chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shot and 1 year and 5 days got them/ Suspected vaccination failure; 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. In DEC-2023, 1 year 5 days after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got the shot and 1 year and 5 days got them/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to 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: 26-FEB-2024 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and 1 year and 5 days later got shingles.  The patient stated that the worst thing ever had that was in December and still the time of the reporting dealing with it. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: RSV
Symptoms: Guillain-Barre syndrome, Nerve injury
Clinical narrative: Guillain-Barré syndrome; Nerve cell damage; This serious case was reported by a consumer and described the occurrence of guillain barre syndrome in an unspecified number of patients 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 guillain barre syndrome (Verbatim: Guillain-Barré syndrome) (serious criteria GSK medically significant) and nerve damage (Verbatim: Nerve cell damage). The outcome of the guillain barre syndrome and nerve damage were not reported.   It was unknown if the reporter considered the guillain barre syndrome and nerve damage to be related to Arexvy.     It was unknown if the company considered the guillain barre syndrome and nerve damage to be related to Arexvy.   Additional Information: GSK Receipt Date: 04-MAR-2024 The reporter reported that Guillain-Barre syndrome (GBS) following Arexvy vaccination in adults. Most people fully recovered from the syndrome but some had permanent nerve damage. Guillain-barre syndrome could occurred in people after they were infected with a virus but in some instates cases had been linked with RSV vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: It hurt but well thought of; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a 64-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included shingles (patient's mother) and ophthalmic herpes zoster (patient's mother).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: It hurt but well thought of). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.    It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 28-FEB-2024 and 02-MAR-2024 This case was reported by a patient via interactive digital media. The patient's mom had terrible shingles and it went into her eyes even. The reporter stated that it hurt but well thought of. The patient was going in next week to get his/her 2nd shot of shingles vaccine.  The first one hurt but well worth it.
Sex: U
Vaccine: VARZOS
Symptoms: Dysgeusia, Malaise, Pain, Pyrexia
Clinical narrative: body aches; fever horrible; bad metal taste in my mouth; I was sick for 2 weeks; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine (unknown arm). In FEB-2024, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: I was sick for 2 weeks). On an unknown date, the patient experienced general body pain (Verbatim: body aches), fever (Verbatim: fever horrible) and taste metallic (Verbatim: bad metal taste in my mouth). The outcome of the sickness was resolved (duration 2 weeks) and the outcome of the general body pain, fever and taste metallic were not reported.   It was unknown if the reporter considered the sickness, general body pain, fever and taste metallic to be related to Shingles vaccine.     It was unknown if the company considered the sickness, general body pain, fever and taste metallic to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2024 The reporter reported that got the shingles shot horrible Worse than having covid never again the reporter was sick for 2 weeks body aches and fever horrible.  The reporter had a bad metal taste in my mouth. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Incomplete course of vaccination
Clinical narrative: allergic to it; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced allergy (Verbatim: allergic to it). Shingles vaccine was discontinued. The outcome of the allergy was not reported.   It was unknown if the reporter considered the allergy to be related to Shingles vaccine.     It was unknown if the company considered the allergy to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2024 and 02-MAR-2024 This case was reported by a patient via interactive digital media. The patient had bad reaction to the first shot and not taking the second shot. The patient had first shingles vaccine and had bad time of it. The patient reported that he/she was allergic to it.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Pruritus
Clinical narrative: Small spot of shingles on my shoulder and lip; Blisters; Painful; Itchy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In DEC-2023, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Small spot of shingles on my shoulder and lip), blister (Verbatim: Blisters), pain (Verbatim: Painful) and pruritus (Verbatim: Itchy). The outcome of the shingles, blister, pain and pruritus were resolved (duration 2 months).   It was unknown if the reporter considered the shingles, blister, pain and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the shingles, blister, pain and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she got the vaccine shot in December, got a small spot of shingles on the shoulder and lip. So, they told the patient to wait till April for the second shot.  It was reported that, those little blisters were painful and itchy and lasted for two months.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2024 This case was reported by a patient via interactive digital media. The patient got the shot and two weeks later he/she suffered with shingles and patient stated that, no fun.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2024AMR027104   Additional Information: GSK Receipt Date: 28-FEB-2024 This case was reported by a patient via interactive digital media. The patient had 1st shot, no side effects, only a mild sore arm.  For tolerance of the 2nd dose refer linked case US2024AMR027104, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR027104:case for Second shot
Sex: U
Vaccine: RSV
Symptoms: Malaise, Pain
Clinical narrative: pain; about feeling very sick; This non-serious case was reported by a physician via sales rep and described the occurrence of pain in an unspecified number of patients 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 pain (Verbatim: pain) and feeling unwell (Verbatim: about feeling very sick). The outcome of the pain and feeling unwell were not reported.   It was unknown if the reporter considered the pain and feeling unwell to be related to Arexvy.     It was unknown if the company considered the pain and feeling unwell to be related to Arexvy.   Additional Information: GSK Receipt Date: 28-FEB-2024 The doctor had two patients who complained about feeling very sick and pain.
