chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Medical assistant called to report an excursion.; This spontaneous report was received from a medical assistant, referring to a patient of unknown gender and age. The patient's medical history, concurrent condition and concomitant therapies were not reported.  On 09-APR-2024, the patient was administered of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, lot # X017486 has been verified to be a valid lot number, expiration date reported and validated as 25-JUN-2025 for prophylaxis (strength, dose, frequency, and route of administration were not provided), after undergoing a temperature excursion (product storage error). Temperature excursion was as following: the vaccine was stored under 7.9 Fahrenheit (F)/6 F up to 14 F for 38 minutes. Previous temperature excursion included 6.3 F / 6 F to 14 F for 13 hours. No additional adverse event (AE)/ product quality concern (PQC) was reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2404USA007180:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Medical assistant called to report an excursion.; This spontaneous report was received from a medical assistant, referring to a patient of unknown gender and age. The patient's medical history, concurrent condition and concomitant therapies were not reported.  On 12-APR-2024, the patient was administered of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) injection, lot # W036940 has been verified to be a valid lot number, expiration date reported and validated as 19-MAY-2024 for prophylaxis (strength, dose, frequency, and route of administration were not provided), after undergoing a temperature excursion (product storage error). Temperature excursion was as following: the vaccine was stored under 7.9 Fahrenheit (F)/6 F up to 14 F for 38 minutes. Previous temperature excursion included 6.3 F / 6 F to 14 F for 13 hours. No additional adverse event (AE)/ product quality concern (PQC) was reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2404USA007180:
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Cough, Influenza like illness, Nasopharyngitis, Nausea
Clinical narrative: bad head cold; sinus congestion; felt weak; felt weak and achy; sore throat; coughing; some nausea; feeling like she had the flu; This spontaneous report was received from a consumer and refers to a 40-year-old female patient. Her medical history, concurrent conditions and concomitant therapies were not provided.  On 03-MAY-2024, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered as Human papillomavirus (HPV) prevention (anatomical location, strength, lot #, expiry date, and route of administration were not provided).  On the same day at evening, after getting the vaccine, she felt the side effects of a bad head cold, she had sinus congestion, felt weak and achy, had sore throat, coughing and some nausea. The patient described her experience as feeling like she had a flu. She woke up the next day feeling the same. She took a Covid test and result came back negative. The patient was still experiencing reported symptoms at the time of report (not recovered).  The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Oropharyngeal pain, Pain, SARS-CoV-2 test negative, Sinus congestion
Clinical narrative: bad head cold; sinus congestion; felt weak; felt weak and achy; sore throat; coughing; some nausea; feeling like she had the flu; This spontaneous report was received from a consumer and refers to a 40-year-old female patient. Her medical history, concurrent conditions and concomitant therapies were not provided.  On 03-MAY-2024, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered as Human papillomavirus (HPV) prevention (anatomical location, strength, lot #, expiry date, and route of administration were not provided).  On the same day at evening, after getting the vaccine, she felt the side effects of a bad head cold, she had sinus congestion, felt weak and achy, had sore throat, coughing and some nausea. The patient described her experience as feeling like she had a flu. She woke up the next day feeling the same. She took a Covid test and result came back negative. The patient was still experiencing reported symptoms at the time of report (not recovered).  The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional AE; receiving her first two doses of GARDASIL 9 on schedule in 2022 but did not receive her third dose of GARDASIL 9 until April 2024; This spontaneous report has been received from a 30-year-old female patient, referring to herself. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not reported.  On unknown dates in 2022, the patient was vaccinated on schedule with the first and second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot# and expiry date were not reported) for prophylaxis. On an unknown date in April 2024, she received the 3rd dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). No additional adverse events were reported (no adverse event).  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Caller reported expired dose of VAQTA was administered.  No additional information provided.  No additional AEs or PQC reported.; Caller reported expired dose of VAQTA was administered.  No additional information provided.  