chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a Pharmacist from medical information team.  A 66-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 24Feb2024 as (0.5 intramuscular shot in deltoid muscle of left arm) (Lot number: HE6176, Expiration Date: Mar2025) at the age of 66 years intramuscular for immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: HEADACHE (medically significant) with onset 25Feb2024, outcome "not recovered". Therapeutic measures were taken as a result of headache.  Additional information: A pharmacist that has a patient that was administered with Prevnar 20 vaccine and experienced side effect of headache. The patient is 65 year old female. Headache started the day after getting the vaccine. The patient received vaccine on Saturday, 24Feb2024. The headache is ongoing and that is why caller is concerned. Reporter states the patient does have chronic medications that she takes. Patient has been taking analgesics as treatment.; Sender's Comments: Based on a drug event temporal association and on the compatibility with the known adverse event profile of the suspect product, the company cannot completely exclude a reasonable possibility that the suspect vaccine PREVNAR 20 may have contributed to the onset of reported event headache.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 as dose 4 (orange cap; booster), single (Lot number: GK1657) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Aug2021 as dose 1, single (Lot number: FA6780), in left arm, on 16Sep2021 as dose 2, single (Lot number: FA6780), in left arm and on 14Oct2021 as dose 3 (booster), single (Lot number: 30145B4), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Immune deficiency" (unspecified if ongoing); "Have no spleen" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Known allergies: ZQuill and Potassium iodide" (unspecified if ongoing), notes: (don't know which ingredient). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 20Feb2024 to 25Feb2024.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400055418 same patient/product, different dose (dose 3)/event;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  An adult male patient received BNT162b2 (BNT162B2), on 01Mar2022 at 12:15 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Acid reflux" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 20Feb2024 to 25Feb2024.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing). The patient has no known allergies. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown, Location of injection: Arm Right), for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown, Location of injection: Arm Right), for COVID-19 Immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective which included Paxlovid from 15Jan2024 to 20Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 28Sep2023 as dose 1, single (Batch/Lot number: unknown) 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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Feb2024) Negative; (25Feb2024) Positive, notes: Symptoms mildly returned and positive COVID test on 25Feb2024; (01Mar2024) Positive, notes: Still having nasal congestion and positive COVID test on 01Mar2024. Therapeutic measures 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: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hbp" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 20Feb2024 to 24Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 32-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Lot number: HG2282) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (Dose Number: 4, Batch/Lot No: GJ2524, Location of injection: Arm Left), administration date: 18Sep2022, when the patient was 30-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: FG3527, Location of injection: Arm Left), administration date: 15Nov2021, when the patient was 29-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EW0182, Location of injection: Arm Left), administration date: 04May2021, when the patient was 29-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EP7533, Location of injection: Arm Left), administration date: 06Apr2021, when the patient was 29-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Mar2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  An 82-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ovarian cancer" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 28Feb2021, when the patient was 79-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE), administration date: 23Mar2021, when the patient was 79-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 15Oct2021, when the patient was 79-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 05May2022, when the patient was 80-year-old, for COVID-19 immunisation; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Anatomical location: Left arm), administration date: 17Oct2022, when the patient was 80-year-old, for COVID-19 immunisation; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 6 (BOOSTER), SINGLE, Anatomical location: Right arm), administration date: 29May2023, when the patient was 81-year-old, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 19Feb2024 to 24Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Rash
Clinical narrative: rash; Chest pain; This is a spontaneous report received from a Nurse.  A 48-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Feb2024 at 17:00 as dose 1, single (Lot number: Unknown) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Gerd" (unspecified if ongoing); "osa" (unspecified if ongoing); "fatty liver" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE; OZEMPIC; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. 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; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: CHEST PAIN (non-serious) with onset 27Feb2024 at 21:00, outcome "not recovered"; RASH (non-serious) with onset 27Feb2024 at 21:00, outcome "not recovered". The events "rash" and "chest pain" required emergency room visit. Therapeutic measures were taken as a result of rash, chest pain.  Additional information: No known allergies. Batch/lot unknown as not available/provided to reporter at the time of report completion. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Events (Chest pain, rash) resulted in Emergency room/department or urgent care. Tylenol was received as treatment for the adverse event. Batch/lot number is not provided, and it cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovered" (28Feb2024) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Feb2024) Nagative, notes: Tested positive again 3 days after finishing product and testing negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 as paxlovid from 23Feb2024 to 28Feb2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained
Age: 52.0
Sex: M
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 53-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna (vaccine brand other=Moderna,, vaccine brand unknown=False,, vaccine administration date=19Sep2022,, vaccine lot number=AS7147B,, vaccine lot unknown=False,, vaccine dose number=5,, vaccine dose number unknown=False}]), administration date: 19Sep2022, when the patient was 51-year-old, for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE ; Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE; Unknown manufacturer), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. 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
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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), in Apr2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Theodur, reaction(s): "Known allergies: Theodur". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, 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 62-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Nov2023 at 14:00 as dose 1; single (Lot number: HG4664) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Pseudoephedrine, reaction(s): "Known allergies: Pseudoephedrine". Vaccination history included: pfizer / biontech (DOSE 2, SINGLE, Batch/Lot No: GJ3268, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 04May2023, for COVID-19 immunization; pfizer / biontech (DOSE 1, SINGLE, Batch/Lot No: GH9693), administration date: 02Oct2022, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High, notes: My blood pressure has also been quite high at various times during the last 2 weeks. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing); "Celiac disease" (unspecified if ongoing); "Known allergies: Celiac disease" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT. The patient also took other concomitant therapy. Vaccination history included: Covid-19 vaccine (Primary immunization, dose 1, single, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Primary immunization, dose 3, single, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Primary immunization, dose 2, single, Manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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 42-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Flu B" (ongoing), notes: Also currently have Flu B. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  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: PNC20
Symptoms: Alopecia
Clinical narrative: She believes that it is causing her hair to fall out; This is a spontaneous report received from a Pharmacist.  An 83-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GY1934, Expiration Date: 31Dec2024) for immunisation. The patient's relevant medical history included: "Blood pressure high" (ongoing); "Hypothyroidism" (ongoing). The patient took concomitant medications. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "She believes that it is causing her hair to fall out". Therapeutic measures were taken as a result of alopecia. Additional information: NDC number of Prevnar 20: 00005200010. Concomitant drugs: Reporter stated, "She is taking some Hypothyroid medicine and high blood pressure medicine." Reporter (Pharmacist) stated, "I have a customer who think she may have had an adverse reaction to the Prevnar vaccine." Reporter stated, "She believes that it is causing her hair to fall out." Treatment: Reporter stated, "She purchase over the counter Rogaine." Dosage Rogaine: Reporter stated, "5 percent foam."  The information on the batch/lot number for [pneumococcal 20-val conj vac (dipht CRM197 protein)] will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram, Nodule
Clinical narrative: I have a knot in my chest, a nodule within my chest, inside of my chest; It is a knot that showed up; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, unknown manufacture), for COVID-19 immunisation. The following information was reported: NODULE (non-serious), outcome "unknown", described as "I have a knot in my chest, a nodule within my chest, inside of my chest; It is a knot that showed up". Relevant laboratory tests and procedures are available in the appropriate section.  Clinical course: Concern: Consumer stated, "I want to report, before I start getting these COVID shot, my chest was clear. I did not have any problem with my chest and now that I have been getting these COVID shots, which I will not ever get another one, I have a nodule in my chest. I have a knot in my chest, a nodule within my chest, inside of my chest. It is a knot that showed up on the CT scan." Name of the shot: Consumer stated, "Can I speak to someone else? This is not working too good and I do not mean to be rude or disrespectful to you but it is a problem because you are missing in understanding everything I am saying and I know it is a language barrier, and I know I am not being rude, please forgive me but it is just stressful to me. Is there somebody else that speaks better or something? Yes, is there speaking representative, that would really good?." Batch/lot number is not provided, and it cannot be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: symptoms of Covid; symptoms of Covid; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 1 (toppac); single (Lot number: HG4628) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, LOT: EP6955), administration date: 18Mar2021, when the patient was 67-year-old, for covid-19 immunisation; BNT162b2 (DOSE 2, LOT: EW0151), administration date: 08Apr2021, when the patient was 67-year-old, for covid-19 immunisation; BNT162b2 (DOSE 3, LOT: FE3590), administration date: 08Oct2021, when the patient was 67-year-old, for covid-19 immunisation; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 4, LOT: GH9702), administration date: 10Sep2022, when the patient was 68-year-old, for covid-19 immunisation; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5, LOT: GL2042), administration date: 09May2023, when the patient was 69-year-old, for covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Feb2024, outcome "not recovered" and all described as "symptoms of Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller (patient) just wanted to pass along to the R and D and medical staff that he was fully vaccinated with Pfizer's mRNA vaccine the original and boosters and as of Thursday last week he started getting symptoms of Covid. Caller's wife got full blown Covid over the weekend. Caller assumed that because he is fully vaccinated and had boosters that he would be better protected. His wife is not fully vaccinated or updated. The only place that caller could have been exposed was the grocery store or doctor's office. Caller was at doctor's appointment on Tuesday and Covid symptoms started Thursday, 29Feb2024.  The symptom is ongoing, but not severe. He has overcome with self medication that is not Mucinex, but something to break up the congestion and speed up what he has to get rid of in his system.  Caller states he is in a Moderna RSV clinical study. Caller doesn't have study number to provide. He gets regular blood work for the Moderna RSV study and that was done about a month ago.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Feb2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid, Treatment start date: 22Feb2024,Treatment stop date: 27Feb2024).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose 1 (toppac); single (Lot number: HG4629) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Nickle" (unspecified if ongoing); "latex" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 5(BOOSTER), SINGLE lot no. GJ6742 on left Arm), administration date: 29Nov2022, when the patient was 70-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4(BOOSTER), SINGLE lot no. FJ4989 on arm Left), administration date: 02May2022, when the patient was 70-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3(BOOSTER), SINGLE lot no. FF2588 on arm Left), administration date: 24Sep2021, when the patient was 69-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE lot no. ER2613 on arm Left), administration date: 18Mar2021, when the patient was 69-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 1, SINGLE lot no. EN6202 on arm Left), administration date: 25Feb2021, when the patient was 69-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19, patient took Paxlovid from 22Feb2024 to 27Feb2024. No follow-up attempts are possible.
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: pneumonia; This is a spontaneous report received from a Consumer or other non HCP, 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: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: PNEUMONIA (medically significant), outcome "unknown". Clinical details: Patient called looking for pneumonia vaccine. He stated he already had pneumonia. Patient took his covid vaccines and he was just wondering if the pneumonia vaccine had the same DNA stuff that they use in the covid is it the same stuff they use in the pneumonia. The patient did not state the pneumonia was a side effect of the covid vaccine.  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: COVID19
Symptoms: COVID-19, Cerebrovascular accident, Hypersensitivity, Lip swelling, Swollen tongue
Clinical narrative: stroke; Covid; lips and tongue swelled; lips and tongue swelled; allergic reaction; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), on 22Mar2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 22Mar2021, outcome "unknown", described as "allergic reaction"; LIP SWELLING (non-serious), SWOLLEN TONGUE (non-serious) all with onset 22Mar2021, outcome "unknown" and all described as "lips and tongue swelled"; COVID-19 (non-serious) with onset 30Mar2021, outcome "unknown", described as "Covid"; CEREBROVASCULAR ACCIDENT (medically significant) with onset 01Jun2021, outcome "unknown", described as "stroke". Therapeutic measures were taken as a result of lip swelling, swollen tongue.  Clinical course: The patient had an allergic reaction to Covid 19 Vaccination given on 22Mar2021. The patient's lips and tongue swelled 20 minutes after the injection. The patient made it home to take 25mg Benadryl, it helped. It was lot number ER8730. 9 days later, the patient got COVID, a mild case. On 01Jun2021, the patient had stroke. The patient had no risk factors that they know of.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for the 1st time; tested positive for the 1st time; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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. 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 "tested positive for the 1st time". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Patient had 4 Pfizer Covid vaccines and just tested positive for the 1st time. She'd like a place to report symptoms.  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-PV202400030203 same product/event; different patient;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Had 4 Pfizer Covid vaccines and just tested positive for the 1st time; Had 4 Pfizer Covid vaccines and just tested positive for the 1st time; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 (BNT162B2 NOS), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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. 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 "Had 4 Pfizer Covid vaccines and just tested positive for the 1st time". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: just tested positive for the 1st time.  Clinical course: The patient's wife stated, "My mom died from Covid in Apr2020. My husband & I had 4 Pfizer Covid vaccines and just tested positive for the 1st time. We'd like a place to report our symptoms. Thank you that you got us this far and that we're still alive".  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-PV202400030202 same product/event; different patient;
