chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Jynneos vaccine was administered intramuscularly to a patient; Case reference number US-BN-2024-002770 is a spontaneous case initially received from a pharmacist via Communication (reference number: USBAV24-2982) on 11-Nov-2024 and concerns a patient of unspecified age and gender.  The patient's medical history and concomitant medication details were not provided.  On unspecified date, the patient received the dose of Jynneos vaccine (batch number: unknown), at unknown dose, intramuscularly, at unknown site of administration, for unknown indication (explicitly codes as 'inappropriate route of vaccination').  At the time of the initial report, the patient did not experience any adverse events due to Jynneos.  No further information was provided.; Reporter's Comments: A patient of unspecified age and gender received the dose of Jynneos vaccine intramuscularly, for unknown indication, which is considered as inappropriate route of vaccination. The patient did not experience any adverse events due to Jynneos. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unspecified age and gender received the dose of Jynneos vaccine intramuscularly, for unknown indication, which is considered as inappropriate route of vaccination. The patient did not experience any adverse events due to Jynneos. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient missed second dose of Jynneos which was due on 25-Oct-2024, because could not get it anywhere.; Case reference number US-BN-2024-002796 is a spontaneous case report initially received from consumer via agency (reference number: USBAV24-3064) on 19-Nov-2024 and concerns a 72-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos vaccine (batch number: unknown), at an unknown dose, route or site of administration, for unknown indication. As reported, the patient missed second dose of Jynneos which was due on 25-Oct-2024, because could not get it anywhere (explicitly coded as 'inappropriate schedule of vaccine administered').   At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos vaccine.  No further information was provided.; Reporter's Comments: A 72-year-old male patient was vaccinated with the first dose of Jynneos vaccine for unknown indication. As reported, the patient missed the second dose of Jynneos which was due on 25-Oct-2024, because could not get it anywhere, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Jynneos vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 72-year-old male patient was vaccinated with the first dose of Jynneos vaccine for unknown indication. As reported, the patient missed the second dose of Jynneos which was due on 25-Oct-2024, because could not get it anywhere, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Jynneos vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: The patient received first dose of Jynneos vaccine intramuscularly instead of subcutaneous; Case reference number US-BN-2024-002817 is a spontaneous case initially received from a nurse via agency (reference number: USBAV24-3130) on 26-Nov-2024 and concerns a 23-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 26-Nov-2024, the patient was vaccinated with a first dose of Jynneos (batch number: FDP00020 and expiration date: 31-Aug-2026), at a dose of 0.5 ml, intramuscularly (instead of subcutaneous), in the left deltoid region, for the indication reported as vaccination (explicitly coded as 'inappropriate route of vaccination').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to the Jynneos vaccination.  No further information was provided.; Reporter's Comments: A 23-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly (instead of subcutaneous), in the left deltoid region, for the indication reported as vaccination, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse event due to the Jynneos vaccination. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 23-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly (instead of subcutaneous), in the left deltoid region, for the indication reported as vaccination, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse event due to the Jynneos vaccination. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: FLU3
Symptoms: Atrophy, Dizziness, Dysarthria, Hyperhidrosis, Nausea
Clinical narrative: faint feeling; Heavy sweating; atrophy in hands and legs; grey/green in color; Throat swell; slurred speech; nausea; This non-serious case was reported by a non-health professional and described the occurrence of felt faint in a 18-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number N7374, expiry date 30-JUN-2025) for prophylaxis.   Concurrent medical conditions included mood change. Concomitant products included fluoxetine hydrochloride (Prozac).   On 16-NOV-2024, the patient received Fluarix 2024-2025 season .5 ml. On 16-NOV-2024, less than a day after receiving Fluarix 2024-2025 season, the patient experienced felt faint (Verbatim: faint feeling), heavy sweating (Verbatim: Heavy sweating), atrophy (Verbatim: atrophy in hands and legs), green discoloration of skin (Verbatim: grey/green in color), throat swelling (Verbatim: Throat swell), slurred speech (Verbatim: slurred speech) and nausea (Verbatim: nausea). On 16-NOV-2024, the outcome of the felt faint, heavy sweating, atrophy, green discoloration of skin, throat swelling, slurred speech and nausea were resolved.   It was unknown if the reporter considered the felt faint, heavy sweating, atrophy, green discoloration of skin, throat swelling, slurred speech and nausea to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     It was unknown if the company considered the felt faint, heavy sweating, atrophy, green discoloration of skin, throat swelling, slurred speech and nausea to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-NOV-2024 The reporter reported that she experienced heavy sweating, faint feeling, atrophy in hands and legs, gray/green in color, throat swell, slurred speech and nausea. Intervention required was reported as seriousness for nausea.
