chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Colonoscopy, Computerised tomogram, Diarrhoea, Impaired work ability
Clinical narrative: Severe uncontrollable diarrhea. Several tests done. Still have chronic diarrhea. EPI. Pancreas not producing digestive enzymes. Been affected since 2021.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pancreatic failure, Stool analysis abnormal, Ultrasound scan
Clinical narrative: Severe uncontrollable diarrhea. Several tests done. Still have chronic diarrhea. EPI. Pancreas not producing digestive enzymes. Been affected since 2021.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was mistakenly given a 2nd dose of Flucelvax at a school flu clinic on 10/02/2024 due to the nurse not being notified that patient was given a flu vaccine at her pediatrician's office the week before on9/25/2024.   No reported side effects or symptoms from additional vaccine.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea exertional, Echocardiogram, Electrocardiogram, Fatigue, Laboratory test
Clinical narrative: JANSSEN #1 4/10/2021  PFIZER #1 12/30/2021 PATIENT WITH BACKGROUND NONISCHEMIC CARDIOMYOPATHY LVEF 45% AND PAROXYSMAL ATRIAL FIBRILLATION.  DEVELOPED VACCINE INDUCED POST-EXERTIONAL MALAISE, LOSS OF MENTAL CLARITY, AND WORSENED SHORTNESS OF BREATH ON EXERTION AND FATIGUE.  TREATED WITH CARVEDILOL, RAMIPRIL, PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Mental impairment
Clinical narrative: JANSSEN #1 4/10/2021  PFIZER #1 12/30/2021 PATIENT WITH BACKGROUND NONISCHEMIC CARDIOMYOPATHY LVEF 45% AND PAROXYSMAL ATRIAL FIBRILLATION.  DEVELOPED VACCINE INDUCED POST-EXERTIONAL MALAISE, LOSS OF MENTAL CLARITY, AND WORSENED SHORTNESS OF BREATH ON EXERTION AND FATIGUE.  TREATED WITH CARVEDILOL, RAMIPRIL, PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 44.0
Sex: F
Vaccine: COVID19, MENB, PNC20
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Trumenba is only approved for ages 10-25 years. pt is 44 years old. no adverse events reported at this time
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Intensive care, Laboratory test, Seizure
Clinical narrative: pt states she was on her way home from being vaccinated went up her ramp to her house and  does not remember anything after this.  Three days later a friend found her and called an ambulance. She was taken hospital. They ran multiple test. They admitted her to ICU. She was diagnosed with having seizures. She was discharged to go home and was set up Home Health. She has had 2 more seizures during the day time while sitting in recliner. She does not remember the dates. She had a couple more episodes she had very small seizures.  She is on seizure medicine and has not had another seizure since. She has a Neurologist for seizures, anther one for her tremors and differnent one for the MD.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Headache, Nausea, Pain, Pharyngeal swelling
Clinical narrative: Her left side of the throat and neck became swollen along with radiating back pain and a headache. She initially complained of a headache and feeling sick to her stomach on 9/30/24. She was seen in urgent care on 10/3/24.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Her left side of the throat and neck became swollen along with radiating back pain and a headache. She initially complained of a headache and feeling sick to her stomach on 9/30/24. She was seen in urgent care on 10/3/24.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Laboratory test, Malaise, Mental impairment
Clinical narrative: JANSSEN #1 5/3/2021 PFIZER #1 1/11/2022 DEVELOPED VACCINE INDUCED  LOSS OF MENTAL CLARITY AND POST EXERTIONAL MALAISE. TREATED WITH NICOTINE PATCH AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient with injection site reaction, red raised and pruritis in the approximate shape of a softball on left thigh
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: *Vaccine not given at clinic, patient reported to clinic for appointment following reaction*  swelling, redness, and itching at the injection site
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal pain upper, Chest X-ray normal, Dyspnoea, Electrocardiogram normal, Rash
Clinical narrative: Patient had rash to LLE in the days following the vaccination.  Patient went to the ED on 9/19/2024 due to SOB and LUQ pain.  Symptoms resolved after office visit without intervention.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Ultrasound abdomen normal
Clinical narrative: Patient had rash to LLE in the days following the vaccination.  Patient went to the ED on 9/19/2024 due to SOB and LUQ pain.  Symptoms resolved after office visit without intervention.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave High Dose influenza vaccine to 55 year old patient. Patient notified via phone of incident gave side effects and advised patient to call if has any side effects. Pt voiced understanding. Sent email to clinic manager.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt was given Fluzone HD instead of Fluzone.  No ADRs reported.
