chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 at 10:00 as dose 1 (toppac), single (Lot number: HG4677) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hyertension" (unspecified if ongoing); "allergies: mild lactose intolerance" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicilllin, reaction(s): "known allergies: Amoxicilllin"; Lisinopril, reaction(s): "known allergies: Lisinopril". Vaccination history included: janssen COVID-19 vaccine (DOSE 1, SINGLE, lot number 1805018), administration date: 03Dec2020, when the patient was 67-year-old, for COVID-19 immunisation; moderna COVID-19 vaccine (DOSE 2, SINGLE, lot number 017E21A A), administration date: 01Nov2021, when the patient was 68-year-old, for COVID-19 immunisation; moderna COVID-19 vaccine (DOSE 3 (BOOSTER), SINGLE, lot number 083J21A A), administration date: 04Apr2022, when the patient was 68-year-old, for COVID-19 immunisation; moderna COVID-19 vaccine (DOSE 4 (BOOSTER), SINGLE, lot number 061F22A), administration date: 13Dec2022, when the patient was 69-year-old, for COVID-19 immunisation; moderna COVID-19 vaccine (DOSE 5 (BOOSTER), SINGLE, lot number AS7180B), administration date: 09May2023, when the patient was 69-year-old, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid 300mg from 12Jan2024 to 17Jan2024. Clinical course: Original case of covid: very runny nose (clear mucus) Day 0; continuous cough at bedtime day 1; felt like a Bad cold another day or two, then felt fine.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Jan2024 at 10:30 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: codeine lisinopril"; Lisinopril, reaction(s): "Known allergies: codeine lisinopril". 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 (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization.  The following information was reported: COVID-19 (non-serious), outcome "not recovered", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19 which included Paxlovid taken from 12Jan2024 to 17Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, 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 52-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 at 16:45 as dose 1 (toppac); single (Lot number: HG4664) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "DM Type 2" (unspecified if ongoing); "Ramsey hunt syndrome" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (Vaccine administration time: 12:00 PM,, lot number: Gh9697, Vaccine location:Left arm, Dose number unknown), administration date: 11Dec2022, when the patient was 51-year-old, for COVID-19 immunization. The patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body mass index: 32. Therapeutic measures were taken as a result of covid-19 included Paxlovid from 09Jan2024 and 15Jan2024.
Age: 66.0
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 67-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Oct2023 as dose 1, single (Lot number: HF9300) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "fibromyalgia" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: PREGABALIN, start date: 01Jan2023, stop date: 22Jan2024. The patient received 25mg/day. 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; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received PAXLOVID as COVID 19 treatment from 28Nov2023 to 03Dec2023 (Lot number: GK5745).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400022080 Same patient/reporter, different drug/event;US-PFIZER INC-202400022131 Same patient/reporter, different drug/event;
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: interchange of vaccine products; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a consumer. A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 4 (booster), single (lot number GJ2524) at the age of 37 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Sep2023 as dose 5 (booster), single, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single, as dose 2, single and as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history included: "kidney stones" (unspecified if ongoing); "acne" (unspecified if ongoing); "chronic urticaria" (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 Jan2024, outcome "not recovered" and all described as "COVID 19 treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "not recovered". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 11Jan2024 to 15Jan2024.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: EW0150) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Throat irritation
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: EW0150) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment.
Age: 70.0
Sex: F
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. A 72-year-old female patient (not pregnant) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 22Oct2021 as dose 2, single (lot number unknown) at the age of 70 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single for covid-19 immunisation. The patient's relevant medical history included: "penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 05Jan2024 to 09Jan2024.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: a friend had the exact same thing happened a 77 year old and he died; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old male patient received BNT162b2 (BNT162B2 NOS), 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: DEATH (death), outcome "fatal", described as "a friend had the exact same thing happened a 77 year old and he died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Reported Cause(s) of Death: a friend had the exact same thing happened a 77 year old and he died
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from an Other HCP.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) 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: "a fib" (unspecified if ongoing); "htn" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS oral, start date: Oct2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid treatment via oral from 11Jan2024 to 16Jan2024. No known allergies.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2, BNT162B2 OMI BA.4-5 cannot be fully excluded.
