chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram, Hypertension, Laboratory test
Clinical narrative: High Blood Pressure; This serious case was reported by a consumer and described the occurrence of blood pressure high in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number RS3A9, expiry date 08-OCT-2024) for prophylaxis.   On 22-SEP-2023, the patient received Shingrix 50 mg. On 23-SEP-2023, 1 days after receiving Shingrix, the patient experienced blood pressure high (Verbatim: High Blood Pressure) (serious criteria clinically significant/intervention required). The outcome of the blood pressure high was not resolved.   It was unknown if the reporter considered the blood pressure high to be related to Shingrix.     It was unknown if the company considered the blood pressure high to be related to Shingrix.   Additional Information: GSK receipt date: 20-OCT-2023 This report was submitted via the online direct entry reporting system.  The reporter gave permission to contact them..
Sex: F
Vaccine: MENB
Symptoms: No adverse event, Product administration error, Wrong product administered
Clinical narrative: Administered Bexsero at 12 year old visit instead of Menveo; This non-serious case was reported by a physician via sales rep and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 12-JUL-2023, the patient received the 1st dose of Bexsero (unknown arm). On 12-JUL-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Administered Bexsero at 12 year old visit instead of Menveo). 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: 17-OCT-2023 This report was submitted via the online direct entry reporting system.  The physician stated that, first dose of Bexsero administered to the patient instead of Menveo, which led to wrong vaccine administered.  No other products received by the patient. Realized maladministration error when child (patient) returned to clinic.  No ADE (adverse event) reported.  The reporter did not give consent to contact. The HCP (Health care professional) consent to contact was not given.
Sex: F
Vaccine: RVX
Symptoms: Product use in unapproved indication, Rash
Clinical narrative: RSV given for indication of rash; Rash; This non-serious case was reported by a other health professional and described the occurrence of rash in a 68-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) (expiry date OCT-2023) for prophylaxis.   On an unknown date, the patient received RSV vaccine .5 ml. On 18-OCT-2023, an unknown time after receiving RSV vaccine, the patient experienced rash (Verbatim: Rash). On an unknown date, the patient experienced drug use for unapproved indication (Verbatim: RSV given for indication of rash). The outcome of the rash was resolving and the outcome of the drug use for unapproved indication was unknown.   It was unknown if the reporter considered the rash to be related to RSV vaccine.   It was unknown if the company considered the rash to be related to RSV vaccine.   Additional Information: GSK receipt Date: 19-OCT-2023 This report was submitted via the online direct entry reporting system.  The symptoms were not treated. The RSV vaccine was given for the indication of rash, which led to drug use for unapproved indication.
Sex: U
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: swelled for about 1 week; This non-serious case was reported by a physician via sales rep and described the occurrence of swelling 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 swelling (Verbatim: swelled for about 1 week). The outcome of the swelling was resolved (duration 1 week).   It was unknown if the reporter considered the swelling to be related to Shingrix.     It was unknown if the company considered the swelling to be related to Shingrix.  Additional Information: GSK Receipt Date: 17-OCT-2023 The healthcare professional (HCP) stated that he had a patient who were swelled for about 1 week after having received a dose of Shingrix. The reporter did not consent to follow-up.