Age: 73.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Duplicate vaccine administration.  Previous RSV vaccine administered DEC 2023 (Abrysvo).  No adverse effects currently reported
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Reaction to previous exposure to any vaccine
Clinical narrative: no
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Wrong age group administerd
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: BASED ON PT REPORT, GIVEN DOSE OF BOOSTRIX TDAP. ELECTRONIC SYSTEM DOWN, UNABLE TO VERIFY AGAINST RECORDS. WHEN SYSTEM UP, DETERMINED LAST TDAP WAS 09/02/2024. PT WAS STILL ON SITE. ABLE TO REPORT INCIDENT TO PT, PROVIDE EDUCATION ON 10 YR RECOMMENDED FREQUENCY, COUNCIL TO DECLINE FUTURE TDAPS, NOT DUE TILL 2034. OBSERVED PT FOR 30 MINUTES, NO ADVERSE REACTIONS OBSERVED OR REPORTED. PT VERBALIZED UNDERSTANDING AND AGREES TO PLAN.
Age: 4.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product preparation error
Clinical narrative: PATIENT WAS GIVEN AN UNDILUTED PFIZER COVID VACCINE. THE DILUENT WAS NOT ADDED TO THE VACCINE SO PATIENT RECEIVED 0.3ML OF UNDILUTED VACCINE. SPOKE WITH MOM 2 DAYS AFTER VACCINATION AND SHE DENIED ANY SIDE EFFECTS OF THE VACCINE, SPECIFICALLY FEVER, FATIGUE, REDNESS OR SWELLING AT INJECTION SITE.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was given outside of the recommended timeframe
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Skin infection
Clinical narrative: Patient's arm began to swell at the injection site one day after administration. Patient went to an urgent care and confirmed a skin infection.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Joint range of motion decreased, Musculoskeletal stiffness
Clinical narrative: PATIENT DEVELOPED HEADACHE AT BASE OF BACK OF HEAD BY END OF DAY. HEADACHE CONTINUED AND ABOUT 2 TO 3 DAYS LATER DEVELOPED A STILL NECK MAKING TURNING DIFFICULT
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was already vaccinated for HPV and was given the vaccine series again due to name change and vaccine record not reconciled.  Was initially vaccinated for HPV on 05/16/18 and 12/06/2018.  Was re-vaccinated with HPV series on 07/19/2022, 06/12/2023, 03/19/2024.  No physical complaints or exam findings.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HCP called for TE for VAXNEUVANCE and VAQTA see TE case 02679745. One dose of VAXNEUVANCE and VAQTA were administered, see other AE case 02679790. Consent to contact is yes. No adverse side effects were reported. No additional information available a; This spontaneous report was received from an administrator regarding a 1-year-old patient of unknown gender.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.  On 27-SEP-2024, the patient was vaccinated with an improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe as prophylaxis (dose, vaccination scheme frequency, route of administration, and anatomical site of injection were not provided; lot number Y006121 has been verified as a valid number for hepatitis A vaccine, inactivated [VAQTA], expiration date 17-MAY-2025). The administered dose of the vaccine experienced a temperature excursion at below 36 degree Fahrenheit (F) (35.4 degree F) for 0 hours, 40 minutes and 0 seconds (Prior TE was in range) (Product storage error).  No adverse effect was reported for the patient. This is one of two reports from the same reporter. ; Sender's Comments:  US-009507513-2409USA010316:MSD
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; VARIVAX was administered to one patient on 09/30/2024 following a TE.; This spontaneous report has been received from a nurse regarding a patient of unknown age and gender.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.  On 30-SEP-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of injection were not reported; lot number W032507 has been verified to be a valid number for varicella virus vaccine live [oka/merck] [VARIVAX], expiration date 11-OCT-2024). The administered dose of the vaccine experienced a temperature excursion (no specific details were provided regarding time or temperature of the excursion) (Product storage error).  No additional adverse event was reported for the patient.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Fainting; This serious case was reported by a nurse via sales rep and described the occurrence of fainting in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number 55n34) for prophylaxis.   On 16-SEP-2024, the patient received Bexsero. On 16-SEP-2024, less than a day after receiving Bexsero, the patient experienced fainting (Verbatim: Fainting) (serious criteria GSK medically significant). On 16-SEP-2024, the outcome of the fainting was resolved.   The reporter considered the fainting to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the fainting to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 26-SEP-2024 The nurse reported that, the patient received a subsequent dose of Bexsero vaccine and experienced fainting.; Sender's Comments: Syncope is a listed event which, due to the following criteria (insufficient information provided about the clinical description ) is considered unrelated to GSK vaccine  Bexsero and Bexsero Pre-Filled Syringe Device.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Fainting; This serious case was reported by a nurse via sales rep and described the occurrence of fainting in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number Ek7dg) for prophylaxis.   On 17-SEP-2024, the patient received Menveo. On 17-SEP-2024, an unknown time after receiving Menveo, the patient experienced fainting (Verbatim: Fainting) (serious criteria GSK medically significant). The outcome of the fainting was unknown.   The reporter considered the fainting to be related to Menveo.     The company considered the fainting to be related to Menveo.   Additional Information: GSK Receipt Date: 26-SEP-2024 The nurse reported that a patient received Menveo vaccine and experienced fainting.; Sender's Comments: Syncope is a listed event which is considered related to GSK vaccine Menveo.
