chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Movement disorder, Throat tightness, Tracheostomy, Walking aid user
Clinical narrative: Within less than a week I was in the bathroom and fell and couldn't move anything from the waist down.  I went to several hospitals and they thought it was a muscle problem. I kept getting sent home and it was gradually working its way up my body and getting worse and my doctor insisted i go to the hospital/ER and  because my throat was closing up. So my wife took me and I was in ICU on a vent and a trach and I don't know how long I was there (several months). I went to another hospital for Rehab to come off the vent and trach and I was there several months. I was in rehab on a walker and then a cane.  Dr. knows more details.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC15, VARCEL
Symptoms: Wrong product administered
Clinical narrative: No additional AE; Caller reported one year old received PROQUAD and VARIVAX at same office visit.  No other information provided.  No additional AEs or PQC reported.; proquad given instead of mmr; This spontaneous report was received from a nurse and other Health Professional (also reported as a vaccine coordinator) and refers to a 12-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 03-JUL-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) at 0.5ml, in the right tight , subcutaneously which had a lot # W036938 with expiry date on 19-MAY-2024, instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). However, the patient received an additional dose with varicella virus vaccine live (oka/merck) (VARIVAX) in left arm, subcutaneously, lot # W031813 expiration date on 05-OCT-2024 (Contraindicated product administered) (Wrong product administered). The Medical assistant inadvertently gave of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and did not realize it until after administration. The patient was also vaccinated with hepatitis a vaccine, inactivated (VAQTA) , lot #X004814, expiration date: 10-OCT-2024, administered intramuscularly for prophylaxis (strength was not provided); intramuscular, the fourth dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) and the third dose of hib vaccine conj (tet tox) (ACT HIB) in the right tight intramuscularly.   The physician immediately notified and tried to call the family to check on the patient. However at the reporting time, no adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Medical assistant reported expired MMRII vaccine administered to a patient.; This spontaneous report has been received from Medical Assistant, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported.    On 18-JUL-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) injection (lot number U019290 which has been verified to be valid, expiration date reported and validated as 18-JUN-2023), administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered).    No additional adverse events were reported in the patient.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Hallucination, Neoplasm malignant, Walking disability
Clinical narrative: hallucinating; cancer for the fourth time.; cannot walk; cannot talk; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HALLUCINATION (hallucinating), NEOPLASM MALIGNANT (cancer for the fourth time.), WALKING DISABILITY (cannot walk) and APHASIA (cannot talk) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L02A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (hallucinating) (seriousness criteria disability and medically significant), NEOPLASM MALIGNANT (cancer for the fourth time.) (seriousness criteria disability and medically significant), WALKING DISABILITY (cannot walk) (seriousness criterion medically significant) and APHASIA (cannot talk) (seriousness criterion medically significant). At the time of the report, HALLUCINATION (hallucinating), NEOPLASM MALIGNANT (cancer for the fourth time.), WALKING DISABILITY (cannot walk) and APHASIA (cannot talk) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Caller said that her mother cannot walk, cannot talk, and going to be dead in a month, she was hallucinating, and has cancer for the fourth time. No treatment information was reported.  Company Comment: This is a Spontaneous case reported by a patient family member, concerning a 71-year-old female patient, with no medical history reported, who experienced the unexpected and serious (due to disability and medically significant) events of Hallucination and Neoplasm malignant, and the unexpected and serious (due to medically significant) events of Aphasia and Walking disability, which occurred on an unknown date related to the first dose of mRNA-1273 vaccine. Since no vaccination nor events dates were provided, temporal association and latency cannot be properly assessed. As reported, the patient cannot walk, cannot talk, and is going to be dead in a month. She was hallucinating, and has cancer for the fourth time. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the events had not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Improper storage of product in use; No Adverse Event; This spontaneous report was received from a physician refers to a 6-month-old patient of unknow gender.  The patient's medical history and concurrent condition was not provided. The patient's concomitant medications included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (PREVENAR 13).  On 21-JUN-2023, the patient was vaccinated with the third dose of improper storage rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #1968386, expiration date: 23-MAY-2024, oral (exact dose was not provided) for prophylaxis.   The administered dose underwent a temperature excursion during unreported amount of time on unreported temperature. It was reported the alarm was believed to be due to sensory issues and the temperatures were monitored with back up logger, which was by the time of the report was replaced with a new one and temperature was then in range. There was a previous temperature excursion (product storage error). No additional adverse event reported (no adverse event).  This is one of two reports of the same patient.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous report was received from a physician refers to a 6-month-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-DEC-2022, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis.   On 01-FEB-2023, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis (inappropriate schedule of product administration).  This is one of two reports of the same patient.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Pain
