chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred; patient received PROQUAD after a temperature excursion.; This spontaneous report was received from a registered nurse referring to 29 patients of unknown age and gender. The patients' historical medications, medical history, concurrent conditions, and concomitant medications were not reported.      On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # Y008788, expiration date 30-OCT-2025 and varicella virus vaccine live (oka/merck)(VARIVAX) lot number Y005919, expiration date 13-MAR-2026 (dose and routes of administration not provided) both for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion of the vaccines was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes. No previous excursions were detected.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the registered nurse regarding a 4-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 12-AUG-2024, a temperature excursion was involved for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) and on 16-AUG-2024, with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated in her left arm with the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) subcutaneously (strength, dose and dose number were not provided) for prophylaxis (product storage error). The nurse further specified that the data logger had an excursion, but it did not alarm. A power outage caused the temperature excursion. It was later discovered, on the monthly temperature uploading, that 28 affected doses were administered.  There were no known adverse events and no product quality complaint involved.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.; Sender's Comments:  US-009507513-2409USA000500:
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred; patient received PROQUAD after a temperature excursion.; This spontaneous report was received from a registered nurse referring to 29 patients of unknown age and gender. The patients' historical medications, medical history, concurrent conditions, and concomitant medications were not reported.      On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # Y008788, expiration date 30-OCT-2025 and varicella virus vaccine live (oka/merck)(VARIVAX) lot number Y005919, expiration date 13-MAR-2026 (dose and routes of administration not provided) both for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion of the vaccines was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes. No previous excursions were detected.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the registered nurse regarding a 5-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 12-AUG-2024, a temperature excursion was involved for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) and on 20-AUG-2024, with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated in her right arm with the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) subcutaneously (strength, dose and dose number were not provided) for prophylaxis (product storage error). The nurse further specified that the data logger had an excursion, but it did not alarm. A power outage caused the temperature excursion. It was later discovered, on the monthly temperature uploading, that 28 affected doses were administered.  There were no known adverse events and no product quality complaint involved.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.; Sender's Comments:  US-009507513-2409USA000500:
Age: 6.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred; patient received PROQUAD after a temperature excursion.; This spontaneous report was received from a registered nurse referring to 29 patients of unknown age and gender. The patients' historical medications, medical history, concurrent conditions, and concomitant medications were not reported.      On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # Y008788, expiration date 30-OCT-2025 and varicella virus vaccine live (oka/merck)(VARIVAX) lot number Y005919, expiration date 13-MAR-2026 (dose and routes of administration not provided) both for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion of the vaccines was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes. No previous excursions were detected.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the registered nurse regarding a 6-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 12-AUG-2024, a temperature excursion was involved for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) and on 20-AUG-2024, with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated in hier left arm with the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) subcutaneously (strength, dose and dose number were not provided) for prophylaxis (product storage error). The nurse further specified that the data logger had an excursion, but it did not alarm. A power outage caused the temperature excursion. It was later discovered, on the monthly temperature uploading, that 28 affected doses were administered.  There were no known adverse events and no product quality complaint involved.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.; Sender's Comments:  US-009507513-2409USA000500:
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred; patient received PROQUAD after a temperature excursion.; This spontaneous report was received from a registered nurse referring to 29 patients of unknown age and gender. The patients' historical medications, medical history, concurrent conditions, and concomitant medications were not reported.      On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # Y008788, expiration date 30-OCT-2025 and varicella virus vaccine live (oka/merck)(VARIVAX) lot number Y005919, expiration date 13-MAR-2026 (dose and routes of administration not provided) both for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion of the vaccines was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes. No previous excursions were detected.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the registered nurse regarding a 5-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 12-AUG-2024, a temperature excursion was involved for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) and on 23-AUG-2024, with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated in her right arm with the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) subcutaneously (strength, dose and dose number were not provided) for prophylaxis (product storage error). The nurse further specified that the data logger had an excursion, but it did not alarm. A power outage caused the temperature excursion. It was later discovered, on the monthly temperature uploading, that 28 affected doses were administered.  