chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Malaise, Myalgia, Petechiae, Rash
Clinical narrative: Woke up at 8 am 10/19 with similar malaise and bone and muscle pain as I with previous four Covid19 Pfizer vaccines. At approximately 12 pm burning and itching to eyes started which rapidly turned into lower face burning. 15 minutes later full body hives began. Eyes and lips started swelling shortly after. Tingling noted to tongue and throat with petechial rash to throat and uvula. No changes to voice or breathing. Hives turned into full body redness about 30 minutes after hives began. ~300 mg Benadryl taken over 5 hours. Most of swelling to lips and lower face resolved by 8 pm. 10/20 hives were faint and fully resolved by the afternoon as was the swelling around eyes. Rash still remains to throat 10/21.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue eruption, Urticaria
Clinical narrative: Woke up at 8 am 10/19 with similar malaise and bone and muscle pain as I with previous four Covid19 Pfizer vaccines. At approximately 12 pm burning and itching to eyes started which rapidly turned into lower face burning. 15 minutes later full body hives began. Eyes and lips started swelling shortly after. Tingling noted to tongue and throat with petechial rash to throat and uvula. No changes to voice or breathing. Hives turned into full body redness about 30 minutes after hives began. ~300 mg Benadryl taken over 5 hours. Most of swelling to lips and lower face resolved by 8 pm. 10/20 hives were faint and fully resolved by the afternoon as was the swelling around eyes. Rash still remains to throat 10/21.
Age: 87.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: After the vaccinations, the patient sat in a chair outside of pharmacy. Her husband reported within minutes, her saying that she was dizzy and stated he caught her as she was passing out. An ambulance was called and pharmacy personnel attended to the patient,who was close to unconscious. EMT's gave patient oxygen, which improved her condition. She was taken to the hospital by ambulance.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling of body temperature change, Headache, Hyperhidrosis, Muscle spasms
Clinical narrative: Alternating extreme cold / hot "jungle fever" condition all night long - sweating bullets, freezing cold; periods of extreme, uncontrollable shaking of hands; muscle cramps through body; severe headache; near nausea; urination hourly, a few times more often; lasted at least eight hours. Very weak following morning. A mild, echo of the symptoms recurred 48 hours later.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Tremor
Clinical narrative: Alternating extreme cold / hot "jungle fever" condition all night long - sweating bullets, freezing cold; periods of extreme, uncontrollable shaking of hands; muscle cramps through body; severe headache; near nausea; urination hourly, a few times more often; lasted at least eight hours. Very weak following morning. A mild, echo of the symptoms recurred 48 hours later.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: High-Dose vaccine Fluzone given to patient early. FLuzone HD recommended for 65 years and older
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Neuropathy peripheral, Pain in extremity, Paraesthesia, Product administered at inappropriate site
Clinical narrative: Patient reports extreme pain in arm for 3 days, but then has neuropathy in arm.  pins and needles feeling in arm.  reports getting vaccines a little high. looks like may have hit a tendon nerve
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram
Clinical narrative: Near fainting and dizziness later the same day of the vaccine and recurred again the following day after the vaccine. Went to urgent care and ER
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity
Clinical narrative: Patient said her arm was bruised and hurt ever since she received the vaccine.  She went to the closest pharmacy to have the Pharmacist look at her arm.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Syncope
Clinical narrative: Per patient, she fainted on 10/20/24.  A family member reports hearing repeated thudding noise.  Patient woke up with bruises on her legs, so she thinks that she was kicking some furniture.  Patient attributes these symptoms to possible seizure.  Per patient, she does not have a history of seizures
Age: 28.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: HPV Vaccine was administered to a 31.4 weeks pregnant female. EDD 12/20/2024.