Age: 16.0
Sex: M
Vaccine: FLU3, MENB, MNQ
Symptoms: Syncope
Clinical narrative: Fainting; This serious case was reported by a nurse via sales rep and described the occurrence of fainting in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number G334j) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number Ek7dg) for prophylaxis and Flu Seasonal TIV Dresden (Fluarix) (batch number N737y) for prophylaxis.   On 26-SEP-2024, the patient received Bexsero and Menveo. On an unknown date, the patient received Fluarix. On 26-SEP-2024, less than a day after receiving Bexsero and Menveo and an unknown time after receiving Fluarix, the patient experienced fainting (Verbatim: Fainting) (serious criteria GSK medically significant). The outcome of the fainting was unknown.   It was unknown if the reporter considered the fainting to be related to Bexsero, Bexsero Pre-Filled Syringe Device, Menveo, Fluarix and Fluarix Pre-Filled Syringe Device.     The company considered the fainting to be related to Bexsero, Bexsero Pre-Filled Syringe Device, Menveo, Fluarix and Fluarix Pre-Filled Syringe Device.   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: 26-SEP-2024 The reporter reported that the patient had experienced fainting after received Bexsero, Menveo and Fluarix vaccine.; Sender's Comments: Syncope is a listed event which is considered related to GSK vaccine Bexsero, Bexsero PRE-FILLED SYRINGE DEVICE, Menveo, Fluarix and Fluarix PRE-FILLED SYRINGE DEVICE.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; patient received 3 doses of Shingles vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles just before got married, just a mild case).   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and extra dose administered (Verbatim: patient received 3 doses of Shingles vaccine). The outcome of the vaccination failure and shingles were not reported and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. The company considered the shingles and extra dose administered to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 26-SEP-2024 This case was reported by a patient via interactive digital media. The reporter reported that she got shingles just before she got married, just a mild case, but she remembered, and further patient stated that at the age of 65 years she got the shot, later she got the 2 shots. The reporter mentioned that she had shingles again just after her husband of 46 years passed away. The reporter guessed she could blame both on him. The patient received 3rd dose of Shingles vaccine, which led to an extra dose administered. 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 is considered related to GSK Shingles vaccine (Dose 1, Dose 2 and Dose 3). Herpes zoster and Extra dose administered are unlisted events which are considered unrelated to GSK Shingles vaccine (Dose 1, Dose 2 and Dose 3).
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles twice after receiving both shots; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles twice after receiving both shots). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 16-SEP-2024 This case was reported by a patient via interactive digital media. The patient got the vaccine and still got shingles twice after receiving both shots. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (1st dose)and Shingrix(2nd dose).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had shingles 11 times after receiving the vaccine; 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles 11 times after receiving the vaccine). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-SEP-2024 This case was reported by a patient via interactive digital media. The patient had shingles 11 times after receiving the vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary schedule, 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 vaccine Shingrix .
