chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Globulin, Interchange of vaccine products, Poor quality product administered, Product administration error
Clinical narrative: Caller says the patient last got 2 moderna doses back on 2021; Expiration on the vial itself shows Sep2022/administration date: 13Jun2023; it was first punctured yesterday at 4pm but was still given today at 3:20PM; it was first punctured yesterday at 4pm but was still given today at 3:20PM; Creatinine: 10.2; CO2: 22; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID: ().  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Jun2023 at 15:20 as dose 3 (booster), 0.3 ml single (Lot number: GL2042, Expiration Date: Sep2022) at the age of 54 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: AZOR [AMLODIPINE BESILATE;OLMESARTAN MEDOXOMIL]; XIGDUO XR; METFORMIN [METFORMIN HYDROCHLORIDE]; PRILOSEC [OMEPRAZOLE]; CRESTOR OD. Vaccination history included: Moderna covid vaccine (Dose 1), administration date: 2021, for COVID-19 immunization; Moderna covid vaccine (Dose 2), administration date: 2021, for COVID-19 immunization. The following information was reported: CARBON DIOXIDE DECREASED (non-serious) with onset 13Jun2023, outcome "unknown", described as "CO2: 22"; BLOOD CREATININE INCREASED (non-serious) with onset 13Jun2023, outcome "unknown", described as "Creatinine: 10.2"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 13Jun2023 at 15:20, outcome "unknown", described as "Caller says the patient last got 2 moderna doses back on 2021"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 13Jun2023 at 15:20, outcome "unknown", described as "Expiration on the vial itself shows Sep2022/administration date: 13Jun2023"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 13Jun2023 at 15:20, outcome "unknown" and all described as "it was first punctured yesterday at 4pm but was still given today at 3:20PM". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that the "vials were first punctured yesterday at 4 PM but were still given today at 3:20 PM to a patient". The reporter stated that prior to this, the patient just had 2 Moderna doses back in 2021. Further, the expiration date of the vial shows Sep2022. Lab work was done on 13Jun2023 and included albumin: 4.6, ALK phosphate: 72, ALT: 27, AST: 19, BUN: 13, Calcium: 9.9, Chloride: 106, CO2: 22, creatinine: 1.3, globulin: 3.4, glucose: 227, potassium: 4.3, sodium: 140, total bili: 0.6, protein: 8.0, and creatinine: 10.2 . The patient had no prior vaccinations (4 week)
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Protein total
Clinical narrative: Caller says the patient last got 2 moderna doses back on 2021; Expiration on the vial itself shows Sep2022/administration date: 13Jun2023; it was first punctured yesterday at 4pm but was still given today at 3:20PM; it was first punctured yesterday at 4pm but was still given today at 3:20PM; Creatinine: 10.2; CO2: 22; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID: ().  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Jun2023 at 15:20 as dose 3 (booster), 0.3 ml single (Lot number: GL2042, Expiration Date: Sep2022) at the age of 54 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: AZOR [AMLODIPINE BESILATE;OLMESARTAN MEDOXOMIL]; XIGDUO XR; METFORMIN [METFORMIN HYDROCHLORIDE]; PRILOSEC [OMEPRAZOLE]; CRESTOR OD. Vaccination history included: Moderna covid vaccine (Dose 1), administration date: 2021, for COVID-19 immunization; Moderna covid vaccine (Dose 2), administration date: 2021, for COVID-19 immunization. The following information was reported: CARBON DIOXIDE DECREASED (non-serious) with onset 13Jun2023, outcome "unknown", described as "CO2: 22"; BLOOD CREATININE INCREASED (non-serious) with onset 13Jun2023, outcome "unknown", described as "Creatinine: 10.2"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 13Jun2023 at 15:20, outcome "unknown", described as "Caller says the patient last got 2 moderna doses back on 2021"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 13Jun2023 at 15:20, outcome "unknown", described as "Expiration on the vial itself shows Sep2022/administration date: 13Jun2023"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 13Jun2023 at 15:20, outcome "unknown" and all described as "it was first punctured yesterday at 4pm but was still given today at 3:20PM". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that the "vials were first punctured yesterday at 4 PM but were still given today at 3:20 PM to a patient". The reporter stated that prior to this, the patient just had 2 Moderna doses back in 2021. Further, the expiration date of the vial shows Sep2022. Lab work was done on 13Jun2023 and included albumin: 4.6, ALK phosphate: 72, ALT: 27, AST: 19, BUN: 13, Calcium: 9.9, Chloride: 106, CO2: 22, creatinine: 1.3, globulin: 3.4, glucose: 227, potassium: 4.3, sodium: 140, total bili: 0.6, protein: 8.0, and creatinine: 10.2 . The patient had no prior vaccinations (4 week)
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure, Investigation
