chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RSV
Symptoms: Respiratory symptom, Vaccination failure
Clinical narrative: Suspected vaccination failure; Lower respiratory symptoms noted; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and lower respiratory disorder (Verbatim: Lower respiratory symptoms noted). The outcome of the vaccination failure was unknown and the outcome of the lower respiratory disorder was not reported.   It was unknown if the reporter considered the vaccination failure and lower respiratory disorder to be related to Arexvy.     It was unknown if the company considered the vaccination failure and lower respiratory disorder to be related to Arexvy.   Additional Information: GSK receipt date: 08-APR-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The lower respiratory symptoms was noted, need to see components. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of lower respiratory symptoms were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Insomnia
Clinical narrative: countless night wIth long hours wIth out sleep; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sleeplessness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced sleeplessness (Verbatim: countless night wIth long hours wIth out sleep). The outcome of the sleeplessness was not reported.   It was unknown if the reporter considered the sleeplessness to be related to Arexvy.     It was unknown if the company considered the sleeplessness to be related to Arexvy.   Additional Information: GSK Receipt Date: 08-APR-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient thought as a live saver, (illegible text) personal goin countless night with long hours without sleep.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered Bexsero and the nurse then noticed the vaccine had expired on 21 march 2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (expiry date 21-MAR-2024) for prophylaxis.   On 03-APR-2024, the patient received Bexsero. On 03-APR-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Patient was administered Bexsero and the nurse then noticed the vaccine had expired on 21 march 2024). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-APR-2024 The nurse was reported that the patient received Bexsero vaccine and the nurse noticed the vaccine was expired on 21st March 2024, which led to expired vaccine used. The patient was doing fine. The reporter consent to follow up.
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Feeling abnormal, Headache, Muscular weakness, Sciatica
Clinical narrative: Fatigue; Headaches; Sciatica; leg muscle weakness; not feeling like myself; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On 10-MAR-2024, an unknown time after receiving Arexvy, the patient experienced feeling abnormal (Verbatim: not feeling like myself). On an unknown date, the patient experienced fatigue (Verbatim: Fatigue), headache (Verbatim: Headaches), sciatica (Verbatim: Sciatica) and muscle weakness lower limb (Verbatim: leg muscle weakness). The outcome of the fatigue, headache, feeling abnormal, sciatica and muscle weakness lower limb were not resolved.   It was unknown if the reporter considered the fatigue, headache, feeling abnormal, sciatica and muscle weakness lower limb to be related to Arexvy.     It was unknown if the company considered the fatigue, headache, feeling abnormal, sciatica and muscle weakness lower limb to be related to Arexvy.   Additional Information: GSK receipt date: 03-APR-2024 The patient was self-reported this case. The patient reported that she received Arexvy vaccine prior to the 10th march 2024 but the exact date was not remember. She noticed that since 10th March 2024 she was not feeling like herself and also experienced headaches, leg muscle weakness, fatigue.  She has been seeing a chiropractor for sciatica. She states it had been weeks and wants to know when her symptoms would go away. Referred to her health care professional. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: hasn't received the second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the 1st dose on 14th September 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: hasn't received the second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-APR-2024 The reporter reported that the patient received the first dose of Shingrix and had not received the second dose yet. This was 1 of the 3 cases, reported by the same reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2024042177:SAME REPORTER US-GSK-US2024042175:SAME REPORTER
Sex: U
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: gave first dose of Bexsero on 12th March 2024 and a second was given on 3rd April 2024.; This non-serious case was reported by a physician via sales rep and described the occurrence of drug dose administration interval too short in a patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero).   On 03-APR-2024, the patient received the 2nd dose of Bexsero. On 03-APR-2024, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: gave first dose of Bexsero on 12th March 2024 and a second was given on 3rd April 2024.). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 03-APR-2024 The reporter reported that he reached out to the adult immunization service and requested information for Bexsero. The reporter reported that the staff member gave the second dose of Bexsero with an interval of less than one month which led, shortening of the vaccination schedule. The reporter was requesting guidance to see if they need to bring patient back in for additional dose or what the next step should be. The vaccine administration facility was the same as primary reporter.