Clinical narrative: Aches; Fatigue; Joint pain; Muscle aches; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Aches), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and MYALGIA (Muscle aches) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Aches), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and MYALGIA (Muscle aches). At the time of the report, PAIN (Aches), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and MYALGIA (Muscle aches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was unknown if the patient experienced any additional symptoms/events.  No lab data results were available.  Treatment information was not reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case dose 1 Pfizer 3/31/21  ER8733 dose 2 Pfizer 4/21/21  EW0158
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Hypoxia, Pneumonia bacterial
Clinical narrative: Presented with shortness of breath and was hypoxic requiring supplemental O2. He was found to have covid 19 as well as high suspicion for bacterial pneumonia. Tx w/abx, steroids, O2, zinc; weaned to RA for DC home.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, SARS-CoV-2 test positive
Clinical narrative: Presented with acute respiratory failure; found to be COVID-19+; tx w/remdesivir, steroids, zinc, abx, O2;
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Dyspnoea
Clinical narrative: Patient comes in with shortness of breath, admitted with COVID-19 pneumonia. Tx w/abx, steroids, VitC, zinc; pt did not require O2.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Cardiac disorder, Chills, Headache, Pain
Clinical narrative: some 24 hours after the second dose, I was having all the symptom listed, fever, chills, upset stomach, body aches, headache. I had heart symptoms much like A-Fib for three days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: some 24 hours after the second dose, I was having all the symptom listed, fever, chills, upset stomach, body aches, headache. I had heart symptoms much like A-Fib for three days.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Hypotension, SARS-CoV-2 test positive, Upper gastrointestinal haemorrhage
Clinical narrative: Presented to the ED c/o weakness; admitted for recurrent UGI bleed & hypotension, COVID-19+ finding but asymptomatic
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Intraventricular haemorrhage, SARS-CoV-2 test positive
Clinical narrative: Presents to the ED via EMS after being d/c from the hospital yesterday. Pt was admitted 12/27 to 1/5 for intraventricular hemorrhage and was sent back to his long-term care facility who then sent pt back here due to pt testing COVID+ today; they reported that they could not care for him b/c he is COVID+. Pt asymptomatic and returned to LTAC.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, COVID-19, Chest pain, Dyspnoea exertional
Clinical narrative: Presents to the ED c/o abdominal pain. Pt states she gets abdominal pain that radiates into her chest, back, and neck associated with SOB whenever she exerts such as walking around or doing laundry. Incidental finding of COVID-19+, asymptomatic
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain
Clinical narrative: Presents to the ED c/o abdominal pain. Pt states she gets abdominal pain that radiates into her chest, back, and neck associated with SOB whenever she exerts such as walking around or doing laundry. Incidental finding of COVID-19+, asymptomatic
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Respiratory failure
Clinical narrative: Came in with chief complaint of shortness of breath cough was diagnosed with respiratory failure secondary to COVID-19. Tx w/remdesivir, abx, steroids, zinc, O2;
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, COVID-19, Cough, Nausea
Clinical narrative: Presented with weakness, nausea, epigastric pain, cough for about the last 10 days. COVID-19+ but asymptomatic
Age: 44.0
Sex: F
Vaccine: HPV9
Symptoms: Dysgeusia, Swollen tongue
Clinical narrative: Within 10 minutes of receiving the Gardasil 9 vaccine, I had a strong metallic taste in my mouth and my tongue started swelling.
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: Patient's wife reported sore arm the day after vaccine administered and 7 days worse pain extending to neck and shoulder. I advised most common event was sore arm. I was concerned still pain at 7 days post vaccine. She wanted recommendation and I stated if pain severe enough should see physician. Please note patient suffers also from dementia, and complained even before needle was inserted in bicep. I advised I would report event as protocol dictates.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Expired product administered, Product preparation issue
Clinical narrative: No additional AE/PQC; Caller reported inadvertent administration of expired STERILE DILUENT that was used to reconstitute MMR-II and VARIVAX.; Caller reported inadvertent administration of expired STERILE DILUENT that was used to reconstitute MMR-II and VARIVAX.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 29-JUN-2023, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) (strengths, vaccination schemes, anatomical sites of vaccination, routes of administration, lot numbers and expiration dates were not reported) as prophylaxis, that were reconstituted with an expired sterile diluent (strength, dose, frequency and route of administration were not reported; lot number T029529, expiration date reported and validated as 16-AP-2023) (expired product administered and product preparation issue). No additional adverse event.