Clinical narrative: Heart failure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 51-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CARDIAC FAILURE (medically significant), outcome "not recovered", described as "Heart failure". The event "heart failure" required physician office visit. The patient underwent the following laboratory tests and procedures: Lab: unknown results. Therapeutic measures were taken as a result of cardiac failure. Clinical course: Patient received treatment of Beta blockers and Propranolol. Reporter stated adverse events do require physician visit but not emergency room and outcome of the event Persisting. Reporter did not had Immunization card handy and stated it was early 2021 and do not know the month. Patient had no other vaccine administered within 4 weeks prior to the first administration date of Pfizer vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300221719 Same patient, different drug/ AE;
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Still have pain in my arm at the point where the vaccine was given; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party (BIONTECH SE). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2021 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 SITE PAIN (non-serious), outcome "not recovered", described as "Still have pain in my arm at the point where the vaccine was given". The event "still have pain in my arm at the point where the vaccine was given" required physician office visit.  Additional information: The patient was vaccinated two doses in 2021. She still had pain in her arm at the point where the vaccine was given. When she went to the doctor, they did not know why and there was no solution.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  BNT162b2 is under agreement with BIONTECH SE.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300104500 same patient, drug, event, different dose;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight fluctuation
Clinical narrative: Chemo brain is taking some of the thinking away.; With chemo her weight has fluctuation; but her platelets and neutrophils were low, so they extended it to every four weeks to give her body more time to rebound; but her platelets and neutrophils were low, so they extended it to every four weeks to give her body more time to rebound; her cancer antigen test, called CA125, had started to rise; She is having a recurrence of cancer, which was originally diagnosed in 2020 and was in chemo during her first two shots, so now she is having a recurrence; PET scan showed still had one or two active spots; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 08Jun2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID: The reporter is the patient.  A 71-year-old female patient received carboplatin (CARBOPLATIN), first regimen since 03Nov2020 and second regimen since 02Mar2023 for fallopian tube cancer, ovarian cancer; paclitaxel (PACLITAXEL), first regimen since 03Nov2020 and second regimen since 02Mar2023 for fallopian tube cancer, ovarian cancer; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 70 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: EL8982), on 03Mar2021 as dose 2, single (Lot number: EN6202), on 20Aug2021 as dose 3 (booster), single (Lot number: EW0167) and on 20May2022 as dose 4 (booster), single (Lot number: FM9992) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AVASTIN [ATORVASTATIN CALCIUM]. The following information was reported: POSITRON EMISSION TOMOGRAM ABNORMAL (non-serious) with onset 07Feb2023, outcome "unknown", described as "PET scan showed still had one or two active spots"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "Chemo brain is taking some of the thinking away."; WEIGHT FLUCTUATION (non-serious), outcome "unknown", described as "With chemo her weight has fluctuation"; PLATELET COUNT DECREASED (non-serious), NEUTROPHIL COUNT DECREASED (non-serious), outcome "unknown" and all described as "but her platelets and neutrophils were low, so they extended it to every four weeks to give her body more time to rebound"; CARBOHYDRATE ANTIGEN 125 INCREASED (non-serious), outcome "unknown", described as "her cancer antigen test, called CA125, had started to rise"; NEOPLASM RECURRENCE (non-serious), outcome "unknown", described as "She is having a recurrence of cancer, which was originally diagnosed in 2020 and was in chemo during her first two shots, so now she is having a recurrence". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for carboplatin and paclitaxel was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Eye disorder
Clinical narrative: My eyes are gone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient. Other Case identifier(s): AE-008557 (LP-BioNTech).  A male patient received BNT162b2 (COMIRNATY), 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: EYE DISORDER (non-serious), outcome "unknown", described as "My eyes are gone".  Additional Information: It was reported that "My eyes are gone because of you".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  COMIRNATY is under agreement with BIONTECH SE.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: she had covid four times; she had covid four times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 79-year-old female 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she had covid four times". Clinical Course: Caller was called to got some covid test. She said that they sent her three to four boxes last year. She wanted to know if they still supply a home testing kit. Caller mentioned that she had covid four times (not clarified if covid virus or shots).