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: 50 years old and was given Engerix B,her first dose as pediatric dosage; 50 years old and was given Engerix B,her first dose as pediatric dosage; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 50-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: 50 years old and was given Engerix B,her first dose as pediatric dosage) and adult use of a child product (Verbatim: 50 years old and was given Engerix B,her first dose as pediatric dosage). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 01-MAR-2024 The local health department reported that the patient presented to them after receiving vaccine from another provider.  The patient was 50 years old and was given Engerix B, her first dose as pediatric dosage which led to underdose and adult use of a child product. The reporter asked that she did need to start over again. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Headache, Malaise
Clinical narrative: Terrific headache; Feeling of malaise; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache 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 headache (Verbatim: Terrific headache) and malaise (Verbatim: Feeling of malaise). The outcome of the headache and malaise were not reported.   It was unknown if the reporter considered the headache and malaise to be related to Arexvy.     It was unknown if the company considered the headache and malaise to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-Mar-2024 This case was reported by a patient via interactive digital media. The patient reported that he or she received Arexvy vaccine and experienced terrific headache and feeling of malaise.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Fatigue
Clinical narrative: Joint pain; Tiredness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint pain 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 joint pain (Verbatim: Joint pain) and tiredness (Verbatim: Tiredness). The outcome of the joint pain and tiredness were not reported.   It was unknown if the reporter considered the joint pain and tiredness to be related to Arexvy.     It was unknown if the company considered the joint pain and tiredness to be related to Arexvy.   Additional Information: GSK receipt date: 01-MAR-2024 This case was reported by a patient via interactive digital media. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Fatigue
Clinical narrative: diabetic fatigue; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included diabetes.   On an unknown date, the patient received Arexvy. On an unknown date, 1 day after receiving Arexvy, the patient experienced fatigue (Verbatim: diabetic fatigue). The outcome of the fatigue was not reported.   It was unknown if the reporter considered the fatigue to be related to Arexvy.     It was unknown if the company considered the fatigue to be related to Arexvy.   Additional Information: GSK receipt date: 01-MAR-2024 This case was reported by a patient via interactive digital media. The patient had diabetic fatigue day after shot non stop since rising in am. The follow-up could not be possible as no contact details were available.
Age: 1.75
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/no PQC; HBP called to report VARIVAX was given after possibly experiencing a temperature excursion.; This spontaneous report has been received from a Physician, referring a 21-month-old female patient.   The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.  On 04-JAN-2024, she was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection as prophylaxis (strength, dose, route and anatomical location of administration, lot # and expiration date were not provided) after possibly experiencing a temperature excursion (product storage error). The reported did no provided details of the excursion; thus, the temperature, time frame and if there was a previous temperature excursion was unknown. No additional adverse event (AE) or product quality complaints (PQC) were reported (no adverse event).   Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Pain
Clinical narrative: pain; joint pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain 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 pain (Verbatim: pain) and joint pain (Verbatim: joint pain). The outcome of the pain and joint pain were not reported.   It was unknown if the reporter considered the pain and joint pain to be related to Arexvy.     It was unknown if the company considered the pain and joint pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-MAR-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient asked, could he/she take a pain reliever (Tylenol) for the pain or joint pain side effects.