No additional AEs or PQC reported.; This spontaneous report was received from a medical assistance and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-MAY-2024, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot #1966107, (expiration date: 06-FEB-2024), administered intramuscularly for prophylaxis (strength and anatomical location were not provided) (Expired product administered). No additional information provided. No additional adverse events (AEs) (No adverse event) or product quality complaint (PQC) reported.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: Injection site pain; fatigue; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In JAN-2021, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain) and fatigue (Verbatim: fatigue). The outcome of the injection site pain and fatigue were resolved.   The reporter considered the injection site pain and fatigue to be related to Shingrix.     The company considered the injection site pain and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-APR-2024 Reporter reported that the patient experiencing side effects when vaccinated with Shingrix. After vaccination patient had injection site pain and fatigue. Reporter reporting as required even though incident was more than 3 years ago from reporting day. The reporter requested to consent to follow-up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I was administered two vaccinations, with two weeks in between.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Varicella zoster vaccine for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Varicella zoster vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced drug dose administration interval too short (Verbatim: I was administered two vaccinations, with two weeks in between.). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 29-Apr-2024 This case was reported by a patient via interactive digital media. The patient received two doses of Shingles vaccination with two weeks interval between. The patient received 2nd dose of Shingles vaccine, early than the recommended interval, which led to shortening of vaccination schedule. The reporter did not consent to follow up.
Sex: U
Vaccine: RSV
Symptoms: Fatigue, Headache, Injection site pain, Injection site reaction, Muscle swelling
Clinical narrative: muscle at the site is swollen; the muscle at the site is swollen & painful; fatigue; headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling 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 swelling (Verbatim: muscle at the site is swollen), injection site pain (Verbatim: the muscle at the site is swollen & painful), fatigue (Verbatim: fatigue) and headache (Verbatim: headache). The outcome of the injection site swelling, injection site pain, fatigue and headache were not reported.   It was unknown if the reporter considered the injection site swelling, injection site pain, fatigue and headache to be related to Arexvy.     It was unknown if the company considered the injection site swelling, injection site pain, fatigue and headache to be related to Arexvy.   Additional Information: GSK Receipt Date: 27-APR-2024 The case was received from the patient via interactive digital media. The reporter reported that the patient had experienced since vaccination, the muscle at the site was swollen & painful. The patient also had fatigue and headache. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: felt bad/felt terrible; This non-serious case was reported by a other health professional via sales rep and described the occurrence of feeling abnormal in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling abnormal (Verbatim: felt bad/felt terrible). The outcome of the feeling abnormal was resolved.   It was unknown if the reporter considered the feeling abnormal to be related to Shingrix.     It was unknown if the company considered the feeling abnormal to be related to Shingrix.   Linked case(s) involving the same patient:  US2024053262   Additional Information: GSK Receipt Date: 25-APR-2024 The patient self-reported this case. The patient felt terrible and that it lasted for 36 to 48 hours. The patient felt bad after shots and never worse after second dose in series. It was unknown if patient was taking other medications. The reporter consented to follow-up. This case had been linked with the case US2024053262, reported by same reporter.; Sender's Comments:  US-GSK-US2024053262:Case created for 1 st dose
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: Device issue, Incorrect dose administered, Needle issue, Product complaint
Clinical narrative: Product Complaint; vaccines were administered partially to 2 different infant patients; the needle detached during the administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 4-month-old male patient who received Hib (Hiberix) (batch number Y24T9, expiry date 14-MAR-2026) for prophylaxis. This case was associated with a product complaint.   On 17-APR-2024, the patient received Hiberix. On 17-APR-2024, an unknown time after receiving Hiberix, the patient experienced incomplete dose administered (Verbatim: vaccines were administered partially to 2 different infant patients) and needle issue (Verbatim: the needle detached during the administration). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the incomplete dose administered, needle issue and pharmaceutical product complaint 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: 19-APR-2024  A pediatric office manager reported that they had issues with some prefilled syringes for Hiberix.  