Sex: M
Vaccine: COVID19
Symptoms: Schizophrenia
Clinical narrative: he is experiencing human made schizophrenia; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2 NOS), 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. Four years later he is being inundated and it seems like the vaccine. He is currently going through this and being attacked around the clock. He stated he is experiencing human made schizophrenia. Asks what are the steps for the thought share retina for the vaccine attack to stop? How does he obtain his human rights as they are being trespassed? He does not go on other peoples channels or high lines or thinking. States this is app training or playing games. He does not engage in any of it. He's been to 5 different hospitals, he's been to psychiatrists, his eyes are turning green. The following information was reported: SCHIZOPHRENIA (medically significant), outcome "unknown", described as "he is experiencing human made schizophrenia". The event "he is experiencing human made schizophrenia" required physician office visit.  Batch/lot number is not provided, and it cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Nov2023 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: mango" (unspecified if ongoing); "severe B6 poisoning 8 years" (unspecified if ongoing); "severe TVOC  /formaldehyde poisoning 5 years" (unspecified if ongoing); "sinus" (unspecified if ongoing); "very sensitive to chemicals so avoid" (unspecified if ongoing); "I had covid", start date: Jan2020, stop date: Feb2020; "cultured dextrose allergy" (unspecified if ongoing); "horse serum allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "drug allergy"; Darvocet, reaction(s): "drug allergy". Vaccination history included: Covid-19 vaccine (DOSE 5, SINGLE; UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4, SINGLE; UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3, 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid treatment (lot number: PAA206779) from 13Jan2024 to 18Jan2024.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Swollen injection site; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "Kidney disease" (unspecified if ongoing); " breast cancer" (unspecified if ongoing); "hysterectomy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: pfizer / biontech (Dose Number: 1, Batch/Lot No: 025L20A, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 05Jan2021, for COVID-19 Immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "recovered" (02Feb2021), described as "Swollen injection site". Therapeutic measures were not taken as a result of vaccination site swelling. Batch/lot number is not provided, and it cannot be obtained.
Age: 71.0
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 71-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 at 09:00 as dose 1 (toppac); single (Lot number: HG4680) at the age of 71 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN; Batch/Lot No: Unknown; Location of injection: Arm Left), administration date: 08May2023, when the patient was 71-year-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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive with home antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient was treated with Paxlovid from 16Jan2024 to 21Jan2024. No known allergies.
Sex: M
Vaccine: COVID19
Symptoms: Hepatic cirrhosis, Hepatic steatosis, Hip fracture
Clinical narrative: Broken hip; fatty liver; Cirrhosis of the liver; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An 84-year-old male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), 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: HIP FRACTURE (hospitalization) with onset 14Apr2023, outcome "recovered" (26Jul2023), described as "Broken hip"; HEPATIC CIRRHOSIS (death) with onset 16Aug2023, outcome "fatal", described as "Cirrhosis of the liver"; HEPATIC STEATOSIS (death), outcome "fatal", described as "fatty liver". The patient date of death was 16Aug2023. Reported cause of death: "Cirrhosis of the liver", "fatty liver". It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Reported Cause(s) of Death: Cirrhosis of the liver; fatty liver
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Each time the patient had the Pfizer COVID-19 vaccine placed in his right deltoid, he experienced between 3 and 6 days of relief from pain from an old (2018) injury in that shoulder; This is a spontaneous report received from a Nurse, Program ID:.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 16Oct2021 as dose 3 (booster), single (Lot number: FE3590) intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "diverticulitis", start date: 2000, stop date: 03Dec2003, notes: colectomy 03Dec2003; "tinnitus", start date: 1999 (ongoing); "colectomy", start date: 03Dec2003 (unspecified if ongoing); "right shoulder injury", start date: 2018 (unspecified if ongoing). Concomitant medication(s) included: VALIUM oral taken for tinnitus, start date: 2010, stop date: 2023. Vaccination history included: pfizer vaccine (dose 1, administered intramuscularly in the left deltoid at 17:30, Lot number: CM9809), administration date: 06Feb2021, for COVID-19 immunisation; pfizer vaccine (dose 2, administered in the right deltoid at 17:30, Lot number: EN6205), administration date: 27Feb2021, for COVID-19 immunisation, reaction(s): "Unexpected therapeutic effect"; Pfizer rsv vaccine (dose number unknown, Lot number: unknown), for immunisation. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Each time the patient had the Pfizer COVID-19 vaccine placed in his right deltoid, he experienced between 3 and 6 days of relief from pain from an old (2018) injury in that shoulder".  Additional information: The reporter is a retired RN. Each time the patient had the Pfizer COVID-19 vaccine placed in his right deltoid, he experienced between 3 and 6 days of relief from pain from an old (2018) injury in that shoulder. This pain was normally merely annoying but sometimes (often) flared up with overuse. The relief that resulted from the vaccine was total.  Follow-up attempts are completed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300205337 same patient/suspect drug/similar events, different dose number;US-PFIZER INC-202400024302 same patient/suspect drug/similar events, different dose number;US-PFIZER INC-202400024302 same patient/suspect drug/similar events, different dose number;
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Each time the patient had the Pfizer COVID-19 vaccine placed in his right deltoid, he experienced between 3 and 6 days of relief from pain from an old (2018) injury in that shoulder; This is a spontaneous report received from a Nurse.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 27Feb2021 at 17:30 as dose 2, single (Lot number: EN6205) intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "diverticulitis", start date: 2000, stop date: 03Dec2003, notes: colectomy 03Dec2003; "tinnitus", start date: 1999 (ongoing); "colectomy", start date: 03Dec2003 (unspecified if ongoing); "right shoulder injury", start date: 2018 (unspecified if ongoing). Concomitant medication(s) included: VALIUM oral taken for tinnitus, start date: 2010, stop date: 2023. Vaccination history included: pfizer vaccine (dose 1, administered intramuscularly in the left deltoid at 17:30, Lot number: CM9809), administration date: 06Feb2021, for COVID-19 immunisation; Pfizer rsv vaccine (dose number unknown, Lot number: unknown), for immunisation. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Each time the patient had the Pfizer COVID-19 vaccine placed in his right deltoid, he experienced between 3 and 6 days of relief from pain from an old (2018) injury in that shoulder".  Additional information: The reporter is a retired RN. Each time the patient had the Pfizer COVID-19 vaccine placed in his right deltoid, he experienced between 3 and 6 days of relief from pain from an old (2018) injury in that shoulder. This pain was normally merely annoying but sometimes (often) flared up with overuse. The relief that resulted from the vaccine was total.  Follow-up attempts are completed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300205337 same patient/suspect drug/similar events, different dose number;
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Impaired work ability, Syncope, Vomiting
Clinical narrative: Fainting; Blood pressure was sky high; Throwing up constantly; had a slow down and cannot work like he used to; This is a spontaneous report received from a Consumer or other non HCP from medical information team and legal division.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 2, single (Lot number: FM7533) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, lot: EN6199; anatomical location: left arm), administration date: 16Mar2021, when the patient was 64-year-old, for Covid-19 immunisation, reaction(s): "Blood pressure systolic high", "Heart enlarged", "Felt faint". The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "Fainting"; HYPERTENSION (non-serious), outcome "not recovered", described as "Blood pressure was sky high"; VOMITING (non-serious), outcome "unknown", described as "Throwing up constantly"; IMPAIRED WORK ABILITY (non-serious), outcome "unknown", described as "had a slow down and cannot work like he used to". The events "fainting", "blood pressure was sky high" and "throwing up constantly" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: sky high. Therapeutic measures were taken as a result of hypertension.  Clinical course: The patient reported that as soon as he took the vaccine he had high blood pressure. This started when he got the Pfizer vaccine and never had the high blood pressure before. The patient indicated that it was so bad he had to go to the hospital and the blood pressure was like way high and ever since his doctor keeps increasing the blood pressure medicine and checks his record. They put him on the blood pressure medicine to try to keep him under control, but it is really high. Upon follow up on 20Jan2024, it was reported that the patient started fainting and throwing up constantly. He went to the hospital and his blood pressure was sky high, since then he had been on blood pressure medicine. He never had a problem with blood pressure until he got the vaccine and not only cost him the job but had a slow down and he could not work like he used to and the patient was afraid for his health and income.  Follow up (20Jan2024): This is a spontaneous follow-up report received from a Consumer. Updated information included: patient's age, suspect product details (therapy date, lot number), historical vaccine details, new events (syncope, vomiting and impaired work ability) and clinical course.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300455133 Same patient, different dose and event;US-PFIZER INC-202400017976 Same patient, different dose and event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: has Covid after getting Covid booster shot in October; has Covid after getting Covid booster shot in October; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "has Covid after getting Covid booster shot in October".  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: Therapeutic response unexpected