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal swelling, Skin discolouration
Clinical narrative: faint feeling; Heavy sweating; atrophy in hands and legs; grey/green in color; Throat swell; slurred speech; nausea; This non-serious case was reported by a non-health professional and described the occurrence of felt faint in a 18-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number N7374, expiry date 30-JUN-2025) for prophylaxis.   Concurrent medical conditions included mood change. Concomitant products included fluoxetine hydrochloride (Prozac).   On 16-NOV-2024, the patient received Fluarix 2024-2025 season .5 ml. On 16-NOV-2024, less than a day after receiving Fluarix 2024-2025 season, the patient experienced felt faint (Verbatim: faint feeling), heavy sweating (Verbatim: Heavy sweating), atrophy (Verbatim: atrophy in hands and legs), green discoloration of skin (Verbatim: grey/green in color), throat swelling (Verbatim: Throat swell), slurred speech (Verbatim: slurred speech) and nausea (Verbatim: nausea). On 16-NOV-2024, the outcome of the felt faint, heavy sweating, atrophy, green discoloration of skin, throat swelling, slurred speech and nausea were resolved.   It was unknown if the reporter considered the felt faint, heavy sweating, atrophy, green discoloration of skin, throat swelling, slurred speech and nausea to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     It was unknown if the company considered the felt faint, heavy sweating, atrophy, green discoloration of skin, throat swelling, slurred speech and nausea to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-NOV-2024 The reporter reported that she experienced heavy sweating, faint feeling, atrophy in hands and legs, gray/green in color, throat swell, slurred speech and nausea. Intervention required was reported as seriousness for nausea.
Sex: M
Vaccine: FLU3
Symptoms: Confusional state, Hyperhidrosis, Nausea
Clinical narrative: Nausea; Confusion; Sweating; This non-serious case was reported by a consumer and described the occurrence of nausea in a 16-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2024-2025 season) (batch number N7374, expiry date 30-JUN-2025) for prophylaxis.   On 16-NOV-2024, the patient received Fluarix Tetra 2024-2025 season .5 ml. On 16-NOV-2024, less than a day after receiving Fluarix Tetra 2024-2025 season, the patient experienced nausea (Verbatim: Nausea), confusion (Verbatim: Confusion) and sweating (Verbatim: Sweating). The outcome of the nausea, confusion and sweating were resolving.   It was unknown if the reporter considered the nausea, confusion and sweating to be related to Fluarix Tetra 2024-2025 season and Fluarix Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the nausea, confusion and sweating 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-NOV-2024 This report was submitted via the online direct entry reporting system by caregiver. The patient received Fluarix on 16-Nov-2024. On the same day, the patient experienced the events of confusion, nausea, and sweating. The patient was treated in ambulance and cleared. The outcome of the events was reported as recovering. The reporter provided consent to contact.
