chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.83
Sex: U
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age, Product storage error
Clinical narrative: Product Storage Error; patient was administered the vaccine at less than approved age; 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 10-month-old patient who received MMR (Priorix) for prophylaxis.   On 21-OCT-2024, the patient received Priorix. On 21-OCT-2024, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient was administered the vaccine at less than approved age). On an unknown date, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error). The outcome of the inappropriate age at vaccine administration and incorrect storage of drug were 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: 19-NOV-2024 The nurse reported that their facility received 2 boxes of Priorix and did not realize they should be refrigerated, so the boxes were stored in the freezer for about a month.  They were exposed to a low of minus 23 degree Celsius.   The product was administered after being stored at inappropriate temperature, which led to incorrect storage of drug. The gender for this patient was not provided.   The reporter states the patient was administered the vaccine at less than approved age due to plans to travel outside of the country, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. This was 1 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024144734:Same reporter/different patient US-GSK-US2024144737:Same reporter/different patient US-GSK-US2024144736:Same reporter/different patient
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles outbreak; This serious case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a 62-year-old male 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: shingles outbreak). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 26-NOV-2024 The patient self-reported this case for himself. After receiving the second dose of Shingrix, the customer (patient) developed a shingles outbreak around the injection site. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1) and Shingrix (dose 2).
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: received an expired dose; 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 24-year-old female patient who received MMR (Priorix) (batch number 2237D, expiry date 01-AUG-2024) for prophylaxis.   On 05-NOV-2024, the patient received the 1st dose of Priorix. On 05-NOV-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: received an expired dose). 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: 27-NOV-2024 The patient received an expired dose which led expired vaccine administered. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Depression
Clinical narrative: Depression; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEPRESSION (Depression) in a patient of an unknown age and gender 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 DEPRESSION (Depression). At the time of the report, DEPRESSION (Depression) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       The concomitant medication was not reported by reporter. It was reported reporter heard from somebody who had the Moderna which he thought they read from the computer that Moderna booster shot had a tendency to intensify depression. It was also reported that if someone had depression saying he does suffered from depression. During the call the caller clarified that this somebody was his friend.  The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-778813 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-778813:Patient's case
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Nausea, Syncope
Clinical narrative: fainted; nauseated; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (fainted) in a 62-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication.    Previously administered products included for COVID-19 prophylaxis: Moderna original (Dose 1,Lot: 042L25A) on 06-Feb-2021, Moderna original (Dose 2 and Lot: 029A21A) on 09-Mar-2021. Past adverse reactions to the above products included No adverse event with Moderna original and Moderna original.   On 19-Dec-2021, the patient received third dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On 24-Apr-2022, received fourth dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant) and NAUSEA (nauseated). At the time of the report, SYNCOPE (fainted) and NAUSEA (nauseated) outcome was unknown.            No Concomitant medication was reported.  On her last three boosters, patient ended up fainting 8 to 12 hours later. The middle of the night, patient was wake up really nauseated. patient got out of bed and one time she was wrapped around the toilet, the other time she fell on the floor.  No treatment information was reported.   This case was linked to MOD-2024-778817 (Patient Link).