Age: 64.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Ageusia, Anosmia, Cough, Diarrhoea, Headache
Clinical narrative: Complete loss of taste and smell, diarrhea, headache, nasal congestion, cough, wheezing
Age: 64.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Nasal congestion, Wheezing
Clinical narrative: Complete loss of taste and smell, diarrhea, headache, nasal congestion, cough, wheezing
Age: 55.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, UNK
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Passed out the same evening of administration/was unconscious; In the evening at home he fainted; This spontaneous case, initially received on 08-Oct-2024, was reported by a health authority, Vaccine Adverse Event Reporting System (VAERS) (Reference number: 2792870-1), and concerns an adult male patient.  At the time of the event the patient had Obesity, Hypertension, Hypercholesterolemia. The patient had no known allergy.  Administration of company suspect drug(s): On 13-Sep-2024, the patient received Flucelvax (TIV) for Not reported., Route of administration: Intramuscular, Anatomical site: Left Arm, batch number reported as 946597. CSL Seqirus Batch number unable to be matched.   Non-company suspect drugs: COVID-19 vaccine Moderna (Elasomeran), Indication: Not reported, Anatomical site: Left Arm.  Adverse reactions/events and outcomes: On 13-Sep-2024, the patient experienced Passed out the same evening of administration/was unconscious (Medically Significant, outcome: Recovered / Resolved), In the evening at home he fainted (Medically Significant, outcome: Recovered / Resolved). The patient's wife reported to pharmacist that her husband had received vaccinations recently and passed out the same evening of administration. He received vaccines in the morning and in the evening at home he fainted and was unconscious. Wife called paramedic and they arrived. He was encouraged to go to hospital but refused. Wife said he was currently feeling fine.  Flucelvax (TIV) action taken: Not Applicable  Reporter assessment: The reporter did not provide the seriousness and causality assessment.; Reporter's Comments: Causality: Events are considered related to the administration of the vaccine, due to close temporal relationship (the same day) and biological plausibility.
Age: 75.0
Sex: F
Vaccine: UNK, UNK, RSV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: pt complained oof pain
Age: 75.0
Sex: F
Vaccine: UNK, UNK, RSV
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: pt complained oof pain
Age: 0.5
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Person who administered the vaccine did not dilute the dose and gave the full vial of covid 19 vaccine, which was 3 doses. So, the patent received 3 concentrated doses at once.
Age: 0.5
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Person who administered the vaccine did not dilute the dose and gave the full vial of covid 19 vaccine, which was 3 doses. So, the patent received 3 concentrated doses at once.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered
Clinical narrative: Patient is asymptomatic/No additional AE; HCP called to report that a patient was inadvertently administered PROQUAD and MMRII at the same time. Patient is asymptomatic. Date of administration was 09/25/2024. Caller was unable to provide lot numbers and expiration dates. No additional detail; This spontaneous report was received from medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 25-SEP-2024, the patient was inadvertently vaccinated with the first doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection, (strengths, exact doses, route of administrations, anatomical locations, lot numbers, and expiry dates were not provided for both suspects) along with sterile diluent (MERCK STERILE DILUENT). On that day (25-SEP-2024), the patient experienced accidental overdose. No additional details were provided and patient was asymptomatic. No additional adverse event (no adverse event).
