chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Erythema, Limb discomfort, Musculoskeletal discomfort, Peripheral swelling
Clinical narrative: Patient called stating that her arm is swollen, with some localized redness and discomfort. She reports some should discomfort and discomfort n her hand.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: 6month -4year old undiluted COVID vaccine administered to patient
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Patient received vaccines, passed out while checking out of the clinic 15 mins later.
Age: 34.0
Sex: M
Vaccine: YF
Symptoms: Dyspnoea, Erythema, Swelling, Urticaria
Clinical narrative: Redness, swelling, trouble breathing, hived
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received a duplicate flu shot. Received another flu shot in July.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient received a duplicate flu shot. Received another flu shot in July.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Magnetic resonance imaging, Pain, X-ray
Clinical narrative: I was in good health before receiving the COVID Spikevax 2023-24 (12YUP) SYRG, and prior to the shot, I had no pain. Since the shot on 3/21/24, severe pain occurs in the upper left shoulder area, in the same area where the COVID shot was injected. The pain is not a steady pain, but sometimes extends from the shoulder down to the elbow. The pain is often unbearable when it strikes, which is quite often. I kept hoping things would eventually improve, and they have not. Several months after the shot, in early August, I did have COVID, and was then totally uncomfortable. My Primary Care Physician advised me to fill out this form, and to get x-rays and an MRI, which I did. Physical therapy will be tried, beginning November 1, 2024.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Rash developed on Right Shoulder at injection site. Patient states itching and burning sensation to the touch.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave 5-11 year old dose instead of 6 months to <5 year old dose
Age: 1.08
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: 6month-4-year-old undilute COVID vaccine administered to patient
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Lymphadenopathy, Muscular weakness
Clinical narrative: Monday 10/21 : arm soreness and are weakness, Tuesday 10/22: worsened arm soreness/weakness, Wednesday 10/23: worsened arm soreness/weakness, itching, warm and red puncture site along with left axillary swollen lymph nodes.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Monday 10/21 : arm soreness and are weakness, Tuesday 10/22: worsened arm soreness/weakness, Wednesday 10/23: worsened arm soreness/weakness, itching, warm and red puncture site along with left axillary swollen lymph nodes.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fine motor skill dysfunction, Hypoaesthesia, Muscular weakness, Pain in extremity
Clinical narrative: About 3 days after receiving the vaccination, my right arm/shoulder hurt, my right hand tingled, I had diminished strength to squeeze/grasp objects with my right hand, and had diminished fine motor dexterity of the fingers of my right hand. The symptoms have diminished over the 2 months since the vaccination, but my right pinkie finger still feels a bit numb.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: About 3 days after receiving the vaccination, my right arm/shoulder hurt, my right hand tingled, I had diminished strength to squeeze/grasp objects with my right hand, and had diminished fine motor dexterity of the fingers of my right hand. The symptoms have diminished over the 2 months since the vaccination, but my right pinkie finger still feels a bit numb.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Prolonged pain in left deltoid after vaccine given on 10/01/2024
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone increased, Endocrine ophthalmopathy, Hyperthyroidism, Tri-iodothyronine
Clinical narrative: Two weeks after vaccination of the Moderna, I went to my private physician and had routine lab work at the time I had a thyroid level, checked for the routine and it came back low years before I ve always had my thyroid check just part of my routine and never had any issues with thyroid levels Since then I have been on thyroid medication for hyperthyroidism, dealing with thyroid eye disease, seeing a ophthalmologist and a endocrinologist for this for this condition now I have never had any type of elevated or hypothyroidism in 69 years. It happened two weeks after the last Moderna Covid vaccine variant.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Pain, Tenderness
Clinical narrative: Patient called pharmacy on 10/28/24 @ 1650 to ask pharmacist on duty if it is normal to still be sore 2 weeks after vaccine administration. Patient reports her arm is still tender and she is unable to lay on her side due to the discomfort. Pharmacist advised patient that this was not a usual duration of soreness after vaccination and recommended that she reach out to her primary provider for further assessment.