Clinical narrative: Within six days after receiving the latest Pfizer booster, there was at least an 80% reduction in swelling and after a month it was virtually gone; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Within six days after receiving the latest Pfizer booster, there was at least an 80% reduction in swelling and after a month it was virtually gone".  Additional information: Patient reported that a positive side affect from latest booster. The patient had edema in legs without interruption for over six years. Within six days after receiving the latest Pfizer booster, there was at least an 80% reduction in swelling and after a month it was virtually gone. As per patient understanding that there was no known cure for long-term edema and the patient have found no reference to this sort of remission. There were no changes in diet, exercise or medication at this time.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Ended up with COVID; Ended up with COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine moderna (dose number unknown), for covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Ended up with COVID". Clinical information: The reporter stated how disappointed patient was at updated COVID vaccine. Patient usually gets Moderna, but went with Pfizer this fall as it was the first available. The vaccine offered no protection and patient ended up with COVID which has been an unacceptable burden in patient's life.  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: Malaise, SARS-CoV-2 test
Clinical narrative: didn't feel well; 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), on 13Jan2024 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: MALAISE (non-serious) with onset 14Jan2024, outcome "unknown", described as "didn't feel well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: On January 13, the patient had a Pfizer booster. The next day the patient didn't feel well and the following day the patient tested for Covid.  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, FLUX
Symptoms: Dermatitis atopic
Clinical narrative: last flare was in september or october 2023; Initial information received on 15-Jan-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves Adult male patient where last flare was in september or october 2023 after receiving covid-19 vaccine and influenza vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Essential hypertension and Dermatitis atopic. The patient had no known drug allergy.   On an unknown date in 2023, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation and received a dose of suspect COVID-19 VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for (dose, formulation, strength and expiration date: not provided) for Immunisation.  On an unknown date in 2023, the patient developed last flare was in september or october 2023 (dermatitis atopic) (unknown latency).  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, IPV
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: one of the patients they had a patient that was administered Pediarix , then IPOL with no reported adverse event; Initial information received on 18-Jan-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case is linked to case 2024SA024644.  This case involves a 2 months old female patient who was administered Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Pertussis Vaccine Acellular 3-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Pediarix), then Poliomyelitis Vaccine (Inactivated) (Ipol)  IPV (VERO) [IPOL]  with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Jan-2024, the patient received an unknown dose of suspect IPV (VERO) Suspension for injection (lot number: W1D511M) (Expiry date: 08-Sep-2025) (strength: standard) (Frequency: once) via intramuscular route in left leg for immunization.  On 18-Jan-2024, the patient received an unknown dose of suspect PEDIARIX not produced by Sanofi Pasteur (with an unknown formulation, strength, expiry date and lot number) via unknown route in unknown administration site for immunisation.  On 18-JAN-2024, the patient was administered PEDIARIX , then IPV (VERO) [IPOL] with no reported adverse event (extra dose administered) (latency: same day).  It was reported, Caller stated that one of the patients they had a patient that was administered Pediarix , then IPOL. Caller wanted to know if they patient will experience any sort of adverse event and if they have to administer the patient's next dose of IPOL which is supposed to be 4 months later. Both vaccines were given at the same facility at the same day by the same person. The nurse who reported the event stated that the doctor was the one how ordered the Medical assistant to administer both the Pediarix and IPOL to the patient. She first administered Pediarix and whens he tried to administer IPOL it would not allow her to input it in their system but she did not question it. Both the Medical assistant and the doctor who ordered her to do both vaccinations found out about it when the IPOL has already been administered.  