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: he got 5 shots of Pfizer vaccine for Covid and he just recently got Covid last six or seven days; he got 5 shots of Pfizer vaccine for Covid and he just recently got Covid last six or seven days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID. The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "he got 5 shots of Pfizer vaccine for Covid and he just recently got Covid last six or seven days". Clinical course: Caller said he got 5 shots of Pfizer vaccine for Covid and he just recently got Covid last six or seven days. The last date of his vaccination was 21Sep2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Gave my mother A-Fib. Now she's dead.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female 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: ATRIAL FIBRILLATION (death), outcome "fatal", described as "Gave my mother A-Fib. Now she's dead.". The patient date of death was unknown. Reported cause of death: "gave my mother A-Fib. Now she's dead.''  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Gave my mother A-Fib. Now she's dead.
Sex: U
Vaccine: TYP
Symptoms: Accidental exposure to product
Clinical narrative: after administering the dose there were a few drops on the outside/ pharmacist thinks the drops were on the patient's skin, with no reported adverse event; Initial information was received on 08-Jun-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient on whom after administering the dose of typhoid vi polysaccharide vaccine [Typhim Vi] there were a few drops on the outside/ pharmacist thinks the drops were on the patient's skin, 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 0.5 ml, total dose of suspect typhoid vi polysaccharide vaccine (Solution for injection) (lot number, expiry date was unknown) strength: standard via unknown route in unknown administration site for TB skin test (Tuberculin test), on whom the after administering the dose there were a few drops on the outside/ pharmacist thinks the drops were on the patient's skin, with no reported adverse event (accidental exposure to product) (latency: same day). The information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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 guidelines. 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: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient was inadvertently administered expired daptacel with no reported adverse event; Initial information was received on 09-Jun-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 2 years old male patient who was inadvertently administered expired diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Jun-2023, the patient received inadvertently administered expired dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine (strength: standard) at dose of 0.5 ml total once (1x) (lot number: C5883AA, expiration date: Unknown) via intramuscular route in the left thigh for Immunization (immunisation) with no reported adverse event (expired product administered) (latency: same day) Information on the batch number was requested.  No lab data reported.  Action taken: not applicable.  Outcome was Unknown for the event patient was inadvertently administered expired daptacel with no reported adverse event.  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 guidelines. 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: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: used the recommended diluent but was not able to administer it together with the lyophilized powder with no reported adverse event; Initial information received on 12-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years old female patient and reporter reported that she used the recommended HIB (PRP/T) VACCINE [ACT-HIB] (diluent) but was not able to administer it together with the lyophilized powder, 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 1 at a dose of 0.5 ml of suspect HIB (PRP/T) VACCINE (frequency: once, Strength: standard, expiry date: 06-Oct-2023 and lot: UJ792AA) via intramuscular route in the right thigh for immunization.  On 09-Jun-2023 the patient used the recommended diluent but was not able to administer it together with the lyophilized powder, with no reported adverse event (product preparation error) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 guidelines. 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: 67.0
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired daptacel was administered today with no reported adverse event; Initial information received on 13-Jun-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 67 years old and unknown gender patient to whom expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] was administered today with no reported adverse event.  The patient's past medical history included Stem cell transplant. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included polio vaccine inact 3V (vero) (IPOL Polio Vaccine); and hepatitis B vaccine RHBSAG (YEAST) (Engerix) for Prophylactic vaccination.  On 13-Jun-2023, the patient received 0.5 mL expired dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (batch number: O5829BA; expiry date: 31-May-2023) via intramuscular route in unknown administration site for Immunization, today with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired daptacel was administered today with no reported adverse event.  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 guidelines. 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: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep apnoea syndrome, Snoring