Age: 10.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pruritus, Rash, Rash papular
Clinical narrative: On 10/25/2024 Pt. father called stating the Pt. began developing a raised rash that looked like hives on her face on 10/24/2024. He stated on 10/25 the rash spread down her back, BUE and BLE and the hives itched on her face only.  , BSN, RN, Manager of Public Health was notified and informed this nurse that per standing orders, inform the Pt. dad to give Benadryl for 24 hrs and if any difficulty breathing to seek emergency medical attention, otherwise we would follow up on 10/28/2024.  Pt. dad was notified and given instructions. On 10/28/2024 Pt. dad was called for follow up and he stated "The rash got way worse over the weekend but the benadry helped and is almost gone now. You can only see it if you look hard for it"
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient has not yet reported any side effects and has not seeked treatment. The patient was given two 2024-25 Spikevax vaccines in one season, about six weeks apart. I called the manufacturer and they could not provide any data for this year's immunization as it has not been studied in clinical trials.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, X-ray
Clinical narrative: Shoulder pain that started on day after vaccine and continues currently (as of 10/28/24). Patient saw orthopedic physician on approximately 2-3 weeks ago and physician referred patient to therapy post-appointment.
Age: 2.0
Sex: F
Vaccine: HEPA, HEPA, HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No Additional AE reported; extra dose of VAQTA; This spontaneous report was received from an a registered nurse referring to a 2-year-old female patient. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 18-OCT-2023, the patient started therapy with the 1st dose of hepatitis a vaccine inact (HAVRIX), administered for prophylaxis (strength, formulation, dose, lot #, expiry date, anatomical site of administration and route of administration were not provided). On 31-MAY-2024, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection as booster dose (strength, dose, lot #, expiry date, anatomical site of administration  and route of administration were not provided) for prophylaxis. On 07-OCT-2024, the patient was inadvertently administered hepatitis a vaccine, inactivated (VAQTA) 25u/0.5ml, intramuscular injection, lot #Y007472, expiration date: 19-OCT-2025, administered for prophylaxis as  3rd dose by a health care professional (strength, dose, anatomical site of administration and route of administration were not provided) (extra dose administered). No additional adverse event (AE) reported (no AE).  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/No PQC; PROQUAD was administered following a temperature excursion; This spontaneous report was received from a medical assistant and refers to an patient of unspecified age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 11-OCT-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) injection, lot #Y009106, expiration date: 06-NOV-2025, administered for prophylaxis (strength, and route of administration were not provided) (improper storage of product in use).  Na adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2410USA004571:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The physician is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VAQTA (y011643    10/25/2025) Temperature: 8.6C Time fram; This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 18-OCT-2024, the patient was vaccinated with an improperly stored doses of hepatitis a vaccine, inactivated (VAQTA), formulation: intramuscular injection, lot # Y011643, expiration date: 25-OCT-2025 (exact dose, route of administration and anatomical location were not provided) for prophylaxis.   Administered dose of vaccine was exposed to the temperature excursion of 8.6 degrees Celsius for 24 minutes (product storage error). No previous temperature excursion had occurred. No additional adverse event reported (no adverse event).
Sex: F
Vaccine: VARCEL
Symptoms: Eye irritation, Headache, Occupational exposure to product, Ocular hyperaemia, Wrong technique in product usage process
Clinical narrative: the nurse was splashed in her right eye and reports irritation, redness and headache after exposure.; the nurse was splashed in her right eye and reports irritation, redness and headache after exposure.; the nurse was splashed in her right eye and reports irritation, redness and headache after exposure.; a nurse was splashed in the right eye with VARIVAX while administering to patient; a nurse was splashed in the right eye with VARIVAX while administering to patient; Medical Assistant who prepared the vaccine did not attach the needle correctly; This spontaneous report was received from a nurse practitioner and refers to a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-OCT-2024, while administering varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #Y000202, expiration date reported as and upon internal review confirmed to be: 03-JAN-2026, administered for prophylaxis (exact dose was not provided), a nurse was splashed in the right eye with the vaccine (route of administration was reported as topical) (occupational exposure to product; accidental exposure to product). The reporter reported that the medical assistant who prepared the vaccine did not attach the needle correctly (wrong technique in product usage process). As a result, on 22-OCT-2024, the nurse was splashed in her right eye and reported irritation, redness and headache after exposure (eye irritation; ocular hyperaemia; headache). Limited information was available at time of report. No additional adverse event (AE) and no product quality complaint (PQC) was noted. As treatment eye flush was provided. At the time of report, the nurse had not recovered from the events of eye irritation, ocular hyperaemia and headache.  The causal relationship between varicella virus vaccine live (oka/merck) (VARIVAX) and the events of eye irritation, ocular hyperaemia and headache was not reported.  This was one of two reports received from the same reported; Sender's Comments:  US-009507513-2410USA011361:
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 15 Year Old Received Dose of Heplisav-B; Initial report received on 25-Sep-2024.  A medical assistant reported that a 15-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization which was an inappropriate age to receive the vaccine.  Medical history and concomitant medications were not reported.   On 23-Sep-2024, the patient received the first dose of a hepatitis B vaccine [HEPLISAV-B (lot # 944915, expiration date 19-Sept-2026, and NDC # 43528-003-05)] intramuscularly in the left deltoid from a medical assistant.  The patient was scheduled to come in for another manufacturer's brand and was accidentally given HEPLISAV-B instead. The patient tolerated the injection, and no adverse effects were reported.  The patient's parents were notified.  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Death, Fall
Clinical narrative: Fall; This serious case was reported by a non-health professional and described the occurrence of fall in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-OCT-2024, the patient received Shingrix. On 24-OCT-2024, less than a day after receiving Shingrix, the patient experienced fall (Verbatim: Fall) (serious criteria death). The patient died on 24-OCT-2024. The reported cause of death was fall.   It was unknown if the reporter considered the fall to be related to Shingrix.     The company considered the fall to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 24-OCT-2024 The patient received Shingrix and after falling down on the stairs the patient had been dead on the spot. The symptoms were not treated.; Sender's Comments: Fall is an unlisted event which is considered unrelated to GSK vaccine Shingrix.; Reported Cause(s) of Death: Fall
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination Failure; Breakthrough shingles; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure high. Concomitant products included metoprolol.   On an unknown date, the patient received Shingrix. On 19-OCT-2024, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: Breakthrough shingles). 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: 21-OCT-2024 This case was self-reported by patient. The patient received Shingrix vaccine and experienced breakthrough shingles. The symptoms was treated. 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.; 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: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles/still got it again; 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.   The patient's past medical history included shingles (had the Shingles 4 times).   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) and shingles (Verbatim: Shingles/still got it again). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-OCT-2024 This case was reported by a patient via interactive digital media. The patient had the Shingles 4 times got the vaccines and still got it again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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, and h/o shingles 4 times) is considered unrelated to GSK Shingles vaccine.
Sex: M
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Product Storage Error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 12-month-old male patient who received MMR (Priorix) (batch number LY377, expiry date 01-APR-2025) for prophylaxis.   On 22-JUL-2024, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-OCT-2024 The reporter stated that they recently started using Priorix because they switched from using the MMR vaccine.  The MMR was frozen, but priorix they realized after it was too late that it was also placed in the freezer. The reporter asked, whether patient had to be reimmunized if they gave him frozen Priorix. The Priorix vaccine stored at minus 21.8 degree Celsius for 2 months and administered to a patient, which led to incorrect storage of drug. This was 1 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024123885: US-GSK-US2024123890:
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Menveo was reconstituted with sterile diluent from another manufacturer and administered to patient; Administration of lyophilized component with sterile diluent instead of Menveo liquid component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA988A, expiry date 30-NOV-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo was reconstituted with sterile diluent from another manufacturer and administered to patient) and inappropriate dose of vaccine administered (Verbatim: Administration of lyophilized component with sterile diluent instead of Menveo liquid component). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 10-OCT-2024 The reporter stated that the Menveo vaccine which was reconstituted with sterile diluent from another manufacturer and administration of lyophilized component with sterile diluent instead of Menveo liquid component to patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise
Clinical narrative: injection site pain; did not feel good; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included corneal transplant. Concomitant products included tetryzoline hydrochloride (Eye Drops).   In APR-2024, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: injection site pain) and feeling unwell (Verbatim: did not feel good). The outcome of the injection site pain was resolved (duration 1 week) and the outcome of the feeling unwell was resolved (duration 2 weeks).   It was unknown if the reporter considered the injection site pain and feeling unwell to be related to Shingrix.     It was unknown if the company considered the injection site pain and feeling unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-OCT-2024 The patient self-reported this case. The patient received the first dose of Shingrix vaccine in April 2024 not yet six months ago, he had Injection site pain for one week after vaccination. He did not feel good for about two weeks following vaccination.
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: second dose of Arexvy was inadvertently administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 66-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number GE3S7, expiry date 13-OCT-2025) for prophylaxis.   Previously administered products included Arexvy (received Arexvy on an unknown date).   On 17-OCT-2024, the patient received the 2nd dose of Arexvy. On 17-OCT-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: second dose of Arexvy was inadvertently administered to a patient). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 18-OCT-2024 The other health professional (Office manager) reported that a second dose of Arexvy was inadvertently administered to a patient which led to extra dose administered.  After administration other health professional  giving the vaccine, realize it was the wrong injection.