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: No additional AE/no PQC.; Merck Employee called on behalf of healthcare worker to report that a 2 year old female patient inadvertently received an expired dose of PROQUAD. Per employee, no symptoms were reported. The dose of PROQUAD expired 6/14/2023 and was administered 7/1; This spontaneous report was received from Other Health Professional and refers to a 2-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 19-JUL-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, expiration date: 14-JUN-2023, administered for prophylaxis (strength, lot #, and route of administration were not provided).  On 19-JUL-2023, Merck Employee called on behalf of healthcare worker to report that a 2 year old female patient inadvertently received an expired dose of PROQUAD. Per employee, no symptoms were reported. Employee stated best phone number for the healthcare worker was XXX-XXX-XXX. Agent placed outbound call and spoke to healthcare worker who stated she had already called in and reported this event. See AE case #02430867. No additional AE/no PQC.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Inbound call from customer to provide updated temperature excursion information. She also provided names and administration dates of improperly stored administered ROTATEQ that was not supported. See original AE case 02429442 which did not include un; This spontaneous report was received from Other and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 06-JUL-2023, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, lot #1968385, expiration date: 22-MAY-2024, administered for prophylaxis (strength, and route of administration were not provided).  On 06-JUL-2023, inbound call from customer to provide updated temperature excursion information. She also provided names and administration dates of improperly stored administered ROTATEQ that was not supported. Temperature excusion occured on 20-JUN-2023 - 34.9F for 6 hours 34 minutes 0 seconds; 03-JUL-2023 - 51.4 F for 7 hours 33 minutes 0 seconds; 04-JUL-2023 - 51.1F for 24 hours 0 minutes 0 seconds; 05-JUL-2023 - 50.7F for 9 hours 27 minutes 0 seconds. See original AE case 02429442 which did not include unique patient identifiers. Company awareness date reflects the date the RA was originally made aware. Additional AE cases were created for all patients involved: 02430210 02430211 02430254 02430255 02430256 02430257 02430258 02430259 02430261 02430267 02430578 02430599 02430623 02430642 02430682 02430683 02430684 02430686 02430687 02430690 02430691 02430699 02430701.  No PQC. No additional information.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Improper storage of product in use; No Adverse Event; This spontaneous report was received from a physician refers to a 6-month-old patient of unknown gender.  The patient's medical history and concurrent conditions were not reported. Concomitant medications included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) pneumococcal vaccine conj 13v (PREVENAR 13), and famotidine.  On 15-JUN-2023, the patient was vaccinated with the third dose of improper storage rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #1968385, expiration date:22-MAY-2024, oral (exact dose was not provided) for prophylaxis.   The administered dose underwent a temperature excursion during unreported amount of time on unreported temperature. It was reported the alarm was believed to be due to sensory issues and the temperatures were monitored with back up logger, which was by the time of the report was replaced with a new one and temperature was then in range. There was a previous temperature excursion (product storage error). No additional adverse event reported (no adverse event).   This is one of two reports of the same patient.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous report as received from a physician refers to a 6-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-DEC-2022, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis. On 20-FEB-2023, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis (inappropriate schedule of product administration).  This i one of two reports of the same patient.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called regarding ROTATEQ. Product was administered to three different patients post TE; No additional AE; This spontaneous report was received from an registered nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1968382, expiration date: 21-MAY-2024, administered orally for prophylaxis (strength was not provided). This vaccine underwent temperature excusion before administration to a patient (Product storage error). No additional adverse event was administered.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Oral herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles. Started in his/her month; Shingles 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), oral herpes zoster (Verbatim: shingles. Started in his/her month) and pain (Verbatim: Shingles pain). The outcome of the vaccination failure was unknown and the outcome of the oral herpes zoster was not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, oral herpes zoster and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, oral herpes zoster and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 21-JUL-2023 This case was reported by consumer via interactive digital media. The patient had the vaccine, and still got shingles. Started in his/her month. Went down throat and on face. Terrible as patient was still in pain 2 months later. This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the vaccination too. But I still got shingles/Suspected vaccination failure; I got the vaccination too. But I still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got the vaccination too. But I still got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got the vaccination too. But I still got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date 23 Jul 2023 This case was reported by a consumer via interactive digital media. The patient got the vaccination too. But he/she still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Just got shingles; Still was painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Just got shingles) and pain (Verbatim: Still was painful). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 24-Jul-2023 This case was reported the patient via interactive digital media. The patient got the vaccine and just got shingles. Very mild but still (the recent time), it was painful This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Eye irritation, Occupational exposure to product