Clinical narrative: It was not noticable at first due to still living in isolated quarters on the job. However, once I've returned home spouse immediately noticed increased snoring and possible sleep apnea symptoms. I have not had any history of sleep disorders or issues prior to that date.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Heart rate increased, Sleep disorder
Clinical narrative: Approx. 2 weeks after receiving the vaccine I experienced rapid pulse/heartbeat at bedtime when laying down. I did not associate it with the vax at that time. I also experienced erratic elevated blood pressure which I had been home monitoring quasi daily since 2017. I ascribed these weird symptoms to other events. For the next six months I experienced continuously erratic sleep patterns, waking up frequently (every 1.5 hrs or so) with rapid heartbeat. In September I neglected to get the recommended vax  booster on schedule. That month I noticed marked improvement in my sleep and bp. I did not associate the improvement with the reduced vax efficacy timeline.
Sex: F
Vaccine: PNC15
Symptoms: Syringe issue
Clinical narrative: the last syringe cut her finger when it broke.; Merck representative reporting a PQC for VAXNEUVANCE. Caller stated he received an email that he would forward to attach to the case. No AE reported by representative.  "the glass portion of the syringe has broken while attempting to separate the cap; Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES; Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES; This spontaneous report was received from a physician and an office manager, referring to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date in 2023, the health care professional broke 3 syringes, while attempting to give the PCV 15 pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) 0.5 milliliters, lot Number: X004289 and expiration date on 10-DEC-2024 (route of administration and anatomical location, were not reported) administered for prophylaxis. On three separate occasions, when the medical assistant (MA) or doctor has given pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), the glass portion of the syringe has broken while attempting to separate the cap from the syringe. Both, the MA´s and the doctors give vaccines all day every day, and over the course of a year, give thousands of vaccines. It was reported that the breaking syringe not only represents a hazard to the patients and the staff but was also lost revenue due to the wasted vaccine. They do not have any similar type of incident with other vaccine products.   The patient (also the MA) relayed that the last syringe cut her finger when it broke. At the reporting time, the outcome of the finger cut was unknown. The casuality assessment between pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) and the finger cut was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Diplopia, IVth nerve paralysis
Clinical narrative: diagnosed with 4th cranial nerve palsy; He was seeing double; his balance has been off; This serious case was reported by a consumer via interactive digital media and described the occurrence of ivth nerve palsy in a male 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 ivth nerve palsy (Verbatim: diagnosed with 4th cranial nerve palsy) (serious criteria hospitalization and GSK medically significant), double vision (Verbatim: He was seeing double) (serious criteria hospitalization) and balance disorder (Verbatim: his balance has been off) (serious criteria hospitalization). The outcome of the ivth nerve palsy, double vision and balance disorder were not reported.   It was unknown if the reporter considered the ivth nerve palsy, double vision and balance disorder to be related to Shingles vaccine.     It was unknown if the company considered the ivth nerve palsy, double vision and balance disorder to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-JUN-2023 This case was reported by a patient's wife via interactive digital media. The reporter asked everyone to be cautious as her husband (patient) had vaccine and a few days later ended up in the hospital.  They thought he had a stroke and ruled that out. He was diagnosed with 4th cranial nerve palsy.  It had been a long road so far. He was seeing double, and his balance had been off.  They had always been pro vaccine but were questioning at that time. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: cold sore on left lip (shingrix vaccine was given IM in left arm); This non-serious case was reported by a consumer and described the occurrence of cold sores lip in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number K4TG5, expiry date MAY-2024) for prophylaxis.   The patient's past medical history included cold sores lip (usually the cold sore was on the right upper lip, not left).   On 09-JUN-2023, the patient received Shingrix (intramuscular, left arm) .5 ml. On 13-JUN-2023, 4 days after receiving Shingrix, the patient experienced cold sores lip (Verbatim: cold sore on left lip (shingrix vaccine was given IM in left arm)). The outcome of the cold sores lip was not resolved.   It was unknown if the reporter considered the cold sores lip to be related to Shingrix.     It was unknown if the company considered the cold sores lip to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-JUN-2023 The report was submitted online. The patient generally get cold sore a year usually on the right upper lip not left and after the administration of Shingrix in her left arm she developed cold sore on left lip. He thought It might be coincidence. The patient received the treatment. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Chemotherapy, Neoplasm malignant