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Pyrexia; Chills; Exhaustion; Headache; Myalgia; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of fever in a female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2024-2025 season) for prophylaxis.   Co-suspect products included Elasomeran (Spikevax) for prophylaxis.   Concurrent medical conditions included systemic lupus erythematosus, lupus vulgaris, hashimoto's disease, sjogren's disease and asthma.   In NOV-2024, the patient received Fluarix Tetra 2024-2025 season and Spikevax. In NOV-2024, an unknown time after receiving Fluarix Tetra 2024-2025 season, the patient experienced fever (Verbatim: Pyrexia), myalgia (Verbatim: Myalgia), chills (Verbatim: Chills), exhaustion (Verbatim: Exhaustion) and headache (Verbatim: Headache). The patient was treated with paracetamol (Tylenol) and paracetamol (Acetaminophen). In NOV-2024, the outcome of the fever, chills, exhaustion and headache were resolved. The outcome of the myalgia was resolving.   It was unknown if the reporter considered the fever, myalgia, chills, exhaustion and headache to be related to Fluarix Tetra 2024-2025 season and Fluarix Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the fever, myalgia, chills, exhaustion and headache 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-NOV-2024 A patient who took the Fluarix and Spikevax vaccine experienced Myalgia, Pyrexia (fever), chills, fatigue (exhaustion) and headache. The body temperature was reported as 103.1 degree. The patient was treated with Paracetamol (Tylenol) (oral use) in November 2024 for Fever with dose of Acetaminophen - 2 doses of Extra Strength Tylenol and the symptoms were resolved within 24 hours. On day 2 following administration, patient had full-body myalgia and the second medication name was unknown. The patient did not experience any additional symptoms and events and no concomitant medication was reported. The patient did not have any additional medical history, concomitant disease or risk factor.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Incomplete course of vaccination; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 2024).   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: Incomplete course of vaccination). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-NOV-2024 The reporter stated that her husband received his first Shingrix vaccine in March. He had not yet received his second shot and it had been 8 months. The reporter stated did he need to start the series over or he only need to receive one more shot. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got it anyway; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and herpes zoster (Verbatim: got it anyway). The outcome of the vaccination failure and herpes zoster were not reported.   It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingrix.     The company considered the vaccination failure and herpes zoster to be unrelated to Shingrix.   Additional Information: GSK receipt date: 04-DEC-2024 This case was reported by a patient via interactive digital media. The patient reported that he/she know risk and had the shot and got it anyway. This case was considered as suspected vaccination failure as details regarding, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.  Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot and Got them again all over my back; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 85-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (The patient had the open bloody one 1 time).   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: Got the shot and Got them again all over my back) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). 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 and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK receipt date: 04-DEC-2024 This case was reported by a patient via interactive digital media. The patient was 85 years old. The patient reported that he had shingles one time. The patient received shingles shot and had shingles again all over his back but it stayed under the skin. 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.  Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Patient had the vaccine and still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Patient had the vaccine and still got shingles). 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.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-DEC-2024 This case was reported by a patient via interactive digital media. The reporter reported that patient had received vaccine and still got shingles. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding herpes zoster were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; 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 Shingles vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: ask if a patient can get the second dose of Shingrix if the first dose was 13 months ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 13 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: ask if a patient can get the second dose of Shingrix if the first dose was 13 months ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-NOV-2024 The pharmacist called to ask if a patient can get the second dose of Shingrix if the first dose was 13 months ago. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Pain in his left leg and left arm; Tingling in his left leg and left arm; Rubbing his arm and leg on the left side; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In SEP-2024, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in extremity (Verbatim: Pain in his left leg and left arm), tingling of extremity (Verbatim: Tingling in his left leg and left arm) and skin irritation (Verbatim: Rubbing his arm and leg on the left side). The outcome of the pain in extremity, tingling of extremity and skin irritation were not resolved.   It was unknown if the reporter considered the pain in extremity, tingling of extremity and skin irritation to be related to Shingrix.     It was unknown if the company considered the pain in extremity, tingling of extremity and skin irritation to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-NOV-2024 This case was reported by the wife of the patient. The reporter stated that her husband (patient) received his second dose of Shingrix in his left arm about two months ago (from the date of reporting) and reported that he continued to have tingling and pain, only on his left side, in both his left leg and left arm. The reporter stated that she saw a heating pad on the couch and thought that the patient was using it for this concern, and she saw her husband still rubbing his arm and leg on the left side. In 2024, the patient experienced pain in extremity, tingling of extremity and skin irritation. The patient's wife was worried that this concern has gone on for so long.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash pustular