Age: 55.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient got the first dose on 2020 and the second dose was administered on October 17th 2024.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 55-year-old female patient who received HAB (Twinrix) (batch number 7x224, expiry date 30-DEC-2025) for prophylaxis.   Previously administered products included Twinrix (received first dose of Twinrix in 2020).   On 17-OCT-2024, the patient received the 2nd dose of Twinrix. On 17-OCT-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: patient got the first dose on 2020 and the second dose was administered on October 17th 2024.). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-OCT-2024 The other health professional (physician assistant) reported that the patient got the first dose on 2020 and the second dose was administered on October 17th 2024.  The other health professional asked when should administer the 3rd dose. The patient received second dose of Twinrix longer than the recommended interval which led to lengthening of vaccination schedule. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: only took one/second late dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient received first dose of vaccine having batch number E9552.).   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: only took one). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-OCT-2024 The pharmacist reported that the patient received the first dose of Shingrix last year but did not receive the second dose. So, they wanted to know that do they need to start the series again or just give the patient the second dose. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 7554T, expiry date 30-JUN-2025) for prophylaxis.   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-OCT-2024 The pharmacist reported that they had a refrigerator that went out of temperature range and, it did not get super hot before they set it, but a number of these fluarix were given after the temperature excursion which led to incorrect product storage error. The vaccine was stored at 56 degree Fahrenheit for 135 hours. The pharmacist reported that the vaccine was given to patient.  The pharmacist reported that the vaccines were given to 17 patients but he gave the initials of 20 patients. The pharmacist was not sure which patients got the doses before the maximum cumulative time of the extended stability data was reached. This was 1 of 20 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024128716:same reporter/different patient US-GSK-US2024128719:same reporter/different patient US-GSK-US2024128727:same reporter/different patient US-GSK-US2024128730:same reporter/different patient US-GSK-US2024128734:same reporter/different patient US-GSK-US2024128736:same reporter/different patient US-GSK-US2024128739:same reporter/different patient US-GSK-US2024128740:same reporter/different patient US-GSK-US2024128741:same reporter/different patient US-GSK-US2024128747:same reporter/different patient US-GSK-US2024128750:same reporter/different patient US-GSK-US2024128754:same reporter/different patient US-GSK-US2024128756:same reporter/different patient US-GSK-US2024128758:same reporter/different patient US-GSK-US2024128760:same reporter/different patient US-GSK-US2024128763:same reporter/different patient US-GSK-US2024128767:same reporter/different patient US-GSK-US2024128771:same reporter/different patient US-GSK-US2024128774:same reporter/different patient US-GSK-US2024128771:same reporter/different patient
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 7554T, expiry date 30-JUN-2025) for prophylaxis.   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-OCT-2024 The pharmacist reported that they had a refrigerator that went out of temperature range and, it did not get super hot before they set it, but a number of these fluarix were given after the temperature excursion which led to incorrect product storage error. The vaccine was stored at 56 degree Fahrenheit for 135 hours. The pharmacist reported that the vaccine was given to patient.  The pharmacist reported that the vaccines were given to 17 patients but he gave the initials of 20 patients. The pharmacist was not sure which patients got the doses before the maximum cumulative time of the extended stability data was reached. This was 1 of 20 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024128763:same reporter/different patient US-GSK-US2024128754:same reporter/different patient US-GSK-US2024128739:same reporter/different patient US-GSK-US2024128724:same reporter/different patient US-GSK-US2024128760:same reporter/different patient US-GSK-US2024128730:same reporter/different patient US-GSK-US2024128771:same reporter/different patient US-GSK-US2024128736:same reporter/different patient US-GSK-US2024128727:same reporter/different patient US-GSK-US2024128758:same reporter/different patient US-GSK-US2024128741:same reporter/different patient
