chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; HCP called to report a patient received a third dose of GARDASIL 9 after competition of the two-dose series on February 19, 2019. No side effects or symptoms reported. No additional information provided. No Additional AE/ No PQC.; This spontaneous report was received from medical assistant and refers to 16-year-old male patient.   The patient's medical history was not reported. His drug history included Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9). The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 28-FEB-2025, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (valid lot #Y018389, expiration date: 04-NOV-2026) 0.5 mL.  On 28-FEB-2025, the patient received a third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) after competition of the two-dose series on 19-FEB-2019. No side effects or symptoms reported. No additional information provided. No Additional AE/ No PQC.. On an unknown date, the patient experienced No additional AE.   At the reporting time, the outcome of HCP called to report a patient received a third dose of GARDASIL 9 after competition of the two-dose series on February 19, 2019. No side effects or symptoms reported. No additional information provided. No Additional AE/ No PQC. and No additional AE was unknown.   The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant was reported as not applicable.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: no side effects or symptoms reported. No Additional AE/ No PQC.; patient received their second dose of VARIVAX too early at 3 years and 8 months old; This spontaneous report was received from a certified medical assistant and refers to a 3 years and 8 months female patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On an unknown date approximately in 2022 (reported as at approximately 12 months of age), the patient was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck)(VARIVAX) (dose, lot #, expiration date, route and site of administration were not reported) reconstituted with sterile diluent (lot # and expiration date were not reported) for prophylaxis. On 29-JAN-2025, at the age of 3 years and 8 months, the patient was vaccinated too early with the second dose of Varicella Virus Vaccine Live (Oka-Merck)(VARIVAX) 0.5 ml, lot # Y014182 was confirmed to be valid, expiration date 20-AUG-2026 (route and site of administration were not reported) reconstituted with sterile diluent (lot # and expiration date were not reported) for prophylaxis.
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; improper storage of prouct in use; improper storage of product in use; This spontaneous report was received from a pharmacist referring to a patient of unknon age and gender. Information regarding the patient's concurrent conditions, historical conditions and concomitant or historical medications was not provided. On an unspecified date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection for prophylaxis, 0.5 milliliters, subcutaneously, lot number Y010045 which has been verified to be valid, expiration date reported and validated as 29-MAY-2026. The vaccine was reconstituted with sterile diluent Solution for injection (BAXTER STERILE DILUENT)  The administered dose of the vaccine was stored at 59.4 Farenheit (F), during one hour and 30 minutes. There were not previous temperature excursions for which details were unknown. There were no symptoms reported.
Age: 5.0
Sex: F
Vaccine: HIBV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Wrong dose; Received at 5 year of age; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of wrong vaccine administered in a 5-year-old female patient who received Hib (Hiberix) for prophylaxis.   On 05-MAR-2025, the patient received Hiberix. On 05-MAR-2025, an unknown time after receiving Hiberix, the patient experienced wrong vaccine administered (Verbatim: Wrong dose) and inappropriate age at vaccine administration (Verbatim: Received at 5 year of age). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable.   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: 05-MAR-2025 The health care professional reported that a patient received wrong dose of vaccine, which led to wrong vaccine administered. The patient received a dose of Hiberix at an inappropriate age, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness, Herpes zoster, Laboratory test, Vaccination failure
Clinical narrative: Suspected vaccination failure; lost my hearing; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), hearing loss (Verbatim: lost my hearing) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure, hearing loss and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The reporter considered the hearing loss to be related to Shingrix.     The company considered the vaccination failure and hearing loss to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-MAR-2025 This case was reported by a patient via interactive digital media. Consumer reported that she got Shingrix vaccine and she experienced shingles and loss of hearing. They made go to all the test and it cost patient to find out by her old fashion physician. Consumer stated that if you don't need shingle shot you already have shingles and getting the shot was useless. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. Deafness is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; within 3 months I got shingles.; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: within 3 months I got shingles.). The outcome of the vaccination failure and shingles were not reported.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2025 This case was reported by a patient via interactive digital media. The patient got live virus shingles shot and within 3 months the patient had shingles. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.  Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I just got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In AUG-2024, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I just got the shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK receipt date: 05-MAR-2025 This case was reported by a patient via interactive digital media.  Patient stated that he/she got the vaccine last August 2024 and just got the shingles.  Patient stated that started meds on the day of reporting. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; experineced shingles 3 times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: experineced shingles 3 times). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2025 This case was reported by a patient via interactive digital media. The patient was vaccinated for shingles and have had shingles 3 times since then. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Extra dose/ third dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number 3939H2S, expiry date 10-MAR-2027) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 19-FEB-2020) and Shingrix (received 2nd dose on 06-AUG-2020).   On 18-FEB-2025, the patient received the 3rd dose of Shingrix. On 18-FEB-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Extra dose/ third dose administered). The outcome of the extra dose administered was not applicable.   Additional Information: GSK Receipt Date: 04-MAR-2025 The Vaccine Administration Facility is the same as Primary Reporter The Practice Director called to enquire if there was any issue with a patient that had the complete schedule for Shingrix vaccine, and received an extra dose (third dose) a few weeks ago. The patient had received the 3rd dose of Shingrix, which had led to extra dose administered.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix early second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number 93kk4, expiry date 31-JAN-2027) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 06-FEB-2025, the patient received the 2nd dose of Shingrix. On 06-FEB-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Shingrix early second dose). The outcome of the drug dose administration interval too short was not applicable.   Additional Information: GSK Receipt Date: 05-MAR-2025 The pharmacist reported a patient received the first dose of Shingrix on 13th January 2025. The patient was not immunocompromised. The reporter consented to follow up. The patient received 2nd dose of Shingrix, earlier than the recommended interval, which led to shortening of vaccination schedule.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: she mentioned that she had spoken with a friend of mine. She was a medical technologist and she got shingles from it.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HERPES ZOSTER (she mentioned that she had spoken with a friend of mine. She was a medical technologist and she got shingles from it.) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (she mentioned that she had spoken with a friend of mine. She was a medical technologist and she got shingles from it.). At the time of the report, HERPES ZOSTER (she mentioned that she had spoken with a friend of mine. She was a medical technologist and she got shingles from it.) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2025-783038 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-783038:Master case (B-G)
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vaccination site pain
Clinical narrative: Like I was, I for like 24 hours I was very um. kind of sickish; the shot when she put the needle in it, it, it hurt a lot/I had a lot of pain; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Like I was, I for like 24 hours I was very um. kind of sickish) and VACCINATION SITE PAIN (the shot when she put the needle in it, it, it hurt a lot/I had a lot of pain) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised and Lung disorder NOS.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced MALAISE (Like I was, I for like 24 hours I was very um. kind of sickish) and VACCINATION SITE PAIN (the shot when she put the needle in it, it, it hurt a lot/I had a lot of pain). At the time of the report, MALAISE (Like I was, I for like 24 hours I was very um. kind of sickish) and VACCINATION SITE PAIN (the shot when she put the needle in it, it, it hurt a lot/I had a lot of pain) outcome was unknown.            No concomitant medications were reported. It was reported that the patient had medical history of rare disease. Administration date was reported as a couple of months ago. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Feb-2025: Non-significant follow-up received, and reference number added On 20-Feb-2025: Upon internal review on 12-Mar-2025, significant correction was performed to update suspect product coding from COVID-19 vaccine to Spikevax NOS.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Illness, Insomnia, Mobility decreased