Age: 8.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 8-year-old female patient who received HBV (Engerix B) (batch number 34G75, expiry date 15-FEB-2024) for prophylaxis.   On 03-APR-2024, the patient received Engerix B. On 03-APR-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired vaccine used). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-APR-2024 The reporter reported that the patient received Engerix B vaccine which was already expired, which led to expired vaccine used. The reporter stated that at the time of reporting the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: an expired vaccines was given to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA765A, expiry date 31-DEC-2023) for prophylaxis.   On 03-APR-2024, the patient received Menveo. On 03-APR-2024, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: an expired vaccines was given to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 04-APR-2024 The reporter mentioned they had one of their health care provider who reported that an expired vaccines was given to a patient.  The vaccine administration facility was the same as primary reporter.
Age: 1.58
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 19 month old patient accidentally received a dose of Bexsero; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 19-month-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 03-APR-2024, the patient received the 1st dose of Bexsero. On 03-APR-2024, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: 19 month old patient accidentally received a dose of Bexsero). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-APR-2024 The 19 month old patient accidentally received a dose of Bexsero on and reporter requested recommendations on how to proceed.  Safety data was offered and accepted, as well as the contact information for the Center for disease control. Data about the event, and patient were collected, but not the vaccine, as the healthcare professional did not had it on file. The vaccine administration facility was the same as primary reporter. The patient received a dose of Bexsero, earlier than the recommended age limit, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product preparation error
Clinical narrative: accidentally drew up the diluent liquid (adjuvant portion) but did not mix it with the powder antigen component; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted product preparation error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced intercepted product preparation error (Verbatim: accidentally drew up the diluent liquid (adjuvant portion) but did not mix it with the powder antigen component). The outcome of the intercepted product preparation error was unknown.   Additional Information: GSK receipt date: 05-APR-2024 The reporter reported that at the time of preparing Shingrix vaccine accidently drew up the diluent(liquid adjuvant) portion did not mix it with the powder antigen component. The liquid adjuvant was then wasted, it was not administered to the patient, which led to intercepted product preparation error. The reporter was seeking a replacement vial of Shingrix liquid adjuvant. No further details collected. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: an 18 year old patient was given the Adult dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 18-year-old female patient who received HAV (Havrix 1440 adult) (batch number HR4RB, expiry date 18-DEC-2025) for prophylaxis.   On 08-MAR-2024, the patient received Havrix 1440 adult (intramuscular, unknown deltoid). On 08-MAR-2024, an unknown time after receiving Havrix 1440 adult, the patient experienced inappropriate age at vaccine administration (Verbatim: an 18 year old patient was given the Adult dose of Havrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 08-APR-2024 The reporter was the manager from a primary care office who was an occupational therapist. She reported that an 18 year old patient was given the adult dose of Havrix, which led to inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 65 year old female was administered a dose of Menveo on 05Apr2024.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 65-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number L7373, expiry date 30-NOV-2024) for prophylaxis.   On 05-APR-2024, the patient received the 1st dose of Menveo. On 05-APR-2024, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: 65 year old female was administered a dose of Menveo on 05Apr2024.). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 09-APR-2024 Pharmacist reported 65 year old female was administered a dose of Menveo, which led to inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter The reporter consented to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; received a series of Shingrix and they suffered from shingles; This serious case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: received a series of Shingrix and they suffered from shingles). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt date: 08-APR-2024 A healthcare professional reported that a patient received a series of Shingrix, and they suffered from shingles.  The reporter wanted to know how to proceed. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: COVID19-2, DTAPIPVHIB, PNC15, RV5
Symptoms: Expired product administered, Irritability, Product storage error