According to the reporter the issue happened to 8 prefilled syringes, the defect was discovered after the reconstitution and in all cases vaccine were administered.  The reporter stated that it was difficult to attach the needle to the luer lock device, and when was finally attached, the needle in all cases were loose.  The reporter reported that the vaccine was administered partially to the patient (infant patient), the needle detached during the administration, missing part of the vaccine which led to incomplete dose administered and needle issue. According to reporter, all syringes and needles were discarded.  The office manager stated that they have another sealed box (10 doses) in the refrigerator and the physician of the practice was concerned about it since it's the same lot that the 8 doses affected and does not want to administer them to her patient.  The reporter reported, the used luer lock needle, the boxes were not damaged and she was not sure about what needle size was used since she was not the preparer. According to the reporter the doctor was well trained and she was the one who informed her about the faulty syringes.  Credit for 12 doses was pending since reporter had no information regarding wholesaler.  The case was linked with case US2024050708, reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2024050708:another patient
Sex: U
Vaccine: HIBV
Symptoms: Accidental underdose, Incorrect dose administered, Product complaint, Syringe issue, Underdose
Clinical narrative: Unknown number of patients may have received partial doses (related AE-underdose); there was leakage from Hiberix prefilled syringes during administration; Product complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in an unspecified number of patients who received Hib (Hiberix) (batch number 2A95F) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced accidental underdose (Verbatim: Unknown number of patients may have received partial doses (related AE-underdose)), syringe leak (Verbatim: there was leakage from Hiberix prefilled syringes during administration) and pharmaceutical product complaint (Verbatim: Product complaint). The outcome of the accidental underdose, syringe leak and pharmaceutical product complaint 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: 19-APR-2024 The nurse reported that, he had received notifications indicating that during the administration of Hiberix prefilled syringes some liquid leaked from the stopper part of the syringe.  They are not sure if patients have gotten the complete dose of Hiberix.  The nurse mentioned that they do not know how many patients had received an incomplete dose.  The nurse reported, but it seems that only prefilled syringes from lot number 2A95F present this issue. The nurse who received several reports from different offices that there was leakage from Hiberix prefilled syringes during administration. Unknown number of patients might have received partial doses, which led to accidental underdose. The reporter did not know the exact number of doses affected. He could not answer product complaint questions since he did not prepare doses. He would have specific offices call with more information.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Accidental exposure to product, Device issue, Device loosening, Exposure via skin contact, Injury associated with device
Clinical narrative: Product Complaint; Skin Exposure; Needle stuck in left leg; Once the medication was being pushed in the infants leg it splattered all over the infant's leg; This non-serious case was reported by a consumer via call center representative and described the occurrence of exposure via skin contact in a 15-month-old male patient who received Hib (Hiberix) (batch number EDP92, expiry date 30-SEP-2025) for prophylaxis. This case was associated with a product complaint.   On 06-NOV-2023, the patient received Hiberix (intramuscular, left thigh). On 06-NOV-2023, an unknown time after receiving Hiberix, the patient experienced exposure via skin contact (Verbatim: Skin Exposure), needle stick/puncture (Verbatim: Needle stuck in left leg) and inadvertent exposure to vaccine (Verbatim: Once the medication was being pushed in the infants leg it splattered all over the infant's leg). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the exposure via skin contact, needle stick/puncture, inadvertent exposure to vaccine and pharmaceutical product complaint 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: 23-APR-2024 The nurse was reported when administering dose the entire luer lock adapter and attached needle pop off the end of prefilled syringe. . The Hiberix vaccine was given to an patient when the needle popped off and stuck in the patient left leg.  