Sex: U
Vaccine: RSV
Symptoms: Fatigue, Injection site mass, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: big lump at injection site; big lump at injection site, warm too touch; big lump at injection site, sore; big lump at injection site, itchy; tiredness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site lump 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 lump (Verbatim: big lump at injection site), injection site warmth (Verbatim: big lump at injection site, warm too touch), injection site pain (Verbatim: big lump at injection site, sore), injection site itching (Verbatim: big lump at injection site, itchy) and tiredness (Verbatim: tiredness). The outcome of the injection site lump, injection site warmth, injection site pain, injection site itching and tiredness were not reported.   It was unknown if the reporter considered the injection site lump, injection site warmth, injection site pain, injection site itching and tiredness to be related to Arexvy.     It was unknown if the company considered the injection site lump, injection site warmth, injection site pain, injection site itching and tiredness to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-MAR-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient had a big lump at injection site, warm too touch, sore, itchy and tiredness.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: only diluent component of Shingrix administered; only diluent component of Shingrix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 5DM77, expiry date 11-DEC-2025) for prophylaxis.   On 26-FEB-2024, the patient received the 1st dose of Shingrix. On 26-FEB-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: only diluent component of Shingrix administered) and inappropriate dose of vaccine administered (Verbatim: only diluent component of Shingrix administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 28-FEB-2024 The reporter was the Other Health Professional. The reporter reported that the patient had received Shingrix vaccine but not properly reconstituted, they only administered diluent component. which led to, Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The reporter consented to the follow up.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: Rotarix expired dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 9742M, expiry date 25-FEB-2024) for prophylaxis.   On 28-FEB-2024, the patient received Rotarix lyophilized formulation. On 28-FEB-2024, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced expired vaccine used (Verbatim: Rotarix expired dose administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-FEB-2024 The nurse reported that a patient received today (on the day of reporting) an expired dose of Rotarix (Lyophilized for reconstitution), which led to an expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Possible late 2nd dose; This non-serious case was reported by a physician via sales rep and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of shingrix on an unknown date).   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 long (Verbatim: Possible late 2nd dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 28-FEB-2024 The physician requested information on 2nd Shingrix dose efficacy administered after 6th months. The patient received 2nd dose of Shingrix delayed than the recommended interval, which led to lengthening of vaccination schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Product supply issue
Clinical narrative: Shingrix supply and demand issue back then/patient forgot the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of product supply issue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose of Shingrix 4 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced product supply issue (Verbatim: Shingrix supply and demand issue back then/patient forgot the second dose). The outcome of the product supply issue was unknown.   Additional Information: GSK Receipt Date: 28-FEB-2024 The pharmacist inquired, should the patient restart the Shingrix series. The registered pharmacist reported a patient received the first dose of Shingrix 4 years ago due to the supply and demand issue back then, the patient forgot the second dose but came back in today (on the day of reporting) to get the Shingrix second dose. The pharmacist administered second dose today (on the day of reporting) in the left deltoid.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pyrexia, Rash
Clinical narrative: pain; fever; rash; outbreak of shingles; This non-serious case was reported by a nurse via call center representative and described the occurrence of shingles in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 3N743, expiry date 20-AUG-2024) for prophylaxis.   On 20-FEB-2024, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). In FEB-2024, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: outbreak of shingles). On 21-FEB-2024, the patient experienced pain (Verbatim: pain), fever (Verbatim: fever) and rash (Verbatim: rash). The outcome of the shingles, pain and rash were not resolved and the outcome of the fever was resolved.   It was unknown if the reporter considered the shingles, pain, fever and rash to be related to Shingrix.     It was unknown if the company considered the shingles, pain, fever and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-FEB-2024 A nurse reported that a patient received her 1st dose of Shingrix and experienced rash, fever, and pain on the evening of 21st February 2024.  On the day of reporting, the patient was seen and it was confirmed that she had an outbreak of shingles. The patient no longer had fever but still experiencing rash and pain at the day of reporting. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Rash
Clinical narrative: Incomplete course of vaccination; She has now developed shingles rash on the left side; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 03-OCT-2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 25-FEB-2024, 510 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: She has now developed shingles rash on the left side). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Incomplete course of vaccination). The patient was treated with acrivastine (Benadryl), cortisone and aciclovir (Acyclovir). The outcome of the shingles was not resolved and the outcome of the incomplete course of vaccination 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: 28-FEB-2024. The patient initially received the first dose of Shingrix but then procrastinated and never received the second dose. Subsequently, she developed now (at the time of reporting) shingles rash on the left side of her body, described it as approximately the size of a half-dollar coin on her back, along her arm and armpit, and slightly on the front of her breast - all confined to the left side. On February 27, 2024, the patient sought urgent care and began using topical Benadryl, oral cortisone, and acyclovir, but the rash had not yet resolved. Additionally, the patient mentioned that she did not have the lot number for the first dose. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter had given consent to follow-up directly with her.