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: Injected in his upper left arm, and there was an immediate burning, he could taste it in his mouth; Sick feeling; Muscle aches; His arm was sore for at least 48 hours or more/there was pain in his left arm.; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Sick feeling), MYALGIA (Muscle aches), PAIN IN EXTREMITY (His arm was sore for at least 48 hours or more/there was pain in his left arm.) and VACCINATION SITE PAIN (Injected in his upper left arm, and there was an immediate burning, he could taste it in his mouth) in a 65-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Nov-2024 at 4:00 PM, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In November 2024, the patient experienced MALAISE (Sick feeling), MYALGIA (Muscle aches) and PAIN IN EXTREMITY (His arm was sore for at least 48 hours or more/there was pain in his left arm.). On 27-Nov-2024, the patient experienced VACCINATION SITE PAIN (Injected in his upper left arm, and there was an immediate burning, he could taste it in his mouth). In November 2024, MALAISE (Sick feeling), MYALGIA (Muscle aches), PAIN IN EXTREMITY (His arm was sore for at least 48 hours or more/there was pain in his left arm.) and VACCINATION SITE PAIN (Injected in his upper left arm, and there was an immediate burning, he could taste it in his mouth) had resolved.            Concomitant medication was not provided. Patient was injected in his upper left arm, and there was an immediate burning, he could taste it in his mouth, and there was pain in his left arm. His arm was sore for at least 48 hours or more. He had muscle aches and had a sick feeling. He had kept up with the vaccines ever since this outbreak started. Thinks that one was one that he had the most trouble with 2 to 2.5 days before the pain went away in his left arm. He thinks that the technician at the pharmacy was competent and had done that plenty of times before. He also going to call his PCP. The only thing he worried about was any possible cardiac issues.  Date of receipt of vaccine was day beforea holiday.  Treatment information was not reported.   Reporter did not allow further contact
Age: 0.33
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Pain, Pyrexia, Vomiting
Clinical narrative: upset stomach; body aches; throwing up; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), PAIN (body aches), VOMITING (throwing up), CHILLS (chills) and PYREXIA (fever) in a 4-month-old male patient who received mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Dec-2024, the patient received dose of mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 03-Dec-2024, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), PAIN (body aches), VOMITING (throwing up), CHILLS (chills) and PYREXIA (fever). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), PAIN (body aches), VOMITING (throwing up), CHILLS (chills) and PYREXIA (fever) was resolving.        The action taken with mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Intramuscular use) was unknown.   For mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was unknown if the patient has experienced any additional symptoms/events. Medication Details and reason for taking the medicine. No treatment information was reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity
Clinical narrative: arm is still sore; looking at arm, it feels bruised; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (arm is still sore) and CONTUSION (looking at arm, it feels bruised) in a 63-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8050750) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. In 2024, the patient experienced PAIN IN EXTREMITY (arm is still sore) and CONTUSION (looking at arm, it feels bruised). At the time of the report, PAIN IN EXTREMITY (arm is still sore) and CONTUSION (looking at arm, it feels bruised) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. It was reported that patient got a Spikevax shot about 4 weeks ago arm was still sore, not sign of any problems if looking at arm, but she said it feels bruised. It was unknown if the patient experienced any additional symptoms/events. The treatment medication was not reported by reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Nausea, Syncope
Clinical narrative: ended up fainting 8 to 12 hours later; The third time I fell and hit my head.; dizzy; wake up really nauseated; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (ended up fainting 8 to 12 hours later) in a 62-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 203J23A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-May-2024, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. In May 2024, the patient experienced SYNCOPE (ended up fainting 8 to 12 hours later) (seriousness criterion medically significant), FALL (The third time I fell and hit my head.), DIZZINESS (dizzy) and NAUSEA (wake up really nauseated). At the time of the report, SYNCOPE (ended up fainting 8 to 12 hours later), FALL (The third time I fell and hit my head.), DIZZINESS (dizzy) and NAUSEA (wake up really nauseated) outcome was unknown.            No concomitant medication was reported. No vaccine within past 4 weeks was given. Patient received the Moderna vaccines 4 times. And the first 2 times that patient received it, everything was fine, no problems whatsoever. Then she was given two Pfizer vaccines in between." The last one was the Moderna Spikevax.  The middle of the night, she was wake up really nauseated. she had gotten out of bed and one time she was wrapped around the toilet, the other time she fell on the floor. The third time she fell and hit her head." she was not prone to fainting.  It was stated, "she got it during her doctor's appointment about 1 o'clock and then at 2 o'clock, around 2 o'clock in the morning, that's when she woke up really nauseated and dizzy. And she got up. And next thing, she knew she was on the floor and she heard a bang and hit her head on the, on the dresser."   Patient generally don't have reactions to any vaccines or any shots. This one was just concerning because it's always been in the middle of the night. 8 to 12 hours or so past getting it. It was unknown if the patient experienced any additional symptoms/events.  No treatment information was reported.   This case was linked to MOD-2024-778825 (Patient Link).; Reporter's Comments: The syncope experienced with the two previous doses of the Pfizer vaccine remain as confounders. The benefit-risk relationship of product is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cardiac flutter, Heart rate, Heart rate irregular, Inflammation