The medication was being pushed in the patient leg it splattered all over the patient leg, which led to exposure via skin contact and inadvertent exposure to vaccine. After confirmation that all operation were performed appropriately before defect was discovered. The defect was discovered during the administration. The mixing/shaking was by gently shaking. The vial held upside-down when the vaccine was being withdrawn. The dose was administered to patients, however, the neck with the needle came off and stuck in each patient left thigh. The healthcare professional was all experienced user. The luer lock adapter was the component impacted. The Jelco safety needle 25G 5/8" luer lock was used needle. The no defect or damage on the syringe noticed. The cap was screwed off. The needle was screwed on the luer lock device. The problem was not detected when screwing the needle on, did the customer continue to attempt to screw it on. The needle used which was not available it was placed in the sharp's container. The vaccine administration facility was the same as primary reporter. The reporter also mentioned that the plunger was also loose when attempting to push the medication lot 5347Z. The part of rod was loose. The defect was related to plunger rod. The plunger loose and fell out completely during the administration.  The reporter consent to follow up.; Sender's Comments:  US-GSK-US2024052018:AE 2/2 different infant
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Product complaint
Clinical narrative: Product Complaint; Skin Exposure; Needle stuck in left leg; Once the medication was being pushed in the infants leg it splattered all over the infant's leg; This non-serious case was reported by a consumer via call center representative and described the occurrence of exposure via skin contact in a 15-month-old male patient who received Hib (Hiberix) (batch number EDP92, expiry date 30-SEP-2025) for prophylaxis. This case was associated with a product complaint.   On 06-NOV-2023, the patient received Hiberix (intramuscular, left thigh). On 06-NOV-2023, an unknown time after receiving Hiberix, the patient experienced exposure via skin contact (Verbatim: Skin Exposure), needle stick/puncture (Verbatim: Needle stuck in left leg) and inadvertent exposure to vaccine (Verbatim: Once the medication was being pushed in the infants leg it splattered all over the infant's leg). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the exposure via skin contact, needle stick/puncture, inadvertent exposure to vaccine and pharmaceutical product complaint 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: 23-APR-2024 The nurse was reported when administering dose the entire luer lock adapter and attached needle pop off the end of prefilled syringe. . The Hiberix vaccine was given to an patient when the needle popped off and stuck in the patient left leg.  The medication was being pushed in the patient leg it splattered all over the patient leg, which led to exposure via skin contact and inadvertent exposure to vaccine. After confirmation that all operation were performed appropriately before defect was discovered. The defect was discovered during the administration. The mixing/shaking was by gently shaking. The vial held upside-down when the vaccine was being withdrawn. The dose was administered to patients, however, the neck with the needle came off and stuck in each patient left thigh. The healthcare professional was all experienced user. The luer lock adapter was the component impacted. The Jelco safety needle 25G 5/8" luer lock was used needle. The no defect or damage on the syringe noticed. The cap was screwed off. The needle was screwed on the luer lock device. The problem was not detected when screwing the needle on, did the customer continue to attempt to screw it on. The needle used which was not available it was placed in the sharp's container. The vaccine administration facility was the same as primary reporter. The reporter also mentioned that the plunger was also loose when attempting to push the medication lot 5347Z. The part of rod was loose. The defect was related to plunger rod. The plunger loose and fell out completely during the administration.  The reporter consent to follow up.; Sender's Comments:  US-GSK-US2024052018:AE 2/2 different infant
Sex: F
Vaccine: HPV9
Symptoms: Injection site discomfort, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Experienced swelling discomfort pruritis at site of injection.; Experienced swelling discomfort pruritis at site of injection.; Experienced swelling discomfort pruritis at site of injection.; HCP reports that on 5/2/24 the pain and bump is still present; Bump; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 03-APR-2024, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #X025115, which had been confirmed to be a valid lot number, expiration date reported and confirmed as 19-MAY-2026, administered for prophylaxis by a health care professional (strength, route of administration, and anatomical location were not provided).  On 10-APR-2024, the patient experienced swelling (vaccination site swelling), discomfort (vaccination site discomfort), and pruritis (vaccination site pruritus) at site of injection. On an unknown date in 2024, the patient developed a bump (injection site mass) and pain, which were still present on 02-MAY-2024, however improving daily. At the time of reporting, the outcome of the events of vaccination site swelling, vaccination site discomfort, and vaccination site pruritus was not provided, while of the events of pain and injection site mass was considered as recovering. It was mentioned that health care professional (HCP) was asking for guidance on whether second dose should be delayed. No other information provided.  The causal relationship between the suspect vaccine and the events was not provided.