Clinical narrative: has been really sick; couldn't sleep last night because the shaking was so bad; couldn't sleep last night because the shaking was so bad; Caller can't really move the arm that much on the right side; Caller's joints hurt on 'that side' badly; Caller took temperature and it was 103'F; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (has been really sick), INSOMNIA (couldn't sleep last night because the shaking was so bad), TREMOR (couldn't sleep last night because the shaking was so bad), MOBILITY DECREASED (Caller can't really move the arm that much on the right side) and ARTHRALGIA (Caller's joints hurt on 'that side' badly) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced ILLNESS (has been really sick), INSOMNIA (couldn't sleep last night because the shaking was so bad), TREMOR (couldn't sleep last night because the shaking was so bad), MOBILITY DECREASED (Caller can't really move the arm that much on the right side), ARTHRALGIA (Caller's joints hurt on 'that side' badly) and PYREXIA (Caller took temperature and it was 103'F). At the time of the report, ILLNESS (has been really sick), INSOMNIA (couldn't sleep last night because the shaking was so bad), TREMOR (couldn't sleep last night because the shaking was so bad), MOBILITY DECREASED (Caller can't really move the arm that much on the right side), ARTHRALGIA (Caller's joints hurt on 'that side' badly) and PYREXIA (Caller took temperature and it was 103'F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2025, Body temperature: 103 degree fahrenheit.     The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.       No Concomitant medications provided by the reporter. It was reported that post vaccination patient was felt really sick, and patient was unable to sleep because she experienced a bad shook last night and her joints hurt on the site of vaccination very badly. Patient was unable to move the arm that much on the right side. No treatment  medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: has been really sick; couldn't sleep last night because the shaking was so bad; couldn't sleep last night because the shaking was so bad; Caller can't really move the arm that much on the right side; Caller's joints hurt on 'that side' badly; Caller took temperature and it was 103'F; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (has been really sick), INSOMNIA (couldn't sleep last night because the shaking was so bad), TREMOR (couldn't sleep last night because the shaking was so bad), MOBILITY DECREASED (Caller can't really move the arm that much on the right side) and ARTHRALGIA (Caller's joints hurt on 'that side' badly) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced ILLNESS (has been really sick), INSOMNIA (couldn't sleep last night because the shaking was so bad), TREMOR (couldn't sleep last night because the shaking was so bad), MOBILITY DECREASED (Caller can't really move the arm that much on the right side), ARTHRALGIA (Caller's joints hurt on 'that side' badly) and PYREXIA (Caller took temperature and it was 103'F). At the time of the report, ILLNESS (has been really sick), INSOMNIA (couldn't sleep last night because the shaking was so bad), TREMOR (couldn't sleep last night because the shaking was so bad), MOBILITY DECREASED (Caller can't really move the arm that much on the right side), ARTHRALGIA (Caller's joints hurt on 'that side' badly) and PYREXIA (Caller took temperature and it was 103'F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2025, Body temperature: 103 degree fahrenheit.     The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.       No Concomitant medications provided by the reporter. It was reported that post vaccination patient was felt really sick, and patient was unable to sleep because she experienced a bad shook last night and her joints hurt on the site of vaccination very badly. Patient was unable to move the arm that much on the right side. No treatment  medications provided by the reporter.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure, Nervous system disorder, Sleep apnoea syndrome
Clinical narrative: heart failure; neurological disease; sleep apnea; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC FAILURE (heart failure) in a 65-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 939905) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Sep-2023, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. On 29-Sep-2021, the patient experienced CARDIAC FAILURE (heart failure) (seriousness criterion medically significant), NERVOUS SYSTEM DISORDER (neurological disease) and SLEEP APNOEA SYNDROME (sleep apnea). At the time of the report, CARDIAC FAILURE (heart failure), NERVOUS SYSTEM DISORDER (neurological disease) and SLEEP APNOEA SYNDROME (sleep apnea) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular use) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.  It was unknown if the patient experienced any additional symptoms/events.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Vaccine: PPV
Symptoms: Drug ineffective, Pneumococcal infection
Clinical narrative: pneumococcal infection; 5 cases of invasive pneumococcal disease in children that have been vaccinated with PCV13 (I am unsure if every child received every dose in the series)/pneumococcal infection; This is a spontaneous report received from a Physician.  A patient (age and gender not provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), 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: PNEUMOCOCCAL INFECTION (medically significant), outcome "unknown", described as "5 cases of invasive pneumococcal disease in children that have been vaccinated with PCV13 (I am unsure if every child received every dose in the series)/pneumococcal infection"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "pneumococcal infection". It was stated that the reporter was hoping to submit an adverse reporting through this route as he/she believes this to be a unique situation. He/she had a clinical meeting with a pediatric infectious disease physician. She is the Director of the newly established Vaccine Center of Excellence and recently has come back in the last year and a half after practicing for 18 years. During their introductory discussion, she elaborated that upon returning, she has witnessed 5 cases of invasive pneumococcal disease in children that have been