Clinical narrative: she started having some back pain/bad pain in my back/I just had a slight backache; inflammation on her lower back; having heart irregularities; pounding of the heart and flutter; pounding of the heart and flutter; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 75-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30Sep2024 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: HEART RATE IRREGULAR (non-serious) with onset 2024, outcome "not recovered", described as "having heart irregularities"; INFLAMMATION (non-serious) with onset 2024, outcome "recovering", described as "inflammation on her lower back"; CARDIAC FLUTTER (medically significant), PALPITATIONS (non-serious) all with onset 2024, outcome "not recovered" and all described as "pounding of the heart and flutter"; BACK PAIN (non-serious) with onset 27Oct2024, outcome "recovering", described as "she started having some back pain/bad pain in my back/I just had a slight backache". The events "she started having some back pain/bad pain in my back/i just had a slight backache" and "inflammation on her lower back" required emergency room visit. The patient underwent the following laboratory tests and procedures: Heart rate: irregularities, notes: she's having heart irregularities; X-ray: inflammation, notes: I took Xray and said there was inflammation in my back. Therapeutic measures were taken as a result of back pain, inflammation. Clinical course: A 75-year-old female that was administered with Comirnaty for 12 years plus on 30Sep2024 at (name). On 27Oct2024 she started having some back pain and a week later her back pain got worse, and she was prescribed ibuprofen. Pain got even worse, and she was rushed to the emergency room (ER). The doctor said it was inflammation on her lower back and the doctor took an x-ray and gave her muscle relaxant. It has gotten better. Her concern now is that she is having heart irregularities which started about a week ago. She is experiencing pounding of the heart and flutter. She asked for side effects and if her symptoms were listed as part of the side effects of COMIRNATY, agent was able to assist with her inquiry and provided information on myocarditis and pericarditis. Caller did not report myocarditis and pericarditis, but agent provided information on myocarditis and pericarditis since this was her inquiry. She was going to be checked by cardiologist later today. Caller did not provide lot number.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, X-ray
Clinical narrative: she started having some back pain/bad pain in my back/I just had a slight backache; inflammation on her lower back; having heart irregularities; pounding of the heart and flutter; pounding of the heart and flutter; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 75-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30Sep2024 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: HEART RATE IRREGULAR (non-serious) with onset 2024, outcome "not recovered", described as "having heart irregularities"; INFLAMMATION (non-serious) with onset 2024, outcome "recovering", described as "inflammation on her lower back"; CARDIAC FLUTTER (medically significant), PALPITATIONS (non-serious) all with onset 2024, outcome "not recovered" and all described as "pounding of the heart and flutter"; BACK PAIN (non-serious) with onset 27Oct2024, outcome "recovering", described as "she started having some back pain/bad pain in my back/I just had a slight backache". The events "she started having some back pain/bad pain in my back/i just had a slight backache" and "inflammation on her lower back" required emergency room visit. The patient underwent the following laboratory tests and procedures: Heart rate: irregularities, notes: she's having heart irregularities; X-ray: inflammation, notes: I took Xray and said there was inflammation in my back. Therapeutic measures were taken as a result of back pain, inflammation. Clinical course: A 75-year-old female that was administered with Comirnaty for 12 years plus on 30Sep2024 at (name). On 27Oct2024 she started having some back pain and a week later her back pain got worse, and she was prescribed ibuprofen. Pain got even worse, and she was rushed to the emergency room (ER). The doctor said it was inflammation on her lower back and the doctor took an x-ray and gave her muscle relaxant. It has gotten better. Her concern now is that she is having heart irregularities which started about a week ago. She is experiencing pounding of the heart and flutter. She asked for side effects and if her symptoms were listed as part of the side effects of COMIRNATY, agent was able to assist with her inquiry and provided information on myocarditis and pericarditis. Caller did not report myocarditis and pericarditis, but agent provided information on myocarditis and pericarditis since this was her inquiry. She was going to be checked by cardiologist later today. Caller did not provide lot number.