Age: 0.42
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; administered after experiencing a temperature excursion; This spontaneous report was received from a nurse and refers to an 1-year-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unspecified date, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 2nd dose, lot #X022980, expiration date reported as and upon internal review confirmed to be: 18-MAY-2026, administered intramuscularly in the upper right thigh for prophylaxis (product storage error). Temperature excursion (TE) of 8.8 degree Celsius (C) for 4 minutes and 45 seconds was noted. No previous TE. No side effects were reported (No adverse event). No additional information/clarification was provided. No additional adverse event (AE) and no product quality complaint (PQC) was noted.; Sender's Comments:  US-009507513-2408USA009052:
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: HCP called to report a patient who is 20 weeks pregnant was administered GARDASIL 9. No symptoms reported.  Consent to contact was granted.  No additional AE/No PQC.; No additional AE/No PQC.; This spontaneous prospective pregnancy report was received from Other Health Professional referring to a female patient of unknown age.  The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 04-OCT-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter, lot #X026668, expiration date: 10-APR-2026, administered for prophylaxis (strength, route of administration and anatomical site of injection were not provided). At the time of the administration the patient was 20 weeks pregnant (Exposure during pregnancy). No symptoms were reported.   At the time of the report, the pregnancy outcome was pending, and the fetal outcome was unknown.  No additional adverse events were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported. No PQC.; Inbound call from pharmacist who reports PNEUMOVAX 23 with an expiration date of 10/7/2024 was administered to a single patient on 10/8/2024.; This spontaneous report was received from Pharmacist regarding to a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, previous drugs reactions or allergies and concomitant medications were not reported.  On 08-OCT-2024, the patient was vaccinated with an expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, at a dose of 0.5 ml, lot #W029533, expiration date: 07-OCT-2024, administered for prophylaxis (strength, route of administration, and anatomical site of injection were not provided) (Expired product administered). The vaccine didnt experience any temperature excursions through the date of administration and no side effects or symptoms were noted.  No additional advert event was reported (No adverse event).
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: the patient noticed a rash that looks like shingles; This spontaneous report has been received from a nurse regarding a 16-year-old male patient.   The patient's concurrent conditions included hypersensitivity and seasonal allergy. The patient's medical history and Concomitant therapies were not reported.  On 02-FEB-2009, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (dose, lot number, expiration date, route of administration and anatomical site of injection were not provided). On 10-APR-2013, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (HAS) (PROQUAD) injection (dose, route of administration and anatomical site of injection were not provided; lot number H015624 has been verified to be a valid number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live [PROQUAD], expiration date 21-FEB-2014); both vaccines administered for varicella prevention.   On 10-JUN-2024, the patient experienced a rash that looked like shingles (Rash vesicular) and throughout that day, the rash got worse and painful to the touch. It was reported that, on 09-OCT-2024, the patient was seen in the office, and he stated that the rash was improving but was still a little painful. The patient Sought Medical Attention and received ibuprofen, as well as acyclovir 800mg, 1 tablet, 4 times daily (QID), amoxicillin trihydrate (+) clavulanate potassium (AUGMENTIN) 875mg, 1 tablet, twice a day (BID), both for 7 days as treatment for the event.   At the time of the report, the patient was recovering from the event of Rash vesicular.   The causal relationship between varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not reported.
Age: 16.0
Sex: M
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: the patient noticed a rash that looks like shingles; the patient's rash got worse and painful to the touch.; This spontaneous report was received from a nurse and refers to a 16-year-old male patient. The patient's medical history was not reported. His concurrent conditions included  seasonal allergy, and hypersensitivity to blue dye. Concomitant therapies were not reported.  On 02-FEB-2009, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported). On 10-APR-2013, he was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (HSA) (PROQUAD) injection, for prophylaxis (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number h015624, with expiration date not provided but upon internal validations established as 21-FEB-2014).  