Clinical narrative: broke out in shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-NOV-2024, the patient received the 1st dose of Shingrix. On 16-NOV-2024, 4 days after receiving Shingrix, the patient experienced shingles (Verbatim: broke out in shingles). The patient was treated with valaciclovir (Valacyclovir). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-NOV-2024 This case was self-reported by patient. The patient received his first dose of Shingrix and he broke out in shingles. The rash was on his right lower buttocks and extends to the front to his stomach, it was also up his back.  The patient went to the emergency room on Sunday and was prescribed valacyclovir 1gm. The shingles had pustules.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis, Hypoaesthesia, Hypoaesthesia eye, Injection site pruritus, Paraesthesia
Clinical narrative: nerve itch at injection site location; Bronchitis; Tingling that moves to multiple location of the body, left side of face; numbness of left side of face; left eye tingling; left eye numb; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-SEP-2024, the patient received the 2nd dose of Shingrix (injection, unknown arm) .5 ml. On 13-SEP-2024, 1 days after receiving Shingrix, the patient experienced injection site itching (Verbatim: nerve itch at injection site location), bronchitis (Verbatim: Bronchitis), tingling (Verbatim: Tingling that moves to multiple location of the body, left side of face), numbness facial (Verbatim: numbness of left side of face), eye paresthesia (Verbatim: left eye tingling) and eye numbness (Verbatim: left eye numb). The outcome of the injection site itching and bronchitis were unknown and the outcome of the tingling, numbness facial, eye paresthesia and eye numbness were not resolved.   It was unknown if the reporter considered the injection site itching, bronchitis, tingling, numbness facial, eye paresthesia and eye numbness to be related to Shingrix.     It was unknown if the company considered the injection site itching, bronchitis, tingling, numbness facial, eye paresthesia and eye numbness to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-NOV-2024 The patient experienced symptoms after receiving second dose of vaccine on 12th September 2024. She was angry multiple times during call. Patient was unwilling to give complete information during call. Therefore, information was limited. Patient stated since the second vaccine dose she has had bronchitis, tingling and numbness of left side of face and left eye, nerve itch at injection site location, generally feeling sick for the entire month, and head cold. Patient had tingling that moved to different locations of her body. Patient stated that symptoms started approximately one day after receiving second dose of suspect vaccine on 13th September 2024. It was unknown when or if symptoms were resolved due to patient disconnecting call. No lot number or NDC number was given of suspect vaccine. No location of injection was given. All information given was in this report. No further information available. Patient did not consent to follow-up. Consent was not obtained for follow up.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not recieved yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Ultomiris infusions, Menveo (1st dose received on 5th October 2023, lot number E74MY) and Bexsero (1st dose received on 5th October 2023, lot number 3CB9L).   On an unknown date, the patient did not receive the 2nd dose of Bexsero and the 2nd dose of Menveo. On an unknown date, an unknown time after receiving Bexsero and Menveo, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not recieved yet). 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-NOV-2024 Pharmacist reported a 67 year old male patient received Ultomiris infusions and was ordered to receive Menveo and Bexsero vaccines. He received first dose of both vaccines on 05 October 2023 and was now requesting a second dose. At the time of reporting, a second dose had not been administered. Till the time of reporting, the patient did not receive 2nd dose of Menveo and Bexsero, which led to incomplete course of vaccination.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Extra dose administered.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received Arexvy somewhere else in May 2024).   On 20-NOV-2024, the patient received the 2nd dose of Arexvy. On 20-NOV-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Extra dose administered.). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 20-NOV-2024  The pharmacist reported that they had administered the Arexvy on the day of reporting to a patient and then she realized that she had received it somewhere else this calendar year which led to extra dose administered.
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction
Clinical narrative: heard a gurgling sound at the end of the injection; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) for prophylaxis.   On 17-NOV-2024, the patient received the 1st dose of Fluarix 2024-2025 season. On 17-NOV-2024, less than a day after receiving Fluarix 2024-2025 season, the patient experienced injection site discomfort (Verbatim: heard a gurgling sound at the end of the injection). The outcome of the injection site discomfort was unchanged.   It was unknown if the reporter considered the injection site discomfort to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     It was unknown if the company considered the injection site discomfort to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-NOV-2024 The consumer was the reporter. The reporter stated that she had Fluarix administered on 17th November 2024 and at the end of the injection she heard a gurgling sound come from the area of injection. The consumer was concerned about an air bubble making that sound. No further information was known including any patient demographics, pharmacy name or site of injection.