Clinical narrative: Cancer; This serious case was reported by a nurse via call center representative and described the occurrence of cancer in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In SEP-2020, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced cancer (Verbatim: Cancer) (serious criteria GSK medically significant). The patient was treated with chemotherapy, nos (Chemotherapy Compound (Unknown)). The outcome of the cancer was unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.     It was unknown if the company considered the cancer to be related to Shingrix.   Additional Information: GSK receipt date: 12-JUN-2023 and 13-JUN-2023 The nurse reported that a patient received full on schedule dosing Shingrix series in September 2020. Health care professional (HCP) was unsure of whether patient would be undergoing chemotherapy or went through chemotherapy, but doctor wanted to revaccinate patient with Shingrix. HCP was unsure of why patient would be/went through chemotherapy. HCP stated patient had already gone through chemotherapy. The reporter consented to follow up.
Age: 74.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.); No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) and NO ADVERSE EVENT (No adverse event) in a 74-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7184B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received 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 EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)).    This case contains information for the 1st of 6 patients described by the reporter.  No concomitant medication was reported.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-729006, US-MODERNATX, INC.-MOD-2023-729007, US-MODERNATX, INC.-MOD-2023-729012, US-MODERNATX, INC.-MOD-2023-729016, US-MODERNATX, INC.-MOD-2023-729015 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729006:(Patient no- 2 out of 6 ) US-MODERNATX, INC.-MOD-2023-729007:(Patient no- 3 out of 6 ) US-MODERNATX, INC.-MOD-2023-729012:(Patient no- 4 out of 6 ) US-MODERNATX, INC.-MOD-2023-729016:(Patient no- 6 out of 6 ) US-MODERNATX, INC.-MOD-2023-729015:(Patient no- 5 out of 6 )
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: Incorrect dose administered, Medication error, No adverse event
Clinical narrative: full dose of medquadfi has not been administered because the patient moved with no reported adverse event; Initial information received on 13-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient who had not administered full dose of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi], because the patient moved, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine, solution for injection (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient had not administered full dose of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi], because the patient moved, with no reported adverse event (incorrect dose administered) (unknown latency) following the administration of Meningococcal A-C-Y-W135 (T Conj) Vaccine.  It was reported, "Caller stated that full dose f Medquadfi has not been administered because the patient moved. Doctor wanted to know recommendations regarding re-administration."  No lab data reported.  Action taken with MENINGOCOCCAL VACCINE was not applicable.  At time of reporting, the outcome was Unknown for the event.   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 guidelines. 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: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: An expired vaccine was administered. No AE was reported by the patient
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reactions at time of phone call.  Patient aware of outdated vaccine
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reactions at time of phone call.  Patient aware of outdated vaccine
Age: 89.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reactions at time of phone call.  Patient aware of outdated vaccine
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reactions at time of phone call.  Patient aware of outdated vaccine
Age: 87.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reactions at time of phone call.  Patient aware of outdated vaccine
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reactions at time of phone call.  Patient aware of outdated vaccine.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reactions at time of phone call.  Patient aware of outdated vaccine.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Lacunar stroke
Clinical narrative: ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: 5 patients affected: Patients were administered Adacel (Tdap) vaccine between 2/3-2/10. on 2/10 it was discovered that the refrigerator had a temperature excursion starting at 22:35 on 2/2, reaching a max temp of 48.9 degrees for approx 130 hrs. Sanofi was contacted to check the viability of the vaccine. Sanofi advised that the vaccine was "most likely viable" but it was up to the physician to decide if revaccination is needed. Per provider he did not wish to revaccinate patients at this time.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic myeloid leukaemia, Granulocytes abnormal, Platelet count decreased, White blood cell count increased
Clinical narrative: Moderna mRNA vaccine use for COVID-19 under Emergency Use Authorization (EUA): 2 years after taking Moderna vaccination series, I am now diagnosed as having CML.