There were no known adverse events and no product quality complaint involved.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred; patient received PROQUAD after a temperature excursion.; This spontaneous report was received from a registered nurse referring to 29 patients of unknown age and gender. The patients' historical medications, medical history, concurrent conditions, and concomitant medications were not reported.      On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # Y008788, expiration date 30-OCT-2025 and varicella virus vaccine live (oka/merck)(VARIVAX) lot number Y005919, expiration date 13-MAR-2026 (dose and routes of administration not provided) both for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion of the vaccines was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes. No previous excursions were detected.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the registered nurse regarding a 5-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 12-AUG-2024, a temperature excursion was involved for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) and on 23-AUG-2024, with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated in her right arm with the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) subcutaneously (strength, dose and dose number were not provided) for prophylaxis (product storage error). The nurse further specified that the data logger had an excursion, but it did not alarm. A power outage caused the temperature excursion. It was later discovered, on the monthly temperature uploading, that 28 affected doses were administered.  There were no known adverse events and no product quality complaint involved.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.; Sender's Comments:  US-009507513-2409USA000500:
Age: 8.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred; patient received PROQUAD after a temperature excursion.; This spontaneous report was received from a registered nurse referring to 29 patients of unknown age and gender. The patients' historical medications, medical history, concurrent conditions, and concomitant medications were not reported.      On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # Y008788, expiration date 30-OCT-2025 and varicella virus vaccine live (oka/merck)(VARIVAX) lot number Y005919, expiration date 13-MAR-2026 (dose and routes of administration not provided) both for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion of the vaccines was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes. No previous excursions were detected.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the registered nurse regarding a 8-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 12-AUG-2024, a temperature excursion was involved for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) and on 23-AUG-2024, with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated in her left arm with the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) subcutaneously (strength, dose and dose number were not provided) for prophylaxis (product storage error). The nurse further specified that the data logger had an excursion, but it did not alarm. A power outage caused the temperature excursion. It was later discovered, on the monthly temperature uploading, that 28 affected doses were administered.  There were no known adverse events and no product quality complaint involved.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.; Sender's Comments:  US-009507513-2409USA000500:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Caller reported expired dose of MMR II was administered.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 18-SEP-2024, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 0.5 mL, intramuscularly (IM), lot # W029538 with expiration date 15-SE¨P-2024, for prophylaxis (strength and anatomical location were not reported). No additional adverse events (AEs) were reported.
Sex: F
Vaccine: HPV9
Symptoms: Fall, Skin laceration, Syncope
Clinical narrative: patients with syncope after receiving GARDASIL 9. One patient (female) fell in exam room; cut her nose on a chair; This spontaneous report was received from a medical assistant via a company representative and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.      On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, lot #, expiration date, dose, route and frequency were not reported) for prophylaxis.     The reporter stated that, shortly after vaccination, the patient fell in exam room when she was trying to leave (syncope) and cut her nose on a chair (skin laceration). The reporter stated they "sent her to the hospital" but it was unknown whether an admission was required.   At the reporting time, the outcome of syncope and skin laceration was unknown. The reporter did not provide a causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  Upon internal review, the event Syncope was determined to be medically significant.   Lot # is being requested and will be submitted if received.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2409USA008902: US-009507513-2409USA008904: US-009507513-2409USA009499:
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Email received in the Contact Center Mailbox with the subject line, "RE: Technical Assistance Question <UID20240925132100>" with the following request, "Hi. If a proquad was administered to an 18 year old, is this considered a valid vaccine? Or; no additional AE; This spontaneous report was received from a physician referring to an 18-year-old patient of unknown gender.  Concurrent condition, medical history, and concomitant medication were not reported.  On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, administered for prophylaxis (strength, dose, route, lot#, and expiration date were not reported) and sterile diluent solution for injection/infusion (strength, dose, frequency, route, lot#, and expiration date were not reported) (Product administered to patient of inappropriate age). No additional adverse event (AE). The reporter wanted to know if this was considered a valid vaccine, or a measles vaccine (+) mumps vaccine (+) rubella vaccine (MMR) and varicella zoster vaccine needed to be readministered.  Lot# is being requested and will be submitted if received.