Sex: U
Vaccine: RSV
Symptoms: Injection site erythema, Lip swelling, Pruritus
Clinical narrative: Pinkish ring around where the shot was; A week later I have a swollen lip; Itcy spots on my upper thigh; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 1 week after receiving Arexvy, the patient experienced injection site erythema (Verbatim: Pinkish ring around where the shot was), lip swelling (Verbatim: A week later I have a swollen lip) and localized itching (Verbatim: Itcy spots on my upper thigh). The outcome of the injection site erythema, lip swelling and localized itching were not resolved.   It was unknown if the reporter considered the injection site erythema, lip swelling and localized itching to be related to Arexvy.     It was unknown if the company considered the injection site erythema, lip swelling and localized itching to be related to Arexvy.   Additional Information: GSK Receipt Date: 17-OCT-2023 A week later patient has a swollen lip and itchy spots on upper thigh. Also, still a pinkish ring around where the shot was given. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Tenderness at the injection site; Terrible headache the day after; muscle achiness; tiredness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site tenderness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site tenderness (Verbatim: Tenderness at the injection site), headache (Verbatim: Terrible headache the day after), muscle pain (Verbatim: muscle achiness) and tiredness (Verbatim: tiredness). The outcome of the injection site tenderness, headache, muscle pain and tiredness were not reported.   It was unknown if the reporter considered the injection site tenderness, headache, muscle pain and tiredness to be related to Arexvy.     It was unknown if the company considered the injection site tenderness, headache, muscle pain and tiredness to be related to Arexvy.   Additional Information: GSK Receipt Date: 17-OCT-2023 This case was reported via (Open field AE monitoring) interactive digital media. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: RVX
Symptoms: Product storage error
Clinical narrative: stored in a freezer or refrigerator; This non-serious case was reported by a consumer and described the occurrence of incorrect storage of drug in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced incorrect storage of drug (Verbatim: stored in a freezer or refrigerator). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date 17 Oct 2023: The reporter stated that he/she went to pharmacy, on Sunday to inquire about your RSV vaccine. I The reporter wanted to make sure they had GSK's vaccine and not Pfizer's. The pharmacist pulled the box of vials out of a Styrofoam cooler on the counter. The reporter stated that shouldn't it be stored in a freezer or refrigerator? They weren't actively unpacking it, which led to incorrect storage of drug. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Eye irritation, Foreign body sensation in eyes, Occupational exposure to product
Clinical narrative: Today it feels a gritty; Pharmacist reports that a small amount of AREXVY squirted out of the syringe/needle when preparing for administration of product.; Pharmacist reports that a small amount of AREXVY squirted out of the syringe/needle when preparing for administration of product.; her eye was burning for about 30 minutes/Today it feels a grittyand irritated.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of burning sensation in eye in a 50-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 16-OCT-2023, the patient received Arexvy. On 16-OCT-2023, less than a day after receiving Arexvy, the patient experienced burning sensation in eye (Verbatim: her eye was burning for about 30 minutes/Today it feels a grittyand irritated.), occupational exposure while preparing product for administration (Verbatim: Pharmacist reports that a small amount of AREXVY squirted out of the syringe/needle when preparing for administration of product.) and exposure via eye contact (Verbatim: Pharmacist reports that a small amount of AREXVY squirted out of the syringe/needle when preparing for administration of product.). On 17-OCT-2023, the patient experienced gritty eyes (Verbatim: Today it feels a gritty). The outcome of the burning sensation in eye and gritty eyes were not resolved and the outcome of the occupational exposure while preparing product for administration and exposure via eye contact were unknown.   It was unknown if the reporter considered the burning sensation in eye and gritty eyes to be related to Arexvy.     It was unknown if the company considered the burning sensation in eye and gritty eyes to be related to Arexvy.   Additional Information: GSK receipt date 17 Oct 2023: The pharmacist reported that a small amount of AREXVY squirted out of the syringe/needle when preparing for administration of product. She stated it was not a product quality issue, and that she had too much pressure in the syringe. She reported that her eye was burning for about 30 minutes before she went to the emergency room. After ER evaluation, she was told everything was fine in her eye - no abrasions or lesions visualized by the attending physician.  Today it felt a gritty and irritated. The patient stated that small amount of AREXVY squirted out of the syringe/needle when preparing for administration of product which led to occupational exposure while preparing product for administration and exposure via eye contact.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal, Muscular weakness, Nausea
Clinical narrative: nausea; dizziness; I just don't feel right; experienced muscle weakness; This non-serious case was reported by a consumer via call center representative and described the occurrence of nausea in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13-OCT-2023, the patient received the 1st dose of Shingrix (left arm). In OCT-2023, an unknown time after receiving Shingrix, the patient experienced nausea (Verbatim: nausea) and dizziness (Verbatim: dizziness). On an unknown date, the patient experienced feeling abnormal (Verbatim: I just don't feel right) and muscle weakness (Verbatim: experienced muscle weakness). In OCT-2023, the outcome of the nausea and dizziness were resolved. The outcome of the feeling abnormal and muscle weakness were not resolved.   It was unknown if the reporter considered the nausea, dizziness, feeling abnormal and muscle weakness to be related to Shingrix.     It was unknown if the company considered the nausea, dizziness, feeling abnormal and muscle weakness to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-OCT-2023 The reporter stated that he received Shingrix dose 1 and experienced muscle weakness, nausea and dizziness. The patient just didn't feel right. Referred to healthcare professional. MI phone number provided. The reporter did not consent to follow-up.