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient given expired vaccine (with no reported adverse event); Initial information received on 28-Feb-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Infant and unknown gender patient who was given expired vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (with no reported adverse event).  It is unknown if the patient had any medical history, concomitant disease or risk factor.The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Suspension for injection via intramuscular route in unknown administration site for immunization (strength, dose, batch and expiry date- unknown) (with no reported adverse event) (expired product administered) (latency same day). Information on the batch number was requested.   It is unknown if there were lab data/results available  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: 0.5
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of an expired dose with no reported adverse event; Initial information received on 28-Feb-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old and unknown gender patient who was administered with an expired dose of HIB (PRP/T) Vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Feb-2024, the patient had received expired (dose and units: Unknown) (dose: 3) suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) (lot number; strength, route and administration site not reported) (expired product administered) (Latency: same day). It was reported that the vaccine has expired by 4 days. Batch number will be requested in this case.  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: 8.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administer an already expired vaccines with no reported adverse event; Initial information received on 28-Feb-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 8 years old male patient was administered an already expired IPV (VERO) [IPOL] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Feb-2024, the patient received an unknown dose of suspect IPV (VERO) (Suspension for injection) (lot: V1A024M; expiry date: 17-Feb-2024) via unknown route in unknown administration site for Immunization.  On 26-Feb-2024 the patient was administered an already expired IPV (VERO) with no reported adverse event (expired product administered) (latency: 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: 62.0
Sex: F
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: received the wrong type of diluent for YF-VAX and these doses has already been administered with no reported AE; received the wrong type of diluent for YF-VAX and has already been administered with no reported AE; Initial information was received on 29-Feb-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case is linked to cases 2024SA071412, 2024SA069585.  This case involves a 62 years old female patient who received the wrong type of diluent for Yellow Fever Vaccine [YF-VAX] and these doses has already been administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.  Concomitant medications included Typhoid Vaccine for Prophylactic vaccination.  On 28-Feb-2024, the patient received a dose of 0.5 ml of suspect Yellow Fever Vaccine (Solution for injection) (lot UK031AA ,Expiry date:31-Mar-2025, strength was unknown) via subcutaneous route in the left arm for Prophylactic vaccination (Immunization) and received the wrong type of diluent for yf-vax and these doses has already been administered with no reported adverse event (product preparation error) and (incorrect product formulation administered) (latency : 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: 71.0
Sex: M
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: an inappropriate use due to administration of vaccine with incorrect diluent with no reported adverse event; Initial information received on 29-Feb-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case is linked to cases 2024SA069585 and 2024SA071799.  This case involves a 71 years old male patient who had an inappropriate use due to administration of vaccine Yellow fever Vaccine [YF-VAX] with incorrect diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Feb-2024, the patient received a 0.5 ml dose of suspect Yellow fever Vaccine (lot UK031AA, Expiry: 31-Mar-2025 with unknown strength) via subcutaneous route in the left arm as prophylactic vaccination which was with incorrect diluent with no reported adverse event (product preparation error) (Latency: 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: 15.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Refrigerator door was left open. Max/low temperature reached: 34.5F to 47.1F Duration out of labelled range: Total of 1 Hour and 30 Minutes (with no reported adverse event); Opened IPOL was given to patient post excursion (with no reported adverse event); Initial information was received on 29-Feb-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 15 years old female patient who experienced opened  IPV (VERO) [IMOVAX POLIO] was given to patient post excursion (with no reported adverse event) and Refrigerator door was left open. Max/low temperature reached: 34.5F to 47.1F Duration out of labelled range: Total of 1 Hour and 30 Minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),Concomitant medications and family history were not provided.   On 21-Feb-2024, the patient received a unknown dose of suspect IPV (VERO) (Suspension for injection) (lot W1A191M,Expiry date: 16-Feb-2025,strength was unknown) via unknown route in unknown administration site for Prophylactic vaccination (Immunization) and opened ipol was given to patient post excursion (with no reported adverse event) (poor quality product administered) (latency : same day) and Refrigerator door was left open. Max/low temperature reached: 34.5F to 47.1F Duration out of labelled range: Total of 1 Hour and 30 Minutes with no reported adverse event (product storage error) (unknown latency) following the administration of IPV (VERO).  Reportedly "Human error? Yes Does extended stability data cover the excursion? Yes - unopened ADACEL is covered by the extended stability data. No - opened IPOL is not covered by the extended stability data. If negative advice, was the product administered to a patient? Opened IPOL was given to 2 patients. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data, and the vaccine involved was given to patients post excursion. "  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.