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix was administered to a 6-month-old patient.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received DTPa-IPV (Kinrix) (batch number mz379, expiry date 25-JAN-2025) for prophylaxis.   On 28-FEB-2024, the patient received Kinrix. On 28-FEB-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 6-month-old patient.). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA receipt date: 28-FEB-2024 The reporter reported that a 6-month-old patient received Kinrix on the day of reporting, which led to inappropriate age at vaccine administration.  The reporter consented to the follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient did not recived 2nd dose yet; This non-serious case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix in 2018).   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 incomplete course of vaccination (Verbatim: patient did not recived 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 29-FEB-2024 The reporter asked that they should restart the series (get both shots of Shingrix) or just complete the series (get one dose of Shingrix). Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No more information was provided.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix-B was administered to a patient after the expiration date; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number SB9RH, expiry date 21-JAN-2024) for prophylaxis.   On 27-FEB-2024, the patient received the 2nd dose of Engerix B. On 27-FEB-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B was administered to a patient after the expiration date). 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: 29-FEB-2024 The certified medical assistant stated that the Engerix-B was administered to a patient after the expiration date, which lead to expired vaccine used. The vaccine administration facility was the same as primary reporter.  The lot number did not pull up as a valid number in the batch finder in SF, but it was repeated back to healthcare professional. The healthcare professional declined to provide patient information and declined follow up.
Age: 0.83
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Havrix being administered to a 10 month old baby today; 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 10-month-old female patient who received HAV (Havrix) (batch number L9R92, expiry date 26-SEP-2025) for prophylaxis.   On 29-FEB-2024, the patient received Havrix. On 29-FEB-2024, an unknown time after receiving Havrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Havrix being administered to a 10 month old baby today). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-FEB-2024 The 10-months-old received Havrix vaccine on the day of reporting which led to an inappropriate age at vaccine administration. The medical assistant requested for information regarding side effects and any important considerations she needs to know before reaching out to the patient's parents. The vaccine administration facility was the same as primary reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I got the vaccine 6 yrs ago but just 1 dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 6 years ago prior to the reporting).   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: I got the vaccine 6 yrs ago but just 1 dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-Feb-2024 The patient reported that he or she received 1 dose of Shingrix vaccine 6 years ago so he or she wanted to know do he or she need to restart the 2 dose series again. The patient did not know if he or she need to get just 1 more dose or if he or she had to do 2 doses again. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. Follow-up would not possible as no contact details were available.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: 2 adjuvant vials were administered to a patient as one dose of Arexvy; 2 adjuvant vials were administered to a patient as one dose of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2KJ34, expiry date 03-JUL-2025) for prophylaxis.   On 17-FEB-2024, the patient received Arexvy (injection, left deltoid). On 17-FEB-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: 2 adjuvant vials were administered to a patient as one dose of Arexvy) and inappropriate dose of vaccine administered (Verbatim: 2 adjuvant vials were administered to a patient as one dose of Arexvy). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 01-MAR-2024 The pharmacist reported that 2 adjuvant vials were administered to a patient as one dose of Arexvy which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The pharmacist stated that the patient had not been notified at that time.  Patient was not administered a dose of Arexvy after having 2 adjuvants administered. The reporter consented to follow up.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Intercepted product preparation error, Liquid product physical issue, Product quality issue
Clinical narrative: warming it up and shaking it a bit, it became normal/discarded the weird one; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted product preparation error in a patient who received DTPa-HBV-IPV (Pediarix) (batch number 7592L, expiry date 12-MAR-2024) for prophylaxis.   On an unknown date, the patient received Pediarix. In MAR-2024, an unknown time after receiving Pediarix, the patient experienced intercepted product preparation error (Verbatim: warming it up and shaking it a bit, it became normal/discarded the weird one). The outcome of the intercepted product preparation error 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: 01-MAR-2024 and 02-MAR-2024 The reporter sent an email saying the following that they pulled out a Pediarix prefilled syringe and it looked a little funny.  Usually, there was an inconsistent cloudiness that turned into a uniform foggy white color when you shake it a bit.  This time, the vaccine was completely clear with all the white stuff settled at the bottom but after warming it up and shaking it a bit, it became normal and they had discarded the weird one, which led to intercepted product preparation error. PQC (product quality complaint) unrelated to HIS (health safety information).