Sex: U
Vaccine: FLU3, TDAP
Symptoms: Circumstance or information capable of leading to medication error, Product packaging confusion, Wrong product administered
Clinical narrative: Exterior packaging look alike, potential for vaccine mix-up and patient harm; Exterior packaging look alike, potential for vaccine mix-up and patient harm; Exterior packaging look alike, potential for vaccine mix-up and patient harm; This non-serious case was reported by a other health professional and described the occurrence of circumstance or information capable of leading to medication error in a patient who received Flu Seasonal TIV Dresden (Fluarix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Fluarix and Boostrix. On an unknown date, an unknown time after receiving Fluarix and Boostrix, the patient experienced circumstance or information capable of leading to medication error (Verbatim: Exterior packaging look alike, potential for vaccine mix-up and patient harm), product packaging confusion (Verbatim: Exterior packaging look alike, potential for vaccine mix-up and patient harm) and wrong vaccine administered (Verbatim: Exterior packaging look alike, potential for vaccine mix-up and patient harm). The outcome of the circumstance or information capable of leading to medication error, product packaging confusion and wrong vaccine administered 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: 18-SEP-2024 The reporter stated that two vaccines with look-alike packaging, Glaxo brand Fluarix Glaxo brand Boostrix, each contain 10 disposable single dose prefilled 0.5mL syringes had exterior packaging look alike which was potential for vaccine mix-up and patient harm. Everything on the packaging nearly identical, except that Fluarix was dark green on the left side of the box, and Boostrix was a lighter green. Would recommend a change in packaging that alerts the user to the difference. Someone could easily grab the wrong box in a hurry which led to circumstance or information capable of leading to medication error, product packaging confusion and wrong vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm and fatigue; Sore arm and fatigue; This non-serious case was reported by a consumer via sales rep and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced fatigue (Verbatim: Sore arm and fatigue) and pain in arm (Verbatim: Sore arm and fatigue). The outcome of the fatigue and pain in arm were resolved.   The reporter considered the fatigue and pain in arm to be related to Shingrix.     The company considered the fatigue and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-SEP-2024 Patient had sore arm and fatigue after receiving Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; fatigue; This non-serious case was reported by a consumer via patient support programs and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Sore arm) and fatigue (Verbatim: fatigue). The outcome of the pain in arm and fatigue were resolved.   The reporter considered the pain in arm and fatigue to be related to Shingrix.     The company considered the pain in arm and fatigue to be related to Shingrix.   Additional Information: GSK receipt date: 18-SEP-2024 The patient had sore arm and fatigue
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash vesicular
Clinical narrative: rash looks like shingles; pain; intense itching; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 60-year-old 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 rash (Verbatim: rash looks like shingles), pain (Verbatim: pain) and pruritus (Verbatim: intense itching). The outcome of the rash, pain and pruritus were not reported.   It was unknown if the reporter considered the rash, pain and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the rash, pain and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-SEP-2024 The reporter reported that the patient received Shingles vaccine. The patient had experienced rash looks like shingles, has the pain and intense itching as well, but it was not just confined to one side of the body. It moved rapidly, one day it might be on his left shoulder, two days later it might be on his right arm. A dermatologist and treated for shingles, however that did not work.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: very very miserable after the shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling miserable 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 feeling miserable (Verbatim: very very miserable after the shot). The outcome of the feeling miserable was not reported.   It was unknown if the reporter considered the feeling miserable to be related to Shingles vaccine.     It was unknown if the company considered the feeling miserable to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-SEP-2024 The case was received from the patient via interactive digital media. The reporter reported that be ready, got very very miserable after the shot you'll love this.  The reporter reported that if the feeling got any worse he/she was going to the hospital, thank god it didn't.