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: caller considers that she got COVID-19 infection from mother of child.; caller considers that she got COVID-19 infection from mother of child.; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 64-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "caller considers that she got COVID-19 infection from mother of child.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: The patient reported that she got the "shot" last year, but that while she babysat a child, the mother of said child was coughing and that caller started to "not feel well". The patient added that it turned out that mother of child was tested for Covid-19 infection and tested positive; therefore, the patient considered that she got COVID-19 infection from mother of child. The patient received the Pfizer-BioNTech Covid-19 Vaccine (2024-2025 Formula) on 03Dec2024.  Batch/lot number is not provided, and it cannot be obtained.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient was given FLUZONE HD but she is only 61 years old with no reported adverse event; Initial information received on 03-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 61 years old female patient who experienced patient was given Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Nov-2024, the patient received a  dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (strength: not reported) (lot: UT8437BA, Expiry date: 30-Jun-2025) via intramuscular route in the left deltoid for Influenza, but she is only 61 years old, with no reported adverse event (product administered to patient of inappropriate age) (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: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: was inadvertently given 2 doses of FLUZONE HD a little bit more than a month apart;given to a pt approximately more than a month apart within the same flu season with no reported adverse event; Initial information received on 04-Dec-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 88 years old male patient who was inadvertently given 2 doses of Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd], a little bit more than a month apart;given to a pt approximately more than a month apart within the same flu season with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Oct-2024 the patient was inadvertently received a dose 1 of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (lot: UT8473DA, Expiry date:30-Jun-2025) and on 03-Dec-2024 the patient also received dose 2 of same vaccine via intramuscular route in the left deltoid for Influenza, a little bit more than a month apart;given to a pt approximately more than a month apart within the same flu season with no reported adverse event (extra dose 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: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: PENTACEL was administered with a different diluent, a sterile diluent and not the one that comes with the vaccine with no reported adverse event; Initial information received on 04-Dec-2024 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 15 months old male patient who was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with a different diluent, a sterile diluent and not the one that comes with the vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant-no other vaccines.  On 04-Dec-2024, the patient received 0.5 ml (Standard) 1X (once) DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Suspension for injection (lot UK045AA, expiry date: 30-Aug-2025) via intramuscular route in the left thigh for immunization administered with a different diluent, a sterile diluent and not the one that comes with the vaccine with no reported adverse event (product preparation error).  Reportedly, RN (Registered Nurse) reports that the PENTACEL (15-month series) was administered with a different diluent, a sterile diluent and not the one that comes with the vaccine. Caller verified that the liquid component was not given to the patient, only the powder component which was diluted with sterile water.  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: F
Vaccine: HPV4
Symptoms: Cervix carcinoma, Smear cervix abnormal
Clinical narrative: development of cancer with a strain that is not included in the 4 valent or the 9 valent GARDASIL 9 vaccine.; This spontaneous report was received from a nurse referring to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.     On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) injection, 0.5 mL/ 3 dose series, intramuscularly, as human papilloma virus (HPV) vaccination (strength, anatomical location, Lot # and expiration date were not reported).         It was stated "We have a patient who was initially vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL)  which has the protection from the 4 strains of HPV and they recently had an abnormal pap smear which showed development of cancer (cervix carcinoma) with a strain that is not included in the 4 valent or the 9 valent hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) vaccine. I just wanted to call with a simple question and I don't want to give any more information." At the time of reporting, the outcome of cervix carcinoma was unknown.   The causality assessment between the event and the suspect vaccine was not provided.   Upon internal review, cervix carcinoma was determined to be a medically significant event.   