Sex: U
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: patient received a 2nd dose of Arexvy after 6 weeks of the first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On an unknown date, the patient received the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: patient received a 2nd dose of Arexvy after 6 weeks of the first dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 17-OCT-2023 The pharmacist reported that patient received a 2nd dose of Arexvy after 6 weeks of the first dose, which led to extra dose administered. No more information available. The reporter did not consent to follow-up.
Age: 38.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure during pregnancy, Injury associated with device
Clinical narrative: pregnant with twins/accidentally stabbed herself with a needle; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 38-year-old female patient who received Herpes zoster (Shingrix) (batch number 7TA92, expiry date 29-SEP-2025) for prophylaxis.   On 17-OCT-2023, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant with twins/accidentally stabbed herself with a needle). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Gestation time at first exposure (Shingrix): 23 Weeks Pregnancy Exposure (Shingrix): To mother in third trimester Last Menstrual Period Date: 03-MAY-2023 Estimated Delivery/Due date: 04-FEB-2024 Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 17-Oct-2023 The reporter reported that after the shingrix was reconstituted and sitting on the counter for 5 minute, she accidentally stuck her self with the needle.   No reactions reported.  However, she was pregnant with twins. The reporter consented to follow-up. A pregnant patient accidentally received a dose of Shingrix, which led to vaccine exposure during pregnancy.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: swelling at the injection site; redness at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (patient had an active case of shingles (rash) at the time of vaccination) and rash.   On 11-OCT-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On 11-OCT-2023, less than a day after receiving Shingrix, the patient experienced injection site swelling (Verbatim: swelling at the injection site) and injection site erythema (Verbatim: redness at the injection site). The outcome of the injection site swelling and injection site erythema were resolved.   It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site swelling and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-OCT-2023 The reporter was the patient. The patient received first dose of Shingrix and experienced redness and swelling at the injection site. The patient mentioned she had an active case of shingles (rash) at the time of vaccination and the shingles rash appeared about 3 or 4 days prior to Shingrix. Nothing else was reported. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Condition aggravated, Feeling abnormal, Pain in extremity, Preictal state
Clinical narrative: "freezes" for a few seconds; generally feeling "bad; sore arm; He experienced slight fever; feels weak; condition aggravated; This non-serious case was reported by a consumer via call center representative and described the occurrence of preictal state in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included neurofibromatosis, preictal state (She stated that these episodes were once every few weeks) and weakness.   On 12-OCT-2023, the patient received Shingrix. On 12-OCT-2023, less than a day after receiving Shingrix, the patient experienced feeling bad (Verbatim: generally feeling "bad), pain in arm (Verbatim: sore arm) and fever (Verbatim: He experienced slight fever). On 13-OCT-2023, the patient experienced preictal state (Verbatim: "freezes" for a few seconds). In OCT-2023, the patient experienced feelings of weakness (Verbatim: feels weak) and condition aggravated (Verbatim: condition aggravated). On 13-OCT-2023, the outcome of the pain in arm and fever were resolved.  On 14-OCT-2023, the outcome of the feeling bad was resolved. The outcome of the preictal state, feelings of weakness and condition aggravated were not resolved.   It was unknown if the reporter considered the preictal state, feeling bad, pain in arm, fever, feelings of weakness and condition aggravated to be related to Shingrix.     It was unknown if the company considered the preictal state, feeling bad, pain in arm, fever, feelings of weakness and condition aggravated to be related to Shingrix.   Additional Information: GSK receipt date 17 Oct 2023: The mother of the patient was the reporter. She stated that her son, received the SHINGRIX vaccine. He experienced slight fever, sore arm and generally feeling bad for about 24 hours.  