Clinical narrative: (vail) was initially stored in the refrigerator on 01-Jun-2023, first punctured on 08-Jun-2023 and was administered on 09-Jun-2023; Fussy that night after vaccines; Doses were given in their facility >12 hours post puncture.; This spontaneous case was reported by an other health care professional and describes the occurrence of IRRITABILITY (Fussy that night after vaccines), EXPIRED PRODUCT ADMINISTERED (Doses were given in their facility >12 hours post puncture.) and PRODUCT STORAGE ERROR ((vail) was initially stored in the refrigerator on 01-Jun-2023, first punctured on 08-Jun-2023 and was administered on 09-Jun-2023) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for Prophylactic vaccination.    Co-suspect products included non-company products PENTACEL for Prophylactic vaccination, PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE) for Prophylactic vaccination and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.    Concurrent medical conditions included Cough (Ongoing at the time of event and prior to one month onwards.) since 2023, Plagiocephaly (Improving) since 12-Jan-2023 and Teething. Concomitant products included IBUPROFEN for Teething.   On 09-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form, third dose of PENTACEL (Intramuscular use) 1 dosage form, third dose of PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE) (Intramuscular use) 1 dosage form and third dose of ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) (unknown route) 1 dosage form. On 09-Jun-2023, the patient experienced IRRITABILITY (Fussy that night after vaccines) and EXPIRED PRODUCT ADMINISTERED (Doses were given in their facility >12 hours post puncture.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR ((vail) was initially stored in the refrigerator on 01-Jun-2023, first punctured on 08-Jun-2023 and was administered on 09-Jun-2023). At the time of the report, IRRITABILITY (Fussy that night after vaccines), EXPIRED PRODUCT ADMINISTERED (Doses were given in their facility >12 hours post puncture.) and PRODUCT STORAGE ERROR ((vail) was initially stored in the refrigerator on 01-Jun-2023, first punctured on 08-Jun-2023 and was administered on 09-Jun-2023) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included Multivitamin [Vitamins NOS]. No treatment medications were reported.
Sex: F
Vaccine: RSV
Symptoms: Occupational exposure to product, Syringe issue
Clinical narrative: Luer Lock broke and the vaccine spilled on caller's desk; Luer Lock broke and the vaccine spilled on caller's desk; This is a spontaneous report received from a Nurse from product quality group.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM9849, Expiration Date: Mar2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious), DEVICE BREAKAGE (non-serious) and all described as "Luer Lock broke and the vaccine spilled on caller's desk". Additional information: the reporting nurse confirmed that there was one Abrysvo syringe where the Luer Lock broke and the vaccine spilled on her desk. The nurse was putting the syringe on the needle and that was when it broke. The nurse clarified there was no patient involvement when the vaccine spilled on her desk.   Causality for "luer lock broke and the vaccine spilled on caller's desk" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Follow-up (01Apr2024): This is a spontaneous follow-up report received from the product quality group. Updated information: Product complaint number was added and malfunction reportability was updated.
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: redness, tenderness, and swelling at her injection site; redness, tenderness, and swelling at her injection site; redness, tenderness, and swelling at her injection site; This is a spontaneous report received from a Nurse from medical information team.  An adult female patient received pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "redness, tenderness, and swelling at her injection site". Additional information: reporter asking for more data regarding local site reactions in adults that she can share with a patient who experienced redness, tenderness, and swelling at her injection site recently.   The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: COVID-19
Clinical narrative: COVID-19; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP.  A 71-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 01Mar2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious), outcome "unknown". Therapeutic measures taken as a result of covid-19 was Paxlovid administration. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Vaccine brand=Moderna; vaccine dose number: 3; Vaccine brand=Pfizer / BioNTech; vaccine dose number: 4; 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 39-year-old male patient received BNT162b2 (BNT162B2), on 19Jul2022 at 14:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 37 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2021 at 10:45 as dose 1, single (Lot number: 027B21A), in left arm, on 30Apr2021 at 12:00 as dose 2, single (Lot number: 007C21A), in right arm and on 19Nov2021 at 14:00 as dose 3 (booster), single (Lot number: 062EUA), in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 14Oct2022 at 14:00 as dose 5 (booster), single (Lot number: 030G22B), in left arm and on 19Sep2023 at 14:00 as dose 6 (booster), single (Lot number: 202F23A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (ongoing), notes: ADHD combined presentation. Take 20mg aderrall daily for treatment. The patient's concomitant medications were not reported. Patient had no Known allergies The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "recovered" (Apr2024) and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovered", described as "Vaccine brand=Moderna; vaccine dose number: 3; Vaccine brand=Pfizer / BioNTech; vaccine dose number: 4". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Mar2024) Positive, notes: days 0-4; (Apr2024) Negative, notes: days 5-8. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 30Mar2024 to 02Apr2024.