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine administered; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of expired vaccine used in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: expired vaccine 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: 19-SEP-2024 The health care professional reported that Priorix being administered after its expiration date, which led to expired vaccine used. No other information was available. No additional adverse event or product quality complaint was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Missed Shingrix Dose; This non-serious case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 23rd October 2023).   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: Missed Shingrix Dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-SEP-2024 First dose of Shingrix given 23rd October 2023, did not receive 2nd dose until 20th September 2023. The reporter questioned should that be considered the 2nd dose or should the series be restarted. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak after taking 1 dose; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles outbreak after taking 1 dose). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-SEP-2024 The physician reported that the patient who had experienced Shingles prior to vaccination with Shingrix had symptoms of Shingles outbreak after taking 1st dose of the 2 dose series of Shingrix. She was trying to decide if these patient should move forward with a second dose. This case is linked with US2024AMR118500, by same reporter.; Sender's Comments:  US-GSK-US2024AMR118500:Same reporter, different patient
Age: 55.0
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: that second dose made me sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 55-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date). Family history included shingles (patient's mother had shingles twice).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: that second dose made me sick). The outcome of the sickness was resolved (duration 2 days).   It was unknown if the reporter considered the sickness to be related to Shingrix.     It was unknown if the company considered the sickness to be related to Shingrix.   Additional Information: GSK receipt date: 16-SEP-2024 This case was reported by a patient via interactive digital media The reporter reported that his/her mother had shingles twice and kept begging her to get the vaccine. The reporter mentioned that he/she finally did at 55 years of age. He/she had received dose of Shingrix and experienced sick for about 2 days, but he/she sure it was with it. The reporter said that had that peace of mind and go get this on.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administered Havrix on the following schedule: 0 and 2 months (Early Second dose); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received HAV (Havrix) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact (Havrix).   On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: administered Havrix on the following schedule: 0 and 2 months (Early Second dose)). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-SEP-2024 The pharmacist reported that they had a pharmacist (patient) and he was supposed to be on the 0 and then the 6 to 12 months for Havrix vaccine and he didn't knew but he got the follow-up at 2 months The health care professional (HCP) administered Havrix on the following schedule of 0 and 2 months (early second dose). The patient received 2nd dose of Havrix earlier than recommended interval, which led to shortening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not received; 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 (1st dose received on an unknown date).   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: 2nd dose not received). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-SEP-2024 Family member was the reporter. Family member stated some one in his immediate family had one dose of Shingrix administered about 1 year ago but had not had the second dose of Shingrix (missed dose). No further information was known about the family member reporting or the family member that missed the second dose of Shingrix. Date of first administration was not known. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: extra dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date in 2019  received 1st dose) and Shingrix (on 23rd October 2019  received 2nd dose).   On 23-SEP-2024, the patient received the 3rd dose of Shingrix. On 23-SEP-2024, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: extra dose). The outcome of the extra dose administered was not applicable.   Additional Information: GSK receipt date: 23-SEP-2024 The patient had both doses of Shingrix administered at his PCP's office within the timeframe specified in 2019. The patient stated he had a third dose administered, which led to extra dose administered.  Consented to follow up.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: shivering; headache,; she had body aches,; felt tired for several days; This non-serious case was reported by a consumer via call center representative and described the occurrence of shivering in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (shingles in eye 2015 and 2018) and cataract operation (cataract surgery in 2015 and 2018). Previously administered products included Zostavax (had on 2007). Concurrent medical conditions included glaucoma.   On 19-SEP-2024, the patient received the 1st dose of Shingrix (intramuscular, unknown arm). In SEP-2024, less than a week after receiving Shingrix, the patient experienced shivering (Verbatim: shivering), headache (Verbatim: headache,) and general body pain (Verbatim: she had body aches, ). On 23-SEP-2024, the patient experienced tiredness (Verbatim: felt tired for several days). In SEP-2024, the outcome of the shivering, headache and general body pain were resolved.  On 23-SEP-2024, the outcome of the tiredness was resolved.   It was unknown if the reporter considered the shivering, tiredness, headache and general body pain to be related to Shingrix.     It was unknown if the company considered the shivering, tiredness, headache and general body pain to be related to Shingrix.   Additional Information: GSK receipt date: 23-SEP-2024 The patient was the reporter.  She received her first Shingrix dose and after Shingrix vaccination she had body aches, headache, shivering and felt tired for several days.  Today, (on the day of reporting) all of the effects resolved.  Nothing else was reported. Did not consent to follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I don't think I got Moderna because my husband was sick for 3 days after he got his; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (I don't think I got Moderna because my husband was sick for 3 days after he got his) 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 ILLNESS (I don't think I got Moderna because my husband was sick for 3 days after he got his). At the time of the report, ILLNESS (I don't think I got Moderna because my husband was sick for 3 days after he got his) outcome was unknown.      The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   The concomitant medication was not reported by reporter.  The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-774496 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774496:Patient 1(Master case)
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient reported experiencing "soreness in the arm" (which may have lasted a few days); This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Patient reported experiencing "soreness in the arm" (which may have lasted a few days)) in a 73-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Pneumonia.    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 PAIN IN EXTREMITY (Patient reported experiencing "soreness in the arm" (which may have lasted a few days)). At the time of the report, PAIN IN EXTREMITY (Patient reported experiencing "soreness in the arm" (which may have lasted a few days)) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2024-774538 (Patient Link).