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: fluarix were given after the temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 7554T, expiry date 30-JUN-2025) for prophylaxis.   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: fluarix were given after the temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-OCT-2024 The pharmacist reported that they had a refrigerator that went out of temperature range and, it did not get super hot before they set it, but a number of these fluarix were given after the temperature excursion. The vaccine was stored at 56 degree Fahrenheit for 135 hours. The pharmacist reported that the vaccine was given to patient.  The pharmacist reported that the vaccines were given to 17 patients but he gave the initials of 20 patients. The pharmacist was not sure which patients got the doses before the maximum cumulative time of the extended stability data was reached. This was 1 of 20 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024128727:same reporter/different patient US-GSK-US2024128754:same reporter/different patient US-GSK-US2024128754:same reporter/different patient US-GSK-US2024128760:same reporter/different patient US-GSK-US2024128763:same reporter/different patient US-GSK-US2024128771:same reporter/different patient US-GSK-US2024128724:same reporter/different patient US-GSK-US2024128730:same reporter/different patient US-GSK-US2024128736:same reporter/different patient US-GSK-US2024128758:same reporter/different patient US-GSK-US2024128739:same reporter/different patient US-GSK-US2024128741:
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: fluarix were given after the temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 7554T, expiry date 30-JUN-2025) for prophylaxis.   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: fluarix were given after the temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-OCT-2024 The pharmacist reported that they had a refrigerator that went out of temperature range and, it did not get super hot before they set it, but a number of these fluarix were given after the temperature excursion. The vaccine was stored at 56 degree Fahrenheit for 135 hours. The pharmacist reported that the vaccine was given to patient.  The pharmacist reported that the vaccines were given to 17 patients but he gave the initials of 20 patients. The pharmacist was not sure which patients got the doses before the maximum cumulative time of the extended stability data was reached. This was 1 of 20 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024128727:same reporter/different patient US-GSK-US2024128754:same reporter/different patient US-GSK-US2024128736:same reporter/different patient US-GSK-US2024128730:same reporter/different patient US-GSK-US2024128724:same reporter/different patient US-GSK-US2024128763:same reporter/different patient US-GSK-US2024128760:same reporter/different patient US-GSK-US2024128771:same reporter/different patient US-GSK-US2024128758:same reporter/different patient US-GSK-US2024128741:same reporter/different patient
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 7554T, expiry date 30-JUN-2025) for prophylaxis.   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-OCT-2024 The pharmacist reported that they had a refrigerator that went out of temperature range and, it did not get super hot before they set it, but a number of these fluarix were given after the temperature excursion. The vaccine was stored at 56 degree Fahrenheit for 135 hours. The pharmacist reported that the vaccine was given to patient.  The pharmacist reported that the vaccines were given to 17 patients but he gave the initials of 20 patients. The pharmacist was not sure which patients got the doses before the maximum cumulative time of the extended stability data was reached. This was 1 of 20 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024128771:same reporter/different patient US-GSK-US2024128774:same reporter/different patient US-GSK-US2024128767:same reporter/different patient US-GSK-US2024128763:same reporter/different patient US-GSK-US2024128760:same reporter/different patient US-GSK-US2024128758:same reporter/different patient US-GSK-US2024128756:same reporter/different patient US-GSK-US2024128754:same reporter/different patient US-GSK-US2024128750:same reporter/different patient US-GSK-US2024128747:same reporter/different patient US-GSK-US2024128741:same reporter/different patient US-GSK-US2024128740:same reporter/different patient US-GSK-US2024128739:same reporter/different patient US-GSK-US2024128736:same reporter/different patient US-GSK-US2024128734:same reporter/different patient US-GSK-US2024128719:same reporter/different patient US-GSK-US2024128716:same reporter/different patient US-GSK-US2024128727:same reporter/different patient US-GSK-US2024128724:same reporter/different patient
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: fluarix were given after the temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 7554T, expiry date 30-JUN-2025) for prophylaxis.   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: fluarix were given after the temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-OCT-2024 The pharmacist reported that they had a refrigerator that went out of temperature range and, it did not get super hot before they set it, but a number of these fluarix were given after the temperature excursion. The vaccine was stored at 56 degree Fahrenheit for 135 hours. The pharmacist reported that the vaccine was given to patient.  The pharmacist reported that the vaccines were given to 17 patients but he gave the initials of 20 patients. The pharmacist was not sure which patients got the doses before the maximum cumulative time of the extended stability data was reached. This was 1 of 20 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024128771:same reporter/different patient US-GSK-US2024128774:same reporter/different patient US-GSK-US2024128767:same reporter/different patient US-GSK-US2024128763:same reporter/different patient US-GSK-US2024128760:same reporter/different patient US-GSK-US2024128758:same reporter/different patient US-GSK-US2024128756:same reporter/different patient US-GSK-US2024128754:same reporter/different patient US-GSK-US2024128750:same reporter/different patient US-GSK-US2024128747:same reporter/different patient US-GSK-US2024128741:same reporter/different patient US-GSK-US2024128740:same reporter/different patient US-GSK-US2024128739:same reporter/different patient US-GSK-US2024128736:same reporter/different patient US-GSK-US2024128734:same reporter/different patient US-GSK-US2024128719:same reporter/different patient US-GSK-US2024128716:same reporter/different patient US-GSK-US2024128730:same reporter/different patient US-GSK-US2024128724:same reporter/different patient