Age: 43.0
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 43-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Shellfish allergy" (unspecified if ongoing); "Mollusks allergy" (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; 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 Apr2024, outcome "recovered" (Apr2024) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2024) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 01Apr2024 to 05Apr2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Crohn's disease, Immunodeficiency
Clinical narrative: Crohn's disease; Immunocompromised; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 78-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 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: CROHN'S DISEASE (medically significant), outcome "unknown"; IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "Immunocompromised". Therapeutic measures were taken as a result of crohn's disease. Clinical course: Caller stated that the last Pfizer COVID-19 vaccine he received was on Sep last year and he would like to know if he should get another booster. He stated that he already contacted his doctor and Informed him that it was okay for him to get a booster of the Pfizer COVID-19 vaccine. Caller stated that he was also immunocompromised as he was also taking the medication Humira for his Crohn's disease.   Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Cardiac failure congestive, Dyspnoea, Hypoaesthesia, Paraesthesia, Respiratory disorder
Clinical narrative: Congestive heart failure; Shortness of breath; Feels numbness/numbness in the finger of his right hand; Tingling in the finger of his right hand; breathing problems; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  An 80-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 30Oct2023 as dose number unknown, single), in left arm for influenza immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC FAILURE CONGESTIVE (medically significant), outcome "unknown", described as "Congestive heart failure"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "Feels numbness/numbness in the finger of his right hand"; PARAESTHESIA (non-serious), outcome "not recovered", described as "Tingling in the finger of his right hand"; RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "breathing problems". Clinical course: Patient had numbness and tingling that never went away and also developed congestive heart failure. Caller asked if the side effects could last that long and if it can cause heart problems like shortness of breath and congestive heart failure. The caller said he got the COVID shot in his arm in October and he still had numbness and tingling in the finger of his right hand and would like to know if that was a side effect of the shot. The caller also stated that he had congestive heart failure and he started having breathing problems shortly after he got the shot. The caller said he went to the (withheld) and they gave him a flu shot and the Pfizer shot at the same time but he got the COVID shot in his right arm.   Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: RSV, VARZOS
Symptoms: Malaise
Clinical narrative: sick; This is a spontaneous report received from a Consumer or other non HCP.  An adult patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; varicella zoster vaccine (VARICELLA ZOSTER VACCINE), as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional information: As reported, "I was very sick after getting shingles and RSV vaccines together."  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: i've had you're too shot vaccine/has COVID; i've had you're too shot vaccine/has 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "i've had you're too shot vaccine/has COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Those three hundred and fifty dollars for a five-day medicine were outrageous.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report received from a Physician, Program ID.  A 34-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (ongoing); "hypertension" (ongoing); "kidney disease" (ongoing); "dialysis" (ongoing). The patient's concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "recovered". Clinical course: A nephrologist reported in PRIVACY that he had seen one case of myocarditis after a COVID19 vaccination. The reporter considered event as caused by suspect product.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: There is a reasonable possibility that the event myocarditis was related to COMIRNATY (2023-24 FORMULA) based on known drug safety profile and temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: Pfizer Covid 19 Vaccine leads to cancer/ his mother in law died 6 days she took the vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (death, medically significant), outcome "fatal", described as "Pfizer Covid 19 Vaccine leads to cancer/ his mother in law died 6 days she took the vaccine". The patient date of death was unknown. Reported cause of death: "Pfizer Covid 19 Vaccine leads to cancer/ his mother in law died 6 days she took the vaccine". It was not reported if an autopsy was performed.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Reported Cause(s) of Death: Pfizer Covid 19 Vaccine leads to cancer/ his mother in law died 6 days she took the vaccine
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant, Sarcoidosis
Clinical narrative: My wife is dying from sarcoidosis. It turned into cancer; My wife is dying from sarcoidosis. It turned into cancer; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SARCOIDOSIS (medically significant, life threatening), NEOPLASM MALIGNANT (medically significant), outcome "unknown" and all described as "My wife is dying from sarcoidosis. It turned into cancer".  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: Pancreatic carcinoma, Pancreatic failure