She also reported that he had a history of episodes where he freezes for a few seconds. She states that he could tell when an episode was coming on, and feels weak after.  She stated that these episodes were once every few weeks, but since receiving the SHINGRIX vaccine, they were happening multiple times per day. The reporter did not consent to follow-up. Also because the patient's doctor was unaware this was happening. It was advised encouraged the mother to encourage her son to speak with his doctor about these episodes as soon as possible.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: "freezes" for a few seconds; generally feeling "bad; sore arm; He experienced slight fever; feels weak; condition aggravated; This non-serious case was reported by a consumer via call center representative and described the occurrence of preictal state in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included neurofibromatosis, preictal state (She stated that these episodes were once every few weeks) and weakness.   On 12-OCT-2023, the patient received Shingrix. On 12-OCT-2023, less than a day after receiving Shingrix, the patient experienced feeling bad (Verbatim: generally feeling "bad), pain in arm (Verbatim: sore arm) and fever (Verbatim: He experienced slight fever). On 13-OCT-2023, the patient experienced preictal state (Verbatim: "freezes" for a few seconds). In OCT-2023, the patient experienced feelings of weakness (Verbatim: feels weak) and condition aggravated (Verbatim: condition aggravated). On 13-OCT-2023, the outcome of the pain in arm and fever were resolved.  On 14-OCT-2023, the outcome of the feeling bad was resolved. The outcome of the preictal state, feelings of weakness and condition aggravated were not resolved.   It was unknown if the reporter considered the preictal state, feeling bad, pain in arm, fever, feelings of weakness and condition aggravated to be related to Shingrix.     It was unknown if the company considered the preictal state, feeling bad, pain in arm, fever, feelings of weakness and condition aggravated to be related to Shingrix.   Additional Information: GSK receipt date 17 Oct 2023: The mother of the patient was the reporter. She stated that her son, received the SHINGRIX vaccine. He experienced slight fever, sore arm and generally feeling bad for about 24 hours.  She also reported that he had a history of episodes where he freezes for a few seconds. She states that he could tell when an episode was coming on, and feels weak after.  She stated that these episodes were once every few weeks, but since receiving the SHINGRIX vaccine, they were happening multiple times per day. The reporter did not consent to follow-up. Also because the patient's doctor was unaware this was happening. It was advised encouraged the mother to encourage her son to speak with his doctor about these episodes as soon as possible.
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Product prescribing error
Clinical narrative: Bexsero booster for a 53 y/o patient / Bexsero 5 years ago 1 month apart; whose specialist has written a prescription for her PCP to administer a Bexsero Booster; unaware if dose was administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 53-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis and Men B NVS (Bexsero) for prophylaxis.   Concurrent medical conditions included immunocompromised and complement deficiency disease (C-2 Complement deficiency).   On an unknown date, the patient received Bexsero, the 2nd dose of Bexsero and the 1st dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, Bexsero and Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Bexsero booster for a 53 y/o patient / Bexsero 5 years ago 1 month apart), drug prescribing error (Verbatim: whose specialist has written a prescription for her PCP to administer a Bexsero Booster) and extra dose administered (Verbatim: unaware if dose was administered). The outcome of the inappropriate age at vaccine administration, drug prescribing error and extra dose 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: 17-OCT-2023 Nurse requested data on administration of a Bexsero booster for a 53-year patient who was immunocompromised and has C-2 Complement deficiency, whose specialist had written a prescription for her primary care physician to administer a Bexsero Booster, which led to drug prescribing error. Patient received primary Bexsero 5 years ago 1 month apart.  The reporter asked was there any data regarding a Bexsero booster and timing of the booster vaccine, did the patient need the 2-part series or a single dose of Bexsero, Bexsero not given at the time of call, unaware if dose was administered or not to the patient. The reporter consented to follow up. The patient above recommended age received primary and booster, which led to inappropriate age at vaccine administration and extra dose administered.