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 and Regulatory Authority 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.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: An expired dose of fluzone high-dose quadrivalent were administered to two patients, with no reported adverse event; Initial information received on 22-Jan-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves 2 patients with an unknown age and unknown gender patient where reporter reported an expired dose of influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent] were administered to two patients, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza quadrival a-b high dose hv vaccine lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation (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: 30.0
Sex: F
Vaccine: RAB
Symptoms: No adverse event
Clinical narrative: she only received 4 doses with no reported adverse event; Initial information received on 22-Jan-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 30 years old female patient who only received 4 doses of Rabies (HDC) Vaccine [Imovax Rabies] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Tetanus Vaccine (Tetanus Vaccine) for Prophylactic vaccination.  On 02-Jul-2023, the patient received dose 1 of suspect Rabies (Hdc) Vaccine Powder and solvent for suspension for injection (with an unknown  expiry date, lot number) (Strength: standard) (Frequency: once) via unknown route in right outer thigh for post-exposure prophylaxis (Immunisation). On 05-Jul-2023 she also received dose 2 of the same vaccine  with an unknown batch number via unknown route in left shoulder-bicep. On 09-Jul-2023 she also received dose 3 of the same vaccine  with an unknown batch number via unknown route in right bicep. On 16-Jul-2023 she also received dose 4 of the same vaccine  with an unknown batch number via unknown route in left outer thigh .  On an unknown date, the patient only received 4 doses of Rabies (HDC) Vaccine [Imovax Rabies] with no reported adverse event (routine immunisation schedule not administered) (unknown latency).  It was reported, Patient reported receiving 4 doses of IMOVAX Rabies as part of post-exposure rabies vaccine series in July 2023. She asked how long the protection lasts. Patient calling on behalf of self. Caller stated that she received IMOVAX on days 0, 3, 7, and she thinks 14. This was her first time being immunized and confirmed that she only received 4 doses. Caller believed this was administered based on a potential post exposure. She found two marks on her buttocks towards the back of her thigh and was concerned that she had been bitten. Caller was in a mountainous area. She was wearing shorts where she was working and noted there could have been bats or another possible exposure. Her provider did not think that she had been exposed, but patient noted that she is overly cautious and nervous about rabies after her previous job working around animals. Caller would like to know how long IMOVAX lasts and provides protection. This situation is reported to PV due to the patient receiving less than recommended doses of product following a potential exposure.  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: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient reports they had localized redness and swelling on their arm 1 day after their vaccine. Pt had some minor redness smaller than the palm of their hand and swelling had gone away 24 hours later,
Age: 41.0
Sex: M
Vaccine: PNC20
Symptoms: Headache, Injection site pain, Lymphadenopathy, Pain
Clinical narrative: Soreness at injection site, swollen lymph nodes, headache, body achesd
Age: 14.0
Sex: F
Vaccine: COVID19, HPV9
Symptoms: Unevaluable event
Clinical narrative: none
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine post 30 days Moderna covid 19 Lot AU3919B  Per Moderna Medical Support (11/22/2023) the vaccine maintained the activity necessary to protect against the virus
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine post 30 days Moderna COVID 19 Lot AU3919B  Per Moderna Medical Support (11/22/2023) the vaccine maintained the activity necessary to protect against the virus
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Administered vaccine post 30 days Moderna Covid 19 Lot AU3919B  Per Moderna Medical Support (11/22/2023) the vaccine maintained the activity necessary to protect against the virus
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Administered vaccine post 30 days Moderna covid 19 Lot AU3919B  Per Moderna Medical Support (11/22/2023) the vaccine maintained the activity necessary to protect against the virus
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Administered vaccine post 30 days Moderna Covid 19 Lot AU3919B  Per Moderna Medical Support (11/22/2023) the vaccine maintained the activity necessary to protect against the virus
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Administered vaccine post 30 days Moderna Covid - 19 Lot AU3917B  Per Moderna Medical Support (11/22/2023) the vaccine maintained the activity necessary to protect against the virus.