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Antibody test negative, Incorrect route of product administration, Injection site pain
Clinical narrative: antibodies were too low; the shot was IM instead of SC; Priorix administration SC very painful; This non-serious case was reported by a physician via call center representative and described the occurrence of injection site pain in a 41-year-old male patient who received MMR (Priorix) for prophylaxis.   Co-suspect products included MMR (Priorix) for prophylaxis and MMR (Priorix) for prophylaxis.   On 06-SEP-2024, the patient received the 3rd dose of Priorix (intramuscular, right arm). On an unknown date, the patient received the 2nd dose of Priorix and the 1st dose of Priorix. On 06-SEP-2024, an unknown time after receiving Priorix and not applicable after receiving Priorix and Priorix, the patient experienced intramuscular formulation administered by other route (Verbatim: the shot was IM instead of SC). In SEP-2024, the patient experienced injection site pain (Verbatim: Priorix administration SC very painful). On an unknown date, the patient experienced therapeutic response decreased (Verbatim: antibodies were too low). The outcome of the injection site pain, therapeutic response decreased and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site pain to be related to Priorix and Priorix Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain to be related to Priorix and Priorix 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: 09-SEP-2024 Doctor contacted Medical Information Department to reported that he received a Priorix third dose vaccine because he was travelling and antibodies were too low. Doctor realized that the shot was intramuscular instead of subcutaneous and the administration was really painful. The shot was on the right arm of the deltoid muscle. Doctor was planning to get influenza vaccine shot this week. At the moment of the call, doctor had not yet received any influenza vaccine.
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Boostrix was administered instead of Infanrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 18-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number Z7L7H, expiry date 09-AUG-2026) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis.   On 10-SEP-2024, the patient received Boostrix. On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Boostrix and not applicable after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Boostrix was administered instead of Infanrix). The outcome of the wrong vaccine administered 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: 10-SEP-2024 Pharmacist called to report the administration of Boostrix to a 1 year-6 month-old patient. Boostrix was administered instead of Infanrix which led to wrong vaccine administered. The pharmacist could not confirm how many prior Dtap doses the patient had received.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Syringe issue, Underdose
Clinical narrative: Incomplete dose administered; she was administering a Flu vaccine to a pregnant patient; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra) for prophylaxis.   On an unknown date, the patient received FluLaval Tetra. On an unknown date, an unknown time after receiving FluLaval Tetra, the patient experienced incomplete dose administered (Verbatim: Incomplete dose administered) and vaccine exposure during pregnancy (Verbatim: she was administering a Flu vaccine to a pregnant patient). The outcome of the incomplete dose administered and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (FluLaval Tetra): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   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-SEP-2024 Pharmacist called to report a nurse was administering a Flu vaccine to a pregnant patient, in clinic and the connection between the syringe and the medication when, she want to pushed it into the arm, part of it score it out into the side of the syringe and it did not get administered which led to incomplete dose administered and vaccine exposure during pregnancy.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: injection site red spot; she had been scratched; red streaks on the left side of her body and back; body was wet/soaked; Headache; the patient began to feel tired; she felt horrible; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date).   On 16-SEP-2024, the patient received the 2nd dose of Shingrix (left arm). On 17-SEP-2024, 1 days after receiving Shingrix, the patient experienced headache (Verbatim: Headache), tiredness (Verbatim: the patient began to feel tired), feels awful (Verbatim: she felt horrible) and sweating (Verbatim: body was wet/soaked). On 18-SEP-2024, the patient experienced injection site erythema (Verbatim: injection site red spot), scratch (Verbatim: she had been scratched) and skin red (Verbatim: red streaks on the left side of her body and back). The outcome of the injection site erythema, scratch and skin red were not resolved and the outcome of the headache, tiredness, feels awful and sweating were resolved.   