Age: 12.0
Sex: U
Vaccine: MNQ, MNQ
Symptoms: Extra dose administered
Clinical narrative: received 3rd dose at 12 years old in Feb-2019; received 2nd dose at 12 years old in Dec-2018; This non-serious case was reported by a physician via sales rep and described the occurrence of extra dose administered in a 17-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (received 1st dose in April 2018 at 11 years of age).   In FEB-2019, the patient received the 3rd dose of Menveo. In DEC-2018, the patient received the 2nd dose of Menveo. In DEC-2018, not applicable after receiving Menveo and an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: received 2nd dose at 12 years old in Dec-2018). In FEB-2019, the patient experienced extra dose administered (Verbatim: received 3rd dose at 12 years old in Feb-2019). The outcome of the extra dose administered and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 26-APR-2024 The physician reporter that the patient received 2nd dose and 3rd dose of Menveo vaccine, which led to extra dose administered.  The reporter asked if she should give a patient a dose of Menveo at 17 years old if they were given the following doses on the following days.  This was a new patient to her and she was reviewing system and noticed the following doses had been given.  She said the patient to her knowledge did not had any condition that would warrant this many doses of an MCV4.
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pain in extremity, Pruritus
Clinical narrative: Rash; Itchy Hives; Aches/injected arm was also sore; Shivering; Flu like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included cefuroxime axetil (Ceftin) for product used for unknown indication.   On 18-APR-2024, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Ceftin. In APR-2024, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: Aches/injected arm was also sore), shivering (Verbatim: Shivering), influenza-like symptoms (Verbatim: Flu like symptoms) and hives (Verbatim: Itchy Hives). On 25-APR-2024, the patient experienced rash (Verbatim: Rash). The action taken with Ceftin was unknown. The outcome of the pain, shivering and influenza-like symptoms were resolved (duration 2 days) and the outcome of the hives was unknown and the outcome of the rash was not resolved.   It was unknown if the reporter considered the pain, shivering, influenza-like symptoms, hives and rash to be related to Shingrix.     It was unknown if the company considered the pain, shivering, influenza-like symptoms, hives and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-APR-2024 This case was reported by patient itself. The patient experienced Flu like symptoms, shivering, and aches which lasted about 2 days.  The injected arm was also sore. The patient began to experience a rash on her chest. The rash was not pronounced and not itchy.  The patient treats the rash with cortisone cream.  The reporter states that she experienced itchy hives from ceftin.  The hives started about a week after taking ceftin and took a long time to go away. The reporter did not consent to follow-up.
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Rash; Itchy Hives; Aches/injected arm was also sore; Shivering; Flu like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included cefuroxime axetil (Ceftin) for product used for unknown indication.   On 18-APR-2024, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Ceftin. In APR-2024, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: Aches/injected arm was also sore), shivering (Verbatim: Shivering), influenza-like symptoms (Verbatim: Flu like symptoms) and hives (Verbatim: Itchy Hives). On 25-APR-2024, the patient experienced rash (Verbatim: Rash). The action taken with Ceftin was unknown. The outcome of the pain, shivering and influenza-like symptoms were resolved (duration 2 days) and the outcome of the hives was unknown and the outcome of the rash was not resolved.   It was unknown if the reporter considered the pain, shivering, influenza-like symptoms, hives and rash to be related to Shingrix.     It was unknown if the company considered the pain, shivering, influenza-like symptoms, hives and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-APR-2024 This case was reported by patient itself. The patient experienced Flu like symptoms, shivering, and aches which lasted about 2 days.  The injected arm was also sore. The patient began to experience a rash on her chest. The rash was not pronounced and not itchy.  The patient treats the rash with cortisone cream.  The reporter states that she experienced itchy hives from ceftin.  The hives started about a week after taking ceftin and took a long time to go away. The reporter did not consent to follow-up.