Clinical narrative: caller got Excedrin pancreatic insufficiency turning into pancreatic cancer.; caller got Excedrin pancreatic insufficiency turning into pancreatic cancer.; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PANCREATIC CARCINOMA (medically significant), PANCREATIC FAILURE (medically significant), outcome "unknown" and all described as "caller got Excedrin pancreatic insufficiency turning into pancreatic cancer.".  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: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired dose of PENTACEL yesterday, with no reported adverse event; Initial information received on 05-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered an expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] yesterday, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Apr-2024, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot UJ858AA, expiry date: 29-Mar-2024, unknown strength) via unknown route in unknown administration site for prophylactic vaccination (Immunization) and administered an expired dose of pentacel yesterday, 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: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: received an expired dose of ACTHIB with no reported adverseevent; Initial information received on 08-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old male patient who received 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.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (dtap) for prophylactic vaccination; hepatitis b vaccine (hepatitis b vaccine) for prophylactic vaccination; polio vaccine (polio) for prophylactic vaccination; influenza vaccine (influenza) for prophylactic vaccination; and rotavirus vaccine (rotavirus vaccine) for prophylactic vaccination.  On 08-Apr-2024, the patient received 0.5 ml dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection(Strength: standard) (Frequecy: once) via intramuscular route in the right vastus lateralis for immunization.  On 08-APR-2024, the patient received an expired dose of acthib with no reported adverse event (expired product administered) (latency: same day) (lot number: UJ855AB) (Expiry date: 22-Mar-2024) .  It was reported, Caller reported that a patient received an expired dose of ACTHIB today. The patient remained in the office for approximately 20-25 minutes post administration and the caller was not aware of any adverse reactions. This situation is reported as a medication error due to the inappropriate administration of an expired product to a patient.   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: 1.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: patient inadvertently received an expired dose of PENTACEL with no reported adverse event; Initial information received on 09-Apr-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 14 months old male patient who inadvertently received an expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] 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 pneumococcal vaccine CONJ 15V (CRM197) (Vaxneuvance) for Prophylactic vaccination.  On 04-Apr-2024, the patient inadvertently received an expired dose of 0.5 ml (dose 4) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot: UJ858AA; expiry date: 29-Mar-2024) via intramuscular route in the right thigh for Immunization 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 and Module of the 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: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event, Product communication issue
Clinical narrative: Nurse states that there was a miscommunication regarding the IMOVAX intervals. She states that she gave the first dose on 18MAR2023, the second dose was not available right away, so it was given today, 09APRIL2024 with no reported adverse event.; Initial information received on 09-Apr-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who was administered with first dose of Rabies (HDC) Vaccine [Imovax Rabies] on 18-Mar-2023, the second dose was not available right away, so it was given today, 09-Apr-2024 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On, 18-Mar-2023 the patient had received (dose and units unknown) (dose: 1) of suspect Rabies (HDC) Vaccine (Powder and solvent for suspension for injection) (lot number, strength and expiry date not reported) via unknown route in unknown administration site and on 09-Apr-2024 he/she also received (dose and units unknown) (dose: 2) of same vaccine (lot number, strength and expiry date not reported) via unknown route in unknown administration site; both for Immunization.  On an unknown date the nurse stated that there was a miscommunication regarding the imovax intervals. She states that she gave the first dose on 18-Mar-2023, the second dose was not available right away, so it was given today, 09-Apr-2024 with no reported adverse event (routine immunisation schedule incomplete) (unknown latency).   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: TDAP
Symptoms: Incorrect route of product administration, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 8 years old patient received Adacel (under the age of 10) instead of the TB skin test  route of administration was intradermally with no reported adverse event; 8 years old patient received Adacel (under the age of 10) instead of the TB skin test  route of administration was intradermally with no reported adverse event; 8 years old patient received Adacel (under the age of 10) instead of the TB skin test  route of administration was intradermally with no reported adverse event; Initial information received on 10-Apr-2024 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves 8 years old male patient who was adminsitered Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] (under the age of 10) instead of the Tuberculin Test [Tubersol] route of administration was intradermally with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Apr-2024, the 8 years old male patient who was administered 0.5 ml of  Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] (under the age of 10)(Suspension for injection) instead of the Tuberculin Test [Tubersol] route of administration was intradermally with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) (wrong product administered) (latency: same day) (incorrect route of product administration) (latency: same day) (lot 2CA61C1) (expiry: 06-Jun-2025) (frequency: once) (strength: standard) in the left forearm for Immunization.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.