Clinical narrative: Eye irritation; vaccine splash into their eye; vaccine splash into their eye; This non-serious case was reported by a nurse via sales rep and described the occurrence of eye irritation in a 20-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 20-JUL-2023, the patient received Menveo. On 20-JUL-2023, less than a day after receiving Menveo, the patient experienced eye irritation (Verbatim: Eye irritation), occupational exposure while administering product (Verbatim: vaccine splash into their eye) and exposure via eye contact (Verbatim: vaccine splash into their eye). On 21-JUL-2023, the outcome of the eye irritation was resolved (duration 1 day). The outcome of the occupational exposure while administering product and exposure via eye contact were unknown.   The reporter considered the eye irritation to be related to Menveo.     The company considered the eye irritation to be related to Menveo.   Additional Information: GSK Receipt Date: 21-JUL-2023 The reporter stated that the medical assistant administering the vaccine to the patient had vaccine splash into their eye. Unsure exactly how that occurred as it was reported by the supervisor to GSK. Supervisor stated employee flushed their eye due to irritation and was now just fine with no ongoing irritation or symptoms. The reporter stated that the event was eye exposure/contact with Menveo by a health care provider, which led to occupational exposure while administering product and exposure via eye contact. The reporter did not consent to follow up.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Gait inability, Head discomfort, Headache, Loss of personal independence in daily activities, Malaise
Clinical narrative: pressure in his brain steam causes constant pain; light sensitivity; he cannot walk; pressure in his brain steam causes constant pain; ill; never was able to even start his senior year or finish school; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced headache (Verbatim: pressure in his brain steam causes constant pain), photophobia (Verbatim: light sensitivity), unable to walk (Verbatim: he cannot walk), head pressure (Verbatim: pressure in his brain steam causes constant pain), unwell (Verbatim: ill) and activities of daily living impaired (Verbatim: never was able to even start his senior year or finish school). The outcome of the headache, photophobia, unable to walk, head pressure, unwell and activities of daily living impaired were not reported.   The reporter considered the headache, photophobia, unable to walk, head pressure, unwell and activities of daily living impaired to be possibly related to Bexsero and Bexsero Pre-Filled Syringe Device.   The company considered the headache, photophobia, unable to walk, head pressure, unwell and activities of daily living impaired to be possibly 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: 17-JUL-2023 This case was reported by a patient's relative via interactive digital media. The patient receive this at age 17 before he was to start his senior year.  The patient became so ill he was now about to turn 21 and never was able to even start his senior year or finish school.  Some days he could not walk.  The pressure in his brain steam caused constant pain and he was so light sensitive he had to stay in his house with lights off during the day.  This and all vaccines had risks (and so did meningitis) but the vaccine was not a safe way to protect your child.  The reporter thought the event might had been related to product/device.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Pain, Photophobia
Clinical narrative: pressure in his brain steam causes constant pain; light sensitivity; he cannot walk; pressure in his brain steam causes constant pain; ill; never was able to even start his senior year or finish school; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced headache (Verbatim: pressure in his brain steam causes constant pain), photophobia (Verbatim: light sensitivity), unable to walk (Verbatim: he cannot walk), head pressure (Verbatim: pressure in his brain steam causes constant pain), unwell (Verbatim: ill) and activities of daily living impaired (Verbatim: never was able to even start his senior year or finish school). The outcome of the headache, photophobia, unable to walk, head pressure, unwell and activities of daily living impaired were not reported.   The reporter considered the headache, photophobia, unable to walk, head pressure, unwell and activities of daily living impaired to be possibly related to Bexsero and Bexsero Pre-Filled Syringe Device.   The company considered the headache, photophobia, unable to walk, head pressure, unwell and activities of daily living impaired to be possibly 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: 17-JUL-2023 This case was reported by a patient's relative via interactive digital media. The patient receive this at age 17 before he was to start his senior year.  The patient became so ill he was now about to turn 21 and never was able to even start his senior year or finish school.  