Nurse refused to provide any patient information or any additional information regarding this report. Nurse refused correspondence.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: we've had all the Pfizer vaccines too/My husband and I have covid; we've had all the Pfizer vaccines too/My husband and I have covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 79-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 included: "Covid-19" (unspecified if ongoing), notes: They have had Paxlovid before. The patient's concomitant medications were not reported. Past drug history included: Paxlovid for Covid-19, notes: They have had Paxlovid before/She thinks they both had it one other time. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "we've had all the Pfizer vaccines too/My husband and I have covid". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  Clinical course: During the call, the reporter stated that her and her husband have covid. They were in their late 70s. The husband was prescribed Paxlovid. Later in the call, the reporter stated that she also had a sinus infection, pneumonia, and she was on day 11 now. Her husband got it after her and Paxlovid was more critical for him. The husband was not doing well at all, and she felt like he really needed it. It's already day five and he'll benefit from it if he could start it today. The reporter added that she was diagnosed eleven days ago with pneumonia and sinus infection. She has done antibiotics, steroids and all that, so she does not need the Paxlovid. They have had Paxlovid before and it made such a difference. The representative then clarifies that both the reporter and her husband have previously taken Paxlovid. She thinks they both had it one other time and they also had all the Pfizer vaccines too.  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-PV202400159203 same reporter/product/events; different patient;
Sex: F
Vaccine: COVID19
Symptoms: Bedridden
Clinical narrative: she was in bed for about four days; This is a spontaneous report received from an Other HCP. Other Case identifier(s): NOV24-00899.  A female 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. The following information was reported: BEDRIDDEN (non-serious), outcome "unknown", described as "she was in bed for about four days".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400159681 same patient, different dose number and event;
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: pentacel that was reconstituted with a sterile diluent instead of the hib component that the pentacel came with was administered to a patient with no reported ae; Initial information received on 04-Dec-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who had Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] that was reconstituted with a sterile diluent instead of the hib component that the pentacel came with was administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (Suspension for injection) strength, expiry date, lot number not reported via unknown route in unknown administration site for Prophylactic vaccination (Immunization) and pentacel that was reconstituted with a sterile diluent instead of the hib component that the pentacel came with was administered to a patient with no reported ae (product preparation error) (latency: same day). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.   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: 10.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: NO REACTION AT TIME OF VACCINE, DISCOVERED WHEN DOING INVENTORY THAT THE LOT NUMBER IS FOR MODERNA SPIKEVAX FOR 12+, PATIENT IS ON LY 10 AND SHOULD HAVE BEEN PEDIATRIC 0.25 ML DOSE
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site mass, Pain in extremity
Clinical narrative: Per patient, she developed a sore arm soon after receiving the vaccination. The patient stated her arm continued to be sore weeks later. Due to pain, and a large red area around the shot administration site, the patient followed up with provider 12/04/24. In case of infection, the patient was  prescribed cephalexin 500 mg 1 BID for 5 days starting  12/04/24. The patient presented to the pharmacy 12/10/24 stating her arm was still sore and there was a knot in the area. There was no redness in the area as of 12/10/24. Patient confirmed understanding that this issue was being submitted to VAERS.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: RINGING OF THE EAR THAT IS STILL ONGOING
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Blister, Blister rupture, Rash, Scab
Clinical narrative: 2 rashes, lasting about 2 weeks total. First rash, many small bumps all over back and belly. After 2 days, small bumps disappear and large blisters form on face, arms, and legs. Blisters eventually popped on own, became scabs and healed.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt is an 11 yr. 6 mo. female that was getting blood work and vaccinations done in the clinic. Covid Vaccine administerd was Spikevax, intended age group is 12-18 yrs of age. No reaction noted when administered in clinic or following vaccination. Vaccine Lot number : B0001 Exp 2025-05-08
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Brief syncopal episode after 2 minutes. normal exam. vitals rechecked
Age: 24.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO REACTION AT TIME OF VACCINATION. UPON RECONCILING INVENTORY THIS PATIENT WAS GIVEN FLUAD SENIOR DOSE IN ERROR AND WAS NOT 65 YEARS OF AGE.