vaccinated with PCV13 (unsure if every child received every dose in the series). She said she had not seen this many cases during her entire tenure, so she had sought to get serotyping and see if anyone is following these cases. She stated she is having trouble with anyone showing interest in this and finds no one researching this area (ie- are we following pediatrics who received PCV13 and then get IPD or PNA? Should pediatric patients who received PCV13 get a booster of PCV20?). She said most research is in pediatrics age < 5 years and is struggling with serotyping and follow up given these patients are over the age of 5 years. The local departments of health utilize a lab in (name) and these cases do not fit their criteria as the patients are over 5 years of age. The adverse event here is the high number of potential breakthrough cases of invasive pneumococcal disease in (name) (she stated one was serotype 3) OR potentially cases of pneumococcal infection that could be covered with PCV20 in patients who received PCV13.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.  Further information like confirmative serotype results, vaccination schedule, patient age, medical history and concomitant medications are needed for full medical assessment.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: The Comirnaty vaccine for ages 12 and above was inadvertently administered to an 11-year-old; The Comirnaty vaccine for ages 12 and above was inadvertently administered to an 11-year-old; fever that lasted for 30 minutes; This is a spontaneous report received from a Nurse from medical information team.  An 11-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 08Feb2025 as dose number unknown, single (Lot number: LP1776, Expiration Date: 26Apr2025) at the age of 11 years for covid-19 immunisation. The patient didn't receive BNT162b2 omicron (kp.2) (PFIZER-BIONTECH COVID-19 VACCINE (2024-2025 FORMULA)). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 08Feb2025, outcome "unknown" and all described as "The Comirnaty vaccine for ages 12 and above was inadvertently administered to an 11-year-old"; PYREXIA (non-serious) with onset 2025, outcome "recovered" (2025), described as "fever that lasted for 30 minutes".  Additional information: Inadvertent administration of higher than the recommended dose of 10 mcg in 5 through 11 years of age. The reporter stated the mother of the patient or the parent of the patient reported that after the injection the patient experienced fever that lasted for 30 minutes.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: just got minor chills and fever; just got minor chills and fever; This is a spontaneous report received from a Consumer or other non HCP.  A 73-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: PYREXIA (non-serious), CHILLS (non-serious), outcome "unknown" and all described as "just got minor chills and fever".  Additional information: stated when got the shot it was no big deal. Patient had gotten all the covid vaccines. Patient always had covid vaccine from Pfizer. When patient previous vaccines he had little reactions. Haven't had anything go bad, just got minor chills and fever.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500052280 Same reporter, different patient/drug/AE;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID; got COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "pulse" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for blood pressure abnormal, pulse abnormal, start date: 2023 (ongoing); ATORVASTATIN taken for blood cholesterol increased (ongoing). Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 Immunization, reaction(s): "little reactions"; Bnt162b2 (DOSE 2), for Covid-19 Immunization, reaction(s): "little reactions"; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER)), for Covid-19 Immunization, reaction(s): "little reactions". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2024, outcome "unknown" and all described as "got COVID". The patient reported he had all the boosters and vaccine before (always had COVID vaccine from Pfizer). He then added, that missed one booster and got COVID in Jul2024 and was pretty sick.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500052280 Same reporter, different patient, drug and AE;US-PFIZER INC-202500052080 Same patient, different dose and event;
Sex: F
Vaccine: PNC20
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This is a spontaneous report received from an Other HCP from a sales representative.  A female patient (unknown if pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 10Mar2025 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: CHILLS (non-serious) with onset 10Mar2025, outcome "unknown"; PYREXIA (non-serious) with onset 10Mar2025, outcome "unknown", described as "fever". It was unknown if therapeutic measures were taken as a result of chills, pyrexia.  Additional information: Patient experienced chills and fever after vaccination with Prevnar 20.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid After Shots; Covid After Shots; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 77-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (primary immunization series complete), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2025, outcome "unknown", COVID-19 (medically significant) with onset 2025, outcome "not recovered" and all described as "Covid After Shots". The event "covid after shots" required emergency room visit. The patient was diagnosed with Covid last night at the doctor's office. Patient went to get his/her prescription and they said patient needed to call the emergency room where the patient went last night and have the doctor call them. Patient was sick and made so many calls. Patient was not at his/her best right now. Patient stated, "Covid is not a walk in the park." Patient have had every single one of our wonderful shots and patient was thanking and wondering as what would he/she be feeling like otherwise. Patient stated, "This is the time when a person that's sick needs somebody to give them a hand...". While looking for a prescription from their doctors office, the patient was given a nose spray that came in a bottle. Patient was not feeling good.