Sex: M
Vaccine: RSV
Symptoms: Asthenia, Lethargy, Malaise, Myalgia
Clinical narrative: malaise; lethargy; muscle pain; reduced muscle strength; This non-serious case was reported by a consumer via call center representative and described the occurrence of malaise in a elderly male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In JAN-2024, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced malaise (Verbatim: malaise), lethargy (Verbatim: lethargy), muscle pain (Verbatim: muscle pain) and muscle strength abnormal (Verbatim: reduced muscle strength). The outcome of the malaise, lethargy, muscle pain and muscle strength abnormal were resolving.   It was unknown if the reporter considered the malaise, lethargy, muscle pain and muscle strength abnormal to be related to Arexvy.     It was unknown if the company considered the malaise, lethargy, muscle pain and muscle strength abnormal to be related to Arexvy.   Additional Information: GSK Receipt Date: 29-APR-2024 The reporter self reported this case. The patient was in late 70s. He reported that he had received the Arexvy vaccine about 3 months prior and experienced malaise, lethargy, muscle pain, and reduction in muscle strength. The reporter stated that at the time of reporting he was recovering and feeling better after 3 months. He did not want to provide any information.  Spoken as per content and referred to the health care professional. The case was linked with case US2024054872, reported by the same reporter fir his wife.; Sender's Comments:  US-GSK-US2024054872:wife case
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient who hasn't had a Shingrix shot since 2020 and he was confirming they just needed to give the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2020).   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: patient who hasn't had a Shingrix shot since 2020 and he was confirming they just needed to give the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-APR-2024 The pharmacist states they had a patient who has not had a Shingrix shot since 2020 and he was confirming they just needed to give the 2nd dose and that they did not need to restart the series (how to proceed if a patient was late for their second dose). Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Lethargy, Malaise, Myalgia
Clinical narrative: malaise; lethargy; muscle pain; reduction in muscle strength; This non-serious case was reported by a consumer via call center representative and described the occurrence of malaise in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In JAN-2024, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced malaise (Verbatim: malaise), lethargy (Verbatim: lethargy), muscle pain (Verbatim: muscle pain) and muscle weakness (Verbatim: reduction in muscle strength). The outcome of the malaise, lethargy, muscle pain and muscle weakness were resolving.   It was unknown if the reporter considered the malaise, lethargy, muscle pain and muscle weakness to be related to Arexvy.     It was unknown if the company considered the malaise, lethargy, muscle pain and muscle weakness to be related to Arexvy.   Additional Information: GSK Receipt Date: 29-APR-2024 The reporter was the husband of the patient. The patient was in her late 70s. He reported that his wife (patient) had received the Arexvy vaccine about 3 months (from the date of reporting) and experienced malaise, lethargy, muscle pain, and reduction in muscle strength in 2024. The reporter stated that at the time of reporting the patient was recovering and feeling better after 3 months. He did not want to provide any information.  The case was linked with case US2024054871, reported by the same reporter for himself.; Sender's Comments:  US-GSK-US2024054871:Male patient case
Age: 44.0
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age, Product prescribing issue
Clinical narrative: Bexsero - Inappropriate age; 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 44-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 27-MAR-2024, the patient received the 1st dose of Bexsero. On 27-MAR-2024, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Bexsero - Inappropriate age). 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-APR-2024: The nurse called to ask for information about a 44 year-old patient who was exposed to meningitis. The physician prescribed a dose of Menveo and Bexsero to this patient and vaccines were administered. The Bexsero vaccine administered at non recommended age, which led to inappropriate age at vaccine administration. The nurse´s notes indicates that patient has been schedule for the second dose of meningitis vaccine in May. The health care professional asked which vaccine should be administered in May, just Bexsero or both Menveo and Bexsero? The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: She had dose 1 Shingrix about 1.5 to 2 years ago. She states she moved in that time and never received dose 2.; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about 1.5 to 2 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: She had dose 1 Shingrix about 1.5 to 2 years ago. She states she moved in that time and never received dose 2.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-Apr-2024 The reporter reported that she received 1st dose of Shingrix vaccine about 1.5 to 2 years ago.  The reporter stated that she moved in that time and never received second dose.  The reporter asked if she had to start the series over again. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Second dose not yet given as of time of call; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose two years ago on 24th July 2022 from lot number 95G27 and expiry date 10th September 2023).   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: Second dose not yet given as of time of call). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-APR-2024 The second dose of Shingrix was not yet given as of time of call.  No further details were provided. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This US2024054899 case has been linked to the case reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2024054899:same reporter/ Different patient