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Paitent has swelling and redness at the site of injection
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO REACTION AT TIME OF VACCINATION. DISCOVERED UPON INVENTORY THAT SENIOR DOSE FLUAD WAS GIVEN IN ERROR, PATIENT IS ONLY 54 YEARS OF AGE.
Age: 71.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events. Vaccine was administered to patient inappropriately outside of guideline recommendations. Patient had gotten vaccine already in April of same year.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: Tdap vaccine was given to patient without providers order. Patient was not due for Tdap vaccine. See providers statement "Extra vaccine given - not ordered 2 correct vaccines given no immunization reaction reported, no hx of allergy to any vaccine. Mom notified by phone by Dr. questions answered- reassured"
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy, Mobility decreased
Clinical narrative: developed Bell's Palsy, left side of face has reduced range of motion,  Treatment with Prednisone and Famciclovir.  too early to determine final outcome.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO REACTION AT TIME OF VACCINATION. FLUAD GIVEN IN ERROR TO AGE 64, DISCOVERED BY LOT # UPON INVENTORY. PATIENT HAD REQUESTED FLUCELVAX.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: My reaction was an almost gel like substance  appeared 3 inches below the injection site, red, warm to the touch and itchy.  It was about  3 inches long and 2 inches wide. Soft and movable. IRash is still present but lessened and still itches. I have never had a physical reaction to flu shot before
Age: 53.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Right arm read and swollen
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Back pain, Influenza like illness, Musculoskeletal pain, Pain, Sciatica
Clinical narrative: flu like muscle aches next morning. then one week later post covid vaccination experienced increased pain (back and sciatia)  10 out of 10 on scale. Continued pain thru 12-7 12-8 12-9 12-10 extreme pain while standing  up .  some relief  while laying down, but pain extending down lower back to buttoks- hamstring to ankle. Classic sciatica  distribution...
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received a second flu vaccine instead of requested COVID Vaccine
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: 01/11/2024: PATIENT STARTED LOSING HAIR ON HEAD AT AN EXCEEDING RATE AND WAS COMPLETELY BALD WITHIN TWO WEEKS. HAIR LOSS NOW AFFECTS ENTIRE BODY. DERMATOLOGIST WAS CONSULTED. TOPICAL TREATMENTS INCLUDED BETAMETHASONE DP 0.05% LOTION, AZELAIC GEL 15%, AND TRETINOIN CREAM 0.025%. IT NOW HAS BEEN A YEAR SINCE VACCINATION AND PATIENT STILL HAS TOTAL HAIR LOSS.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PT CAME IN WITH AN RX RECOMMENDED FOR AREXVY FROM PRIMERY CARE. IT WAS ADMNISTERED, AND LATER FOUND THEY THE VACCINATION A LITTLE OVER A YEAR AGO.  THEY STATED THEY HAD NO REACTION FROM THE VACCINE.
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PT CAME IN WITH AN RX RECOMMENDED FOR AREXVY FROM PRIMERY CARE. IT WAS ADMNISTERED, AND LATER FOUND THEY THE VACCINATION A LITTLE OVER A YEAR AGO.  THEY STATED THEY HAD NO REACTION FROM THE VACCINE.