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Cytokine test, Diarrhoea
Clinical narrative: severe diarrhea; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (severe diarrhea) in a patient of an unknown age and gender 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.   In September 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (severe diarrhea). At the time of the report, DIARRHOEA (severe diarrhea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2024, Cytokine test: Going quite up on a GI.     The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the patient had usual effects of vaccine and patient also had diarrhea which likely are the results of the usual cytokines going up on a GI that was sensitive to inflammation.   No treatment medications were reported.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Unilateral numbness (left side), same side as administration; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Unilateral numbness (left side), same side as administration) in a 30-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042573) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 27-Sep-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced HYPOAESTHESIA (Unilateral numbness (left side), same side as administration) (seriousness criterion medically significant). At the time of the report, HYPOAESTHESIA (Unilateral numbness (left side), same side as administration) had not resolved.            Concomitant medication was not provided.  Treatment information was not reported.  Company Comment: This is a spontaneous case concerning 30-year-old male patient with no reported medical history, who experienced the serious (due to medically significant) unexpected, event of Hypoaesthesia, which occurred on the same day after a dose of SPIKEVAX 2024-2025 KP.2 PFS vaccine, (unknown COVID-19 vaccination schedule). It was reported that patient experienced unilateral numbness (left side), same side as administration. The outcome of the event was reported as not recovered. No further information was disclosed. The benefit-risk relationship of SPIKEVAX 2024-2025 KP.2 PFS vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: arm started to itch; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (arm started to itch) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. ASKU) 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) (unknown route) 1 dosage form. On 25-Sep-2024, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced PRURITUS (arm started to itch). At the time of the report, PRURITUS (arm started to itch) was resolving.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site infection, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Arm hurt at the injection site. Next day - red & swollen & very warm; I know that warmth usually means infection & I still have the same effects today; Arm hurt at the injection site; hat night my arm hurt at the injection site. The next day it was red; Arm hurt at the injection site. Next day - red & swollen & very warm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Arm hurt at the injection site. Next day - red & swollen & very warm), VACCINATION SITE INFECTION (I know that warmth usually means infection & I still have the same effects today), VACCINATION SITE PAIN (Arm hurt at the injection site), VACCINATION SITE ERYTHEMA (hat night my arm hurt at the injection site. The next day it was red) and VACCINATION SITE SWELLING (Arm hurt at the injection site. Next day - red & swollen & very warm) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In September 2024, the patient experienced VACCINATION SITE WARMTH (Arm hurt at the injection site. Next day - red & swollen & very warm), VACCINATION SITE INFECTION (I know that warmth usually means infection & I still have the same effects today), VACCINATION SITE PAIN (Arm hurt at the injection site), VACCINATION SITE ERYTHEMA (hat night my arm hurt at the injection site. The next day it was red) and VACCINATION SITE SWELLING (Arm hurt at the injection site. Next day - red & swollen & very warm). At the time of the report, VACCINATION SITE WARMTH (Arm hurt at the injection site. Next day - red & swollen & very warm), VACCINATION SITE PAIN (Arm hurt at the injection site), VACCINATION SITE ERYTHEMA (hat night my arm hurt at the injection site. The next day it was red) and VACCINATION SITE SWELLING (Arm hurt at the injection site. Next day - red & swollen & very warm) had not resolved and VACCINATION SITE INFECTION (I know that warmth usually means infection & I still have the same effects today) outcome was unknown.            It was reported that patient had relevant medical history/conditions, allergy, concomitant diseases, and risk factor.  Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  It was reported that that night patient arm hurt at the injection site. The next day it was red and swollen and very warm. Patient knew that warmth usually means infection and patient still had the same effects at the time of reporting.  Treatment information was not provided.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: they put COVID with other things as the cause of death; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (they put COVID with other things as the cause of death) in an 89-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Dementia, COVID-19, Heart failure, Colloid brain cyst and Hypertension.    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 COVID-19 (they put COVID with other things as the cause of death) (seriousness criterion death). The patient died in February 2022. The reported cause of death was they put covid with other things as the cause of death. It is unknown if an autopsy was performed.