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug ineffective, Herpes zoster
Clinical narrative: receiving prescriptions for shingles (lack of effect); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) (batch number 2f9c5, expiry date 18-APR-2026) for prophylaxis.   On 16-APR-2024, the patient received the 1st dose of Shingrix (left arm). In APR-2024, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: receiving prescriptions for shingles (lack of effect)). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-APR-2024 The heath care professional called to report regarding administering Shingrix vaccine to a patient. The reporter reported that on the day of reporting, the patient was receiving prescriptions for shingles reported as lack of effect. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Injection site nodule
Clinical narrative: developed an injection site nodule; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site nodule in a 60-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 01-OCT-2023, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site nodule (Verbatim: developed an injection site nodule). The outcome of the injection site nodule was unknown.   It was unknown if the reporter considered the injection site nodule to be related to Arexvy.     It was unknown if the company considered the injection site nodule to be related to Arexvy.   Additional Information: GSK Receipt Date: 29-APR-2024 A representative called in and reported that a health care professional mentioned that a patient received a dose of Arexvy and developed an injection site nodule.  The agent did not provide any additional data beyond what was presented in the case for this particular patient but mentioned that the health care professional agreed to receive follow-up. The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: the nurses administered the Shingrix adjuvant only.; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2024, the patient received Shingrix. In APR-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: the nurses administered the Shingrix adjuvant only.) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-APR-2024 The Nursing Supervisor reported that two weeks ago, one of the nurses administered the Shingrix adjuvant only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Injection site nodule
Clinical narrative: nodule at the injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site nodule in a 60-year-old female 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 nodule (Verbatim: nodule at the injection site). The outcome of the injection site nodule was unknown.   It was unknown if the reporter considered the injection site nodule to be related to Arexvy.     It was unknown if the company considered the injection site nodule to be related to Arexvy.   Additional Information: GSK Receipt Date: 29-APR-2024 The pharmacist reported that the patient developed a nodule at the injection site of Arexvy. The reporter consent to follow up.
Age: 31.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: spleen removal/after Menveo first dose; on 4 week early 2nd dose of menveo after spleen removal; This serious case was reported by a pharmacist via call center representative and described the occurrence of splenectomy in a 31-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   Concurrent medical conditions included splenectomy.   On an unknown date, the patient received the 2nd dose of Menveo and the 1st dose of Menveo. On an unknown date, not applicable after receiving Menveo and an unknown time after receiving Menveo, the patient experienced splenectomy (Verbatim: spleen removal/after Menveo first dose) (serious criteria clinically significant/intervention required) and drug dose administration interval too short (Verbatim: on 4 week early 2nd dose of menveo after spleen removal). The outcome of the splenectomy and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the splenectomy to be related to Menveo.     It was unknown if the company considered the splenectomy to be related to Menveo.   Additional Information: GSK Receipt Date: 29-APR-2024 The patient had the spleen removed after the first dose of Menveo vaccine. On 4 weeks early 2nd dose of Menveo vaccine after spleen removal which led to shortening of vaccinations schedule. The reporter did not consent to follow up.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: patient received Menveo one vial presentation expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number J52PN, expiry date 31-MAR-2024) for prophylaxis.   On 09-APR-2024, the patient received Menveo. On 09-APR-2024, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: patient received Menveo one vial presentation expired dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 30-APR-2024 This was 1 of 3 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2024055471:another patient/ same reporter US-GSK-US2024055469:another patient/ same reporter