontaneous report received from a Pharmacist from medical information team. A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for maternal exposure timing unspecified. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PREMATURE RUPTURE OF MEMBRANES (hospitalization), outcome "unknown", described as "premature rupture of membrane and want to hold/delay the birth until 34 weeks gestational age". Clinical information: The pharmacist was asking about the time of vaccine to create an antibody build-up in the fetus with the maternal indication after the mom has been inoculated as there was a potential that the birth can be induced early. It was stated that the patient was a pregnant individual in the hospital with premature rupture of membrane and want to hold/delay the birth until 34 weeks gestational age.  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: A possible contributory role of the suspect products cannot be excluded for the reported event based on the known safety profile  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: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Neck injury
Clinical narrative: Heart attack/the worst pain he felt in his life; neck surgery/neck problem/getting neck Surgery from duty injuries; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1), administration date: 08Sep2021, for Covid-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant, life threatening), outcome "unknown", described as "Heart attack/the worst pain he felt in his life"; NECK INJURY (medically significant), outcome "unknown", described as "neck surgery/neck problem/getting neck Surgery from duty injuries". The events "heart attack/the worst pain he felt in his life" and "neck surgery/neck problem/getting neck surgery from duty injuries" required physician office visit. Therapeutic measures were taken as a result of myocardial infarction. Clinical course: The patient stated that Pfizer Covid vaccine almost killed him while he was (name withheld) - first dose was on 08Sep2021 and second dose on 30Sep2021 (one in his right shoulder and one in the left shoulder). He never knew what myocarditis or 'myocardial infarctition' until he had a heart attack in his (name withheld) room after 2 shots, just to stay in the (name withheld). That was the worst pain he felt in his life. And he got neck surgery this Thursday. That hurts worst than all his neck problems. They don't really make a big deal out of this but now that he is out and he has all these problems, it's pretty alarming. After the incident, they sent him right back to the (name withheld) with aspirin. The Nurse at (facility withheld) where he is getting his neck surgery says there's a bunch of people coming in with heart problems linked to Pfizer vaccine. The patient had to got shots while the patient was duty and the patient would have a neck surgery this Thursday (01Feb2024) while was duty. He is going to probably go to the (name withheld) because he is getting neck Surgery from duty injuries and they have recorded and now they are getting cases about Pfizer vaccine being linked to the heart conditions. The center of disease control already came out with a report about Pfizer vaccine being linked to heart problems. They almost killed him, that was the first thing he will mention.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Follow-up (01Feb2024): This is a follow-up report combining information from duplicate reports 202400029476 and 202400028928. The current and all subsequent information will be reported under manufacturer report number 202400028928. The new information reported from the same consumer (patient) includes: Event verbatim Subsumed, and clinical details.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Batch/Lot number: unknown) 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 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 at 15:45 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (Dose: Unknown, Batch/Lot No: GJ3275, Location of injection: Arm Left), administration date: 04Oct2022, when the patient was 60-year-old, for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 in which patient received Paxlovid.  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, COVID19
Symptoms: Somnolence
Clinical narrative: first Pfizer COVID vaccine made him sleep for hours; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 (BNT162B2), 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: SOMNOLENCE (non-serious), outcome "unknown", described as "first Pfizer COVID vaccine made him sleep for hours". Additional information: It was reported that the patient's concern is about the Comirnaty vaccine. He also mentioned that the first Pfizer COVID vaccine made him sleep for hours.   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-202400030023 Same Reporter, Patient, Product / Different AE;US-PFIZER INC-202400030022 Same Reporter, Patient, Product / Different AE;US-PFIZER INC-202400030021 Same Reporter, Patient, Product / Different AE;US-PFIZER INC-202400030024 Same Reporter, Patient / Different Product, AE;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Constipation, Drug ineffective