On 06-OCT-2024, the patient presented rash that looks like shingles which got worse and painful to the touch during that day (rash vesicular, rash). On 09-OCT-2024, the patient visited the office. As treatment for the event, he was administered acyclovir tablet 800 mg, 1 tablet 4 times daily for 7 days, (AUGMENTIN) 875 mg tablet, 1 tablet twice a day for 7 days, and ibuprofen. Indications for collecting the rash samples to the nurse were given.  At the reporting time, the patient was recovering from the events, but the rash was still a little painful. The causal relationship between the events and the suspect vaccines was not provided.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; The nurse practitioner is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VAQTA y011643   10/25/2025 Temperature: 0.4C  Ti; This spontaneous report was received from nurse practicioner and refers to a patient of unknown ange and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 09-OCT-2024, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 dose, lot #Y011643, expiration date: 25-OCT-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excusion in 0.4 defree Celsius for 8 hours 34 minutes with previous excursion in 0.1 degree Celsius for 6 hours 9 minutes (Product storage error). No additional adverse event was reported. ; Sender's Comments:  US-009507513-2410USA005785:
Age: 1.17
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report PEDVAXHIB administered to a patient after it expired.; Product also experienced a TE on 1/3/2024.; This spontaneous report was received from a nurse, referring to a 14-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-OCT-2024, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 ml, lot #W010875, expiration date: 12-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided) after the vaccine expired (Expired product administered). The vaccine also experienced a temperature excursion (TE) on 03-JAN-2024 (Product storage error). No symptoms reported. No additional adverse event (AE) (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No adverse event; Caller reported expired VAQTA administered.; Vaccine had experienced a previous temperature excursion; This spontaneous report was received from a pharmacist referring to a patient, age and gender was not reported.  Information regarding the patient's concurrent conditions, medical history, drug reaction or allergies or concomitant medications was not provided.  On 17-OCT-2024, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) injection for prophylaxis 1 ml intramuscular (anatomical location was not reported, lot number X006702 with an expiration date on 10-OCT-2024) (Expired product administered).   Additionally, the administered dose of the vaccine experienced a temperature excursion 74 degrees Fahrenheit for 12 hours, it was not reported if the information was recorded by a data logger or not (Product storage error). There was no adverse effect reported.
Sex: U
Vaccine: TDAP
Symptoms: Product packaging confusion, Wrong product administered
Clinical narrative: incorrect vaccine administered/intending to receive Flulaval have received Tdap inadvertently; look alike and could be mistaken for each other at a glance; This non-serious case was reported by a other health professional and described the occurrence of wrong vaccine administered in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: incorrect vaccine administered/intending to receive Flulaval have received Tdap inadvertently) and look alike packaging (Verbatim: look alike and could be mistaken for each other at a glance). The outcome of the wrong vaccine administered and look alike packaging were unknown.   Additional Information: GSK Receipt Date: 26-SEP-2024 The reporter wanted to reach out to inform about the safety concern that had been escalated in the past few days where a mix up of Flulaval and Tdap occurring. There had been two events where individuals intending to receive Flulaval had received Tdap inadvertently, which led to wrong vaccine administered. When comparing the similarity of the products, it was very evident they were vey much alike and could be mistaken for each other at a lance, which led to look alike packaging. The reporter said that could please escalate this concern, that would be wonderful as this problem may persist throughout flu season. This case has been linked to the case US2024AMR120690 reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR120690:Original Case : US2024AMR120690
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient had 1st SHINGRIX dose in 2021, did not yet have 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Patient had 1st SHINGRIX dose in 2021, did not yet have 2nd dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 04-OCT-2024 Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Neuralgia, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; nerve pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and post herpetic neuralgia (Verbatim: nerve pain). The outcome of the vaccination failure and shingles were not reported and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 14-OCT-2024 This case was reported by a patient via interactive digital media. The patient had the two Shingles shots and still got the Shingles, bad stuff and the nerve pain was suffering. 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine(dose 1 and 2).