Sex: M
Vaccine: RSV
Symptoms: Intercepted product prescribing error
Clinical narrative: 59 year old male asthmatic patient came in to pharmacy with prescription from his physician to receive Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 59-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included asthma.   On an unknown date, the patient did not received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted drug prescribing error (Verbatim: 59 year old male asthmatic patient came in to pharmacy with prescription from his physician to receive Arexvy). The outcome of the intercepted drug prescribing error was unknown.   Additional Information: GSK receipt date 17 Oct 2023 The pharmacist stated a 59 year old male asthmatic patient came in to pharmacy with prescription from his physician to receive Arexvy. The vaccine had not been administered which led to intercepted drug prescribing error.  The Vaccine Administration Facility was the same as primary reporter.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Arthritis, Condition aggravated, Immediate post-injection reaction, Oral herpes, Rash
Clinical narrative: Viral cold sore in lip.; patient had a systemic inflammatory arthritis flare; had a diagnosis of arthritis and that a week after the administration the patient had a systemic inflammatory arthritis flare; Rash in arm/ rash that covered the entire arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of rash in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included arthritis (diagnosis of arthritis form many years ago).   On 08-OCT-2023, the patient received Arexvy. On 08-OCT-2023, immediately after receiving Arexvy, the patient experienced rash (Verbatim: Rash in arm/ rash that covered the entire arm). On 15-OCT-2023, the patient experienced cold sores lip (Verbatim: Viral cold sore in lip.), flare up of arthritis (Verbatim: patient had a systemic inflammatory arthritis flare) and condition aggravated (Verbatim: had a diagnosis of arthritis and that a week after the administration the patient had a systemic inflammatory arthritis flare). The outcome of the rash was not resolved and the outcome of the cold sores lip, flare up of arthritis and condition aggravated were unknown.   It was unknown if the reporter considered the rash, cold sores lip, flare up of arthritis and condition aggravated to be related to Arexvy.     It was unknown if the company considered the rash, cold sores lip, flare up of arthritis and condition aggravated to be related to Arexvy.   Additional Information: GSK receipt date: 17-OCT-2023 The pharmacist called to inform that a patient that received Arexvy and experienced a rash that covered the entire arm immediately after receiving the vaccine.  According to reporter, the patient had not recovered from the rash at the moment on the call.  Also, reporter informed that a week after receiving the vaccine, the patient presented a viral cold sore on the lip.  The reporter shared that the patient had a diagnosis of arthritis form many years ago, and that a week after the administration of the vaccine the patient had a systemic inflammatory arthritis flare. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: adult received a pediatric dose of engerix-b (17-October-2023) inadvertently; adult received a pediatric dose of engerix-b (17-October-2023) inadvertently; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 56-year-old female patient who received HBV (Engerix B pediatric) (batch number P49X7, expiry date 07-DEC-2023) for prophylaxis.   On 17-OCT-2023, the patient received Engerix B pediatric (intramuscular, left deltoid). On 17-OCT-2023, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: adult received a pediatric dose of engerix-b (17-October-2023) inadvertently) and adult use of a child product (Verbatim: adult received a pediatric dose of engerix-b (17-October-2023) inadvertently). The outcome of the accidental underdose and adult use of a child product were unknown.  Additional Information: GSK Receipt Date: 18-OCT-2023 The MA (medical assistant) reported an adult received a pediatric dose of Engerix-B inadvertently, which led to accidental underdose and adult use of a child product. The reporter consented to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: he started breaking out with Shingles/ lack of effect; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13-OCT-2023, the patient received the 1st dose of Shingrix (left arm). On 14-OCT-2023, 1 days after receiving Shingrix, the patient experienced shingles (Verbatim: he started breaking out with Shingles/ lack of effect). The outcome of the shingles was not resolved.   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: 18-OCT-2023 The patient self-reported this case. The patient stated that, he had his first dose of Shingrix and started breaking out with Shingles. The reporter consented to follow up.