Age: 35.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: it was a pediatric dose; it was a pediatric dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 35-year-old female patient who received HAV (Havrix pediatric) (batch number LM99N, expiry date 04-MAR-2026) for prophylaxis.   On 19-NOV-2024, the patient received the 1st dose of Havrix pediatric. On 19-NOV-2024, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: it was a pediatric dose) and adult use of a child product (Verbatim: it was a pediatric dose). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-NOV-2024 The nurse reported that an patient received their first dose of Havrix but it was a pediatric dose which led to underdose and adult use of a child product.  The Vaccine Administration Facility was the same as Primary Reporter
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Bursitis
Clinical narrative: subacromial subdeltoid bursitis; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subacromial bursitis in a 33-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 333SK, expiry date 28-SEP-2025) for prophylaxis.   On 04-NOV-2024, the patient received Boostrix. In NOV-2024, an unknown time after receiving Boostrix, the patient experienced subacromial bursitis (Verbatim: subacromial subdeltoid bursitis). The outcome of the subacromial bursitis was not reported.   It was unknown if the reporter considered the subacromial bursitis to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the subacromial bursitis to be related to Boostrix and Boostrix 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: 22-NOV-2024 Pharmacist called and reported that a patient who recently got the Tetanus vaccine had some pain in the arm for two weeks had gone to the ER they did not believe or understand what it was, seemed like it was a nerve injury. Reporter wanted to know more information about that particular injury and how to treat it. Later it was found that patient had a bursae injury and was diagnosed with mild subacromial subdeltoid bursitis.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: the Infanrix vaccine and the expiration date on it is November 2nd, 2024; one of our teammates administered to a child; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a child patient who received DTPa (Infanrix) (expiry date 02-NOV-2024) for prophylaxis.   On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: the Infanrix vaccine and the expiration date on it is November 2nd, 2024; one of our teammates administered to a child). 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: 21-NOV-2024  The nurse reported that they had some DTAP, the Infanrix vaccine and the expiration date on it was November 2nd, 2024. The nurse reported, one of their teammates administered to a patient which led to expired vaccine used. The nurse asked what procedure does she need to follow. The nurse reported that the incident occurred in another facility and that she did not have the information.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: third dose of Shingrix was given to a patient inadvertently; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number 354M3, expiry date 13-NOV-2026) for prophylaxis.   Previously administered products included Shingrix (Patient received first dose on an unknown date) and Shingrix (Patient received second dose on an unknown date).   On 20-NOV-2024, the patient received the 3rd dose of Shingrix. On 20-NOV-2024, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: third dose of Shingrix was given to a patient inadvertently). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 22-NOV-2024 The reporter reported that a third dose of Shingrix was given to a patient inadvertently which led to, extra dose administered. During the same call Health care professional reported same AE (Adverse event) for two different patients with same initials and stated they were married. The vaccine administration facility was the same as primary reporter. This is report for patient 1 of 2. This case had been linked with US2024146632, reported by the same reporter.; Sender's Comments:  US-GSK-US2024146632:another patient
Sex: F
Vaccine: RSV
Symptoms: Syringe issue, Underdose
Clinical narrative: there was a leakage; leading to an underdose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number A9KR2, expiry date 29-OCT-2025) for prophylaxis.   On 19-NOV-2024, the patient received Arexvy. On 19-NOV-2024, an unknown time after receiving Arexvy, the patient experienced accidental underdose (Verbatim: leading to an underdose). On an unknown date, the patient experienced syringe leak (Verbatim: there was a leakage). The outcome of the accidental underdose and syringe leak were unknown.   It was unknown if the reporter considered the syringe leak to be related to Arexvy.     It was unknown if the company considered the syringe leak to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-NOV-2024 The pharmacist reported that while injecting Arexvy to a patient, there was a leakage, leading to an underdose which led to accidental underdose.