Clinical narrative: first Pfizer COVID vaccine made him sleep for hours; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 (BNT162B2), 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: SOMNOLENCE (non-serious), outcome "unknown", described as "first Pfizer COVID vaccine made him sleep for hours". Additional information: It was reported that the patient's concern is about the Comirnaty vaccine. He also mentioned that the first Pfizer COVID vaccine made him sleep for hours.   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-202400030023 Same Reporter, Patient, Product / Different AE;US-PFIZER INC-202400030022 Same Reporter, Patient, Product / Different AE;US-PFIZER INC-202400030021 Same Reporter, Patient, Product / Different AE;US-PFIZER INC-202400030024 Same Reporter, Patient / Different Product, AE;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Somnolence
Clinical narrative: COVID-19; COVID-19; 4th and most recent he was constipated; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID:,.  A 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 1, SINGLE), for COVID-19 immunization, reaction(s): "sleepy"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "screwed up his stomach"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "sleepy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; CONSTIPATION (non-serious), outcome "unknown", described as "4th and most recent he was constipated". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The most recent one, patient was constipated, he had to take 3-4 eatings, he had to eat 3-4 times for him to go to the bathroom, so that's how constipated he was. 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, COVID19
Symptoms: COVID-19, Constipation, Drug ineffective
Clinical narrative: COVID-19; COVID-19; 4th and most recent he was constipated; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID:,.  A 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 1, SINGLE), for COVID-19 immunization, reaction(s): "sleepy"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "screwed up his stomach"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "sleepy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; CONSTIPATION (non-serious), outcome "unknown", described as "4th and most recent he was constipated". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The most recent one, patient was constipated, he had to take 3-4 eatings, he had to eat 3-4 times for him to go to the bathroom, so that's how constipated he was. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; Moderna booster; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 16Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Nov2021 as dose 3 (booster), single), in right arm, on 18Sep2022 as dose 4 (booster), single), in right arm and on 31Oct2023 at 13:00 as dose 5 (booster), single), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Ehlers - Danlos syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Nov2021, outcome "unknown", described as "Moderna booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received treatment with Paxlovid from 20Jan2024 to 25Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Nov2022 as dose 5 (booster), single (Lot number: GL0446) at the age of 65 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4 (booster), single). The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "Cancer" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "allergies:Ibuprofen". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 20Jan2024 to 24Jan2024.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Nurse.  A 44-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Nov2023 as dose 1, single (Lot number: HG7557) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Dilaudid, reaction(s): "Known allergies: Dilaudid". 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; Covid-19 vaccine (DOSE 4 (BOOSTER) , SINGLE ; Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE ; Manufacturer unknown), for Covid-19 immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal disorder
Clinical narrative: 2nd one screwed up his stomach for about 5 months; This is a spontaneous report received from a Consumer or other non-HCP from the Medical Information Team. The patient is the reporter.  A male patient received BNT162b2 (BNT162B2), as DOSE 2, SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose, via an unspecified route of administration, on an unspecified date (batch/lot number: unknown) as DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "it made him sleepy/ made him sleep for hours." The following information was reported: GASTROINTESTINAL DISORDER (non-serious), outcome "unknown" described as "2nd one screwed up his stomach for about 5 months."  Additional information: The patient mentioned that when he got the 1st Pfizer vaccine, it made him sleepy/ made him sleep for hours. The 2nd one screwed up his stomach for about 5 months.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400030023 same reporter and patient; different vaccine dose and events;US-PFIZER INC-202400030022 same reporter and patient; different vaccine dose and events;US-PFIZER INC-202400029960 same reporter and patient; different vaccine dose and events;
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: 3rd one made him sleepy again; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A male patient received BNT162b2 (BNT162B2 NOS), 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. Vaccination history included: Bnt162b2 (dose 1, Lot number: unknown), for COVID-19 immunisation, reaction(s): "sleepy/ sleep for hours"; Bnt162b2 (dose 2, Lot number: unknown), for COVID-19 immunisation, reaction(s): "constipated for 5 months/ screwed up his stomach". The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "3rd one made him sleepy again".  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-202400030023 same reporter/patient/suspect drug, different dose number/event;US-PFIZER INC-202400030021 same reporter/patient/suspect drug, different dose number/event;US-PFIZER INC-202400029960 same reporter/patient/suspect drug/event, different dose number;