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: 46 years old who was given a pediatric dose of engerix b; 46 years old who was given a pediatric dose of engerix b; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 46-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: 46 years old who was given a pediatric dose of engerix b) and underdose (Verbatim: 46 years old who was given a pediatric dose of engerix b). The outcome of the adult use of a child product and underdose were unknown.   Additional Information: RA Receipt Date: 01-MAR-2024 The reporter stated 46 years old was given a pediatric dose of Engerix b and when she presented for her second dose, they gave her the adult dose. The reporter shared with her that they thought she would have to get 2 more adult doses to complete her series.  The reporter wants to know if they were correct that she needs 2 additional doses or would the pediatric dose be effective. No other details available.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: due to Covid-19 pandemic her mother did not take the second shot until the end of 2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of social problem in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix by the end of 2019).   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 social problem (Verbatim: due to Covid-19 pandemic her mother did not take the second shot until the end of 2023). The outcome of the social problem was unknown.   Additional Information: GSK receipt date: 01-MAR-2024 The reporter was the son of the patient who stated his mother received first dose of Shingrix by the end of 2019, due to Covid-19 pandemic her mother did not take the second shot until the end of 2023, 4 years later, to complete the series. The reporter did not consent to follow-up.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Boostrix stored at -2.8C x 50 minutes; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 26-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number P5SR5, expiry date 26-APR-2026) for prophylaxis.   On 28-FEB-2024, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Boostrix stored at -2.8C x 50 minutes). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 01-MAR-2024  A medical assistant reported to request stability data for Boostrix stored at minus 2.8 degree Celsius for 50 minutes and administered to 5 different patient which led to incorrect storage of drug.  The reporter consented to follow up. This was 1 of 5 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2024027788:Different patient US-GSK-US2024027789:Different patient US-GSK-US2024027790:Different patient US-GSK-US2024027791:Different patient
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Boostrix stored at minus 2.8 degree Celsius for 50 minutes & administered to 5 different patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 22-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number P5SR5, expiry date 26-APR-2026) for prophylaxis.   On 28-FEB-2024, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Boostrix stored at minus 2.8 degree Celsius for 50 minutes & administered to 5 different patient). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 01-MAR-2024  A medical assistant reported to request stability data for Boostrix stored at minus 2.8 degree Celsius for 50 minutes and administered to 5 different patient which led to incorrect storage of drug.  The reporter consented to follow up. This is 2 of 5 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2024027787:Different patient US-GSK-US2024027789:Different patient US-GSK-US2024027790:Different patient US-GSK-US2024027791:Diffrent patient
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Fatigue, Insomnia
Clinical narrative: burning from her head to toes, like her body was on fire; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of burning sensation in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number DN75X, expiry date 15-SEP-2025) for prophylaxis.   Concurrent medical conditions included chronic lymphocytic leukemia.   On 04-NOV-2023, the patient received the 1st dose of Shingrix (left arm). On 04-NOV-2023, less than a day after receiving Shingrix, the patient experienced burning sensation (Verbatim: burning from her head to toes, like her body was on fire). The outcome of the burning sensation was resolved.   It was unknown if the reporter considered the burning sensation to be related to Shingrix.     It was unknown if the company considered the burning sensation to be related to Shingrix.   Additional Information: GSK Receipt date: 04-MAR-2024 and 05-MAR-2024 The reporter reported that the patient came in for the second dose of Shingrix dose, and reported that after her first dose for 4 hours straight she felt like she was burning from her head to toes, like her body was on fire. The patient was on treatment for leukemia, and was not sure if this would contribute to this side effect. At the time of reporting, a second dose had not been administered. The vaccine administration facility was the same as primary reporter. Upon call back to health care provider, she clarified that the patient was up all night with the burning and lasted more than 4 hours but unsure exactly how long. The patient was administered Shingrix at 10 ante meridiem and then by 10 post meridiem the symptoms started and lasted through the night. Patient finally go to sleep and by morning the symptoms was gone but she felt wiped out, probably because of being up all night. The health care provider also mentioned patient had chronic lymphocytic leukemia and was not on treatment at the time. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: The plain adjuvant suspension only was administered to a patient; The plain adjuvant suspension only was administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication 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 inappropriate preparation of medication (Verbatim: The plain adjuvant suspension only was administered to a patient) and inappropriate dose of vaccine administered (Verbatim: The plain adjuvant suspension only was administered to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 04-Mar-2024 The reporter had a nursing facility that we sent a Shingrix vaccine to that did not mix the powder with the adjuvant. The reporter asked was there something else that can be mixed with the antigen so they do not had to waste it  The reporter stated that they just gave the diluent without mixing the powder with it.  The reporter wanted to know was there something else like normal saline or sterile water that can be mixed with the powder so they are not out the cost of the screw up. The plain adjuvant suspension only was administered to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Injury
Clinical narrative: RUINED SO MANY LIVES INCLUDING HER MOTHER; INJURIES; -This spontaneous report received from a consumer via J&J managed social media site concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. we are unable to perform follow up to request batch/lot numbers.  No concomitant medications were reported.  This user shared complaints about injuries received from vaccines, and claimed the vaccine 'ruined' her mother's life. Exact text: "I hope you take all your earnings from this and help out all the C vaccine injured with it. You have ruined so many lives including my mother's".(dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injuries and ruined so many lives including her mother was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Adverse event; The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.