Age: 13.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Expired product administered
Clinical narrative: Administered vaccine post 30 days Moderna COVID-19 Lot AU3917B  Per Moderna Medical Support (11/22/2023) the vaccine maintained the activity necessary to protect against the virus.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine post 30 days Moderna Covid - 19 Lot AU3917B  Per Moderna Medical Support (11/22/2023) the vaccine maintained the activity necessary to protect against the virus
Age: 69.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Product storage error
Clinical narrative: Administered vaccine post 30 days Moderna Covid-19 Lot AU3917B  Per Moderna Medical Support (11/22/2023) the vaccine maintained the activity necessary to protect against the virus
Age: 19.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Product storage error
Clinical narrative: Administered vaccine post 30 days Moderna Covid-19 Lot# AU3919B  Per Moderna Medical Support (11/22/2023) the vaccine maintained the activity necessary to protect against the virus
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered vaccine post 30 days Moderna Covid-19 Lot AU3917B  Per Moderna Medical Support (11/22/2023) the vaccine maintained the activity necessary to protect against the virus.
Age: 50.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Product storage error
Clinical narrative: Administered vaccine post 30 days Moderna Covid-19 Lot AU3917B  Per Moderna Medical Support (11/22/2023) the vaccine maintained the activity necessary to protect against the virus.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered vaccine post 30 days Moderna Covid-19 Lot AU3919B  Per Moderna Medical Support (11/22/2023)  the vaccine maintained the activity necessary to protect against the virus.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from Regulatory Authority.  This spontaneous report refers to an adult male patient (age group reported as 55-59 years). Information regarding the patient's concurrent conditions, medical history, and concomitant medications was not provided.  On unknown date, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (exact dose, strength, lot #, expiry date, site and route of administration were not provided).  On an unknown date in 2019, the patient experienced Streptococcus pneumoniae pneumonia. On an unknown date in 2019, Streptococcus pneumoniae serotype was tested with result reported as not applicable. The outcome of the event was not reported.  The causal relationship between Streptococcus pneumoniae pneumonia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.  Upon internal review, the event of Streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from Regulatory Authority.  This spontaneous report refers to an adult male patient (age group reported as 40-44 years). Information regarding the patient's concurrent conditions, medical history, and concomitant medications was not provided.  On unknown date, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (exact dose, strength, lot #, expiry date, site and route of administration were not provided).  On an unknown date in 2019, the patient experienced Streptococcus pneumoniae pneumonia. On an unknown date in 2019, Streptococcus pneumoniae serotype was tested with result reported as not applicable. The outcome of the event was not reported.  The causal relationship between Streptococcus pneumoniae pneumonia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.  Upon internal review, the event of Streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from National Notifiable Diseases Surveillance System (NNDSS)", concerning an elderly male patient of more than 85 years old. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unspecified date, the patient was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered as prophylaxis (dosage regimen, route of administration, lot number and expiration date were not reported).   On an unknown date in 2018, the patient experienced an Pneumonia (Streptococcus pneumoniae pneumonia) and streptococcus pneumoniae serotyping was not available. At the time of the report, outcome of the event was not reported.   Causal relationship between suspect vaccine and the event was not reported. Upon internal review, the event Streptococcus pneumoniae pneumonia was determined to be medically significant.