Some days he could not walk.  The pressure in his brain steam caused constant pain and he was so light sensitive he had to stay in his house with lights off during the day.  This and all vaccines had risks (and so did meningitis) but the vaccine was not a safe way to protect your child.  The reporter thought the event might had been related to product/device.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Worst pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a 82-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Worst pain). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 23-JUL-2023 This case was reported by a consumer via interactive digital media. Worst pain the patient ever had as received 1st shot, but got them before could get the 2nd. The reporter suggested to get shot if someone haven't had them.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Skin warm
Clinical narrative: my arm was sore and warm for 5 days; my arm was sore and warm for 5 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (got the single dose on an unknown date, before came out with the 2 part vaccine).   On 15-JUL-2023, the patient received the 1st dose of Shingles vaccine. In JUL-2023, less than a week after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: my arm was sore and warm for 5 days) and skin warm (Verbatim: my arm was sore and warm for 5 days). In JUL-2023, the outcome of the pain in arm and skin warm were resolved (duration 5 days).   It was unknown if the reporter considered the pain in arm and skin warm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and skin warm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-JUL-2023 This case was reported by a patient via interactive digital media. The patient asked his/her doctor, should he/she get the 2-part vaccine (better protection) and got 1st dose on Saturday and his/her arm was sore and warm for 5 days. The pharmacy tech warned him/her ahead of time, she stated the 2nd dose was even rougher, but still got to be better than getting shingles. The follow up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives; itches; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of hives in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced hives (Verbatim: Hives) and pruritus (Verbatim: itches). The outcome of the hives and pruritus were not reported.   It was unknown if the reporter considered the hives and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the hives and pruritus to be related to Shingles vaccine.   Additional Information: GSK receipt date: 21-JUL-2023 This case was reported by a patient via interactive digital media. The patient stated that he was glad that he got the vaccine however, since then was experiencing hives and itches. The patient was not sure if adverse event was related to the vaccine. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR101704, same reporter.
Sex: M
Vaccine: MNQ
Symptoms: Occupational exposure to product
Clinical narrative: Drawing up vaccines and possible air pocket caused some to squirt out. He rinse his eyes and went back to; This non-serious case was reported by a nurse via sales rep and described the occurrence of occupational exposure to product via eye in a 20-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced occupational exposure to product via eye (Verbatim: Drawing up vaccines and possible air pocket caused some to squirt out. He rinse his eyes and went back to). The outcome of the occupational exposure to product via eye was unknown.   Additional Information: GSK receipt date: 21-Jul-2023 The nurse reported that he drawing up vaccines and possible air pocket caused some to squirt out and it rinse his eyes and went back to work, which led to occupational exposure to product via eye. The reporter consented to follow-up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test abnormal
Clinical narrative: lab levels doubled/thin blood doubled; This non-serious case was reported by a consumer via call center representative and described the occurrence of blood test abnormal in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included warfarin.   In JUL-2023, the patient received the 1st dose of Shingrix. In JUL-2023, an unknown time after receiving Shingrix, the patient experienced blood test abnormal (Verbatim: lab levels doubled/thin blood doubled). The outcome of the blood test abnormal was unknown.   It was unknown if the reporter considered the blood test abnormal to be related to Shingrix.     It was unknown if the company considered the blood test abnormal to be related to Shingrix.   Additional Information: GSK Receipt date: 18-JUL-2023 The patient was reporter's sister. The patient received dose 1 of Shingrix about a week ago from reporting date. She stated patient labs doubled.  The reporter stated the patient was on warfarin and the labs she gets to determine how thin her blood was doubled. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: The second dose has not been administered yet, most likely due to the pandemic; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2020).   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 social problem (Verbatim: The second dose has not been administered yet, most likely due to the pandemic). The outcome of the social problem was unknown.   Additional Information: GSK receipt date 24 Jul 2023: The pharmacist stated that a patient received her first dose of Shingrix in December 2020. The second dose had not been administered yet, most likely due to the pandemic.  The reporter did consent to follow up. The Vaccine administration facility was the same as primary reporter. The VAERS details reported for 1st dose. The patient did not received 2nd dose most likely due to the pandemic, which led to social problem.