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Arexvy on 18Oct2023 (lot number 4HY3A, expiration date 23Jan2025), and then afterward the patient stated he had already received a dose on 30Sep2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4HY3A, expiry date 23-JAN-2025) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 18-OCT-2023, the patient received the 2nd dose of Arexvy. On 18-OCT-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Arexvy on 18Oct2023 (lot number 4HY3A, expiration date 23Jan2025), and then afterward the patient stated he had already received a dose on 30Sep2023). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 18-Oct-2023 The pharmacist stated that the first dose was not showing up in the state database, so he did not had the lot number or expiration date. The Vaccine Administration Facility was the same as Primary Reporter. Reporter gave permission for follow-up. The patient received second dose of Arexvy, which led to extra dose administered.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Inadvertently administered Kinrix to sibling patients/but noticed the recommended age after; 3rd dose of DTAP and 3rd dose of IPV; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   On 16-OCT-2023, the patient received Kinrix. On 16-OCT-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inadvertently administered Kinrix to sibling patients/but noticed the recommended age after) and inappropriate schedule of vaccine administered (Verbatim: 3rd dose of DTAP and 3rd dose of IPV). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of 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-OCT-2023 The reporter was a medical assistant. The reporter reported that they inadvertently administered Kinrix vaccine to patient. The reporter mentioned that patient need to receive both DTAP and IPV and Kinrix had both but noticed the recommended age.  The reporter stated that it was the 3rd dose of DTAP and 3rd dose of IPV for the patient. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. This US2023144287 case has been linked to the case reported by the same reporter. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2023144287:Same reporter,2nd patient
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered Kinrix; inadvertently administered Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2023) for prophylaxis.   On 16-OCT-2023, the patient received Kinrix. On 16-OCT-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: inadvertently administered Kinrix) and inappropriate schedule of vaccine administered (Verbatim: inadvertently administered Kinrix). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of 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 Oct 2023 Medical Assistant called to inquire, what to look for? How to proceed? Medical assistant  reported they inadvertently administered Kinrix to sibling patients. MA mentioned both patients needed both DTAP and IPV and Kinrix had both but noticed the recommended age after. The HCP stated, it was the 3rd dose of DTAP and 3rd dose of IPV for each patient. The reporter did not consent to follow-up. 2 year patient received kinrix, as 3rd dose of DTAP and 3rd dose of IPV which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. This case has been linked with case reported by same reporter.; Sender's Comments:  US-GSK-US2023144288:Same reporter,2nd patient
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received the second dose of the shingrix vaccine 30 days after the first dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: patient received the second dose of the shingrix vaccine 30 days after the first dose.). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 18-Oct-2023 The case was received from the pharmacist. The patient received second dose of the shingrix vaccine 30 days after the first dose, which led to shortening of vaccine schedule. The follow-up could not be possible as no contact details were available.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: red mark at injection site; a massive swelling at the injection site/Patient described it as a "bump; red welt reaction from the vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included pneumonitis and ground glass opacity on chest x-ray (Grown Glass Opacity in the right lung).   On 07-SEP-2023 14:30, the patient received Arexvy (intramuscular, left arm). On 08-SEP-2023, 1 days after receiving Arexvy, the patient experienced erythema urticarial (Verbatim: red welt reaction from the vaccine). On an unknown date, the patient experienced injection site erythema (Verbatim: red mark at injection site) and injection site swelling (Verbatim: a massive swelling at the injection site/Patient described it as a "bump). The outcome of the injection site erythema was not resolved and the outcome of the injection site swelling was resolved and the outcome of the erythema urticarial was not reported.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Arexvy. The reporter considered the erythema urticarial to be related to Arexvy.     It was unknown if the company considered the injection site erythema and injection site swelling to be related to Arexvy. The company considered the erythema urticarial to be related to Arexvy.   Additional Information: GSK Receipt Date: 18-OCT-2023 The reporter was a patient. The patient reported that she received Arexvy vaccine 6 weeks ago from reporting day, and the next morning she had a big red welt reaction from the vaccine. Patient described the size of the redness of about 4 inches in circumference. Patient reported a massive swelling at the injection site which described as bump. Patient reported that the swelling and the bump had decreased but and the redness was now a pink color that had not disappeared. The reporter consented to follow up with the pharmacist at the vaccination facility.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received first dose of Bexsero on 13Oct2023, and then received second dose too early, on 18Oct2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number E74MY, expiry date 31-JUL-2024) for prophylaxis.   Concomitant products included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO).   On 18-OCT-2023, the patient received the 2nd dose of Bexsero. On 18-OCT-2023, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: received first dose of Bexsero on 13Oct2023, and then received second dose too early, on 18Oct2023). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 18-OCT-2023 The medical assistant reported that, the patient received first dose of Bexsero and then received second dose too early, on 18-OCT-2023, which led to shortening of the vaccination schedule. Both doses were administered from same lot number and expiration date. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Injection site reaction, Peripheral swelling
Clinical narrative: experienced an injection site reaction; swollen arm; red arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 63-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number 9e5ke, expiry date 30-JUN-2024) for prophylaxis.   On 06-OCT-2023, the patient received FluLaval Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced injection site reaction (Verbatim: experienced an injection site reaction), swelling arm (Verbatim: swollen arm) and erythema of extremities (Verbatim: red arm). The outcome of the injection site reaction was not reported and the outcome of the swelling arm and erythema of extremities were resolved (duration 24 hrs).   It was unknown if the reporter considered the injection site reaction, swelling arm and erythema of extremities to be related to FluLaval Quadrivalent 2023-2024 season.     It was unknown if the company considered the injection site reaction, swelling arm and erythema of extremities to be related to FluLaval Quadrivalent 2023-2024 season.   Additional Information: GSK receipt date: 18-OCT-2023 The reporter was the health care professional (pharmacist). The patient received a dose of FLULAVAL and experienced an injection site reaction.  The patient had a swollen and red arm which last for 24 hours then resolved. The reporter consented to follow up.