Sex: M
Vaccine: COVID19
Symptoms: Amyloidosis
Clinical narrative: Amyloidosis; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  A 71-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. The following information was reported: AMYLOIDOSIS (medically significant), outcome "unknown".  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, COVID19
Symptoms: Cerebrovascular accident, Facial discomfort, Limb discomfort, Tongue disorder
Clinical narrative: still has some issues with his arm, leg, and tongue.; still has some issues with his arm, leg, and tongue.; still has some issues with his arm, leg, and tongue.; face was really bad shape; Stroke; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 4 (booster), single) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 12Nov2022, outcome "unknown", described as "Stroke"; LIMB DISCOMFORT (non-serious), LIMB DISCOMFORT (non-serious), TONGUE DISORDER (non-serious), outcome "not recovered" and all described as "still has some issues with his arm, leg, and tongue."; FACIAL DISCOMFORT (non-serious), outcome "unknown", described as "face was really bad shape". The events "stroke", "still has some issues with his arm, leg, and tongue." and "face was really bad shape" required physician office visit. Therapeutic measures were taken as a result of cerebrovascular accident, limb discomfort, limb discomfort, tongue disorder, facial discomfort.  Clinical course: The stroke caller experienced was away. He went to the hospital. Was told they couldn't find anything, nothing. Caller couldn't believe it. He had a stroke and still has some issues with his arm, leg, and tongue. His face was really bad shape when he was away. When he saw the doctor 2 hours later, the doctor was surprised and asked caller what did he do. Caller states he did nothing. The doctor stated something happened because now his face is all straight up like nothing happened. Caller didn't know because he didn't see himself in the mirror. States it wasn't very good. He sees a doctor tomorrow and goes from there. States he went to the doctor and after was given some medicine, which he took. After that he had to come back home. He called his doctor. Was told as soon as he got home they are going to do something. When he came back home he was sent to a specialist and everything. They didn't find anything. Attempted to clarify if caller was admitted to the hospital. States he was a patient, he just pulled in there, he had one bed and had to wait for a doctor. It was crowded. Caller was unable to clarify if he was admitted to the hospital. Country of Incidence is documented as caller clarified he was down for a visit when the stroke occurred.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 12:00 as dose 1 (toppac); single (Lot number: HG4629) at the age of 60 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Batch/Lot No: G10446, Location: Arm Left), administration date: 11Nov2022, when the patient was 59-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: FP7105, Location: Arm Left), administration date: 26Aug2022, when the patient was 59-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: FSB762, Location: Arm Right), administration date: 26Nov2021, when the patient was 58-year-old, for COVID-19 Immunization; moderna (DOSE 2, SINGLE, Batch/Lot No: 020B21A, Location: Arm Right), administration date: 20Apr2021, when the patient was 57-year-old, for COVID-19 Immunization; moderna (DOSE 1, SINGLE, Batch/Lot No: 027L20A, Location: Arm Right), administration date: 23Mar2021, when the patient was 57-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jan2024) Positive; (31Jan2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Sore throat and runny nose began on 19Jan2024. Tested positive for COVID on 20Jan2024, received Paxlovid from 20Jan2024 to 24Jan2024 for treatment of COVID-19. Ran a fever 20Jan through 23Jan. Ended isolation and did ok on 25Jan-27Jan. Developed a stuffy nose with head congestion 28Jan. Did not test for COVID until 31Jan, and showed positive at that time.  No follow-up attempts are possible.
Age: 65.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Headache, Rash
Clinical narrative: Rash; it almost looks like a shingles rash on my arm; Headache; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 65-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 23Jan2024 at 11:30 as dose number unknown, 0.5 ml single (Lot number: HM9855, Expiration Date: Feb2025) at the age of 65 years intramuscular, in right arm for immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing); "Cholesterol" (ongoing). Concomitant medication(s) included: AMLODIPINE taken for blood pressure abnormal. The patient also took other concomitant therapy. The following information was reported: HEADACHE (non-serious) with onset Jan2024, outcome "unknown"; RASH (non-serious) with onset Jan2024, outcome "unknown", described as "Rash; it almost looks like a shingles rash on my arm". Therapeutic measures were taken as a result of rash, headache. Additional information: Along with the rash I had a pretty severe headache for three days constant." Consumer stated for the treatment, "No, I am on a z-pak right now. I am on prednisone right now (clarified as prednisolone)."  The patient did not take any vaccines four weeks prior to taking the Abrysvo vaccine.