Age: 32.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Juvenile idiopathic arthritis
Clinical narrative: Juvenile idiopathic arthritis; This is a spontaneous report received from an Other HCP.  A 32-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 32 years, in arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 01Oct2024 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history included: "Eczema" (unspecified if ongoing). There was no Known allergies. There were no concomitant medications. There was no other vaccine in four weeks or other medications in two weeks.  The following information was reported: JUVENILE IDIOPATHIC ARTHRITIS (medically significant) with onset 13Oct2024, outcome "recovering". Joint pain and swelling which was diagnosed as juvenile idiopathic arthritis. Therapeutic measures were taken as a result of juvenile idiopathic arthritis with Naproxen 125mg/5mL 7.5mL BID, steroid injection.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: The event juvenile idiopathic arthritis is conservatively assessed as related to the suspect drug BNT162B2 OMICRON (KP.2) based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: lung infection with headache, fever, and fatigue; injection site redness; injection site swelling; This is a spontaneous report received from an Other HCP, Program ID.  A 76-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Apr2024 as dose 1, 30 ug single (Batch/Lot number: unknown) at the age of 76 years intramuscular for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in 2024 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 2024, outcome "recovered" (2024), described as "injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 2024, outcome "recovered" (2024), described as "injection site swelling"; PNEUMONIA (medically significant) with onset 2024, outcome "unknown", described as "lung infection with headache, fever, and fatigue". The clinical course was reported as follows: the patient reported that she currently had a lung infection with headache, fever and fatigue, she also experienced injection site redness and swelling that lasted for approximately 5 days. The patient believed these side effects could possibly be related to the respiratory syncytial virus vaccine that recently got but she was not sure.   The information on the batch/lot number for BNT162b2 omi xbb.1.5, rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event pneumonia (lung infection, headache, fever, and fatigue) and the suspect drugs BNT162B2 OMI XBB.1.5, and RSV VACCINE PROT.SUBUNIT PREF 2V cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: one dose of FLUZONE T was administered post-excursion with no reported adverse event; Initial information received on 13-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 years old female patient who received one dose of influenza USP trival A-B subvirion vaccine [Fluzone T] was administered post-excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received one dose of 0.5 ml  of suspect influenza USP trival A-B subvirion vaccine 45 µg, Suspension for injection (lot U8442AA; expiry date: 30-Jun-2025) via unknown route in unknown administration site for Immunization post-excursion with no reported adverse event (poor quality product administered) (same day: latency).  1st excursion on 04-Nov-2024 Max/low temperature reached: 48 degrees F Duration: 30 minutes, 2nd excursion on 12Dec2024 Reason: an UTR issue with the fridge Max/low temperature reached: negative 0.1 degrees C Duration: 37 minutes, No Human error.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash; Hives; General internal itching; This spontaneous case, initially received on 09-Dec-2024, was reported by a non-health professional and concerns an elderly female patient.  Administration of company suspect drug: On 16-Oct-2024, the patient received Fluad (TIV) for Not reported, Dose regimen: 0.5 ml, Route of administration: not reported Lot number: No batch number available and would be requested with follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On Oct-2024, the patient experienced Rash (outcome: Not Reported), Hives (outcome: Not Reported), General internal itching (outcome: Not Reported).  Clarifies that was asking this because he and his wife took Fluad on 16-Oct-2024 and two days after that they started experiencing internal itching. In his case, an internal itching in his throat ad ears, while his wife experienced rash and hives, and a general internal itching. Refers that the hives and itching come and go, and wonders if that would be related to Fluad, and maybe it being a time released vaccine.  Fluad (TIV) action taken: Not Applicable  Treatment medication: Cortisone cream  Reporter's assessment: The reporter did not provide the seriousness and causality assessment for events.; Reporter's Comments: The events assessed as related
Sex: M
Vaccine: UNK
Symptoms: Pruritus, Throat irritation
Clinical narrative: Internal itching in the throat and ears; This spontaneous case, initially received on 09-Dec-2024, was reported by a non health professional and concerns an elderly male patient.  Administration of company suspect drug: On 16-Oct-2024, the patient received Fluad (TIV) for indication: not reported, Dose regimen: 0.5 ml, Route of Administration: Not Reported, Anatomical location: Not Reported, Lot number: Not reported, and will be requested upon follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 18-Oct-2024, the patient experienced Internal itching in the throat and ears (outcome: Not Reported).  Patient went to doctor, and she gave me a cortisone cream, although only complaint of an internal itching.  Fluad (TIV) action taken: Not Applicable Treatment medication: Cortisone cream  Reporter's assessment:  The reporter's seriousness was unknown and causality assessment was not provided.; Reporter's Comments: Causality was assessed related
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Inflammation
Clinical narrative: gout like inflammation to both knees slowly resolving over last 2 weeks with allopurinal, colchicine, ibuprofen, and RICE
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Moderna vaccine was received 10-09-24 As per County we have 60 days to administer vaccine, if vaccine was stored in refrigerator.  Vaccine was administered 12-17-24, no reaction to vaccine. Called Moderna Manufacture, as per staff, they don't provide recommendations for management of administration error or deviations associates with moderna covid vaccine however, CDC provides clinical guidance or management of administration error in which we have to report.