It was unknown if the reporter considered the injection site erythema, headache, tiredness, feels awful, scratch, skin red and sweating to be related to Shingrix.     It was unknown if the company considered the injection site erythema, headache, tiredness, feels awful, scratch, skin red and sweating to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR117024   Additional Information: GSK Receipt Date: 18-SEP-2024 The reporter was the patient. The patient received the second dose of Shingrix on Monday September 16, 2024 in the left arm. About 24 hours later, the patient began to feel tired, and last night she felt horrible, she was very tired, her whole body was wet/soaked, and she had a headache. These now had subsided and she felt better. However, on day of reporting (Wednesday, September 18, 2024), the patient had red streaks on the left side of her body and back. It looked as if she had been scratched. The injection site had a red spot. The patient reported that she experienced soreness of the injected arm after the first dose of Shingrix. For tolerance of 1st dose refer case US2024AMR117024.; Sender's Comments:  US-GSK-US2024AMR117024:Same patient 1st dose
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Scratch
Clinical narrative: injection site red spot; she had been scratched; red streaks on the left side of her body and back; body was wet/soaked; Headache; the patient began to feel tired; she felt horrible; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date).   On 16-SEP-2024, the patient received the 2nd dose of Shingrix (left arm). On 17-SEP-2024, 1 days after receiving Shingrix, the patient experienced headache (Verbatim: Headache), tiredness (Verbatim: the patient began to feel tired), feels awful (Verbatim: she felt horrible) and sweating (Verbatim: body was wet/soaked). On 18-SEP-2024, the patient experienced injection site erythema (Verbatim: injection site red spot), scratch (Verbatim: she had been scratched) and skin red (Verbatim: red streaks on the left side of her body and back). The outcome of the injection site erythema, scratch and skin red were not resolved and the outcome of the headache, tiredness, feels awful and sweating were resolved.   It was unknown if the reporter considered the injection site erythema, headache, tiredness, feels awful, scratch, skin red and sweating to be related to Shingrix.     It was unknown if the company considered the injection site erythema, headache, tiredness, feels awful, scratch, skin red and sweating to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR117024   Additional Information: GSK Receipt Date: 18-SEP-2024 The reporter was the patient. The patient received the second dose of Shingrix on Monday September 16, 2024 in the left arm. About 24 hours later, the patient began to feel tired, and last night she felt horrible, she was very tired, her whole body was wet/soaked, and she had a headache. These now had subsided and she felt better. However, on day of reporting (Wednesday, September 18, 2024), the patient had red streaks on the left side of her body and back. It looked as if she had been scratched. The injection site had a red spot. The patient reported that she experienced soreness of the injected arm after the first dose of Shingrix. For tolerance of 1st dose refer case US2024AMR117024.; Sender's Comments:  US-GSK-US2024AMR117024:Same patient 1st dose
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired Dose Administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-month-old female patient who received DTPa (Infanrix) (expiry date 13-SEP-2024) for prophylaxis.   On 17-SEP-2024, the patient received Infanrix. On 17-SEP-2024, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired Dose Administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date : 18-Sep-2024 The patient received an expired dose of Infanrix, which led to expired vaccine used.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: given an expired Hepatitis B vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 57-year-old female patient who received HBV (Engerix B adult) (batch number NT9X3, expiry date 09-SEP-2024) for prophylaxis.   On 17-SEP-2024, the patient received Engerix B adult (intramuscular, left deltoid). On 17-SEP-2024, an unknown time after receiving Engerix B adult, the patient experienced expired vaccine used (Verbatim: given an expired Hepatitis B vaccine). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-SEP-2024 The other health professional (medical assistant) reported that 57 year old female was given an expired Hepatitis B vaccine which led to expired vaccine used.  The other health professional reported that the Engerix B vaccine was provided by the medical office and was administered to the patient into the left deltoid. No additional event was reported.