Age: 65.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Chills, Headache, Peripheral coldness, Rash
Clinical narrative: Rash; it almost looks like a shingles rash on my arm; Headache; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 65-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 23Jan2024 at 11:30 as dose number unknown, 0.5 ml single (Lot number: HM9855, Expiration Date: Feb2025) at the age of 65 years intramuscular, in right arm for immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing); "Cholesterol" (ongoing). Concomitant medication(s) included: AMLODIPINE taken for blood pressure abnormal. The patient also took other concomitant therapy. The following information was reported: HEADACHE (non-serious) with onset Jan2024, outcome "unknown"; RASH (non-serious) with onset Jan2024, outcome "unknown", described as "Rash; it almost looks like a shingles rash on my arm". Therapeutic measures were taken as a result of rash, headache. Additional information: Along with the rash I had a pretty severe headache for three days constant." Consumer stated for the treatment, "No, I am on a z-pak right now. I am on prednisone right now (clarified as prednisolone)."  The patient did not take any vaccines four weeks prior to taking the Abrysvo vaccine.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA [FEXOFENADINE HYDROCHLORIDE], start date: 01Jan2024, stop date: 31Jan2024. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 3, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 23Jan2024 to 25Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 40-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Shellfish allergy" (unspecified if ongoing); "Finfish allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "Allergy". 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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 23Jan2024 to 28Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 46.0
Sex: 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 46-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Weight issues" (unspecified if ongoing); "allergies" (unspecified if ongoing); "gi concerns" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna (17Sep2022 12:00 PM, left arm), administration date: 17Sep2022, when the patient was 45-year-old, for Covid-19 immunization. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, vaccination failure. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] will be requested and submitted if and when received.
Age: 67.0
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 68-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19, treatment included Paxlovid from 22Jan2024 to 26Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 50-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 as dose 1, single (Lot number: HF9300) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Severe pneumonia", stop date: 2016, notes: in childhood, hospitalized twice by age 4. A few incidents of adult pneumonia, last was 2016.; "Asthma" (unspecified if ongoing), notes: Asthma symptoms before age 10, diagnosed at age 12. ; "Known allergies: Food: Kiwi" (unspecified if ongoing), notes: whole fruit, juice, even extracts or natural flavoring. The patient's concomitant medications were not reported. Past drug history included: Claritin for respiratory allergy prophylactic, notes: Take Claritin daily as respiratory allergy prophylactic. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; Unknown Manufacturer), 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 included Paxlovid from 19Jan2024 to 23Jan2024 were taken as a result of vaccination failure, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 38-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. 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).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Nov2023 at 10:45 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hemolytic anemia" (unspecified if ongoing); "ITP" (unspecified if ongoing); "Cancer" (unspecified if ongoing); "Heart Arrithmia" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: Jan2020. Past drug history included: Silver nitrate, reaction(s): "known allergies: Silver Nitrate". Vaccination history included: moderna (Dose Number: 3, Batch/Lot No: Unknown. Not available/provided to reporter, Location of injection: Arm Left), administration date: 26Feb2022, when the patient was 76-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided, Location of injection: Arm Left), administration date: 12Oct2021, when the patient was 75-year-old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: Mar2021, when the patient was 75 years old, 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 with Paxlovid from 21Jan2024 to 27Jan2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 47.0
Sex: F
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 47-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "depression" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: j&j COVID-19 vaccine (DOSE 1, SINGLE, Manufacturer: J&J), administration date: 23Mar2021, when the patient was 44-year-old, for COVID-19 Immunization; moderna COVID-19 vaccine (DOSE 2, SINGLE, Manufacturer: moderna), administration date: 29Oct2021, when the patient was 45-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 22Feb2022, when the patient was 45-year-old, for COVID-19 Immunization; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE), administration date: 06Oct2022, when the patient was 46-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Jan2024, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jan2024) Positive. Therapeutic measures included paxlovid from 16Jan2024 to 21Jan2024 were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 70.0
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 70-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 70 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: 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: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19, vaccination failure with Paxlovid from 20Jan2024 to 25Jan2024. 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, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Lot number: EN6206), in left arm and on 30Mar2021 as dose 2, single (Lot number: EP6935), in left arm for covid-19 immunisation. The patient's relevant medical history included: "chronic bronchitis" (unspecified if ongoing); "DVT (mechanically induced)" (unspecified if ongoing); "Basal Cell Skin Cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 10Jan2024 to 14Jan2024.
Age: 54.0
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 54-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "allergic rhinitis/sinusitis" (unspecified if ongoing); "allergic rhinitis/sinusitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergy.  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 with Paxlovid from 21Jan2024 to 26Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: he has taken Paxlovid in the past; he has taken Paxlovid in the past; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 77-year-old male patient received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "he has taken Paxlovid in the past". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.