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Disturbance in attention, Sleep disorder, Tinnitus
Clinical narrative: Shortly after my second dose of the Pfizer Covid-19 vaccine, tinnitus increased quite dramatically. At 61 years of age, some degree of very mild tinnitus was present before vaccination. The increase after the second dose was subjectively quite substantial and enough to cause issues with sleep. Now at 63 years of age, the amplitude of noise has increased and am experiencing issues with concentration and short term memory loss.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ischaemic stroke
Clinical narrative: ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Symptom recurrence
Clinical narrative: PERIPHERAL NEUROPATHY 2/10/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Symptom recurrence
Clinical narrative: PERIPHERAL NEUROPATHY 3/9/2022 --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Atrial flutter, Malaise, Mobility decreased, Peripheral swelling
Clinical narrative: I had a swollen arm and unable to lift my arm for about 24 hours. I was on a trip and on the third day, I started not feeling well. I was diagnosed with atrial flutter and AFIB. My first episode occurred on 03/23/2021. I went to the emergency room and got the help I needed. As of today, I feel better after starting new medication, and I have a follow-up appointment in two weeks.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neuropathy peripheral
Clinical narrative: NEUROPATHY
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Guillain-Barre syndrome, Neuropathy peripheral, Symptom recurrence
Clinical narrative: GUILLAIN BARRE SYNDROME NEUROPATHY 11/9/2022 &  1/18/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Moderna 3/12/21 lot# 040A21A;  Moderna 4/9/21 Lot# 037A21B;  Moderna 12/17/21 lot# 045J21A
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines Pfizer 1/28/21 lot# EL9265;  Pfizer 2/18/21 lot# EN6200;  Pfizer 10/7/21 lot# 30155BA;  Moderna 4/21/22 lot# 002M21A
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ANGIOEDEMA, INIT
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after4 vaccines Moderna 2/28/21 lot# 025A21A;  Moderna 3/24/21 lot# 001B21A;  Moderna 11/17/21 Lot# 039F21A;  Moderna 4/21/22 lot# 002M21A;
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines  Moderna 1/21/21 lot# 032H20A;  Moderna 2/18/21 lot# 010M20A
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Breathing-related sleep disorder
Clinical narrative: BREATHING RELATED SLEEP DISORDER
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Atrial flutter, Cardioversion, Electrocardiogram abnormal, Heart rate increased
Clinical narrative: I had a episode of atrial flutter.  It was treated over the course of two days at Hospital.  I was admitted on the 14JUN2023 my symtoms began 13JUN2023 wirth a high heart rate, it was lowered on the 14JUN2023  but was elevated again on 15JUN2023 and was brought back into rythym with electric shock at the hospital on 15JUN2023 and I was released from th hospital.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Hypotension
Clinical narrative: ACUTE NON ST ELEVATION MI HYPOTENSION
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired by 5 days No adverse reactions noted
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Moderna 2/6/21 lot# 031L20A;  Moderna 3/6/21 lot# 030A21A;  Moderna 11/2/21 lot# 071F21A
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines Moderna 2/28/21 lot# 010A21A;  mOdern a3/28/21 Lot# 018B21A;  MOdern a12/29/21 lot# 041J21A;  Moderna 6/29/22 lot# 060A22A
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines Moderna 2/28/21 lot# 010A21A;  mOdern a3/28/21 Lot# 018B21A ; MOdern a12/29/21 lot# 041J21A;  Moderna 6/29/22 lot# 060A22A
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: Severe vomiting
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 5/3/21 lot# Ew0172; Pfizer 5/24/21 lot# Ew0183
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ischaemic stroke
Clinical narrative: ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Rash, Rash erythematous, Skin exfoliation
Clinical narrative: Persistent red rash on both sides of the face, 1cm below the eyes, and extending outward from the nose 4cm in width and 3cm in height.The rash never goes away. The skin is dry and flaky. I never had any skin issues before the covid shots.