Age: 17.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: patient received Flulaval after the expiration date; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2024-2025 season) (batch number 379AT, expiry date 29-JUN-2024) for prophylaxis.   On 27-AUG-2024, the patient received FluLaval Quadrivalent 2024-2025 season. On 27-AUG-2024, an unknown time after receiving FluLaval Quadrivalent 2024-2025 season, the patient experienced expired vaccine used (Verbatim: patient received Flulaval after the expiration date). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-OCT-2024 The practice manager stated that a patient received Flu Laval  Quadrivalent vaccine after the expiration date, which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 63.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix-B - Expired dose administered; 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 63-year-old male patient who received HBV (Engerix B) (batch number 4JG5Y, expiry date 12-AUG-2024) for prophylaxis.   On 03-OCT-2024, the patient received Engerix B. On 03-OCT-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B - Expired dose administered). 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: 07-OCT-2024 The office manager called and reported that there was administration of expired Engerix-B vaccine to a patient, which led to expired vaccine used. The reporter asked if the dose should be repeated. This case is linked with US2024123286, reported by same reporter.; Sender's Comments:  US-GSK-US2024123286:same reporter
Age: 67.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix-B - Expired dose administered; 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 67-year-old female patient who received HBV (Engerix B) (batch number 4JG5Y, expiry date 12-AUG-2024) for prophylaxis.   On 03-OCT-2024, the patient received Engerix B. On 03-OCT-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B - Expired dose administered). 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: 07-OCT-2024 The office manager called and reported that there was administration of expired Engerix-B vaccine to a patient, which led to expired vaccine used. The reporter asked if the dose should be repeated. This case is linked with US2024123285, reported by same reporter.; Sender's Comments:  US-GSK-US2024123285:same reporter
Age: 40.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose was administered 9 months later than the first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 40-year-old female patient who received HAB (Twinrix) (batch number D4774, expiry date 12-SEP-2026) for prophylaxis.   Previously administered products included Twinrix (received 1st dose in JAN-2024).   On 07-OCT-2024, the patient received the 2nd dose of Twinrix. On 07-OCT-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: second dose was administered 9 months later than the first dose). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-OCT-2024 The patient got her first dose of Twinrix in JAN-2024, and she waited until yesterday (day before reporting) to get her second dose. The patient received 2nd dose of Twinrix, later than the recommended time interval, which led to lengthening of the vaccination schedule.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: received two doses of Arexvy 3 months apart; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 9RP9M, expiry date 04-OCT-2025) for prophylaxis.   Previously administered products included Arexvy (1st dose received in JUN-2024).   In SEP-2024, the patient received the 2nd dose of Arexvy. In SEP-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: received two doses of Arexvy 3 months apart). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 08-OCT-2024 The pharmacist reported that the patient received two doses of Arexvy vaccine in 3 months apart which led to extra dose administered.
Age: 51.0
Sex: M
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Product Storage Error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 51-year-old male patient who received MMR (Priorix) (batch number LY377, expiry date 01-APR-2025) for prophylaxis.   On 24-SEP-2024, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-OCT-2024 The reporter stated that they recently started using Priorix because they switched from using the MMR vaccine.  The MMR was frozen, but priorix they realized after it was too late that it was also placed in the freezer. The reporter asked, whether patient had to be reimmunized if they gave him frozen Priorix. The Priorix vaccine stored at minus 21.8 degree Celsius for 2 months and administered to a patient, which led to incorrect storage of drug. This was 1 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024123885: US-GSK-US2024123952:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received a year ago the first dose of Shingrix, but she had not received the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose one year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Patient received a year ago the first dose of Shingrix, but she had not received the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-OCT-2024 The pharmacist reported that the patient came into the pharmacy and wanted to receive 2nd dose of Shingrix but she had not received the 2nd dose and got her first dose a year ago and asked should they re-start the schedule. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Deafness unilateral, Viral infection