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Nurse gave a 6 month old the Kinrix Vaccination; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 25ZH4) for prophylaxis.   On 18-JUL-2023, the patient received the 1st dose of Kinrix (intramuscular, left thigh) .5 ml. On 18-JUL-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Nurse gave a 6 month old the Kinrix Vaccination). The outcome of the inappropriate age at vaccine administration 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: 24-Jul-2023 The health care professional (HCP) called to report that a nurse gave a Kinrix vaccination. The HCP had not heard of any effects from receiving the vaccination from the child parents.  HCP to followed up today with the parents of the child. The Vaccine Administration Facility was the same as primary reporter. The 6 month old child received Kinrix by a nurse, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Not received second dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 5 years 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: Not received second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 24-JUL-2023 The reporter was the spouse of the patient who stated that patient received first dose of Shingrix 5 years ago and never got the second dose to complete the series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: Adult patient accidentally administered pediatric dose of Engerix B; Adult patient accidentally administered pediatric dose of Engerix B; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 23-year-old female patient who received HBV (Engerix B pediatric) (batch number yy2r3, expiry date 12-MAY-2024) for prophylaxis.   On 20-JUL-2023, the patient received Engerix B pediatric. On 20-JUL-2023, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: Adult patient accidentally administered pediatric dose of Engerix B) and adult use of a child product (Verbatim: Adult patient accidentally administered pediatric dose of Engerix B). The outcome of the accidental 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: 25-JUL-2023 The adult patient was accidentally administered a pediatric dose of Engerix B, which led to accidental underdose and adult use of a child product. The reporter did consent to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient was administered Menveo powder component with a non-GSK diluent; patient was administered Menveo powder component with a non-GSK diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient was administered Menveo powder component with a non-GSK diluent) and inappropriate dose of vaccine administered (Verbatim: patient was administered Menveo powder component with a non-GSK diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 25-JUL-2023 The reporter was a clinic supervisor. The reporter called to inquire that any information available and how to proceed.  The reporter stated that they had the liquid component left on hand but the powder was missing.  The reporter was unable to provide any patient or vaccine details due to healthcare professional still investigating. The reporter did not consent to follow-up. The reporter reported that they were sure a patient was administered Menveo powder component with a non-GSK diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Fall, SARS-CoV-2 test positive
Clinical narrative: Presented w c/o generalized weakness causing fall; incidental COVID-19+ finding, asymptomatic
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: 'beyond use date' was 7/19/2023. no known adverse outcome at this time
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, COVID-19, SARS-CoV-2 test positive
Clinical narrative: Presented to abdominal pain with the 1 day history of epigastric abdominal pain.  She was tested COVID 19 positive in the ED but asymptomatic.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Facial paralysis, Hemiparesis
Clinical narrative: Patient comes in with left-sided weakness and facial droop; incidental finding of COVID-19, asymptomatic
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Death, General physical health deterioration, Haemorrhage, Mental impairment
Clinical narrative: Presented to ED d/t no improvement w/outpt tx for COVID-19 pna; tx w/O2, abx, steroid, zinc; during stay, pt developed head bleed; d/t age and decline in mental/physical status, pt made comfort care and expired 1/8.
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: 'beyond use date' was 7/19/2023. no known adverse outcome at this time
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Thalamic stroke
Clinical narrative: ACUTE STROKE OF THALAMUS, UNSPECIFIED TYPE AND ARTERY
Age: 1.25
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Thigh turned red with hives at injection site
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Pharmacist states that an expired dose of Boostrix was administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4M2EZ, expiry date 03-JUN-2023) for prophylaxis.   On 24-JUL-2023, the patient received Boostrix. On 24-JUL-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Pharmacist states that an expired dose of Boostrix was administered to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 25-Jul-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. The patient received an expired dose of Boostrix, which led to expired vaccine used.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, MILD
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Hypoxia, Pulmonary embolism, Pulmonary infarction
Clinical narrative: HYPOTENSION IATROGENIC PULMONARY EMBOLISM W INFARCTION HYPOXIA
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Agency discovered the patient and his family that abused the system and obtained numerous COVID vaccinations most likely for financial gain of the $25 store gift cards issued at each patient encounter.