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: fluarix were given after the temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 7554T, expiry date 30-JUN-2025) for prophylaxis.   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: fluarix were given after the temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-OCT-2024 The pharmacist reported that they had a refrigerator that went out of temperature range and, it did not get super hot before they set it, but a number of these fluarix were given after the temperature excursion. The vaccine was stored at 56 degree Fahrenheit for 135 hours. The pharmacist reported that the vaccine was given to patient.  The pharmacist reported that the vaccines were given to 17 patients but he gave the initials of 20 patients. The pharmacist was not sure which patients got the doses before the maximum cumulative time of the extended stability data was reached. This was 1 of 20 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024128771:same reporter/different patient US-GSK-US2024128774:same reporter/different patient US-GSK-US2024128767:same reporter/different patient US-GSK-US2024128763:same reporter/different patient US-GSK-US2024128760:same reporter/different patient US-GSK-US2024128758:same reporter/different patient US-GSK-US2024128756:same reporter/different patient US-GSK-US2024128754:same reporter/different patient US-GSK-US2024128750:same reporter/different patient US-GSK-US2024128747:same reporter/different patient US-GSK-US2024128741:same reporter/different patient US-GSK-US2024128740:same reporter/different patient US-GSK-US2024128739:same reporter/different patient US-GSK-US2024128736:same reporter/different patient US-GSK-US2024128734:same reporter/different patient US-GSK-US2024128719:same reporter/different patient US-GSK-US2024128716:same reporter/different patient US-GSK-US2024128730:same reporter/different patient US-GSK-US2024128727:same reporter/different patient
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 7554T, expiry date 30-JUN-2025) for prophylaxis.   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-OCT-2024 The pharmacist reported that they had a refrigerator that went out of temperature range and, it did not get super hot before they set it, but a number of these fluarix were given after the temperature excursion. The vaccine was stored at 56 degree Fahrenheit for 135 hours. The pharmacist reported that the vaccine was given to patient.  The pharmacist reported that the vaccines were given to 17 patients but he gave the initials of 20 patients. The pharmacist was not sure which patients got the doses before the maximum cumulative time of the extended stability data was reached. This was 1 of 20 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024128771:same reporter/different patient US-GSK-US2024128774:same reporter/different patient US-GSK-US2024128767:same reporter/different patient US-GSK-US2024128763:same reporter/different patient US-GSK-US2024128760:same reporter/different patient US-GSK-US2024128758:same reporter/different patient US-GSK-US2024128756:same reporter/different patient US-GSK-US2024128750:same reporter/different patient US-GSK-US2024128747:same reporter/different patient US-GSK-US2024128741:same reporter/different patient US-GSK-US2024128740:same reporter/different patient US-GSK-US2024128739:same reporter/different patient US-GSK-US2024128734:same reporter/different patient US-GSK-US2024128727:same reporter/different patient US-GSK-US2024128716:same reporter/different patient US-GSK-US2024128724:same reporter/different patient US-GSK-US2024128730:same reporter/different patient US-GSK-US2024128719:same reporter/different patient US-GSK-US2024128754:same reporter/different patient
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: body aches; fatigue; chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body aches), FATIGUE (fatigue) and CHILLS (chills) in a 65-year-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 PAIN (body aches), FATIGUE (fatigue) and CHILLS (chills). At the time of the report, PAIN (body aches), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was reported that patient had previous vaccines and booster and had body aches, fatigue and chills.  Treatment information was not provided.  Reporter causality was not reported.   This case was linked to MOD-2024-775833 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Device issue, No adverse event
Clinical narrative: plunger detached from the syringe; No adverse effect; This spontaneous case was reported by a non-health professional and describes the occurrence of DEVICE ISSUE (plunger detached from the syringe) and NO ADVERSE EVENT (No adverse effect) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080797) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection (batch no. 8080797) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (plunger detached from the syringe) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (plunger detached from the syringe) and NO ADVERSE EVENT (No adverse effect) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  The Device problem code for Spikevax syringe include FDA code 2907, IMDRF code A0501 which include Detachment of Device or device Component. Malfunction type was reported as CIRM.