Age: 69.0
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I had COVID again; I had COVID again; got Covid; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 13Feb2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "osteoarthritis" (unspecified if ongoing); "rheumatory arthritis" (unspecified if ongoing); "immune system very weak" (unspecified if ongoing). The patient was on an expensive medication to keep the patient's rheumatory arthritis from overcoming the patient and that left the patient's immune system very weak. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset Nov2023, outcome "recovered", described as "got Covid"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jan2024, outcome "recovered" and all described as "I had COVID again". The patient got the vaccine on 18Nov2023 and tested positive for COVID on 20Nov2023 and took PAXLOVID. Unbeknownst to the patient, s/he got very sick, didn't know what s/he had, couldn't believe anything. Tested positive for COVID for a second time 20Jan2024 and was on PAXLOVID again. That's how easy the patient succumb to things. PAXLOVID had helped the patient and patient's doctor prescribed it so patient can get over Covid because otherwise it could do great harm to his/her body. The patient did not have a problem right now.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: all these shots doesn't help; 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 (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: COVID-19 (medically significant) with onset 08Feb2024, outcome "unknown", described as "COVID"; DRUG INEFFECTIVE (medically significant) with onset 08Feb2024, outcome "unknown", described as "all these shots doesn't help". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Feb2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was ordered to take Paxlovid. The patient came down with COVID this morning; symptoms started last night." Later in the call, patient guess getting all these shots doesn't help. Patient has had every COVID shot.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 88.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Daptacel on an 88-year-old patient with no reported adverse event; Initial information received on 10-Mar-2025 regarding an unsolicited valid  non-serious case received from a other healthcare professional.  This case involves a 88 years old male patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.   On 27-Feb-2025, the patient received standard dose of 0.5 ml of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection with lot 3CA25C1 and expiry date 30-Apr-2026 via intramuscular route in the left arm for Immunization (product administered to patient of inappropriate age) (Latency same day).  Action taken was not applicable.   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: 1.0
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: child was administered pentacel, but the polio portion was given without being mixed with the hib portion with no reported adverse event; Initial information received on 10-Mar-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 1 years old and unknown gender patient who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] but the polio portion was given without being mixed with the hib portion 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 an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) but the polio portion was given without being mixed with the hib portion with no reported adverse event (single component of a two component product administered) (Latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.  Reportedly,They want to ensure that this is safe and that the patient will not experience any side effects. Per SRD (Standard Reference Data) informed that Pentacel vaccine components should not be used separately. However, if the DTaP-IPV (Diphtheria, tetanus, and pertussis inactivated poliovirus) liquid component was administered separately it would count as a valid DTaP and IPV dose. Additionally informed that any dose of Act-HIB reconstituted with a diluent other than specific Act-HIB diluent should not be counted as valid and must be repeated.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient was given Tdap [ADACEL] instead of DTaP [DAPTACEL] as the fifth dose in the supposed 5 dose-series of DTaP with no reported adverse event; Initial information received on 11-Mar-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient who was given tdap (Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine) [adacel] instead of dtap (Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine) [daptacel] as the fifth dose in the supposed 5 dose-series of dtap 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 5 of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (strength, dose, batch and expiry date unknown) via unknown route in unknown administration site for immunization instead of dtap [daptacel] as the fifth dose in the supposed 5 dose-series of dtap with no reported adverse event (wrong product administered) (same day latency). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  Action taken: not applicable.   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.