Age: 61.0
Sex: M
Vaccine: COVID19, PNC20, VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: redness in right arm , mostly below the site of vaccination
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient was seen on 12/9 for her appointment at 10 am with PCP Dr. A Moderna vaccine was ordered by Dr. MA obtained a COVID vaccine from the Medication Room. Upon looking in the vaccine fridge, MA only noted one location of the COVID vaccines. She reported she did not "look around" closely to find the adult vaccine and did not realize she grabbed a pediatric vaccine at the time when she was in the Medication Room. She did notice the difference in color but did not proceed with looking in the vaccine fridge any further. She completed a dual verification with MA. The dual verification was not a computer so the order in the patient's chart was not reviewed by either MA. MA administered the vaccine to the patient without charting the information in the patient's medical record first. MA realized the error and reported the incorrect vaccine administration to leadership.   PharmD was contacted for review of options for patient given the patient had now only received a pediatric dose for a COVID vaccine. PharmD provided the below options:  1. Patient can receive a second dose of a pediatric COVID vaccine 2. Patient can receive a regular dose of an adult Moderna COVID vaccine  3. Patient can receive a Novavax to supplement the Moderna vaccine which offers slightly different strain 4. Patient can opt to not receive any additional vaccine follow up  RN spoke with the patient by phone to review the options. The patient opted to not have any further COVID vaccination completed. The patient was updated that if she were to change her mind, she can be scheduled at the clinic for any of the above options. The patient confirmed understanding. Record documentation has been completed.   MA was coached on the policy for Clinic Vaccine Administration Work Instruction - Policy Number. The vaccine fridge was also labeled with a pink sign indicating pediatric COVID vaccine dose. Dr. was notified. MA will also receive coaching regarding dual verification.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Asthenia, Injection site pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Severe weakness, and pain in left arm up through the shoulder and neck. Painful and stiffness when tried to move, or lift in any direction. Constant throbbing pain in upper left arm
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Pain in extremity
Clinical narrative: Severe weakness, and pain in left arm up through the shoulder and neck. Painful and stiffness when tried to move, or lift in any direction. Constant throbbing pain in upper left arm
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: large bumps on both arms at injection site, localized swelling, erythema, and urticaria
Age: 54.0
Sex: F
Vaccine: COVID19, FLU3, COVID19
Symptoms: Balance disorder, Blood test abnormal, Cerebral thrombosis, Computerised tomogram head abnormal, Electrocardiogram
Clinical narrative: Stroke, had a blood clot developed in the back of my head; Stroke, had a blood clot developed in the back of my head; It was intravenous, a shot in the shoulder; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Nov2024 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years intravenous for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Diabetes; "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: GLIPIZIDE taken for diabetes mellitus; METFORMIN; CLAVIX [CLARITHROMYCIN]; ASPIRIN [ACETYLSALICYLIC ACID]; JARDIANCE; METOPROLOL; VIT D [VITAMIN D NOS]. Vaccination history included: Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN), for COVID-19 immunization. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 06Nov2024, outcome "unknown", described as "It was intravenous, a shot in the shoulder"; CEREBROVASCULAR ACCIDENT (hospitalization), THROMBOSIS (hospitalization) all with onset Nov2024, outcome "unknown" and all described as "Stroke, had a blood clot developed in the back of my head".  The clinical course was reported as follows: The patient started feeling bad after she got the shot, it was intravenous, a shot in the shoulder (as reported) but she took Moderna, she never took Pfizer before, since the stroke she had been on blood thinner. The patient was hospitalized for cerebrovascular accident, thrombosis (start date: 22Nov2024, discharge date: 23Nov2024, hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: Blood test: (Nov2024) Unknown results; Computerised tomogram: (Nov2024) Unknown results; Magnetic resonance imaging: (Nov2024) Unknown results; Ultrasound scan: (Nov2024) Unknown results. Therapeutic measures were taken as a result of thrombosis.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.