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.   She had at least 3 times tested positive from Oct 2020 to Feb 2022. She was deteriorated from Oct 2019 until Feb 2022 when she was in the hospital for two weeks in a nursing home for one month. She was in a therapy to learn how to walk again. She had dementia before she died. She received two vaccines and some boosters but didn't know if it was Pfizer or Moderna. She had 6 or 8 underlying health problems including heart failure, inoperable brain cyst and hypertension. Every time she got COVID, the cognitive skills declined. She died in 2022.  The treatment medication was not reported by reporter.  Company comment-This fatal spontaneous case concerns an 89-year-old female patient, with concurrent conditions of dementia, heart failure, hypertension, and colloid brain cyst, who experienced the unexpected, serious (due to death) event COVID-19 unknown days after an unspecified dose of SPIKEVAX COVID-19 VACCINE NOS. It was reported patient had at least 3 times tested positive. She received two vaccines and some boosters but didn't know if it was Pfizer or Moderna. Every time she got COVID, the cognitive skills declined. She died in 2022. The reported cause of death was COVID (with other things, as reported). It is unknown if an autopsy was performed. Patient´s age along with multiple comorbidities remain as contributors for fatal outcome. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-774192 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774192:Reporter's case(Master case); Reported Cause(s) of Death: they put COVID with other things as the cause of death
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in an 8-decade-old female patient 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 COVID-19 (COVID) (seriousness criterion death). The reported cause of death was died of covid. It is unknown if an autopsy was performed.            Patient age was reported as was in her late seventies.  Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  Company Comment: This is a spontaneous case concerning a 8-decade-old female patient with no reported medical history, who experienced the serious (due to fatal) unexpected event of COVID. The event occurred on an unknown date, after a dose of SPIKEVAX COVID-19 VACCINE NOS (onset date, date for vaccination and dose number were not provided, hence latency could not be estimated). On an unknown date, the patient died; the reported cause of death was Covid. It is unknown if an autopsy was performed. The outcome of the event was reported as fatal. Medical history, current conditions, habits, concomitant medications, supportive diagnostic procedures, and treatment, that would contribute the assessment of the case, were not provided. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-774192 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774192:Reporter's case(Master case); Reported Cause(s) of Death: died of COVID
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: has a big red mark about 3-4 inches long on the arm where she was vaccinated; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (has a big red mark about 3-4 inches long on the arm where she was vaccinated) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.  On 28-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 29-Sep-2024, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced VACCINATION SITE ERYTHEMA (has a big red mark about 3-4 inches long on the arm where she was vaccinated). At the time of the report, VACCINATION SITE ERYTHEMA (has a big red mark about 3-4 inches long on the arm where she was vaccinated) had not resolved.     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.  Reporter stated that she received her Moderna COVID-19 vaccine and had a big red mark about 3-4 inches long on the arm where she was vaccinated which appeared the following day, 29-Sep-2024 and wanted to ask if this was part of the side effects of the vaccination. She added that she just never had any reaction before. She also added that in the pharmacy where she got the vaccine, she was not given any handouts regarding side effects of the Moderna vaccine which they used to have before, and she was not even informed which Moderna vaccine she had received. She wanted to know if she needs to take any medicine such as Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2024: Live follow-up information received included non-significant information added reference numbers in reference section.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: that she missed her last year's Vaccination as she had COVID; that she missed her last year's Vaccination as she had COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (that she missed her last year's Vaccination as she had COVID) and PRODUCT DOSE OMISSION ISSUE (that she missed her last year's Vaccination as she had COVID) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19.    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 COVID-19 (that she missed her last year's Vaccination as she had COVID) and PRODUCT DOSE OMISSION ISSUE (that she missed her last year's Vaccination as she had COVID). At the time of the report, COVID-19 (that she missed her last year's Vaccination as she had COVID) and PRODUCT DOSE OMISSION ISSUE (that she missed her last year's Vaccination as she had COVID) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.  Dosage text for suspect product was reported as unknown. The treatment medication was not reported by reporter.   Reporter did not allow further contact