Clinical narrative: Deaf in left ear; Viral infection; This serious case was reported by a consumer via call center representative and described the occurrence of deafness unilateral in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27-AUG-2024, the patient received Shingrix (intramuscular, left arm). On 09-SEP-2024, 13 days after receiving Shingrix, the patient experienced deafness unilateral (Verbatim: Deaf in left ear) (serious criteria GSK medically significant) and viral infection (Verbatim: Viral infection). The outcome of the deafness unilateral and viral infection were not resolved.   It was unknown if the reporter considered the deafness unilateral and viral infection to be related to Shingrix.     The company considered the deafness unilateral and viral infection to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 14-OCT-2024 and 15-OCT-2024 The patient self-reported this case for herself. The reporter reported that she got the Shingrix vaccine and within 2 weeks, she had a viral infection and was deaf in her left ear.  The reporter reported that she was seeing a hearing specialist and these symptoms were ongoing.  The Vaccine Administration Facility was the same as Primary Reporter.; Sender's Comments: Deafness unilateral and Viral infection are unlisted events which are considered unrelated to GSK vaccine Shingrix.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Underdose
Clinical narrative: Second Late Dose; Underdose; hep B pediatric was given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 19-year-old female patient who received HBV (Engerix B pediatric) (batch number 32M5G, expiry date 14-SEP-2025) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B ADULTO).   On 07-OCT-2024, the patient received the 2nd dose of Engerix B pediatric. On 07-OCT-2024, an unknown time after receiving Engerix B pediatric, the patient experienced drug dose administration interval too long (Verbatim: Second Late Dose), underdose (Verbatim: Underdose) and adult use of a child product (Verbatim: hep B pediatric was given). The outcome of the drug dose administration interval too long, underdose and adult use of a child product 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: 14-OCT-2024 A patient received the hepatitis B, the Engerix-B adult vaccine at the age of 18 and then received the second dose out of the timeframe of the hep B pediatric was given about three months later, which led to underdose, adult use of a child product and lengthening of vaccination schedule. Consented to follow up.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Hepatic enzyme increased
Clinical narrative: had a blood panel and states her liver enzymes were "all screwed up"/enzymes are still elevated; This spontaneous case was reported by a patient and describes the occurrence of HEPATIC ENZYME INCREASED (had a blood panel and states her liver enzymes were "all screwed up"/enzymes are still elevated) in a 76-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 10-Oct-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced HEPATIC ENZYME INCREASED (had a blood panel and states her liver enzymes were "all screwed up"/enzymes are still elevated). At the time of the report, HEPATIC ENZYME INCREASED (had a blood panel and states her liver enzymes were "all screwed up"/enzymes are still elevated) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Oct-2024, Blood test: her liver enzymes were "all screwed up". On 14-Oct-2024, Blood test: enzymes were still elevated.         No concomitant medications were reported.  The patient received vaccine last Wednesday (09-Oct-2024) and the following day had a blood panel and stated her liver enzymes were "all screwed up". Her provider ordered the blood work, told her this was possibly due to the vaccine. Caller states she went to have panel repeated on 14-Oct-2024. She did not have the values in front of her.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Chemotherapy
Clinical narrative: "somebody else that was in remission for years who's being fitted for a freaking chemotherapy yesterday because of your shots"; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of CHEMOTHERAPY ("somebody else that was in remission for years who's being fitted for a freaking chemotherapy yesterday because of your shots") in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEMOTHERAPY ("somebody else that was in remission for years who's being fitted for a freaking chemotherapy yesterday because of your shots"). At the time of the report, CHEMOTHERAPY ("somebody else that was in remission for years who's being fitted for a freaking chemotherapy yesterday because of your shots") outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that he received 3 vaccines and dates were unknown. It was also reported that he was in remission for years who had been fitted for a freaking chemotherapy last day because of shots.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-775284 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-775284:Master case
Age: 79.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Cerebrovascular accident