Sex: U
Vaccine: RSV
Symptoms: Incorrect dose administered, Single component of a two-component product administered
Clinical narrative: Only adjuvant administered; Only adjuvant administered; 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 RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 19-SEP-2024, the patient received Arexvy. On 19-SEP-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: Only adjuvant administered) and inappropriate dose of vaccine administered (Verbatim: Only adjuvant administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 19-SEP-2024 A healthcare professional called to inform that they just gave a dose of Arexvy, and they did not reconstitute it, all they gave was the adjuvant, and the patient was now gone which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: accidentally administered a 3rd Shingrix injection to a patient; was also noted that the 2nd dose was late; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 27th May 2022).   On 12-SEP-2024, the patient received the 3rd dose of Shingrix. On 01-AUG-2023, the patient received the 2nd dose of Shingrix. On 01-AUG-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: was also noted that the 2nd dose was late). On 12-SEP-2024, the patient experienced extra dose administered (Verbatim: accidentally administered a 3rd Shingrix injection to a patient). The outcome of the drug dose administration interval too long and extra dose administered were not applicable.   Additional Information: GSK receipt date: 19-SEP-2024 Supervisor stated a nurse accidentally administered a 3rd Shingrix injection to a patient.  When asking for the dates of the injections, it was also noted that the 2nd dose was late, which led to lengthening of vaccination schedule. The patient received 3rd dose of Shingrix, which led to extra dose administered. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of product administration
Clinical narrative: A 19 year old patient was given a menveo vaccine intradermally in error; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate route of vaccination in a 19-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo (intradermal). On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate route of vaccination (Verbatim: A 19 year old patient was given a menveo vaccine intradermally in error). The outcome of the inappropriate route of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-SEP-2024 Pharmacist reported that a 19 year old patient was given a Menveo vaccine intradermally in error which led to inappropriate route of vaccination. Healthcare professional did not know the lot number or the presentation of the Menveo vaccine.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Flushing, Nausea, Pruritus
Clinical narrative: a massive amount of diarrhea; Patient reports she had nausea; she had flushing on her face, neck, and upper chest; Itching all over the body; This non-serious case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 57-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2024-2025 season) (batch number 7554T, expiry date 30-JUN-2025) for prophylaxis.   Concurrent medical conditions included alpha galactosidase a deficiency.   On 18-SEP-2024, the patient received Fluarix Tetra 2024-2025 season (intramuscular, left arm). On 19-SEP-2024, 1 days after receiving Fluarix Tetra 2024-2025 season, the patient experienced diarrhea (Verbatim: a massive amount of diarrhea), nausea (Verbatim: Patient reports she had nausea), flushing (Verbatim: she had flushing on her face, neck, and upper chest) and generalized pruritus (Verbatim: Itching all over the body). The outcome of the diarrhea, nausea, flushing and generalized pruritus were not resolved.   It was unknown if the reporter considered the diarrhea, nausea, flushing and generalized pruritus to be related to Fluarix Tetra 2024-2025 season and Fluarix Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the diarrhea, nausea, flushing and generalized pruritus to be related to Fluarix Tetra 2024-2025 season and Fluarix Tetra 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: 19-SEP-2024 The reporter was the patient. Female patient reported on September 19th, 2024, that she had Alpha-gal syndrome and received the Flu vaccine yesterday at her doctor's office. Patient reported she got the vaccine with Fluarix Trivalent 2024-2025. Patient reported she received the vaccine in the afternoon and was administered into the left arm. Patient reported that on September 19th at 2:30 AM, her entire body started itching, she had flushing on her face, neck, and upper chest, flushing. Patient reported she had nausea and a massive amount of diarrhea. Patient reported she was given a steroid prescription. Patient reported that symptoms have not resolved.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Second dose not administered; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received in March 2021).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Second dose not administered). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-SEP-2024 A physician contacted GSK on September 19th, 2024 to request information about the administration of Twinrix, specifically the second dose, after the first dose was administered in March 2024. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, COVID-19 immunisation
Clinical narrative: EXTREME ALLERGIC REACTIONS THAT MADE HER COLLAPSE; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient concerned an 80 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. Non-company suspect vaccine included: tozinameran (dose in series 2) (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for covid-19 prophylaxis and elasomeran (dose in series 3) ( form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for product use for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. It was reported that the patient to be 80 years old and have had extreme allergic reactions that made her collapse with previous vaccines as Pfizer, Moderna and J&J shingles. On an unspecified date, the patient experienced extreme allergic reactions that made her collapse (dose in series 1), and revaccination with different covid-19 vaccine (dose in series 2). The patient stated she knew that the NVX vaccine was different from Pfizer and Moderna as it was not mRNA. The patient also stated she wanted to make sure before getting the NVX vaccine that the ingredients were different from the J&J shingles vaccine. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran, and elasomeran was not applicable. The outcome of the revaccination with different covid-19 vaccine and extreme allergic reactions that made her collapse was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:Anaphylactic reaction-. This event(s) is labeled per RSI and is therefore considered potentially related.