Age: 9.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Boostrix was accidentally given instead of Flulaval; Boostrix was accidentally given to a 9 year old female patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 9-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 25A2F, expiry date 19-JAN-2026) for prophylaxis.   On 18-OCT-2023, the patient received Boostrix. On 18-OCT-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Boostrix was accidentally given instead of Flulaval) and inappropriate age at vaccine administration (Verbatim: Boostrix was accidentally given to a 9 year old female patient). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 18-OCT-2023 A nurse reported that Boostrix was accidentally given instead of Flulaval to a 9 year old female patient which led to inappropriate age at vaccine administration and wrong vaccine administered. The healthcare professional notes that the error occurred because it was given to the wrong sibling. The reporter consented to follow up via mail.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Infanrix was given to an 11 year old patient instead of a dose of Boostrix; Infanrix was given to an 11 year old patient instead of a dose of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 11-year-old male patient who received DTPa (Infanrix) (batch number 7HM5J, expiry date 13-SEP-2024) for prophylaxis.   On 10-OCT-2023, the patient received Infanrix. On 10-OCT-2023, an unknown time after receiving Infanrix, the patient experienced underdose (Verbatim: Infanrix was given to an 11 year old patient instead of a dose of Boostrix) and inappropriate age at vaccine administration (Verbatim: Infanrix was given to an 11 year old patient instead of a dose of Boostrix). The outcome of the underdose and inappropriate age at vaccine administration 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-OCT-2023 The medical assistant reported that a dose of Infanrix was given to an 11 year old patient instead of Boostrix which led to inappropriate age at vaccine administration and underdose. The reporter consented to follow up.
Age: 34.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 35 weeks pregnant, was administered Arexvy instead of Abrysvo on 17Oct2023 at a local pharmacy.; Administered Arexvy instead of Abrysvo; 34 year patient experienced Arexvy vaccine; This non-serious prospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a 34-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 17-OCT-2023, the patient received Arexvy. On 17-OCT-2023, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: Administered Arexvy instead of Abrysvo) and inappropriate age at vaccine administration (Verbatim: 34 year patient experienced Arexvy vaccine). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 35 weeks pregnant, was administered Arexvy instead of Abrysvo on 17Oct2023 at a local pharmacy.). The outcome of the vaccine exposure during pregnancy, wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 18-OCT-2023 The reporter reported that his daughter who was 35 weeks pregnant received Arexvy instead of Abrysvo vaccine, which led to wrong vaccine administered. The physician did not have the lot number or expiration date information. The patient received Arexvy who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Fluarix exposed to below 0 C; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Flu Seasonal TIV Dresden (Fluarix) (batch number UT8040JA, expiry date 30-JUN-2024) for prophylaxis.   On an unknown date, the patient received Fluarix. On an unknown date, an unknown time after receiving Fluarix, the patient experienced incorrect storage of drug (Verbatim: Fluarix exposed to below 0 C). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 18-Oct-2023 The reporter mentioned that it might be a sanofi vaccine.  The reporter did not see in the batch.  Documenting just in case.  Consented to follow up via email. Fluarix exposed to below 0 C and was administered to over 86 people at a flu clinic, which led to incorrect storage of drug.
Sex: U
Vaccine: RSV
Symptoms: Intercepted product prescribing error
Clinical narrative: received RX for Arexvy and patient was under age of 60; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient did not receive Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted drug prescribing error (Verbatim: received RX for Arexvy and patient was under age of 60). The outcome of the intercepted drug prescribing error was unknown.   Additional Information: GSK Receipt Date: 19-OCT-2023 The pharmacist reported that she received a RX for a patient for Arexvy and the patient was under the age of 60 which led to intercepted drug prescribing error. The reporter consented to follow up via email. It was reported that Healthcare professional was not at work and had no details of physician who wrote Rx.