Clinical narrative: Diagnosed with him having a slight stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Diagnosed with him having a slight stroke) in a 79-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product Influenza vaccine for an unknown indication.    The patient's past medical history included AFib and Bell's palsy. Previously administered products included for Product used for unknown indication: covid-19 vaccine (dose 1), covid-19 vaccine (dose 2), covid-19 vaccine (dose 3), covid-19 vaccine (dose 7), covid-19 vaccine (dose 5), covid-19 vaccine (dose 6) and covid-19 vaccine (dose 4). Past adverse reactions to the above products included No adverse effect with covid-19 vaccine, covid-19 vaccine, covid-19 vaccine, covid-19 vaccine, covid-19 vaccine, covid-19 vaccine and covid-19 vaccine.   On 01-Oct-2024, the patient received eighth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On 02-Oct-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced CEREBROVASCULAR ACCIDENT (Diagnosed with him having a slight stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 02-Oct-2024 to 05-Oct-2024 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Diagnosed with him having a slight stroke) was resolving.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Suspect vaccine dosage text was reported as unknown. Patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine On Wednesday, the patient started slurring and it looked like his tongue couldn't fit in his mouth. It was real big. Thought he was having a stroke. The patient was taken to the hospital, they ran all the tests and diagnosed with him having a slight stroke because of A fib. Patient had Bell's palsy before. This one looked a little different. No facial drooping as before. Patient still had slurring on 09-Oct-2024 and was discharged from hospital on Saturday (05-Oct-2024). Last two days, seems like at night patient was still slurring more. In the morning the patient sounds stronger. The patient had previously received 7 doses. Reporter causality was not reported. Treatment information was not provided.  Company Comments: This spontaneous case concerns a 79-year-old male patient who experienced serious events of Cerebrovascular accident . The events are assessed as related  due to temporal association and lack of other preceding factors. The benefit-risk relationship of product is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2021-363471 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-363471:Same reporter differernt patient (H-M)
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Idiopathic pancreatitis, Lipase
Clinical narrative: acute idiopathic pancreatitis/acute pancreatitis; This spontaneous case was reported by a patient and describes the occurrence of IDIOPATHIC PANCREATITIS (acute idiopathic pancreatitis/acute pancreatitis) in a 34-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042646) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 03-Oct-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced IDIOPATHIC PANCREATITIS (acute idiopathic pancreatitis/acute pancreatitis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 04-Oct-2024 to 09-Oct-2024 due to IDIOPATHIC PANCREATITIS. At the time of the report, IDIOPATHIC PANCREATITIS (acute idiopathic pancreatitis/acute pancreatitis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Oct-2024, Lipase: Lipase levels peaked on 05-Oct-2024 and then trended down.     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter considered IDIOPATHIC PANCREATITIS (acute idiopathic pancreatitis/acute pancreatitis) to be related.    No concomitant medications were reported.  The patient started feeling off following the Covid-19 vaccine on 25-Sep-2024. On 03-Oct-2024, the patient had bloating, extreme fullness, nausea, pain and vomiting. That increased and went to urgent care on 04-Oct-2024, where was diagnosed with acute pancreatitis and then sent to the ER and was subsequently admitted to the hospital.  The patient was still dealing with exhaustion and pain due to the pancreatitis, which in turn was impacting her ability to eat and work. She was a healthcare professional, and this was significantly life interfering. It also led to other issues such as extreme constipation from medications to manage pain, shifts in blood pressure, etc.  There was no cause identified for her pancreatitis (she did not drink alcohol, no issues with gallbladder, or triglycerides), and feeling unwell started shortly after the vaccine, thus it was suspected to be vaccine induced. It was unknown if the patient experienced any additional symptoms/events. Company Comments: This spontaneous case concerns a 34-year-old female patient who experienced serious event of Idiopathic pancreatitis. The events are assessed as related due to temporal association and lack of other preceding factors. The benefit-risk relationship of product is not affected by this report.
Age: 46.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Dyspnoea, Fatigue, Lipids, Night sweats, Pyrexia
Clinical narrative: shortness of breath; night sweats; feverish feelings; pain in injection site; extreme fatigues; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (shortness of breath), NIGHT SWEATS (night sweats), PYREXIA (feverish feelings), VACCINATION SITE PAIN (pain in injection site) and FATIGUE (extreme fatigues) in a 46-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product Influenza vaccine for an unknown indication.    No Medical History information was reported.   On 10-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On 11-Oct-2024, the patient experienced DYSPNOEA (shortness of breath), NIGHT SWEATS (night sweats), PYREXIA (feverish feelings), VACCINATION SITE PAIN (pain in injection site) and FATIGUE (extreme fatigues). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), NIGHT SWEATS (night sweats), PYREXIA (feverish feelings), VACCINATION SITE PAIN (pain in injection site) and FATIGUE (extreme fatigues) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Lipids: Normal. On an unknown date, Vitamin A: Normal.     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events. Patient had no concomitant disease or risk factor. Patient had annual checkup just before receiving the flu and COVID shots in the same arm. All lab results were normal.