Sex: M
Vaccine: UNK
Symptoms: Influenza, Influenza A virus test positive, Oropharyngeal pain, Pyrexia, Vaccination failure
Clinical narrative: Vaccination failure; Fever broke; Severe sore throat; Flu virus type A; This spontaneous case, initially received on 03-Mar-2025, was reported by a non health professional and concerns an adult male patient.  Administration of company suspect drug: On 22-Oct-2024, the patient received Flucelvax (TIV) for Indication not reported. Dose regimen: Not reported, Route of administration: Not reported. Anatomical location: Left Deltoid. Lot number: 946624.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 21-Feb-2025, the patient experienced Flu virus type A (Medically Significant, outcome: Not Reported). Associated symptoms included:  Fever broke , Severe sore throat. On unknown date, the patient experienced Flu virus type A after receiving Flucelvax/Vaccination failure (Medically Significant, outcome: Not Reported)  It was reported that 25-Feb-2025, severe sore throat subsided. Source of infection was not known for certain. Possibly obtained at a sporting event on 19-Feb-2025. Flu was verified by swab on 24-Feb-2025.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment:  The reporter did not provide the seriousness and causality of the events.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, the events are considered related for reporting purposes.  For influenza and vaccination failure, patient tested positive within 21 to 180 day time period and also tested positive to Influenza A on swab. Furthermore, A lack of effect can generally be expected for any medicinal/drug product as a 100% success rate cannot be reasonably assumed in every patient treated.
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Gait inability, Guillain-Barre syndrome, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: 90 percent bed ridden; unable to walk; unable to function; balance issues; Guillain-Barre syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barre syndrome) (serious criteria GSK medically significant and other: Serious as per reporter), bedridden (Verbatim: 90 percent bed ridden), unable to walk (Verbatim: unable to walk), performance status decreased (Verbatim: unable to function) and balance difficulty (Verbatim: balance issues). The outcome of the guillain barre syndrome was unknown (duration 2 days) and the outcome of the bedridden, unable to walk, performance status decreased and balance difficulty were not reported.   The reporter considered the guillain barre syndrome to be related to Shingrix. It was unknown if the reporter considered the bedridden, unable to walk, performance status decreased and balance difficulty to be related to Shingrix.     The company considered the guillain barre syndrome to be unrelated to Shingrix. It was unknown if the company considered the bedridden, unable to walk, performance status decreased and balance difficulty to be related to Shingrix.   Additional Information: GSK Receipt Date : 09-MAR-2025 This case was reported by a patient via interactive digital media. Patient developed Guillain-Barre syndrome (GBS) after receiving the first shingles shot.  As a result, she was 90 percent bedridden, unable to walk or function.  She had to re-learn to walk, dealing with balance issues, and it was a long three year journey.  Her physician had recommended the vaccine after she recovered from shingles to prevent a recurrence, but the vaccination was worse and caused nerve damage. she should have never taken the shot.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Shingrix