Age: 97.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 5 doses Moderna 2/16/21 lot# 006MA20;  Moderna 3/6/21 lot# 001B21A;  Moderna 10/3/21 lot# 026D21A;  Moderna 4/9/22 lot# 002M21A;  Moderna 11/9/22 lot# 014H22A
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 1/21/21 lot# 012L20A;  Moderna 2/18/21 lot# 016M20A
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Biopsy chest wall normal, Chest wall mass, Surgery
Clinical narrative: 3/27/23 I made a doctor?s appointment because of a lump in my chest I discovered in the shower.  I had a biopsy on 4/4/23 which was non-cancerous. I had surgery on 5/2/23 and had the lump removed. It was non-cancerous and I was told it would not come back.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines  Pfizer 4/29/21 lot# Ew0167;  Pfizer 5/20/21 lot#Ew0183;  Pfizer 4/7/22 lot# FL3198
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 3/15/21 lot# 045A21A;  Moderna 4/2/21 lot# 037A21B
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 12/30/22 lot# 026L2-0A;  Moderna 1/27/21 lot# 029L20A
Age: 51.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Discomfort, Musculoskeletal discomfort, Paraesthesia
Clinical narrative: experiencing shoulder, elbow and finger discomfort.  Tingling in the fingers.  Has experienced this in the past but not sure if it directly correlates with the vaccine
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE ST ELEVATION MI, INFERIOR WALL ACUTE ST ELEVATION MI, UNSPECIFIED
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eye pruritus, Hypersensitivity, SARS-CoV-2 test negative, Sinus headache, Throat irritation
Clinical narrative: I had an extremely itchy throat and sinus headache. I took a home COVID-19 test that came back negative, so I went to my doctor's office. Upon examination my doctor said he felt that it may be my seasonal allergies, he did prescribe an antibiotic just in case I was getting an infection. I am feeling better, I am experiencing some itchy eyes, but I believe that may be allergy related.
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: pt was given dose that was expired x 1 days
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea, No adverse event, Pneumonia, Rhinorrhoea, Upper respiratory tract infection
Clinical narrative: I did not have an adverse reaction to the vaccine. On 02/26/2023, I had difficulty breathing and a runny nose. On 03/6/2023, I went to my doctor and was diagnosed with pneumonia and an upper respiratory illness. I was prescribed two antibiotics. As of today, I am feeling better with no lingering symptoms.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Chronic respiratory failure, Respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest pain, Condition aggravated, Electrocardiogram, Hiatus hernia, Laboratory test abnormal
Clinical narrative: On 26MAY2023 I had chest pains that were a seven out of ten in pain. It subsided then on 27MAY2023 it came back in the afternoon it continued an eight of ten and I called EMS and went to the same hospital where blood clots in my lungs (bilateral pulmonary emboli) had been diagnosed two years before. Testing was done and Hiatal hernia was diagnosed and I was released.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pulmonary embolism
Clinical narrative: On 26MAY2023 I had chest pains that were a seven out of ten in pain. It subsided then on 27MAY2023 it came back in the afternoon it continued an eight of ten and I called EMS and went to the same hospital where blood clots in my lungs (bilateral pulmonary emboli) had been diagnosed two years before. Testing was done and Hiatal hernia was diagnosed and I was released.